ML20134N883
| ML20134N883 | |
| Person / Time | |
|---|---|
| Issue date: | 03/21/1995 |
| From: | David Tang NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20057G418 | List: |
| References | |
| SSD, NUDOCS 9702250019 | |
| Download: ML20134N883 (1) | |
Text
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A > M 5 From: David T, Tang To:
SLB Date: Tuesday,darch 21, 1995 7:31 am
Subject:
Picker Actions Steve, Martone called yesterday on progress in all questions we raised..
l Formal response will be forthcoming in about two weeks. Briefly. item by i
item: (1) Will reconstruct radiation profiles: some deltas will be added: (2) are conducting tests with phatoms for extremeties in different orientations; j
TLD readings are being sent out for
)rocessing: field trials data as collected in handling.TC-99m for 3 months are 3eing analyzed: (3) will supply Dwg. #
l 101881, (4) will conduct life tests for shutter operation: (5)-is reviewing bend. test approach and will work with source vendors to develop the data. if.
not already available: (6) will provide warning in the manual on asking for help in case source will not come out: (7) will provide labels as appropriate:
and (8) will state that manufacturing is per FDA GMP program. Dave-i 4
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION
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AT WASHINGTON, D.C. 20555-0001 o
March 23, 1995
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1 Mr. James M. Fulton Picker International Picker - Ohio Imaging 23060 Miles Road Bedford Heights, OH 44128
Dear Mr. Fulton:
i This is in reference to your letter and affidavit dated February 14, 1995, in which you requested that Addendum 2, " Engineering Drawings,' and Addendum 5, j
" Quality Control," of the February 14, 1995, Picker report " Application for Radiation Safety Evaluation and Registration of a Device Designed to Contain Byproduct Material," for the Model STEP transmission line-source holding device be withheld from public disclosure pursuant to 10 CFR 2.790.
You stated that the submitted information should be considered exempt from mandatory public disclosure since the information in these addenda is:
o considered proprietary by the company and held in confidence with release only on a need to know basis-I held in confidence and early release would deny Ohio-Imaging a o
competitive advantage that took considerable time and expense to achieve; i
transmitted to the Commission in confidence and not available in public o
sources; and to cause substantial harm to Ohio-Imaging's competitive position as the o
development expenditure could be avoided by a competitor.
We have reviewed your application and the material' in accordance with the requirements of 10 CFR 2.790 and, on the basis of your statements, b.:we determined that the information in these addenda constitutes trade secrets or proprietcry com'-
...o informatt or.. Therefore, these addenda will be withheld from public dir ;1usure pursuant to 10 CFR 2.790(b)(5) and Section 103(b) of j
the Atomic Energy Act of 1954, as amended.
Withholding from pubik inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents.
If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.
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J. Fulton If the basis for withholding this information from public inspection should change in the future, such that the information could then be made available for public inspection, you should promptly notify the NRC.
You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes your information.
In all review situations, if the NRC needs additional information from you or makes a determination adverse to the above, you will be notified in advance of any public disclosure.
Sincerely, OriginalSignedBy:
StevenL Baggett Steven L. Baggett, Section Chief Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards i
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SKimberly Distribution:
SSSS Staff SCDB r/f NE01 SSD-95-13 DOCUMENT NAME:
PICKER 2.790
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DATE 03/g/95 03/dF95 0FFICIAL RECORD COPY s
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e N a g as February 14,1995 Steven L Baggett,Section Chief U.S. Nuclear Regulatory Commission Sealed Source Safety Section Source Containment and Device Branch Division ofIndustrial and Medical Nuclear Safety. NMSS Washington,D.C. 205S5-0001 DcarSir:
Attaclad in duplicate, please find a device review application prepared in the format described in USNRC Regulatory Guide 10.10 dated March,1987.
It is the intention of Picker-Ohio Imaging to manufacture and distribute an accessoryx device *not containing radioactive material, but designed to hold a sealed source manufactured by others. The device is designated by the model name STEP and is designed to be an image clarity accessory to Picker's various models of scintillation camera systems.
The sealed sources to be used with STEP are presently manufactured and distributed direct to specific licensees by Isotope Product Laboratories of Burbank, California.
Isotope Product Laboratories has submitted to the California Department of Health a sealed source (s) safety evaluation request and has received registry number CA 406S16SS in reply.
Other manufacturers may in the future receive similar authorization to distribute sealed sources suitable for use in the STEP system, W,
In addition to sealed sources supplied to specific licensees by authorized vendors, the
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STEP system is designed to be used with Tc99m as supplied by the STEP user hhnselfin v3/p z
accordance with a specific license and per the provisions ofi 10CFRc35.S7 or 10CFR 35.200, or equivalent state regulations.
A Picker-Ohio Imaging has received permission to distribute STEP for medical imaging purposes from the U.S. Department of Health and Human Services. A copy of an F.D.A.
letter to this effect dated May 13,1994 is included in the application as Addendum #9.
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In accordance with 10CFR 2.790 (a) (4), it is requested that a portion of this application i
be withheld from public disclosure on the grounds that release of certain proprietary l
information regarding the design and fabrication of STEP devices would do irreparable l
commercial harm to Picker-Ohio Imaging by providing competitors access to designs and fabrication procedures developed by Ohio Imaging at considerable cost.
In accordance with 10CFR 2.790 (b) (1), the following portions of the application are requested to be withheld from public disclosure Engineering Drawings l
Addendum #2 Addendum #5 Quality Control An affidavit is hereby submitted over my signature below. As Vice President and General Manager of Picker-Ohio Imaging. I am on behalf of the company specifically delegated to i
review the attached application and select that portion for which withholding is-l requested.
In accordance with 10CFR 2.790 (b) (4), the following information is supplied:
10CFR'2.790 (b) (4) (1) the engineering drawings and quality control j
procedures are considered proprietary by the company and held in confidence with release only on a need to know basis.
l 10CFR 2.790 (b) (4) (11) - the engineering drawings and quality control procedures for all new products such as STEP are normally held in.
i confidence until such time that competitor's products reaching the marketplace negate the need. Early release would deny Ohio Imaging a competitive advantage that took considerable time and expense to achieve.
10CFR 2.790 (b)(4)(111)- the information contained in Addenda #2 and
- 5 of the application is hereby transmitted to the Commission in confidence.
10CFR 2.790 (b) (4) (iv) - the information contained in Addenda #2 and
- S is not available in public sources.
10CFR 2.790 (b) (4) (v) - public disclosure of the information found in Addenda #2 and #5 would cause substantial harm to our competitive position in as much as it represents an expenditure of 4.5 years in development at a cost approximating one million dollars that could be avoided by a competitor in developing his own product.
2
In closing, it is requested.that consideration be given to prompt review of this application. We have already received firm orders for several STEP systems and anticipate many more. The medicalimaging community is very enthusiastic over the potential improved cardiac studies made possible by STEP. NRC device approval remains the sole impediment to full market accessibility.
Appended are two (2) drafts totalling 53,700.00 to be applied to review fees as prescribed in 10CFR 170.31 category 9A.
Thank you for your attention to this matter. If there is any way I or my Manager of Regulatory Affairs, Mr. Ron Martone, can do to assist you in your review, please do not hesitate to call. His direct telephone numberis (216) 473-7651.
Sincerely.
O& W (James M. Fulton V4ce President and GeneralManager i
Notary Public RA?.'DAll. A. ?MZSd. CD-bt $! -
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E-mail Messaae on the PICKER STEP Imaaina Device And the ADAC VANTAGE Imaaina Device j
Contacts: Larry Camper. Josie Piccone, Steve' Baggett ALERT:
This message is to alert you to current action by Headqu3rters staff and request that the regions do not authorize =the use of the STEP or i
1 VANTAGE devices discussed below until a sealed source device review has been performed of each device, and favorable results have been coamunicated to the regions.
This issue was discussed by Janet Schlueter of this staff during the
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Monthly Regional Conference Call conducted on April 4,1995.
Devices: SIEP_4Tr sion Line Source Holding Device) by Ohio Imaging (CAregistere nd FDA approved
- )
VANTAGE by ADAC, Inc'. Undergoing a CA and FDA device review.
Sources: Tc-99m (14-20 mci);
Gd-153 (75 mci); or Co-57 (25 mC1)
. Issue: As some of you are aware, Ohio Imaging (Picker) recently requested a sealed source and device review of a device used with SPECT imaging systems that contains either a Gd-153, Tc-99m or Co-57 sealed source. The request was submitted in a letter dated February 14, 1995, and is currently under review by David Tang of the Sealed Source Safety Section (SSSS). The completion of the device review will depend on the timely submission of information by Ohio Imaging.
Additionally, since this issue surfaced, the SSSS learned of a similar device referred to as VANTAGE, maufactured by ADAC, Inc. This device is currently undergoing a sealed source device review by the State of California and is under FDA review for a 501(K) approval.
4 It is our understanding through conversations with regional staff that at least one medical licensee has been authorized for the STEP device prior to i
the required regulatory review.
In conversation with ADAC, they indicated that "NRC had approved" the use of the VANTAGE device. Headquarters is not aware of such authorization or approval.
We have received guidance from OGC on this issue. As a result, No action is needed at this time for either device if currentl3 in use by medical licensees i
when identified through licensing and/or inspection. However, if identified, licensees should be informed of the need for an amendment request, which in turn, will entail a sealed source device review.
Device Description for STEP: (Information on VANTAGE is not available at this time). Basically, the source holding device is a shutter shield affixed to the rotating gantry of a triple headed scintillation camera patient imaging system.
Its purpose is to provide, during image acquisition, a photon beam of differing energy from that of the radiopharmaceutical administered to the
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patient that can be used to improve resolution losses normally experienced in i
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radionuclide tomography studies due to the non-uniform absorption
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The STEP device is manufactured by Ohi but the sources must be obtained by the licensee from some other manufacturer. As a result, Ohio d
i Imaging is not a 10 CFR 32.74 licensee and does not intend to become one.
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According to Steve Baggett, there are approximately 10 other manufacturers that are in the. process of manufacturing or marketing a similar device, and i
FDA currently has ~4 under review.
I Based on a preliminary review of the information by IMAB and SSSS, the device
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does not appear to fit either the " reference / calibration source" (10 CFR 35.57) or " sealed source for diagnosis" (10 CFR 35.500) categories.
- Rather, it should probably be licensed as a "line item" on the medical use license.
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1 NRC SORM 567 PAGE1 (6 23)
U. S. NUCLEAR REGULATORY COMMISSION REQUEST FOR A SEALED SOURCE OR N
DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of all felated letters /apphcations and drawings to:
OWFN Mail Stop 6 H3. Change the License Tracking System milestone to 19 and assign to reviewer code I-5.The Sealed Source NOTE: Retain a copy of this request with the application and background files, s.EouESTER REGION / LOCATION:
/( :FC
'O M *' C) i A 8)
]I 11 Ill IV V
HQ R LFDCB TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate)
APPLws NAME SOURCE REVIEW AMENDMENT OF REGISTRATION SHEET MAIL CONTROL NUMBER (S)
EVICE REVIEW
" O I)
LETTER /
ucENSE NVM CUSTOM REVIEW
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.te-e w c o s rfu c~d y %7f6 GWF C~&Y oe d & d * '1%i ch ct 9yas FOR SSSS USE ONLY f,EVIEWER MODEL NUMBERS NUMBER ASSaGHED bal Tag 3y sree 9'5- /9
^" " T / d / #
^"/i*/I"y/M
^"'j"/z7/u-T1(PE OF ACTION (Indicate the number of each type) 25] COMMERCIAL DISTRIBUTION (FOR_ MAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C)
DEVICE (9A)
SOURCE (90)
DEVICE (98)
NEW R NEW NEW
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NEW AMENDMENT AMENDMENT AMENDMENT AMENDMENT
] NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN NO FEES REQUIRED
,k NO
) OTHER (Specdy)
TOTAL NUMBER OF NOTES REVIEW HOURS
(,,.c[,
w pgg?)
NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY OsLLS FOR BILLING PURPOSES ONLY N
R GI ATION -
] PRODUCT INAWE -
NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY
]9A 98 BC 90 AMOUNT RECOVED CHECK NUMBER MATANN UPDATED AS REQUIRED DATE or cHCcK LOG
] MATSYS UPDATED AS REQUIRED APPROVED BY DATE RETURN DATF i
COMME NTS I
NRC FORM 567 (6 93)
ORIGINAL TO SSSS j
11
@ PICKER o
RBi?gw February 14,1995 j
Steven L Baggett,Section Chief
. U.S. Nuclear Regulatory Conunission Scaled SourceSafetySection
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Sourre Containment and Device Branch Division ofIndustrial and Medical Nuclear Safety, NMSS -
Washington,D.C. 20S55 0001
DearSir:
Attached in duplicate, please find a device review application prepared in die format described in USNRC Regulatory Guide 10.10 dated March,1987.
It is the intention of Picker-Ohio Imaging to reanufacture and distribute an accessory device not containing radioactive material, but designed to hold a sealed source J
manufactured by others. The device is designated by the model name STEP and is i
designed to be an image clarity accessory to Picker's various models of scintillation camera systems.
. The scaled sourtes to be used with STEP are presendy manufactured and distributed direct to specific licensees by Isotope Product Laboratories of Burbank, California.
Isotope Product Laboratories has submitted to the California Department of Health a.
sealed sourre(s) safety evaluation request.and has received registry number CA 406S16SS in ' reply.
Other manufacturers may in the future receive similar authorization to distribute scaled sources suitable for use in the STEP system.
In addition to sealed sources supplied to specific licensees by authorized vendors, the STEP system is designed to be used wiui Tc99sa as supplied by die STEP user himself in accordance with a specific license and per the provisions of 10CFR 35.57 or 10CFR 35.200, or equivalent state regulations.
Picker-Ohio Imaging has received permission to distribute STEP for medical hnaging purposes from the U.S. Department ofIIcalth and Human Services. A copy of an F.D.A.
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letter to this effect dated May 13,1994 is included in the application as Addendum #9.
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In accordance with 10CFR 2.790 (a)(4), it is requested that a portion of tids application be withheld from public disdosure on the grounds that release of certain proprietary information regarding the design and fabrication of STEP devices would do irreparable commercial harm to Picker-Ohio Imaging by providing competitors access to designs and fabrication procedures developed by Oldo Imaging at considerable cost.
In accordance with 10CFR 2.790 (b)(1), the following portions of the application are requested to be withheld from public disdosure:
' Addendum #2 Engineering Drawings Addendum #S QualityControl An affidavit is hereby submitted over my signature below. As Vice President and General Manager of Picker Ohio Imaging, I am on behalf of the company specifically delegated to review the attached application and select that portion for which withholding is requested.
in accordance with 10CFR 2.790 (b) (4), the following information is supplied:
10CFR 2.790 (b) (4) (1) - the engineering drawings and quality control procedures are considered proprietary by the company and held in confidence with release only on a need to know basis.
10CFR 2.790 (b) (4) (11) - the engineering drawings and quality control procedures for all new products such as STEP are normally held in confidence until such time that competitor's products reacidng the marketplace negate the need. Early release would deny Ohio Imaging a competitive advantage that took considerable time and expense to achieve.
10CFR 2.790 (b) (4) (iii) - the information contained in Addenda #2 and
- S of the application is hereby transmitted to the Commission in confidence.
10CFR 2.790 (b) (4) (iv)- the information contained in Addenda #2 and
- S is not available in public sources.
10CFR 2.790 (b) (4) (v) - public disclosme of the information found in Addenda #2 and #S would cause substantial harm to our competitive position in as much as it represents an expenditure of 4.S years in development at a cost approximating one million dollars that could be avolded by a competitor in developing his own product.
2
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In closing, it is requested that consideration be given to prompt review of dils application. We have already received firm orden for several STEP systems and anticipate many more. The medical imaging community is very enthusiastic over the potential improved cardiac studies made possible by STEP. NRC device approval remahls the sole impediment to full market accessibility.
l l
Appended are two (2)-drafts totalling 53,700.00 to be applied to review fees as i
presaibed in 10CFR 170.31 category 9A.
Thank you for your attention to this matter. If there is any way I or my Manager of Regulatory Affairs, Mr. Ron Martone, can do to assist you in your review, please do not hesitate to call. His direct telephone numberis (216) 473 7651.
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Sincerely, l
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(James M.Fdion l
Vice Prer%tand GeneralManager l
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Notary Public nt#Dt11. A. !JOTZEN. E00.
I tJatory FuSO. State of Oih Couaty of E*smmR BRy Commission Caos Ibt Ex$a
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r nm OHIO IMAGING 23060 MILES ROAD CHECM QCQO AA BEDFORD HTS., OHt0 44128-5443 NO.
GUUU 44 CHECM DATE CHECM AAAOWT 2/7/95 PAY EXACTLY One-Thousand, Seven-DOLLARS AND 00 CENTS 1,700.00 Hundred PAY TO THE 01110 IMAGING ORDER OF U.S. Nuclear Regulatory Commission
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23060 MILES ROAD CMECM QCQQ BEDFORD HTS.. OHIO 44128-5443 NO.
GUUU CHECM OATE CHECM AMOUNT 2/7/95 PAY EXACTLY Two-Thousand DOLLARS AND 00 CENTS 2,000.00 PAY TO THE OHIO IMAGING ORDER OF U.S. Nuclear Regulatory Commission se -
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i ORIGINAL PO DATE: 02/07/95 CONTRACT NUMBER:
CONTACT:
i VENDOR ID: 07467 SHIP TO:
j U.S. NUCLEAR REGULATORY COMM.
PICKER INTERNATIONAL DIV. OF FUEL CYCLE & MAT'L OHIO IMAGING s SAFETY MATERIAL LICENSING BRA.
23130 MILES RD.
WASHINGTON DC BEDFORD HTS.
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' ORDER BALANCE PROMISED UNIT EXTENDED T LNN DESCRIPTION UM REV QUANTITY DUE DOCK PRICE PRICE X 001 EA i
1 02/15/95 3700.00 3700.00 N
[3, APPLICATION FEE FOR STEP REGISTRAT.
ACCOUNT 1002-440-83-78017 REO NU 06352 STEP DEVICE REdISTRA-TION APPLICATION FEE l
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