The Implant Sciences 125 lodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The 155 lodine Seeds 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 and other accessible tumors are commonly treated.

Device Description

The Implant Sciences 125 lodine (Model 3500) Brachytherapy Seeds consist of a laser welded titanium capsule containing a silica capillary tube that serves as a substrate for the radioactive iodine source. The tube is positioned around a silver radiopaque x-ray marker that identifies the source location and orientation. The seeds are provided non-sterile and must be sterilized prior to use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Implant Sciences "I-plant" 125 Iodine Brachytherapy Seeds (Model 3500) based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance that would typically be seen in studies evaluating diagnostic accuracy or prognostic prediction. Instead, the "acceptance criteria" are implied by the requirements of the ANSI Standard for Sealed Radioactive Sources (ANSI/HPS N43.6 - 1997) and the demonstration of substantial equivalence to predicate devices. The reported device performance is that the device meets these requirements and is consistent with or equivalent to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Safety testing per ANSI/HPS N43.6 - 1997 (including temperature resistance, external pressure resistance, impact resistance, vibration integrity, puncture resistance).	Results are consistent with predicate devices and satisfy performance requirements for temperature resistance, external pressure resistance, impact resistance, vibration integrity, and puncture resistance as specified by ANSI Standard N43.6-1997. Results confirm that the ISC 125 Iodine (Model 3500) Brachytherapy Seeds meet the requirements for radioactive sources in its class.
Radiation profile consistency with similar brachytherapy seeds.	Standardized studies describe the radiation profile of the sources, and these profiles are consistent with data generated from other Iodine-125 brachytherapy seeds with similar physical geometries.
Capsule leak testing compliance with ANSI standards.	Capsule leak testing was carried out in accordance with ANSI standards. The results support the equivalence of the ISC Model 3500 device to the predicate devices.
Material safety and history of use.	The materials from which the Implant Sciences device is fabricated have an established history of use in medical applications, and the specific materials used by Implant Sciences have been thoroughly tested in accordance with applicable guidelines.
Equivalence in design and function to predicate devices.	The device uses the same titanium capsule material and has the same physical dimensions (length and diameter) as predicate devices. The range of apparent activity levels is similar. The device is substantially equivalent in design and function to the specified predicate devices.

Note: The "acceptance criteria" here are based on engineering and safety standards for the device itself, rather than a clinical performance metric like sensitivity or specificity for a diagnostic device.

Study Information

The provided text describes in vitro studies and comparisons to predicate devices, but not a clinical study with human subjects, a test set, or expert-established ground truth in the context of diagnostic or prognostic performance. The focus is on demonstrating physical and functional equivalence and safety according to engineering standards.

Here's what can be extracted based on the document:

Sample size used for the test set and the data provenance: Not applicable in the traditional sense of a clinical test set. The data provenance is related to in vitro studies and standardized tests performed by the manufacturer. The document doesn't specify sample sizes for these in vitro tests (e.g., how many seeds were tested for impact resistance).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is compliance with engineering standards (ANSI/HPS N43.6 - 1997) and consistency with known properties of similar devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a brachytherapy seed, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's evaluation is primarily adherence to established engineering and safety standards for sealed radioactive sources (ANSI/HPS N43.6 - 1997) and comparison to the known characteristics and performance of legally marketed predicate devices.
The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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K994317
Page 1 of 2

SUMMARY OF SAFETY AND EFFECTIVENESS

General Company Information

Name:	Implant Sciences Corporation
Address:	107 Audubon Road, #5Wakefield, MA 01880-1246
Telephone:	(781) 246 - 0700

(781) 246 — 1167

General Device Information

Product Name:	Implant Sciences "I-plant" 125 Iodine Brachytherapy Seeds (Model 3500)
Classification:	Brachytherapy Radionuclide Source, 21 CFR 892.5730 - Class II

Predicate Devices

Fax:

lmplant Sciences, Inc. I-Plant™ I-125 Brachytherapy Seeds (Model 3000) [510(k) K990193]

Medi-Physics, Inc. (Amersham) I-125 Seeds (No. 6711) [510(k) K914281]

Description

Intended Use

The Implant Sciences 125 Iodine (Model 3500) Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or surface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The 155 lodine Seeds 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 and other accessible tumors are commonly treated.

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K994317
Page 2 of 2

Technological Characteristics Versus Predicate Devices

The Implant Sciences 155 lodine Brachytherapy Seeds use the same titanium capsule material and are the same physical dimensions (length and diameter) as the predicate devices. The range of apparent activity levels is similar to that of the predicate devices. The results of safety testing in accordance with the ANSI Standard for Sealed Radioactive Sources (ANSI/HPS N43.6 - 1997) are consistent with the test results for the predicate devices.

Substantial Equivalence

This 510(k) Notice supports the position that the Implant Sciences 155 lodine (Model 3500) Brachytherapy Seeds are substantially equivalent in design and function to the Implant Sciences (Model 3000) 125 lodine Brachytherapy Seed [510(k) K990193] and the Medi-Physics, Inc. (Amersham) I-125 Seeds (No. 6711) [510(k) K914281], which are brachytherapy radionuclides that have previously been cleared for marketing under the Premarket Notification requlations. These devices have been placed in the same classification category (21 CFR 892.5730) as the ISC Model 3500 seeds; and each is indicated for the same clinical application.

The 510(k) Notice contains summaries of in vitro studies which were conducted to evaluate the safety, and appropriateness of the ISC Model 3500 Brachytherapy Seeds. Data are presented which demonstrate that the Model 3500 seeds satisfy performance requirements for temperature resistance, external pressure resistance, impact resistance, vibration integrity, and puncture resistance as specified by ANSI Standard N43.6-1997. These test results confirm that the ISC 125 lodine (Model 3500) Brachytherapy Seeds meet the requirements for radioactive sources in its class and are equivalent to other currently marketed radionuclide brachytherapy sources. The 510(k) Notice also describes further standardized studies which describe the radiation profile of the sources. These profiles are consistent with the data generated from other lodine-125 brachytherapy seeds with similar physical geometries. In addition, capsule leak testing was carried out in accordance with ANSI standards. The results of these studies also support the equivalence of the ISC Model 3500 device to the predicate devices.

Both the Model 3500 device and the predicate devices are provided non-sterile and must be sterilized by autoclave or ethylene oxide at the hospital prior to use. The manufacturing and cleaning processes for the seeds introduce no new chemical or biological entities to the surface of the device.

Implant Sciences believes that the information provided establishes that similar predicate devices have been used historically for the same types of clinical applications as the Implant Sciences 145 lodine (Model 3500) Brachytherapy Seeds. The materials from which the Implant Sciences device is fabricated have an established history of use in medical applications, and the specific materials used by Implant Sciences have been thoroughly tested in accordance with applicable guidelines.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2000

Howard L. Schrayer Implant Sciences Corp. 107 Audubon Road #5 Wakefield, MA 01880-1246 Re:

K994317 I-plant Model 3500 (125-Iodine Brachytherapy Seeds) December 21, 1999 Dated: Received: December 22, 1999 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK

Dear Mr. Schrayer:

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 26, 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 practice, labeling, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication 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 classfication 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for question 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 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K994317

Device Name: Implant Sciences 125 lodine Brachytherapy Seeds - (Model 3500)

Indications For Use:

The Implant Sciences 125 lodine Brachytherapy Seeds with activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial or intracavity implantation or sufface application to treat selected localized tumors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual treatment (each as is is in the 135 lodine Seeds may be 135 lodine Seeds 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 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 (Per 21 CFR 801.109)

Over-The-Counter Use

David C. Bergman

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number

(Optional Format 1-2-96)

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.