(203 days)
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.
Implant Sciences Seed Link, containing Implant Sciences 125Iodine 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.
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".
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.
The provided document is a 510(k) summary for the Seed Link brachytherapy source. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not present in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria and reported device performance in the context of a dedicated performance study. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device(s).
The key "performance" aspect mentioned is that the Seed Link "is designed to pass freely through an 18 Gauge thin-walled implant needle (which has an inside diameter of 0.041 inch (1.04 mm))." However, no specific acceptance criteria (e.g., success rate, force required) or detailed study results demonstrating this ability are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a performance study with a test set. This is a 510(k) submission, which focuses on substantial equivalence rather than a clinical trial or a standalone performance study with a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no mention of a test set or ground truth established by experts in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a brachytherapy source, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device (brachytherapy source) and not an algorithm.
7. The Type of Ground Truth Used
Not applicable. The document does not describe a study involving ground truth in the context requested (e.g., expert consensus, pathology, outcomes data). The "ground truth" for a 510(k) is typically the performance and characteristics of the legally marketed predicate device(s).
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/algorithm-based device, there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
Summary of Device and its Claimed Equivalence:
- Device Name: Seed Link
- Manufacturer: Implant Sciences Corp.
- Intended Use: Treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation.
- Technological Characteristics: An assembly of I-Plant Model 3500 interstitial brachytherapy seeds, titanium sleeves, and bioresorbable polymer spacers. Designed to maintain specified spacing between seeds and pass through an 18 Gauge thin-walled implant needle.
- Predicate Devices:
The 510(k) submission asserts that Seed Link is substantially equivalent to these predicate devices based on its intended use and technological characteristics. The provided text details the device's design and mechanism but does not present a formal study with acceptance criteria and results as typically found for diagnostic or screening devices.
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Kø23ø73
Attachment F 510(k) Summary
Section 807.92(a)
| (1) | Submitter | Implant Sciences Corp.107 Audubon Road #5Wakefield, MA 01880 | Tel: | 781.246.0700Fax: 781.246.1167 | |||
|---|---|---|---|---|---|---|---|
| Establishment Registration No.: | 1226547 | ||||||
| Contact Person: | John J. Munro IIIVice President, Brachytherapy Productse-mail: jmunro@implantsciences.com | ||||||
| (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 under510(k) number K940632 dated 2 September 1994, andIBT, Inc. Interstrand 125, cleared under 510(k) numberK011155 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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K$\phi$23$\phi$73
(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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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 |
|---|---|
| --------------- | --------- |
§ 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.