125-IMPLANT SEEDS, MODEL STM1250

K991881 · Sourcetech Medical, LLC · KXK · Mar 16, 2000 · Radiology

Device Facts

• Record ID: K991881
• Device Name: 125-IMPLANT SEEDS, MODEL STM1250
• Applicant: Sourcetech Medical, LLC
• Product Code: KXK · Radiology
• Decision Date: Mar 16, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. 125 mplant Seeds may be used in superficial, intraabdominal or intra-thoracic locations. 125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.

Device Story

I-125 Implant Seeds are radioactive brachytherapy sources used for permanent interstitial treatment of localized tumors. Seeds are implanted directly into tumor tissue to deliver localized radiation therapy. Used in clinical settings by physicians (oncologists/radiologists) for treating head, neck, lung, pancreatic, and prostate cancers. Output is localized ionizing radiation to induce tumor cell death. Benefits include targeted radiation delivery to tumor sites while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Radioactive I-125 implant seeds for interstitial brachytherapy. Class II device (21 CFR 892.5730).

Indications for Use

Indicated for permanent interstitial brachytherapy of localized tumors including head, neck, lung, pancreas, and early-stage prostate. Applicable for superficial, intra-abdominal, or intra-thoracic locations, and treatment of residual or recurrent tumors post-external beam radiation.

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

MAR 1 6 2000

David T. Sieracki Quality Assurance Manager SourceTech Medical, L.L.C. 295 E. Lies Road Carol Stream, IL 60188

Re:

K991881 I-125 Implant Seeds, STM 1250 Dated: December 22, 1999 Received: December 27, 1999 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK

Dear Mr. Sieracki:

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 legally marketed predicate devices marketed in interstate commerce pror 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 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 (QS) 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 requlation may result in requlator. 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 yitr 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## SECTION D: STATEMENT OF INDICATIONS FOR USE

Applicant:

510(k) Number:

Device Name:

SourceTech Medical, L.L.C.
K991881

125 Implant Seeds

Indications for use:

125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. 125 mplant Seeds may be used in superficial, intraabdominal or intra-thoracic locations. 125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.

**Prescription Use**
(Per 21 CFR 801.109)

David A. Symm

Division Sign-Off Division of Reproductive. Ahdominal. F and Radiological 510(k) Number