NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633

K973363 · Ml Strategies, Inc. · IWI · Jul 2, 1998 · Radiology

Device Facts

• Record ID: K973363
• Device Name: NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
• Applicant: Ml Strategies, Inc.
• Product Code: IWI · Radiology
• Decision Date: Jul 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The North American Scientific Corporation's Pd-103 Radionuclide Brachytherapy Source is a device intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions.

Device Story

Pd-103 Radionuclide Brachytherapy Source delivers localized radiation therapy for malignant lesions. Device utilizes Palladium-103 isotope as radiation source; applied interstitially, intracavitarily, or via surface contact. Used by clinicians in oncology/radiology settings to treat tumors. Radiation emission provides therapeutic effect by damaging malignant cell DNA. Device is a sealed source; requires professional handling and placement by trained medical personnel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radionuclide brachytherapy source containing Palladium-103. Sealed source design for interstitial, intracavity, or surface application. Class II device (21 CFR 892.5730).

Indications for Use

Indicated for the treatment of malignant lesions via interstitial, intracavity, or surface radiation application. No specific age or gender restrictions provided.

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

- 2 1998 ..............................................................................................................................................................................

North American Scientific, Inc. c/o Alian M. Green, M.D., Ph.D., J.D. ML Strategies, Inc. One Financial Center Boston, MA 02111

Re:

K973363 PD-103 Radionuclide Brachytherapy Source Dated: April 22, 1998 Received: April 23, 1998 Regulatory class: II 21 CFR 892.5730/Procode: XKX

Dear Dr. Green:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal. Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 requirements, 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 542 of the Act for devices under the Electronic Product 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 questions on the promotion 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/dsmaddsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

Number (If know) : Not Known 5 10(k.

I Device Name :

Pd-103 Radionuclide Brachytherapy Source

Indica ions For Use :

The North American Scientific Corporation's Pd-103 Radionuclide Brachytherapy Source is a device intended to deliver radiation by interstitial, intracavity or surface application for therapy of malignant lesions.

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(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Prescription Use . (Per 21 CFR 801.109)