NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A

K972271 · Ml Strategies, Inc. · KXK · Oct 28, 1997 · Radiology

Device Facts

• Record ID: K972271
• Device Name: NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
• Applicant: Ml Strategies, Inc.
• Product Code: KXK · Radiology
• Decision Date: Oct 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

I-125 Radionuclide Brachytherapy Source Model MED3631-A is a radioactive source used for brachytherapy. Device delivers localized radiation to malignant lesions via interstitial, intracavity, or surface application. Used by clinicians in oncology or radiology settings to treat cancer. Output is ionizing radiation; clinical decision-making relies on physician assessment of tumor location and radiation dose requirements. Benefits include targeted radiation delivery to malignant tissue while minimizing exposure to surrounding healthy structures.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory classification and intended use.

Technological Characteristics

I-125 radionuclide brachytherapy source. Form factor designed for interstitial, intracavity, or surface application. Device functions as a sealed radioactive source. No software or electronic components.

Indications for Use

Indicated for the delivery of radiation via interstitial, intracavity, or surface application for the treatment of malignant lesions in patients requiring brachytherapy.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

K972271

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)