(132 days)
The North American Scientific Corporation's I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant lesions.
I-125 Radionuclide Brachytherapy Source Model MED3631-A
This document is a 510(k) premarket notification letter from the FDA regarding an I-125 radionuclide brachytherapy source. As such, it does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.
The letter approves the device based on substantial equivalence to a predicate device, meaning it was determined to be as safe and effective as a device already legally marketed. It does not provide data from a specific study designed to prove new acceptance criteria for this particular device.
Therefore, I cannot provide the requested information, which typically would be found in a clinical study report or a detailed performance validation report:
- Table of acceptance criteria and reported device performance: Not present in this document.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable or present for this type of device (a brachytherapy source, not an AI diagnostic tool).
- Standalone (algorithm only) performance: Not applicable or present.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (no AI/machine learning involved).
- How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 1997
L. Michael Cutrer President, North American Scientific 7435 Greenbush Avenue North Hollywood, CA 91605
Re: K972271 I-125 Radionuclide Brachytherapy Source Model MED3631-A Dated: September 12, 1997 Received: September 15, 1997 Regulatory Class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Mr. Cutrer:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the including for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). . You may, therefore, subject __ to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
501 (k) Number (If know) :
Not Applicable
Device Name :
Indications For Use :
I-125 Radionuclide Brachytherapy Source Model MED3631-A
The North American Scientific Corporation's I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . lesions.
Signature
Signature
L. Michael Cutrer Printed Name
President Title
June 9, 1997 Date
David A. Lessem
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.