SEEDLINKS, MODELS 70301, 70302, 70303

• K Number: K023210
• Device Name: SEEDLINKS, MODELS 70301, 70302, 70303
• Manufacturer: SOURCETECH MEDICAL, L.L.C.
• Date Cleared: 2003-03-28 ( 183 days)
• Product Code: KXK
• Regulation Number: 892.5730
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: K113210

Intended Use

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

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets them in the format requested. The document is a 510(k) clearance letter from the FDA, which confirms that the SeedLinks™ device is substantially equivalent to a legally marketed predicate device.

Specifically, the text does not include:

• A table of acceptance criteria and reported device performance.
• Details about the sample size used for the test set or its data provenance.
• Information about the number or qualifications of experts used for ground truth.
• The adjudication method.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on the regulatory clearance and the intended use of the device, which is "for use in brachytherapy source spacing and linking in brachytherapy procedures." It confirms that the device is classified as a radionuclide brachytherapy source (21 CFR 892.5730, Class II, Product Code 90 KXK) and can be marketed based on its substantial equivalence to a predicate device, subject to general and special controls.

Summary

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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

Regulation Number and Section

§ 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.