Imagyn 125I Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can to 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 Imagyn 125I Seeds use 125I beads encapsulated in a titanium tube.

AI/ML Overview

The provided document does not contain information about acceptance criteria or a study proving the device meets them in the way typically expected for a diagnostic or AI device.

This document is a 510(k) summary for a medical device called the "Imagyn 1251 Seed," which is a brachytherapy seed used for treating localized tumors. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than performing a performance study to meet specific acceptance criteria for a new type of device or an AI algorithm.

Here's a breakdown of why the requested information isn't present and what is discussed:

Table of acceptance criteria and the reported device performance: Not applicable. The document states, "There are no biocompatibility or other safety and effectiveness differences between this device and other predicate devices." The substantiation is based on similarity to already approved devices.
Sample size used for the test set and the data provenance: Not applicable. There was no specific "test set" in the context of typical device performance evaluation (e.g., for diagnostic accuracy). The comparison is foundational, asserting that the new device's design (encapsulation method, activity range) is similar to approved devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established in the context of evaluating a diagnostic or AI device's performance.
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 imaging or diagnostic AI-powered device that a human reader would use.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. This is a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "acceptance criteria" and "proof":

Instead of performance criteria and studies, the document describes the following:

Acceptance Criteria/Proof: The device's "acceptance" is based on demonstrating substantial equivalence to predicate devices already approved by the FDA. The crucial statement is: "The Imagyn 1251 Seed 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."
Study/Evidence: The "study" isn't a performance trial but rather a comparison of technological characteristics and safety/biocompatibility testing against existing standards and predicate devices.
- Technological Characteristics: The device "uses the same type of encapsulation of I251 as predicate devices. The range of activity is similar to other devices."
- Safety and Biocompatibility: It "has been tested for safety and biocompatibility by standard tests used for radionuclide devices." While the specific details of these standard tests are not included in this summary, the FDA's acceptance of the 510(k) implies these tests were deemed sufficient for demonstrating equivalence.

In essence, the device meets "acceptance criteria" by being proven to be "substantially equivalent" to legally marketed predicate devices in terms of its intended use, technological characteristics, safety, and effectiveness. This is a common pathway for medical device approval, particularly for devices that are variations of existing technologies.

Summary

{0}------------------------------------------------

JUL 3 | 1998

K982421

510(k) Summary International Isotopes , Inc. Imagyn 1251 Seed

General Information on Submitter: I.

Name:	International Isotopes, Inc
Address:	3100 Jim Christal Road
	Denton, TX 76207
Phone:	(940) 484-9492
Fax:	(940) 484-0877

Name of Contact Person:	Betsy C. King
	International Isotopes, Inc.
Phone:	(940) 484-9492
Fax:	(940) 484-0877

Date Summary Prepared: July 10, 1998

II. General Information on Device Imagyn 1251 Seed Product Name:

Classification Name:

Source, Radionuclide, Brachytherapy, 21 C.F.R. & 892.5730 -

III. Predicate Devices: EndoSeed, 510(k) number K914825/A

Amersham Model 6711, K914281

Mentor IoGOLD, K972271

Imagyn 1251 SEED 7/10/98 International Isotopes, Inc.

Page 64

{1}------------------------------------------------

Description of the Device: IV.

The Imagyn 1251 Seeds use 1231 beads encapsulated in a titanium tube.

V. Intended Use:

The Imagyn 1251 seeds 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.

Technological Characteristics of Device Compared to Predicate Device: VI.

The Imagyn 1251 Seed uses the same type of encapsulation of 1331 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.

Substantial Equivalence VII.

The Imagyn 1251 Seed 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.

Imagyn 1251 SEED International Isotopes, Inc.

7/10/98

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JU 31 1000

Betsy C. King Director of Quality and Regulatory Affairs International Isotopes, Inc. 3100 Jim Christal Road Denton, Texas 76207

Dear Ms. King:

Imagyn 1251 Seed Dated: July 10, 1998 Received: July 13, 1998 Regulatory class: II 21 CFR 892.5730/Procode: 90 IWG

K982421

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 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 proctice, labeling, and prohibitions against misbranding and adulteration.

Re:

If your device is classified (see above) into either class II (Special Controls) or class 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 Reseulations, 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 (2) CFR Part 820) and that, through periodic OS 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 notification submission does not affect any obligation you might have under sections 542 of the Act for derices 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%) premarket notification. The FDA finding of substantial equivalence of your derice 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/odrh/dsmaraan.html".

Sincerely yours,

Lillian Yip, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

INDICATION FOR USE FORM

Page 1 of 1

510 (k) Number (if known):	K982421
Device Name:	Imagyn 125 I Seed

Indications for Use:

Imagyn'131 Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can to 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

William
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982421

Prescription Use
(Per 21 CFR 801.1091)

Over-The-Counter Use

(Optional Format 1-2-96)

Imagyn 1251 SEED International Isotopes, Inc.

7/10/98

Page 9

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.