Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment for residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

Device Description

The Imagen isoSTARTM I-125 Interstitial Seed, Model IS-12501 uses 131 spheres encapsulated in a titanium tube.

AI/ML Overview

Here's an analysis of the provided text regarding the Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, focusing on acceptance criteria and study details.

Based on the provided 510(k) summary (K991526), this device is a medical implant (brachytherapy seed) and not an AI or software-as-a-medical-device (SaMD). Therefore, most of the requested information regarding AI device acceptance criteria, study design, and ground truth is not applicable. The regulatory pathway for this device is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria through clinical studies in the way an AI/SaMD would.

However, I can extract the relevant information from the provided document as it pertains to medical device approval, even without a direct AI component.

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI medical devices like brachytherapy seeds, "acceptance criteria" are generally related to demonstrating substantial equivalence to existing predicate devices in terms of safety and effectiveness, and meeting relevant performance standards. The provided document doesn't list explicit, quantifiable acceptance criteria in the way a diagnostic AI algorithm might (e.g., "sensitivity > 90%"). Instead, the acceptance is based on demonstrating comparable characteristics and safety/biocompatibility.

Acceptance Criteria (Demonstrated)	Reported Device Performance (as stated in the submission)
Technological Characteristics: Uses same type of encapsulation of I-125 as predicate devices.	"The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, uses the same type of encapsulation of 125I as predicate devices."
Range of Activity: Similar to other devices.	"The range of activity is similar to other devices."
Biocompatibility: No biocompatibility differences compared to predicate devices.	"There are no biocompatibility or other safety and effectiveness differences between this device and other predicate devices."
Safety and Effectiveness: Safe and effective, substantially equivalent to other predicate devices.	"The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, has been tested for safety and biocompatibility by standard tests used for radionuclide devices and found to safe and effective and substantially equivalent to other predicate devices."
Intended Use: For permanent interstitial implantation in selected localized tumors (prostate, head, neck, lung, pancreas, etc.).	The device's stated "Indications for Use" directly align with this.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable in the context of an "AI test set."
For this type of device, the "testing" refers to bench testing for safety (e.g., radiation leakage, physical integrity) and biocompatibility, not performance on a dataset of patient cases. The document states "has been tested for safety and biocompatibility by standard tests used for radionuclide devices." It does not specify sample sizes or data provenance for these engineering/material tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. As this is a physical medical device (radioactive seed), there is no 'ground truth' in the context of expert diagnosis or interpretation of an AI output. The ground truth for such a device would be its physical properties, radiation output, and biological safety/biocompatibility, confirmed through laboratory and engineering tests, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

Not Applicable. There is no "test set" in the sense of medical images or patient data requiring expert adjudication for this device.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is relevant for diagnostic devices (especially imaging-based AI) where human readers interpret cases. It is not applicable to a radioactive implantable seed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

For the purpose of substantial equivalence for this brachytherapy seed, the "ground truth" (or basis for comparison) is primarily:
- Predicate Device Characteristics: The established safety, effectiveness, and technological characteristics of legally marketed I-125 brachytherapy seeds (e.g., Imagyn isoSTAR™ I-125 Interstitial Seed Model IS-12500, EndoSeed, Amersham Model 6711, Mentor IoGOLD).
- Standard Test Outcomes: Results from "standard tests used for radionuclide devices" confirming physical integrity, radiation safety, and biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set exists for this device.

Summary regarding the device:

The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, gained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. The key elements for this determination were:

Similar technological characteristics (encapsulation method, range of activity).
No differences in biocompatibility or other safety and effectiveness aspects.
Confirmation of safety and biocompatibility through "standard tests used for radionuclide devices."
Identical intended use as predicate devices.

The regulatory process for this device did not involve clinical trials or performance assessments against diagnostic accuracy metrics, as it is a physical therapeutic implant rather than a diagnostic AI/software.

Summary

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K991526

JUN 17 1999

510(k) Summary Imagyn Technologies Imagyn 125I Seed

General Information on Submitter: I.

Name:	Imagyn Medical Technologies10005 Muirlands, Suite GIrvine, CA 92618
Address:
Phone:	949-465-1710
Fax:	949-465-1718
Name of Contact Person:	Cheryl Blake, Vice President Regulatory Affairs andCorporate Quality AssuranceImagyn Medical Technologies3050 Redhill Ave.Costa Mesa, CA 92626
Phone:	949-708-7748
Fax:	949-708-7795

April 30, 1999 Date Summary Prepared:

II. General Information on Device Product Name: Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501 Source, Radionuclide, Brachytherapy, 21 C.F.R. 892.5730 Classification Name:
III. Predicate Devices: Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12500, K982421

EndoSeed, 510(k) number K914825/A

Amersham Model 6711, K914281

Mentor IoGOLD, K972271

IV. Description of the Device:

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Mentor loGOLD, K972271

IV. Description of the Device:

The Imagen isoSTARTM I-125 Interstitial Seed, Model IS-12501 uses 131 spheres encapsulated in a titanium tube.

V. Intended Use:
The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi, are indicated for permanent interstitial implantation of selected localized tumors. They are to be used either as primary treatment (such as prostate cancer or unresectable tumors) or as treatment of residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.
VI. Technological Characteristics of Device Compared to Predicate Device:
The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, uses the same type of encapsulation of 1251 as predicate devices. The range of activity is similar to other devices. There are no biocompatibility or other safety and effectiveness differences between this device and other predicate devices.
VII. Substantial Equivalence
The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, has been tested for safety and biocompatibility by standard tests used for radionuclide devices and found to safe and effective and substantially equivalent to other predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 17 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Debra A. Rinderer Regulatory Affairs Specialist Imagyn Medical Technologies, Inc. 3050 Redhill Avenue Costa Mesa, California 92626

K991526 Re:

Isostar I-125 Interstitial Seeds, Model IS-12501 Dated: June 8, 1999 Received: June 9, 1999 Regulatory Class: II 21 CFR 892.5730/Procode: 90 KXK

Dear Mr. Rinderer:

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 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). 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 (Special Controls) or dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination 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 requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE FORM

Page	1	of
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510 (k) Number (if known):

Imagyn isoSTARTM I-125 Interstitial Seed. Model IS-12501 Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991526

Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501 4/30/1999 Imagyn

Page 9

Over-The-Counter 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.