SEED LINK

K023073 · Implant Sciences Corp. · KXK · Apr 7, 2003 · Radiology

Device Facts

• Record ID: K023073
• Device Name: SEED LINK
• Applicant: Implant Sciences Corp.
• Product Code: KXK · Radiology
• Decision Date: Apr 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of Implant Sciences Corp. Seed Link is for the treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

Device Story

Seed Link is a radionuclide brachytherapy source assembly; integrates multiple I-Plant Model 3500 interstitial brachytherapy seeds into a single assembly to maintain precise spacing during treatment. Components include I-Plant 3500 seeds, titanium sleeves, and bioresorbable polymer spacers. Assembly is designed for delivery through an 18-gauge thin-walled implant needle. The device is used by clinicians for cancer treatment via interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation. The assembly length and seed spacing are customizable based on clinical requirements (2 to 6 seeds; spacing up to 50 mm). The device provides localized radiation to tumors, potentially benefiting patients by enabling precise, consistent seed placement during brachytherapy procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, technological characteristics, and comparison to legally marketed predicate devices.

Technological Characteristics

Radionuclide brachytherapy source assembly. Components: I-Plant Model 3500 seeds, titanium sleeves, bioresorbable polymer spacers. Form factor: linear assembly for 18-gauge needle delivery. Energy source: I-125 radionuclide. Sterilization: provided sterile. No software or electronic components.

Indications for Use

Indicated for temporary or permanent interstitial, intracavitary, intraluminal, intraoperative, or surface treatment of localized tumors. Applicable to prostate cancer, unresectable tumors, or residual disease post-excision. May be used concurrently or sequentially with external beam therapy, hyperthermia, or chemotherapy. Sites include head, neck, lung, pancreas, prostate, breast, and other accessible tumors.

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.

Predicate Devices

• Nycomed Amersham I-125 Rapid Strand (K940632)
• IBT, Inc. Interstrand 125 (K011155)

Reference Devices

• I-Plant Model 3500 interstitial brachytherapy seed (K994317)

Submission Summary (Full Text)

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Kø23ø73

Attachment F 510(k) Summary

Section 807.92(a)

| (1) | Submitter | Implant Sciences Corp.<br>107 Audubon Road #5<br>Wakefield, MA 01880 | | | Tel: | 781.246.0700<br>Fax: [phone] | |
|-----|------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------|-----------------------------------|--|
| | | Establishment Registration No.: | | | 1226547 | | |
| | | | Contact Person: | | John J. Munro III<br>Vice President, Brachytherapy Products<br>e-mail: [e-mail] | | |
| (2) | Device Name: | | | | | | |
| | Classification Name: | Radionuclide Brachytherapy Source (892.5730) (KXK) | | | | | |
| | Common or Usual Name: | Brachytherapy Source Assembly | | | | | |
| | Proprietary Name: | Seed Link | | | | | |
| (3) | Legally Marketed Predicate Device: | | Nycomed Amersham I-125 Rapid Strand, cleared under<br>510(k) number K940632 dated 2 September 1994, and<br>IBT, Inc. Interstrand 125, cleared under 510(k) number<br>K011155 dated 12 July 2001, and | | | | |

## (4) Description of Seed Link:

Seed Link is a radionuclide brachytherapy source designed to incorporate a number of individual brachytherapy "seeds" into an integral assembly, and to maintain the specified spacing between the seeds during treatment. Seed Link incorporates the I-Plant Model 3500 interstitial brachytherapy seed, which has been previously cleared for marketing under 510(k) number K994317. Seed Link is an assembly of I-Plant 3500 interstitial brachvtherapy seeds, sleeves and spacers designed to pass freely through an 18 Gauge thin-walled implant needle (which has an inside diameter of 0.041 inch (1.04 mm)). The length of the assembly is determined by the number of seeds to be joined and the spacing required between seeds. As a minimum, an assembly would contain two seeds and a spacing of 5.5 mm, resulting in an overall length of 14.5 mm. As many as six seeds may be incorporated into an assembly, and the spacing between seeds may be as large as 50 millimeters. The Seed Link shell and sleeve subassembly may also be supplied without attached spacers as individual "seeds".

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## (5) Intended Use

The intended use of Implant Sciences Corp. Seed Link is for the treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

- Technological Characteristics: (6)
Implant Sciences' Seed Link 1231odine Brachytherapy Seed Assembly is a radionuclide brachytherapy source designed to incorporate a number of individual brachytherapy "seeds" into an integral assembly, and to maintain the specified spacing between the seeds during treatment. Seed Link incorporates the I-Plant Model 3500 interstitial brachytherapy seed into a titanium sleeve, which is coupled to other seeds by means of a bioresorbable polymer spacer. Seed Link is provided sterile.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 7 2003

Mr. John J. Munro III Vice President, Brachytherapy Products Implant Sciences Corporation 107 Audubon Road, #5 WAKEFIELD MA 01880-1246

Re: K023073

Trade/Device Name: SeedLink™ Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: January 10, 2003 Received: January 13, 2003

Dear Mr. Munro:

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. Drue, 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. Iisting 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

Enclosure

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510(k) Number

Kd 23ø73

Implant Sciences Seed Link Device Name:

Indications for Use:

Implant Sciences Seed Link, containing Implant Sciences 12510dine Brachytherapy Seeds with individual activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment, such as for prostate cancer or for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors. Seed Link may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

| (Division Sign-Off) | |
|---------------------|--|
|---------------------|--|

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K023073 |
|---------------|---------|
|---------------|---------|