SEEDLINKS, MODELS 70301, 70302, 70303

K023210 · Sourcetech Medical, LLC · KXK · Mar 28, 2003 · Radiology

Device Facts

• Record ID: K023210
• Device Name: SEEDLINKS, MODELS 70301, 70302, 70303
• Applicant: Sourcetech Medical, LLC
• Product Code: KXK · Radiology
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeedLinks™ are indicated for use in brachytherapy source spacing and linking in brachytherapy procedures.

Device Story

SeedLinks (Models 70301, 70302, 70303) are medical devices used for spacing and linking radioactive sources during brachytherapy procedures. The device facilitates the precise positioning of brachytherapy seeds within the target tissue. Used by clinicians in a clinical or hospital setting during radiation therapy. The device aids in maintaining consistent source geometry, which is critical for delivering the prescribed radiation dose to the tumor while sparing surrounding healthy tissue.

Clinical Evidence

Bench testing only.

Technological Characteristics

Radionuclide brachytherapy source accessory; used for spacing and linking seeds; Class II device; 21 CFR 892.5730.

Indications for Use

Indicated for use in brachytherapy source spacing and linking during brachytherapy procedures. No specific patient population, 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

MAR 2 8 2003

Mr. David T. Sieracki QA Manager SourceTech Medical, L.L.C. 295 E. Lies Road CAROL STREAM IL 60188-9421 Re: K023210

Trade/Device Name: SeedLinks Models 70301, 70302, and 70303 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: January 2, 2003 Received: January 3, 2003

Dear Mr. Sieracki:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

. .....

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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1023210

SourceTech Medical, L.L.C., SeedLinks™, Model #: 70301, 70302, 70303 510(k) Application

## SECTION D: STATEMENT OF INDICATIONS FOR USE

| Applicant: | SourceTech Medical, L.L.C. |
|----------------|----------------------------|
| 510(k) Number: | K023210 |
| Device Name: | SeedLinks™ |

The SeedLinks™ are indicated for use in brachytherapy source spacing Indications for use: and linking in brachytherapy procedures.

Nancy C. Broado
D
(Division Sign-Ofm
Division of Reproductive, Abdental,
and Radiological Devices

*Prescription Use*