ML20212G452
| ML20212G452 | |
| Person / Time | |
|---|---|
| Issue date: | 08/08/1996 |
| From: | Michele Burgess NRC |
| To: | NRC |
| Shared Package | |
| ML20212G311 | List: |
| References | |
| SSD, NUDOCS 9711060183 | |
| Download: ML20212G452 (1) | |
Text
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UNITED STATES i
B Nu^ LEAR REGULATORY COMMISSION WASHINGTON o.C. 2065H21
'%.....,5 NOTE TO:
SSD96-16 (ELSCINT MODEL TRANSACT)
FROM:
MICHELE L. BURGESS 7t.'f DATE:
AUGUST 8,1996 RE:
A bend test was not required due to the fact that the source should not experience bending dur qg use and installation. During use, the sources remain in a rod source holdei.2nd do not leave the device. During installation, the shipping container that the source is shipped from the source manufacturer in is screwed to the source cavity of the device. The source, mounted in its metal holder, is pushed from the shipping container into the device. the alignment of the shipping container and the device prevents any bending of the source during the installation process.
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NUCLEAR REGULATORY COMMISSION
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WASHINGTON, D.C. 20666 4 001 August 7, 1996 Robert Popilock Nuclear Medicine Production Mgr.
Elscint, Inc.
505 Main Street Hackensack, NJ 07601 l
Dear Mr. Popilock:
This letter is in response to your application dated March 15,1996, requesting registration of Models CTACT and VTACT Gadolinium 153 line source housings. We are in the process of performing a safety evaluation for the device. However, in order to continue our evaluation, the following information is necessary:
y1.-
The applicatio. includes sections that are marked as proprietary. Please be aware that you may request that certain portions of your submittal to NRC be withheld from public disclosure as proprietary ir, formation. To do this, vou must execute an affidavit as specified in 10 CFR 2.790. You must list all portions that you wish to be held proprietary, along with your reasoning as to why that is appropriate..While it is y
allowable. please refrain from submitting proprietary ' information in support of a registration unless necessary. Keep in mind that all registration certificates in the Sealed Source and Device Registry, and all NRC licenses are considered to be in the public domain, and are therefore may be viewed by any member of the public who requests to see them.
2.
Your application references both the models CTACT and VTACT. 'In addition, your facsimile dated August 2,1996, references a model Transact. Please describe the relationship and differences between these models.
<3.
There are some discrepancies in the part names and drawing numbers referenced in your application. For example, page 7 of your application references a drawing in
- Appendix A, "473-3671-1602, Source Holder Assembly". Referring to Appendix A, the title for that drawing number is "TE SOURCES 1". Please provide the correct title and drawing number.' In addition, some drawings in Appendix C reference a drawing number 473-3671-16, and other. drawings referocce a drawing number 473-3671-160.
Please discuss this apparent discrepancy.
7 v4.
Pages 1 and 2 of your application states that the device can contain North American
. Scientific models 3601 through 3620. The copy of the facsimile dated January 15,
~ 1996, (ir Npendix H of your application) from North American Scientific to Elscint, indicates that the device contains only the model 3604. Please discuss this apparent discrepancy.
5.
Please provide additional drawings which clearly show the dimensions and materials' of the source housing. These should include clear drawings which illustrate the cavity' in which the source is mounted and the details of the source / solenoid interfaces and the source shipping container / source housing interface. Any reference to part numbers or part names should be consistecit and clearly indicated, n / s pC w ~ i iO LfWVDV[WNS g
R Popilock 2
i 6.
Please indicate the location of the source on/off indicator and the manual switch.
l
' 7.
In addition to the information submitted, the device label should include the model and I i
an identification of the manufacturer or distributor. Please indicate the materials of construction and method of attachment for the label. Please be aware that the placement of the device label must be such that it can be easily seen while the device is in its installed position and while in use, v 8.
Please define the term "ET mode".
/$.
Please indicate whether the source housing has a 510k approval from the Food and Drug Administration?
l
- 10.
The prototype testing information submitted in your application is only for the source and its operability. You also need to discuss the testing or engineering evaluation performed on the source housing design to ensure that during normal use conditions,-
over the expected lifetime of the housing, the byproduct material will not be released to the environment, and the source will not be inadvertently unshielded. The tests,
typically include shutter function, drop, puncture, and vibration. If more than one source proposed for use in the device, please specify which source was used in the-prototype testing, and provide justification of why the results obtained with that source l
are applicable to all other proposed sources.
c 11.
Please provide details concerning the typical usage of the device for the worker, the estimated dose associated with these activities, and the expected frequency that the activity will be performed. Your discussion should include normal operation and maintenance. service, source exchanges, and user removing and storing the source housing. Please provide the dose rate at the surface,5 cm, and 30 cm from the source shipping container.
s12.
Please confirm that there will be no adverse affects to the adhesive used to secure
_.the source to the aluminum rod due to environmentaal conditions or radiation dose over the lifetime of the source assembly. Please provide drawings, with dimensions, of the aluminium rod.
13.
Please describe a typical patient procedure and provide a dose estimate.
14.
Please provide a copy of the complete user's manual.
1E Your application included a written set of directions for installing the source into the source holder. In step 7 of the procedures, the source and plastic rod are attached to the solenoid by screwing it into the solenoid in a CW direction. In the following step, the plastic rod is removed from the source by unscrewing in a CCW direction. What prevents the source from being unscrewed from the solenoid during this process?
4 16.
Page 3 of your application lists the labeling information for the device and source.
Please note that according to the registration certificate issued for the source, the source is also labeled with the isotope. Please correct your application as appropriate.
1-
R. Popilock 3
- p 22.
Your rpplic tion contains s v:ral r;f:r:ncis to s:rvicing and maintenrnce stat:s that these operations can only be performed by 'Elscint quahfied personnel." ? lease note that the NRC requires only that these operations be performed by entities that are licensed by the NRC or an Agreement State to perform such services, and that the NRC can not require the user to use a particular company.
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)6 23.
Please indicate whether Elscint has a service license or whether you will work under #
the user's license.
M.
Page 5 of your application refers to an ISO 90001 standard Should this be 90017 If not, please submit a copy of the standard for reference.
f 25'..
A Please provide additional details concerning the;QC, including steps taken to assure that the device is manufactured and distributed according to the statements made in support of your application, and details of the receipt inspection program performed at the New Jersey facihty and at the customer's site. This should describe any tests or checks performed. For tests such as shutter reliability and power failure, please indicate how many times the test is performed on each device, and what the minimum cnterion is for passing the test.
M6.
Your application indicates that the leak test frequency will be 6 months. Please be aware that the on/off indicator must also be tested on some frequency. We are continuing review of the application on the assumption that the on/off test frequency will also be 6 months. If this is incorrect, please provide sufficient information to support a longer frequency.
Please provide the requested information within thirty (30) days of the date of this letter. If you have any questions, please contact me at (501) 415-5868 or Mr. Steven Baggett at (301) 415-7273.
Sincerely,
/s/
Michele L. Burgess, Mechanical Engineer Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and S afeguards Distribution:
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