Implant Sciences I-Plant Model 3500 (135)odine Brachytherapy Seed)-Sterile 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 turnors. 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. I-Plant Model 3500 Brachytherapy 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, breast 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 summary of the acceptance criteria and study information based on the provided text, focusing on the device "Implant Sciences 'I-plant' 125 Iodine Brachytherapy Seeds (Model 3500)":

Acceptance Criteria and Device Performance

The core of the "study" described for this device is centered around demonstrating substantial equivalence to existing predicate devices, particularly in safety and performance characteristics, rather than a clinical efficacy study with human outcomes.

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance
Physical Characteristics	Same titanium capsule material as predicate devices	"The Implant Sciences 135 Jodine Brachytherapy Seeds use the same titanium capsule material..."
	Same physical dimensions (length and diameter) as predicate devices	"...and are the same physical dimensions (length and diameter) as the predicate devices."
Activity Levels	Range of apparent activity levels similar to predicate devices	"The range of apparent activity levels is similar to that of the predicate devices."
Safety Testing (ANSI N43.6-1997 for Sealed Radioactive Sources)	Consistent results with predicate devices for various aspects.	"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." This implicitly covers: - Temperature resistance - External pressure resistance - Impact resistance - Vibration integrity - Puncture resistance (Explicitly stated: "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.")
Radiation Profile	Consistent with profiles of other Iodine-125 brachytherapy seeds with similar physical geometries.	"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 Iodine-125 brachytherapy seeds with similar physical geometries."
Capsule Leak Testing	Adherence to ANSI standards.	"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."
Sterilization & Biocompatibility	No new chemical or biological entities introduced to the surface from manufacturing/cleaning.	"The manufacturing and cleaning processes for the seeds introduce no new chemical or biological entities to the surface of the device." (Note: Device is provided non-sterile and must be sterilized by hospital). "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."

Study Details

1. Sample sized used for the test set and the data provenance:
- The document describes "in vitro studies" and "standardized studies" on the device itself, rather than human patient data. There is no mention of a "test set" in the context of patient data, nor country of origin or retrospective/prospective nature. The "sample size" would refer to the number of devices or components tested in the various engineering and safety assessments (e.g., how many seeds were tested for impact resistance), but this specific number is not provided.
- Data Provenance: The studies were internal company studies ("summaries of in vitro studies which were conducted to evaluate the safety, and appropriateness of the ISC Model 3500 Brachytherapy Seeds" and "standardized studies which describe the radiation profile").
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the traditional sense of a clinical ground truth. The "ground truth" for the performance criteria (e.g., meeting ANSI standards, physical dimensions) would be established by the specifications of the standards themselves and the measurable properties of the device, likely assessed by qualified engineers and quality control personnel within the company or a testing laboratory. No specific number or qualifications of such "experts" are listed in this summary.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to human interpretation of medical images or data. The "test set" here refers to the device and its components undergoing engineering and physical performance tests.
4. 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:
- No, a MRMC comparative effectiveness study was not done. This device is a radioactive implant, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for this submission is based on engineering standards and direct physical measurements of the device's properties (e.g., dimensions, material composition, radiation output, resistance to physical stressors) as per recognized standards like ANSI/HPS N43.6 - 1997. The ultimate "ground truth" for regulatory clearance is substantial equivalence to legally marketed predicate devices.
7. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
8. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

General Company Information

DEC 0 4 2002

Name:	Implant Sciences Corporation
-------	------------------------------

MAR 2 1 2000

107 Audubon Road, #5 Address: Wakefield, MA 01880-1246

(781) 246 - 0700 Telephone: (781) 246 - 1167 Fax:

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

Implant Sciences, Inc. I-Plant™ I-125 Brachytherapy Seeds (Model 3000) 1510(k) K990193]

Medi-Physics, Inc. (Amersham) 1-125 Seeds (No. 6711) [510(k) K9142811

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 145 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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$\qquad K_{0}23242$

page 2 of 2

Technological Characteristics Versus Predicate Devices

The Implant Sciences 135 Jodine 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 125 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 regulations. 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 salisfy 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 155 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right. The profiles are connected and appear to be emerging from a single form.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023242

Trade/Device Name: I-Plant Model 3500 (125 Iodine Brachytherapy Seeds)-Sterile Regulation Number: 21 CFR 892.5730 . Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: November 5. 2002 Received: November 6, 2002

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, 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 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 this 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" (21 CFR Part 807.97). 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/cdrl/dsma/dsmamain.html.

Sincerely yours,

Henry C. Snoddon

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:

Device Name: Implant Sciences Corp. I-Plant Model 3500 (123 odine Brachytherapy Seed)-Sterile

Indications for Use:

(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)

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

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K023742

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.