ML23156A126
| ML23156A126 | |
| Person / Time | |
|---|---|
| Issue date: | 04/06/1989 |
| From: | NRC/SECY |
| To: | |
| References | |
| 54FR13892, PRM-035-007, PR-035 | |
| Download: ML23156A126 (1) | |
Text
DOCUMENT DATE:
TITLE:
CASE
REFERENCE:
KEYWORD:
ADAMS Template: SECY-067 04/06/1989 PRM-035-007 and PR-035 - 54FR13892 - PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF CANCER PRM-035-007 and PR-035 54FR13892 RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete
STATUS OF RULEMAKING PROPOSED RULE:
PR-035 OPEN ITEM (Y/N) N RULE NAME:
PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF CANCER PROPOSED RULE FED REG CITE:
54FR13892 PROPOSED RULE PUBLICATION DATE:
04/06/89 ORIGINAL DATE FOR COMMENTS: 05/08/89 NUMBER OF COMMENTS:
EXTENSION DATE:
I I
1 FINAL RULE FED. REG. CITE: 54FR41819 FINAL RULE PUBLICATION DATE: 10/12/89 NOTES ON PROPOSED AND FINAL RULE SIGNED BY EDO.
ALSO SEE PETITION OF NORMA TATUS H MCELROY OH SAME SUBJECT (PRM-35-7) WHICH IS STORED WITH RULEMAKI F RULE ING FILE.
FILES LOCATED ON Pl.
TO FIND THE STAFF CONTACT OR VIEW THE RULEMAKING HISTORY PRESS PAGE DOWN KEY HISTORY OF THE RULE PART AFFECTED: PR-035 RULE TITLE:
PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF CANCER PROPOSED RULE SECY PAPER:
FINAL RULE SECY PAPER:
CONTACTl: ANTHONY TSE CONTACT2:
PROPOSED RULE SRM DATE:
FINAL RULE SRM DATE:
STAFF CONTACTS I
I I
I ON THE MAIL MAIL DATE PROPOSED RULE SIGNED BY SECRETARY:
DATE FINAL RULE SIGNED BY SECRETARY:
RULE STOP: NLS 129 PHONE:
STOP:
PHONE:
03/28/89 09/26/89 492-3797
THERAGENICS CORPORATION 430 Tenth Street, N.W., Suite N 210, Atlanta, Georgia 30318 (404) 876-4531 C 15 P2 :37 November 30, 1988 Mr. Norman McElroy Medical and Academic Section-6H3-0WFN US Nuclear Regulatory Commission Washington, DC 20555 RE:
Modifications to Title 10 Part 35.400
Dear Mr. McElroy:
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Theragenics Corporation requests that Title 10 Part 35.400 be modified as follows:
(g)
Palladium-103 as a sealed source in seeds for interstitial treatment of cancer Theragenics manufactures and markets TheraSeedN, a sealed brachytherapy source used for interstitial treatment of cancer.
In support of this request, the following documents are enclosed:
- 1.
FDA 510K approval letter.
Equivalency to Iodine-125 was the basis for approval.
- 2.
Georgia sealed source registration
- 3.
TheraSeedN product literature.
- 4.
Package insert and Dose Rate Table.
- 5.
List of Theragenics Management personnel.
Business cards are included.
Presently, TheraSeedN users must go through the cumbersome process of having their licenses amended to use the product.
Amending Part 35.400 as stated above will eliminate this cumbersome process for Qoth Theragenics and the user.
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November 30, 1988 Mr. Norman McElroy Page 2 Please call me or Julie Stephens at (404) 381-8338 if you have any questions.
Your efforts in expediting this request will be appreciated.
I look forward to working with you.
Sincerely, Howard T. Cooper Regulatory and Medical Affairs Director cc: J. Herndon
- c. Jacobs J. Carden B. Kirkland J. Stephens D. Fialkowski R
- Powers
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DEPARTMENT Of HEALTH & HUMAN SERVIC[S Public Hulth Strvic:t Hr. John L. Russell, Jr.
President lluclear Medicine, Inc.
900 Atlantic Drive, N.W.
Atlanta, Georgia 30332
Dear Mr. Russell:
- .' I I ".
Re:
K852542/ A Food and Drug Adminiatration 8757 Georgia Avenue Silver Spring MO 2091 0 Palladium Seed Model 100 Dated:
October 9, 1985 Received: October 10, 1985 We have reviewed your Section 510(k) notification of intent to market the above device and we have determined the device to be substantially equivalent to d~vices marketed in interstate co!1ll'1lercc prior to Hay 28, 1976, the
~nactment date of the Medical Device A~endments.
You may, therefore, m~rket your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) until such time as your device has been classified under Section 513, At that time, if your device is classified into either class II (Perforunce Standards) or class Ill (Pre~arket Approval), it would be subject to additional controls.
Pleaijc note:
This action docs not affect any obligation you llight have under the Radiation Control for Health and Safety Act of 1968, or other Federal Lawe or regulations, General controls presently include regulations on annual registration, listing of devices, good manufacturing practice, labeling, and the misbranding ~nd adulteration provisions of the Act. In the future, the scope of gcn~ral controls may be broadened to include additional regulations.
All regulations and infor11ation on meetings of the device advisory CO!Ul..1itt~es, th~ir -recomm~ndations, and the final decisioos of the Food acd Drug Administration (FDA) will be published in the Federal Register.
We suggest you subscribe to this publication so you can convey your views to FDA if you d~sire and be notified of any additional requirements iraposed on your d~vice, Subscriptions may be obtained from the Superintendent of Documents, U.S.
Covernmcnt Printing Office, Washington, D.C.
- 20402, Such information also may b~ reviewed in tho Dockets Management nronch (HfA-305), food ~nd Drug Administration, Room 4-62, 5600 Fishers Lano, Rockville, Maryland
- 20ij57, Thi~ letter do~o not 1n any way denote official FDA approval of y~ur <l~vic~ or i_ts labeling. Any representation that creates an impression of official
~pproval of this device because of compliance with the preinarket notification rcgulat~one is misleading and constitutes misbranding.
If you desire advice on the labeling for your device or other information on your responsibilities under the Act, please contact the Office of Compliance, Division of Compliance Operations (IIFZ-320), 8757 Georgia Avenue, Silver Spring. Maryland 20910.
Sincerely youra,
~~
Kshitij H han, Ph.D.
Director Office of Device Evaluation Center for Devices and bdtolo3ical Health
REGISTRY OF RADIOACTIVE SEALED SOURCES AlID DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)
NO:
GA645S101S SEALED SOURCE TYPE:
HODEL:
200 l1.ANUFACTURER/DISTRIJ3UT0Rz ISOTOPE:
Palladium-103 LEAK *rnsT FREQUENCY:
DATE1 June 6, 1988 Sealed brachytherapy source (Old Model No. 100)
Theragenics Corporation 900 Atlanta Drive, N.W.
Atlanta, Georgia 30318 PAGE1 l of 8
}~XIMUM ACTIVITY:
Not to exceed 10 millicurics each PRTHCIPLF. USE:
General 'Medical Use CUSTOM SOURCE:
___ YES X
NO CUSTOM USER:
NO:
GA645Sl01S REGISTRY OF RADIOACTIVE SEALED SOURCES J\tm DEVICES SAFF.TY EVALUATION OF SEALED SOURCE (Amended in its entirety)
DATE:
June 6 1 1988 PAGE: 2 of 8 SEALED SOURCE TYPE:
Sealed brachytherapy source DESCRIPTION:
The ~lodel 200 Palladium Seed consists of a cylindrical titanium tube sealed at both ends with laser \.Jelded titanium end cups.
Enclosed in the tube are two pal ladium-103 plated graphite cylinders and a lead rod X-ray marker to identify the position of implanted s~ccls on a radiograph.
The cylindrical l u I:, e i s O, 1 77 inch ( 4. 5 r.,m) in over ;:i 11 1 e 11 gt h and O, 0 3 2 inch ( 0. 81 mm) in dia:-.eter, All of the titc1nium material is commerd.ally pure ASTM B265-78, Grade
- 2.
The lead and graphite are both 99.99+/-% pure.
The radioactive palladium-103 is electrolytically plated upon all outer surface of the graphite substrate.
J..ABELIHGa The size of the Hode 1 200 Palladium Seed prcc ludes any engraved, etched or printed labeling.
The seeds will be shipped in a small vial inside a lead vial holder.
The lead vial holder will be placed inside.
Labeling that will be affixed to each of these containers are illustrated in Fi.eures 1, 2, 3,
.1nd 4.
DIAGRAM:
Figure five shows the material of construction, dimensions, method of sealing, and the relationship of all major components for the Hodel 200 palladium Seed.
REGISTRY OF RADIOACTIVE SEAL~D SOURCES Alro DEVICF.S SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety) t:O:
GA645S101 S DATE:
June 6, 1988 PAGE: 3 of 8 SEALED SOURCES TYPE r Sealed brachytherapy source cmmITIONS OF NORMAL USE:
The ~'.ode l 200 Palladium Seed is intende d to be used as a permanent interstitial implant.
The soft therapeutic X-ray (20-23kev) emitted by the Palladium Seed interact with the tissue to be treated, Palladium Seeds are indicated for tumors with the following characteristics:
o Localized o Unresectable o Low to moderate radiosensitivity The tumors may be of the following typesr o Superficial o Intrathoracic o Intraabdominal o Lung, Pancreas, Prostrate (Stage A or B) o Residual followi ng external r adi ation o Recurrent The seed s are designed to withstand temperatures and pressures up to 272°F (1J3°C) and 30 psig for 30 minutes.
Nominal autoclaving conditions are 2S0°F (121°C) at 15 psig for 15 minutes.
The seed s are capable of withstanding moderate to severe challenges to their integrity.
It is possible through rou6h handling, high temperatures or crushing that a seed could leak or be ruptured.
If such an occurence does happen, there is little or no biological hazard due to the non-toxic nature and physical form of the internal components.
PROTOTYPE TESTING1 The Palladium Seeds were subjected to four prototype tests to demonstrate their integrity under expected stresses of use or accidents.
These tests provided evaluation under the following conditions,
- 1) Autoclave;
- 2) Impact,
- 3) Percussion and 4) Bend.
The tests were conducted generally as suggested in NBS Handbook
- 126, ANS I N542-1977, Appendix C
and ANSI N44.l-1973.
Brae,ytherapy seeds containing Pd-103 sealed in a tube of dimensions as shown in figure 5 do not entirely fit the Classifications or Definitions in the
.. ~fc renced ANSI standards.
Some mod i fie at ions of the test conditions were iquired.
These prototype tests for the Model 200 Palladium Seed follow closely he nodif ied ANSI prototype tests that were performed by the 3M Company for 1e ir approved I-125 Seeds,
REGISTRY OF MDIOACTIVE SEALED SOURCES Alffi DEVICES S/\flffY EVALUATIOH OF Sl.::ALED SOURCE (Mended in its entirety)
NO:
GA645Sl01S DATE:
June 6, 1988 PAGE:
4 of 8 SEALED SOURCE TYPE:
EXTERNAL RADIATION/LEVELS:
Hodel 200 Seed Activity 0.5 mCi (Comp)
- 5. 0 rnC i ( Comp QUALITY ASSURANCE AND CONTROL:
Sealed brachytherapy source Average Dose Rate (mR/hr) at 5 cm at 30 cm 25.86 258.60 0.718
- 7. 180 The oajor quality control tests that are used include the following, After Ccrapletion of Seed Assembly Visual inspection to verify proper seating of the titanium end cups in the tit~niu~ tubes and verify overall seed integrity.
After LRscr Weldin&
Visual optical inspection to check verify overall seed integrity.
cleanliness and soundness of welds and pi~cnsional checks performed to verify that the seeds are within specifications.
X-_1:!1_ to verify the seed was loaded correctly.
After Irradiation Autoclave leak test performed to verify no leakage of radioactive palladium.
The radiation activity level of each seed is measured using a Capintec Dose Calibration apparatus or, equivalent so seeds of the same Curie level can be grouped together.
REGISTRY OF nADIOACTIVE SEALED SOURCES AHD DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)
NO:
GA64SS101S DATE:
June 6, 1988 PAGEs 5 of 8 SEALED SOURCE TYPE s Sealed brachytherapy source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
A.
Palladium seeds are licensed by the State of Georgia for distribution to persons licensed pursuant to (9)(c) and (2)(c) of Chapter 290-5-23, Schedule C, Group VI or under equivalent licenses of the U.S. Nuclear
~egulatory Co~rnission, an Agreement State or a Licensing State.
B.
The seeds will be 100%
leak tested
- by the manufacturer prior to distribution.
No further leak testing is necessary due to the 16.97 day half-life.
C.
7he vial should remain in the lead pig during storage.
When transporting seeds within the hospital, an appropriate carrier with adequate shielding should be used.
D.
Adequate radiation protection should be used during im?lantation procedures, however, in r:iany instances in surgery, radiation protective barriers are not practical, thus the medical personnel must rely upon speed and distance to minimize radiation exposure.
E.
The titanium cncapsu lat ion provides very good biocompat ibi lity a long with excellent corrosion resistance but it is not designed to be used in a concentrated acid environment due to the chemical reaction.
F.
G.
The use of Palladium Seeds, as with other brachytherapy sources, is not recommended for the treatment of tumors in generally poor or ulcerated condition, The radioactive Palladium Seeds are not sterilization process must be performed, sterile when shipped, hence a Sterilization may be accomplished by either ethylene oxide (EtO) or by steam (autoclave) prior to implantation.
REGISTRY OF RADIOACTIVE SEALED SOURCES Mill DEVICES St.FETT EVALUATION OF SEALED SOURCE (A.wended in its entirety)
NO:
GA645S101S DATE1 June 6, 1988 PAGE:
6 of 8 SEALED SOURCE TYPE 1 Sealed brachytherapy source SAFETY ANALYSIS S(J}!NARYr The }fodel 200 Palladium Seeds were subjected to Autoclave, Impact, Percussion, and Rend tests to verify their structural integrity under both normal and abnormal us,1ge.
The seeds successfully passed these tests which generally follow ANSI N524-1977, ANSI N44.l-1973 and ANSI N44.2-1973.
The }:odel 200 Palladium Seeds should not be subjected to temperatures greater than 272°F (133°C) or pressures greater than 30 psig.
Under the abnornal conditions of fire or explosion, these conditions undoubtedly will be exceeded.
Failure or rupture of a seed could permit release of the palladium pellets.
This physical form of the radioactive content of the seed has no tendency to pulverize into airborne rcspirable particles (sec ANSI N/~4.1-1973, Section 5.2).
Release of Pd-103 as a vapor is considered very remote.
As a member of the platinum group of metals, it has a characteristically low vapor pressure of l.6X 10-4 atm. at its melting point of 2826°F (1SS0°C).
Chemically, the palladium is insoluble in water.
Although not designed for a concentrated acid environment, it is only slightly attacked by sulfuric and hydrochloric acids.
In the event of seed failure when implanted in the body tissue, it has been shown that palladium is biocompatible.
~---------- -
1\0:
GA645Sl01S REGISTRY OF R/JJIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUJ\'l'ION OF SEAJ.ED SOURCE DATE1 June 6, 1988 PAGE: 7 of 8 SEALED SOURCE TYPE:
Sealed brachytherapy source
REFERENCES:
This Certificate of Registration is based on information and test data contained in the following supporting documents which are hereby incorporated by reference and r.ade a part of this registry document:
- 1.
- Hilaris, B. S, ed Handbook of In terst it ial Brachytherapy, Sciences Group, Inc,, Acton MA, 1975.
Publishing 2,
NCRP Report No.
37 NCRP Publication, P, o.
Box 30175, Washington, DC
- 20014,
'3.
NCRP Report No, 40 NCRP Publication, P. o.
Box 30175, Washington, DC 20014.
- 4.
NCRP Report No.
41 NCRP Publication, P. o.
Box 30175, Washington, DC 20014.
- 5.
NCRP Report No, 48 NCRP Publicati.on, p *. o. Box 30175, Washington, DC 20014.
6, NCRP Report No.
49 NCRP Publication, P.O.
20014.
Box 30175, Washington, DC
- 7.
Ling, C. Proceedings of Fourth International Conference on Medical Physics, Ottawa, Canada, July 1976,
- 8.
Harper, Paul V. and Lathrop "Palladium-103 as Therapeutic Radiation Source" Nuclear Medicine, Stuttsart, F,R. G., 1965. '
- 9.
Theraacnics Corporation application dated March 3, 1986 and enclosures thereto.
- 10.
Letter from Theragenics Corporation dated March 5, 1986 and enclosures thereto.
- 11.
Letter from Theragenics Corporation dated July 3, 1986.
- 12.
Letter from Theragenics Corporation dated March 15, 1988 and enclosure thereto.
- 13.
Letter from Theragen ics Corporation dated March 21, 1988.
- 14.
Letter from Theragenics Corporation dated May 13, 1988 and enclosures
- thereto,
REGISTRY OF RADIOACTIVE SEAT.ED SOURCES Alm DEVICES SAFETY EVALUJ\TIOH OF SEALED SOURCE NO:
GA645S 1.01S SEALED SOURCE TYPE:
ISSUING AGENCY:
&J - &) - 88
(!u:icndcd in its entirety)
DATE:
June 6 1 1988 PAGE:
8 of 8 Sealed brachytherapy source Georgia Department of Human Resources Radiological Health Section REVIEWER: _Cf'\~/4,, d,. 4BMP~
COHCUl<REN CE, ~
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2 STEPS FORWARD...
I NTR ODUCING TheraSeed *M Alternative Permanent Implant 17 day half life provides higher dose rote -
critical to the treatment of rapidly grow-ing tumors.
Insoluble, non-volatile iso-tope -
critical in case of capsule damage such as dur-ing subsequent procedure for removal of urethral blockage.
Palladium-103 active isotope.
21 Kev x-rays for ease of radiation protection of medical personnel and the patient.
Biologically compatible titanium capsule.
Sized for standard applicators.
17 day half life Doc = 11,500 Rods > Biologically Equivalent Doses Orton, C.G., Br. J. of Rod. 47(603-607) 60 day half life
~
Doo = 16,000 Rads Tumor Regression (co. tongue)
DHEW Publication (FDA) 76-8022
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Urology Focus Harold P. McDonald, Jr., M.D.
Prostate Cancer-Harold P.,\ftDonald, Jr., M.D. Radioactive implant provides effective treatment s men age. problems associated with their Frostate gland r more freque~tly. Infection.
mmation. cysts. ;tones. benign growths -even cancer-become increasingly comm,,n in men 50
~cars of age and older But today.
the availability oi a radioactive implant called TheraSeed is help-ing many men fight back. By placing this subst:rnce into the prostate. ham1ful tt:;,1,,r ti"ue can By placing this substance into the prostate, harmful tumor tissue can be effectively destroyed.
Aerrcctivcly destroyed. The new Wtmiquc offer.; parients success-ful cancer rreatment with less trauma at a significant cost savings compared to trJditional treatment methods.
Enlarged prostate The pnist.1te i, a male sc, gland impvrtanr to semen production.
Approximately the size of a chest-nbl. the pn>statc encircle, the urine pa"agc. or urethra. between the bladder and the ha...e of the penis.
Though the prostate is fully devel-oped at puberty. it begins to en-large in most men around the age of 50. causing the urine flcm to he pinched off.
An enlarged pmsla/e, common among men 50 and older, may signal cancer in this region.
lniti,1I s~ mri.1m, 0f prostate en-largcrncnt include a decrease in the size and force of the urine stream and difficulty in starting and st()pping the urine flow. Fre-quent urination may abo signal a prnstatc pro hi em. Because an en-Facts about Prostate Cancer
- One out of three men over 50 will get cancer of the prostate.
- Men with prostate cancer may have no symptoms at all.
- A yearly checkup is recommended after age 40.
- If men wait until they have symptoms or cancer, it is often too late for curative treatment.
largement of the prnstate gland can signal canc.:r. pn>mpt dia!.'nosis is important.
Using an ultrasound scanner, urologist\ can analyze the internal structure of the pmst.ite and deter-mine the weight and size of this gland with amazi_ng accuracy. Tra-diti,1nally. if canrer was found.
sur!.'ical removal or external radi-ation were pr,*,crihed.
'foday. using the ThcraS,*ed ra-di,,actiw material. doctor, can dissolve the tumi,r far more simply.
Guided by ultrasound. the urolo-gist places rice-sized titanium cap-sules containing radioactive pal-ladium 103 in10 the tumor with a needle inserted into the prostate.
The capsules. which remain in the pro>late. reka,c radiation equiva-knt to one X*ra:, per second for the first ~O days,ind then diminish in strength.
The procedure ranks a, effective a, external radiation or sur!,'.Cf).
however. unlik,* traditional meth-ods. the radioactive implant pro-cedure can be performed on an outpatient ba,is using a local anesthetic. The procedure. which ThcraSecd, manufactured b:,
Thcragcnics Corp. of Atlanta. i, only effective in treating localize.:
tumors. If the cancer has spread beyond the prostate gland, tradi-tional t rcatrnent such as chem,,-
therapy is necessary.
The availability of TheraSeed offers many men the chance IC' fight prostate cancer. Still. earl~
detection is one's best chance for The procedure ranks as effective as external radiation or surgery, however, unlike traditional methods, the radioactive implant procedure can be performed on an outpatient basis using a local anesthetic.
takes appro,imatcly one hour to complete. costs nearly 50 percent less than remo*,ing the tumor sur-gically. Overall. the technique is less traumatic to the patient and is free fmm unwanted side effects.
In most ca<.<:~. sexual function is not affected by the radioactive treatment. l'dtients also experience fewer problems of incontinence and rectal and 'or hi adder irritation than with other types of treatment.
cure. Remember, an initial ultra-sound examination of the prostate gland should be performed at age
- 40. Men age 50 and over should receive annual examinations.
MA.KE A NOTE.**
Dr.. itcD<mald "*rlromt! rails rtxarrl-ing this articlt or r,/aud tupics. Coll hi.J o/Jicr al (404) 95/-8-166 btt.,..ttn 8 a.1t1.
and 5 p.m., Monday through FridaJ.
Harold P..1/cDonald, Jr.,.lf.D.. is a urofogisl and /ht dirtctor oftht Gto'l{ia Pro stall' Crnttr. * *hirh.\ptciali:Rs in prostaJc ultrosound terhniquts. 17rt Gtorgia Pro,tat, C,ntrr 011d th,.\fcDona/d l'rolog_,* Ctn/er art locat,d al 2550 "7ndy Hill Road. Suitt 115, in.\fari,na.
Dr.. \fcDonold rrcrfr,d his m,dical dcgrer from the.lfcdicol Co/leg, o/Gto'l{ia and laur corr"t,ftrrd an intrmJhip aJ Orarily /lospiJal of Louisiana in,\'rw Oruans.
lfr then Un!' d a n*\idcnc:,.- in patholo,:y at St. Jo:r;rph's lnflnnar,* in A.tlan/a and JU')(t'f)" and 1,m.,/ogy rr.tidrncirt at thr l.'nfrrrxity of.\fichigan,\frdfral Ccn/tr in Ann.4.rbor. Dr.,\lrf>onald also complrtrd a surgrry rtsidtnq at tht A'idn~*
IAhnrotory, Pttu R,*nt Rn):ham Ho,pital, in Boslon.
l)r.. \fcfJunald rurrt*ntly itn*t s a.,,*icr prrsidtnl of thf' /nltmational Socitty of f."ndmrr,pir l'rol,~
- and president of the Gtu11:ia ProstaJr Ccntrr. lit is a board tnl'mhcr of 1hr /ntrmational SOcirtJ for Photoscopy and a.ssistont srcrrtary of the.*\mrn*can SMitty of Outpah'tnt Su,xrons. Dr. JlcDonald is also a mtm!Hr of,*an*ous narw nal. Jtatr and /oral medical a.Hociations and.rnrith'ts, among them tht.-tmrriran i\ltdiral Association,.-tmrrican Sorirty of,\'tphrologJ' and tht Amtrican l. 'rologiral A.ssociation.
In addition to his pri*'Olt pmctiu, Dr. AfcDonald maintains staff affiUation1 wi'th un*ral fo.ca/ hospi'tals. Ht and his tt'i/t, Patn"da, rFsidr i'n Atlanta.. ;,h thtir four rhi/Jrr,..
Reprinted from the East Cobb/Cherokee Edition of Health Care News, Vol. 1. No. 4 r Health Care News, Inc.
- 1 (800) 543-4351
500 400 ca C
- ca 300 a: -
w ti a:
w
(/'J 0
200 C
100 TheraSeed - Palladium103 Permanent Implant for Cancer Therapy Pd103 Characteristics Energy Half-life Characteristic
- 21 KeV
- 17 days
- Non-volatile, Insoluble
-Palladium-103 17 day half life TheraSeed Configuration D = 11,500 Rads Capsule : Laser welded titanium tube Size
- Sized for standard applicators
', __ lodlne-125 60 day half life D = 16,000 Rads 1
2 3
4 5
6 7
8 9
10 11 12 TIME (Months)
DECAY COMPARISON OF EQUIVALENT DOSES Blologlcally Equivalent Ooaea Orton, C.G.,Br. J. of Rad. 47(603-607)
THERAGENICS CORPORATION 900 AIJantlc ~. N.W., Atlanta. G~g.a 30318 (404) 873-6309 Toll tr11 (100)4~1-4J7Z
~
X(cm) 0.000 0.500 1.000 1.500 0.000 1.030 0.518 0.356 0.500 1.271 1.020 0.549 0.358 1.000 0.946 0.869 0.587 0.396 1.500 0.697 0.677 0.545 0.388 2.000 0.510 0.497 0.443 0.334 2.500 0.372 0.353 0.328 0.262 3.000 0.272 0.249 0.235 0.196 3.500 0.200 0.180 0.174 0.147 4.000 0.148 0.136 0.139 0.116 4.500 0.112 0.106 0-.115 0.095 5.000 0.085 0.084 0.091 0.077 5.500 0.065 0.066 0.066 0.058 6.000 0.050 0.049 0.045 0.041 6.500 0.037 0.035 0.038 0.029 7.000 0.027 0.025 0.044 0.023 TberaSeed -
Palladiuml03 Dose rate times distance squared around a 1.Ci (compensated) Pd-103 TheraSeed Model 200 in solid water, cGy ca2 hr-1 mei-1 2.000 2.500 3.000 3.500 4.000 0.239 0.222 0.169 0.113 0.084 0.276 0.212 0.174 0.107 0.077 0.282 0.198 0.144 0.103 0.082 0.268 0.183 0.130 0.099 0.078 0.241 0.166 0.125 0.093 0.072 0.208 0.148 0.120 0.087 0.090 0.173 0.130 0.108 0.079 0.066 0.139 0.112 0.095 0.071 0.076 0.110 0.095 0.078 0.062 0.054 0.085 0.078 0.062 0.053 0.053 0.065 0.063 0.050 0.044 0.038 0.050 0.049 0.040 0.036 0.035 0.039 0.037 0.032 0.029 0.029 0.031 0.027 0.026 0.023 0.023 0.025 0.019 0.021 0.019 0.017
>x 4.500 5.000 5.500 6.000 6.500 7.000 7.500 0.069 0.041 0.040 0.028 0.018 0.015 0.014 0.065 0.055 0.036 0.027 0.028 0.015 0.014 0.063 0.037 0.035 0.027 0.025 0.018 0.013 0.062 0.050 0.035 0.027 0.020 0.017 0.013 0.060 0.047 0.036 0.029 0.022 0.017 0.013 0.058 0.045 0.036 0.029 0.023 0.018 0.012 0.055 0.042 0.035 0.028 0.023 0.018 0.012 0.050 0.040 0.033 0.027 0.022 0.017 0.012 0.045 0.037 0.031 0.025 0.020 0.016 0.012
$).039 0.033 0.028 0.023 0.022 0.016 0.012 0.033 0.028 0.024 0.021 0.018 0.015 0.012 0.027 0.024 0.020 0.018 0.016 0.014 0.012 0.022 0.020 0.017 0.016 0.014 0.013 0.012 0.018 0.016 0.014 0.013 0.013 0.012 0.011 0.015 0.013 0.012 0.011 0.011 0.011 0.011 THERAGENICS CORPORATION 900 Adantic DriYe, N.W., Atlanta. Georgia 30318 (404) 873-6309 Toll fr** (800)458-4372
Package Insert TheraSeedN Implants GENERAL INFORMATION Description The TheraSeedN Implant consists of a titanium tube sealed at both ends with laser welded titanium end cups.
Enclosed are two Palladium-103 plated graphite pellets and an lead x-ray marker to identify the position of the implanted seeds on a radiograph (Figure 1).
Trt~ [nd c...,
Pd p(G~*d g,-o.pt-,"w pe-11*'1
<.030'L x.oe.-a x.ooe*t>
<.036'L x.oeJ'lP
,E=::=~~~~~=_:::=5~~::fu::::=z===-
I-====2* ~-
~~~~~
I Trt~ Tube
<.t77'L x.o:ie*oD x.ooe:e*t.>
L.-od X-ftAy No.rl<w
. <.OO'L X.oeO'D>
..... --------- 0.177' ------ ----t Figure 1 Radiation Characteristics The TheraSeedN Implant utilizes a Palladium-103 isotope t o produce the desired therapeutic x-ray emissions.
Palladium-103 (Pd-103) has a 17-day half-life and decays by electron capture with the emission of characteristic x-rays of 20-23 keV and Auger electrons.
The electrons are absorbed by the titanium wall of the TheraSeedN Implant.
Palladium-102 is activated to palladium-103.
The Pd-103 is electroplated onto graphite pellets.
Manufacturing consists of placing the activated pellets in titanium tubes and laser welding end cups on the tube.
Both the pellets and TheraSeedN Implants are analyzed for trace activity.
Due to limitation of chemical purity, trace elements are present in the TheraSeedN Implant.
The total trace activity will contribute to less than 0.4% of that produced by the palladium 103 at the certification reference date.
A decay chart is used to correct for physical decay of the Pd-103.
The decay factors at selected days after the assay date are shown in Table 1.
Page 1 of 12
}:ackage Insert;;
Decay Chart Pd-103, Half Life 16.97 Days Decay Decay Days Factor Days Factor 1
0.95998 31 0.28190 2
0.92156 32 0.27062 3
0.88467 33 0.25979 4
0.84927 34 0.24939 5
0.82528 35 0.23941 6
0.78265 36 0.22983 7
0.75132 37 0.22063 8
0.72125 38 0.21180 9
0.69239 39 0.20332 10 0.66468 40 0.19518 11 0.63807 41 0.18737 12 0.61254 42 0.17987 13 0.58802 43 0.17267 14 0.56449 44 0.16576 15 0.54190 45 0.15913 16 0.52021 46 0.15276 17 0.49939 47 0.14665 18 0.47940 48 0.14078 19 0.46180 50 0.12973 20 0.44180 50 0.12973 21 0.42411 51 0.12454 22 0.40714 52 0.11956 23 0.39084 53 0.11477 24 0.37520 54 0.11018 25 0.36019 55 0.10577 26 0.34577 56 0.10154 27 0.33193 57 0.09747 28 0.31865 58 0.09357 29 0.30589 50 0.08983 30 0.29365 60 0.08623 Table 1 Radiation Protection The half-value thickness of lead for Pd-103 is.008 mm.
Thus, the exposure from the TheraSeedN Implant is reduced by> 97% by only a
.06 mm lead sheet.
Page 2 of 12
Package Insert Design Theragenics has designed the TheraSeedN Implant to be an alternative source for permanent interstitial implants.
The soft therapeutic ionizing x-rays (20-23 keV) emitted by the TheraSeedN Inplant interact with the tissue to be treated.
The use of titanium for the tube and end cups assures good tissue compatibility.
The dose distribution surrounding each individual seed is moderately anisotropic which reduces the potential for low dose shadow spots in the tumor.
Dose distribution calculations may need to account for this degree of anisotropy.
Total attenuation resulting from titanium encapsulation, x-ray marker, and self absorption from the Pd-103 pellet is approximately 75 percent.
Indications TheraSeedN Implants are indicated for tumors with the following characteristics:
Localized Unresectable Low to Moderate Radiosensitivity The tumors may be of the following type:
Contraindications Superficial Intra thoracic Intraabdominal Lung, Pancreas, Prostate (Stage A or B)
Residual Following External Radiation Recurrent The use of TheraSeedN Implants, as with other brachytherapy sources, is not recommended for the tr1atment of tumors in generally poor or ulcerated condition.
Patient Education As with all brachytherapy sources, the patient needs to be informed of the nature of the TheraSeedN Implant and also the expected period of time during which radiation precautions will be necessary.
The National Council on Radiation Protection and Measurements has detailed the guidelines for necessary radiation safety procedures which the patients, thei~ ~l~s5 gssociates and medical personnel are required to follow.
The patient and any close associates should be acquainted with the procedure for handling a TheraSeedN Implant which has sloughed off and has become detached from the patient.
Depending on the treated Page 3 of 12
Package Insert tumor, bandages or linens which come in contact with the site of the implant should be examined for the small metallic seeds.
If a seed is found, tweezers or a spoon should be used to pick the seed up and place it into a sealable container such as a glass jar.
The container should be placed and isolated within a designated area in the house.
The local radiation center should be contacted as soon as possible following the occurrence.
Medical Personnel TheraSeedN Implants should be used only by individuals who are trained and experienced in a safe use and handling of radionuclides and who have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
DIRECTIONS FOR USE Preparation/Sterilization The radioactive TheraSeedN Implants are NOT sterile when shipped, hence a sterilization process must be performed.
Sterilization may be accomplished by either ethylene oxide (EtO) or by steam (autoclave) prior to implantation.
Both procedures require manipulation of the TheraSeedN Implant.
All manipulation involving TheraSeedN Implants should be performed behind shielding of such size and thickness to shield the handler adequately.
DIRECT CONTACT WITH THE THERASEEDN IMPLANTS SHOULD BE AVOIDED.
THERASEEDN IMPLANTS SHOULD NOT BE PICKED UP WITH THE HANDS.
Use forceps to handle TheraSeedN Implants and maintain maximum distance between handler and TheraSeedN Implants.
DO NOT STERILIZE THE THERASEEDN IMPLANTS WITH GLUTARALDEHYDE BASED COLD STERILIZATION SOLUTIONS BECAUSE OF THE GUMMY FILM WHICH STICKS TO THE SEEDS.
Sterilization - Autoclave Before using an autoclave to sterilize the TheraSeedN Implants, make sure there are drain screens, traps or some other means to prevent the loss of seeds through the drain.
If sterilization is performed in the delivered dose vial, vent the cap of the vial prior to autoclaving.
The TheraSeedN Implants have been designed to withstand normal autoclave temperature and pressure variations, however, DO NOT exceed 138"C and 35 psi. It is necessary to autoclave the TheraSeedN Implants, whether in bulk or individually, in a container of autoclavable material.
The materials include glass, stainless steel, nylon and teflon. It is also possible to autoclave the TheraSeedN Implants in a few of the commercially available accessories of the implant applicators to include the seed holding nylon and teflon tubes of the Henschke and Scott or the stainless steel cartridge of the Mick applicator and gun.
If Page 4 of 12
Package Insert there is any question as to the autoclavability of the material, autoclave a sample of the material with test seeds.
Alternatively, use ethylene oxide (EtO) for sterilization.
DO NOT AUTOCLAVE THERASEEDN IMPLANTS IN LOW MELTING POINT PLASTIC TUBING OR CONTAINERS.
Precautions and Monitoring Appropriate precautions must be taken when handling TheraSeed*
Implants.
All personnel who will be working with the TheraSeedN I mplants are required to wear adequate personnel dosimetry monitors.
A film badge or TLD dosimeter is worn on the body.
In addition, a ring badge must be worn by personnel who are handling the TheraSeedN Implants.
Advanced planning of the implant procedure is suggested to minimize radiation exposure to personnel.
Radi~tion exposure should be consistent with published exposure limits.
Accountability TheraSeedN Implants need to be strictly controlled and stored in a locked safe.
If any seeds cannot be accounted for, the appropriate regulatory agency must be contacted.
Cautions TheraSeed* Implants have a high structural integrity and have successfully passed the tests prescribed by the Nuclear Regulatory Commission for Sealed Brachytherapy Sources.
It is possible through rough handling, high temperatures or crushing, that a seed could rupture and leak.
In the event of this rare occurrence, there is little or no biological hazard due to the nontoxic nature of all the internal components.
The area should be closed off immediately and the seeds put into a sealable container.
Personnel movement should be limited to avoid spread of any radioactive contamination.
The area should then be decontaminated.
Successful decontamination is confirmed by taking "wipe" samples of the contaminated area.
Dose and Administration The dose for a given implant is based on a TDF (Total Dose Factor) analysis for the specific isotope Palladium-103.
From these calculations, a nomograph has been developed (Figure 2), relating tumor volume to total activity to be implanted using dimension averaging.
This information is then used to determine the number of seeds and their respective spacing (Figure 2).
The decay chart is used to correct for the decay of the 17-day half-life Palladium-103 ( Table 1).
The angular dose distribution of the Page 5 of 12
Package Insert TheraSeedN Implants is moderately anisotropic. 1 This degree of anisotropy should be given consideration in dose distribution calculations.
Techniques The TheraSeedN Implant and the I-125 9 Seed both have the same external dimensions.
This allows the TheraSeed-Implant to use the same applicators as the I-1259 Seed uses.
Several commercially available applicators, to include the Henschke, Mick and Scott are suitable for this purpose.
The Royal Marsden Gold Grain Gun will not accept TheraSeedN Implants.
When handling the TheraSeed-Implants, radiation detection equipment capable of detecting 20-23 keV x-rays should be available.
This equipment may be useful to find dropped seeds as they are very small and may be difficult to detect visually.
Adequate radiation protection should be used during implantation procedures.
However, in many instances in surgery, radiation protective barriers are not practical, thus the medical personnel must rely upon speed and distance to minimize radiation exposure. 2 Warnings The titanium encapsulation provides very good biocompatibility along with excellent corrosion resistance but it is not designed to be used in a concentrated acid environment due to the chemical reaction.
THERASEEDN IMPLANTS ARE N.QI STERILE WHEN SHIPPED.
Adverse Reports There have been no reports of adverse reactions from the use of Theraseed* Implants.
CALCULATIONS Dimension Averaging The total mCi activity required to treat a given tumor, based on clinical evidence, is proportional to the tumor volume.
Dimension averaging, the average of the three mutually perpendicular dimensions of the tumor, is a more practical way of determining the tumor volume and correspondingly the total activity required.
A simple yet effective formula is shown below to determine the total activity required. 8, 9 1
Page 6 of 12
Package Insert D = Average Dimension =
sl +
A = Total Activity Required A = 21.5 ol A= 16.64 ol. 283 A = 11.87 ol.SSl Seed Spacing Nomograph b + c 3
cm Where D < 2.4 cm Where 2.4 cm< D < 3.24 cm.
Where D > 3.24 cm.
A simple nomograph has been developed for the TheraSeedN Implant to help simplify calculations for the number of seeds and spacing required to carry out the implant (Figure 2).
Example Calculation A 3 x 4 x 2 cm. tumor (average dimension is [3+4+2)/3 = 3 cm) is to be implanted with TheraSeedN Implants of 2.1 mci (comp.) activity.
The spacing along the needle is to be 1.0 cm.
In Figure 2, a line connecting 3.0 cm on the average dimension scale with 2.1 mci on the seed strength scale intersects at 34 for the number of seeds.
A line connecting 2.1 mci on the seed strength scale with 3.0 cm on the average dimension scale is extended to the tie line.
A second line is drawn between the tie line intersection and the 1.0 cm point on the spacing along needle scale.
Extension of this line allows the needle spacing to be read at the point of intersection on the spacing between needles scale, 0.6 cm.
By using the nomograph, one can determine total recommended activity, desired number of seeds and spacing between needles.
The determinations made from the nomograph must be considered to*be approximations only.
Page 7 of 12
Ave,aQP Otmen~*on,
(Cm)
I I j
10 I.I IA Io u
10 ll
'° u
,o
,o 10 Re<: omme"0e0 j
Act,v>ly (rrC,)
Ave**Qe O,m.-,1,on
,0 (tm)
~,
"° 01
~e-dl u
\A 1,6..
10 So.c,ng Along Need~
(tm)
O I 14 LO LI T,e Ltr>e PALLADIUM SEED SPACING, NOMOGRAPH Figure 2 Page 8 of 12 Spac,ng
~ween d'O (tm)
,.0 LI LI 1.0 Q.I u
o.,
Angular Distribution of Radiation From Palladium Seeds Pag~_ 9 9f 12 e: --.,
.,v J
Package Insert SERVICES Availability TheraSeedN Implants are available from Theragenics Corporation, Atlanta, Georgia.
TheraSeedN Implants are available with an activity between 1.5 and 2.3 mci (comp.).
The seeds are shipped as a group in an screw cap vial, which is labeled to indicate the Isotope, Total Apparent Activity, Apparent Activity Range, Assay Date, Lot Number, and Number of Seeds.
If there happens to be any discrepancy between the information of the vial and that which is on the certification sheet accompanying the order, Theragenics Corporation should be contacted within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the shipment.
The vial is contained in a lead pig which is labeled to provide the same information which is on the vial as well as a statement pertaining to licensing of the product.
The vial should remain in the lead pig during storage.
When transporting seeds within the hospital, an appropriate carrier with adequate shielding should be used.
Disposal/Return A TheraSeedN Implant disposal service is also provided by Theragenics Corporation for used or decayed seeds.
If customers wish to utilize this service, they must first contact Theragenics Corporation, for approval, specific shipping containers and forms.
When applicable, there will be cancellation and restock charges.
Contact your Sales Representative for information.
TheraSeed-Implants approved for either return or disposal must comply with Department of Transportation Regulations (Title 49, U.S.
Code of Federal Regulations Parts 171-177), regarding packaging and labeling.
Shipments are to be directed to:
Theragenics Corporation 430 Tenth Street, N.W.
Suite N-210 Atlanta, Georgia 30318 Phone 1-800-45 THERA Page 10 of 12
Package Insert QUALITY CONTROL The TheraSeedN Implants have passed the prescribed tests for Sealed Brachytherapy Sources required by the Nuclear Regulatory Commission.
Before the TheraSeedN Implants are shipped, they have passed an extensive series of quality control tests to include autoclave, leak, microscopic, and assay.
These tests assure that the TheraSeedN Implant is of superior quality.
LICENSING TheraSeedN Implants are licensed by the State of Georgia for distribution to persons licensed pursuant to Title 10 U.S. Code of Federal Regulations Part 35 Sections 35.14 and 35.100 Group VI or under equivalent licenses of Agreement States.
Page 11 of 12
Package Insert References
- 1.
Hilaris, B.S., ed., Handbook of Interstitial Brachytherapy, Publishing Sciences Group, Inc., Acton, MA 1975.
- 2.
NCRP Report No. 37 NCRP Publication, P.O. Box 30175, Washington, DC 20014.
- 3.
NCRP Report No. 40 NCRP Publication, P.O. Box 30175, Washington, DC 20014.
- 4.
NCRP Report No. 41 NCRP Publication, P.O. Box 30175, Washington, DC 20014.
- 5.
NCRP Report No. 48 NCRP Publication, P.O. Box 30175, Washington, DC 20014.
- 6.
NCRP Report No. 49 NCRP Publication, P.O. Box 30175, Washington, DC 20014.
- 7.
Ling, c., Proceedings of Fourth International Conference on Medical Physics, Ottawa, Canada, July, 1976.
- 8.
L. L. Anderson:
Private Cornmunication--to be published.
Presented at International Endocurietherapy Meeting, LAC/USC, Los Angeles, 6/30/78 - 7/2/78.
- 9.
Calculated Dose from TheraSeedN Implants, Dr. John L. Russell, Jr.
Available through Theragenics Corporation, Atlanta, GA.,
upon request.
Page 12 of 12
FIGURE 2 TheraSeedTII P.nadlum !lftds*ll'<l-1031 Radionuclide Brachytherap Caution RAOIOA _ *
- ,i:.,1 Ap i
Tot,.... 111r.,..,..-C1
*----- -cc\"mJ
_Lot (1)
Seed Vial
-~-
.,;-.z::.'1/4ERAGENICS CORPORATION TheraSeedTM Palladium Seeds-(Pd-103)
Radio nuclide Apparent
~~
Brachytherapy Source Act1v1ty RanQe mC1 Model 200 Total App~Act1v1 comp Desc""°"
~~
- ~
mC1 The-fa$tt(l 0
... cr ", ~
,1 l[ 'T' comp lcl,esea,*-**oc; -, _.,,......,~
m ro!Seeds __ ~-==
PI a::.,.. *O)'Grapn,4e
..., J**.: ")"u'T' e'lOCuO~
~
- .,. ~, *e Assay Date ____ _
WARNING LicenMd by the ~11 Oepa,rimenl ol Human Resources fof' d1s1r 1bution to per,ons llcensed pursuar,! to (9) fc) and (21) (C) of Chapter 29C !>*23 Schtiou1n C G*oop VI Of uno.i e<J\l*Yll~nl hcensei of the US Nucle** Re-g...,i*tory Con,m,n,on. an ~
..,,,.nt State 01 l.c:en111,g S11:~
CNJTK)N Feo.ral law,..,ICtl th15 ~
to Nie by o, DI"! !ht 01d*r of I phytki&n. Mafnealn p,ope, rad1a1,on utr.y proc-.cluret a, aft t1met.
(2) Lead Vial Holder C&ution RAOIOACTIVE MATERIAL See pc\C kage insert fo, 1nstrucl1ons on handling atorage of TheraSeed'nl w-,.~uSA 11y The,agen1cs Corporation Atlante. GA 30318
TheraSeed' Palladium Seeds. (Pd-103)
Radionuclide Brachytherapy Source Total Apparent Activity _______ _
mCi comp.
Surface Dose Rate
~~~
mRem/hr.
~,~
Assay Date -
-C.,~-:\'I_~ ____ _
9 Total No. Of Vials _____ _ _
Total No. Of Seeds _
This Product Made in U.S.A. By:
Theragenics Corporation Atlanta, GA 30318 (3)
Outer Container
~-~
A Cautioti RADIOACTIVE MATERIAL
LIST OF THERAGENICS MANAGEMENT PERSONNEL John V. Herndon Chief Operating Officer Executive Vice President John L. Carden, Jr.
Vice Pres ident Research, Development and Manufacturing Christine Jacobs rector of General Sales and Marketing Roberts. Kirkland Manager of Manufacturing and Operations Julie A.K. Stephens Manager Technical and Clinical Services Diana Fialkowski Marketing Manager Rick Powers Manager of Distribution and Purchasing 4!!lf_~
-~
THERAGENICS l '
CORPORATION CHRISTINE JACOBS DIRECTOR OF GENERAL SALES ANO MAAKE11NG 900 Atlantic Drive, N.W.. Atlanta, Georgia 30318 1-800-458-4372 (404) 873-6309
- ~~~
(~l) THERAGENICS f
CORPORATION HOWARD T. COOPER DIPECTOR or REi'.;ULl,lORY
& '-'EOICAL Aff.\lAS 900 Atlant,c Drive, N.W. Atlanta. Georg:a 30318 1-800-458-4372 (404) 873-6309 4(~
qff;'
THERAGENICS CORPORATION JULIE A. K. STEPHENS PROJECT ~IRECTOR,~AOIQMICROSPHERE TheiaSphere *
(404) 873-630t*
900 Atlantic Drive, N.W., Atlanta, Georgia 30318
~
~
THERAGENICS V CORPORATION DR. JOHN L. CARDEN, JR.
VICE-PRESIDENT RESEARCH ANO DEVELOPMENT (404) 873-63L1 Res. 491-643t 900 Atlantic Drive, N.W., Atlanta. Georg a 30318
- ~
1 ~
THERAGENICS
'f CORPORATION JOHN V. HERNDON CHIEF OPERATING OFFICER EXECUTIVE VICE PRESIDENT (404) 873-63, I 900 Atlantic Drive, N.W., Allanta, Georgia 30318 I
~
~~
THERAGENJCS CORPORATION RICK POWERS
'-'.ANAGER OF OISTRJBUmN AND~
900 Allan11c Drive, N.W., Atlanta, Georgia 30318 1-800-458-4372 (404) 873-6309 Res. 421-8485