I3RAD 1351 Seeds 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 of residual disease after excision of the primary tumor or recurring turnors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.

Device Description

The I3RAD. 1251 Seeds use 1251 beads encapsulated in a titanium tube.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the International Isotopes Inc. I3RAD 125I Seed, a radionuclide brachytherapy source.

This submission does NOT contain the details of a study that establishes acceptance criteria or reports device performance based on objective metrics.

Instead, the documentation focuses on demonstrating substantial equivalence to previously marketed devices. The core of the argument is that the I3RAD 125I Seed is technologically similar to its predicates (EndoSeed, Amersham Model 6711, Mentor IoGOLD) and thus, is expected to be equally safe and effective.

Here's what can be extracted and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics in the provided document. The acceptance criteria seem to be implicit in demonstrating "safety and efficacy" and "substantial equivalence" to predicate devices, which implies meeting the performance standards already established for those devices.
Reported Device Performance: No specific quantitative performance data (e.g., radiation output accuracy, seed integrity under specific conditions) derived from a study of the I3RAD 125I Seed are reported in this summary. The summary states: "The I3RAD 125 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." This is a qualitative statement of compliance, not a report of specific performance values against defined acceptance criteria.

Acceptance Criteria (Inferred)	Reported Device Performance (Qualitative)
Safety	"safe"
Efficacy	"effective"
Biocompatibility	Met "standard tests"
Substantial Equivalence	"substantially equivalent to other predicate devices"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document refers to "standard tests," but no sample sizes for these tests are provided.
Data Provenance: Not specified. It's unclear if the testing was performed internally by International Isotopes, Inc. or by an external laboratory, or where it occurred. The nature of "standard tests" for radionuclide devices would typically involve physical and radiological measurements rather than clinical data in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The "ground truth" concept relating to expert consensus or clinical outcomes is typically relevant for diagnostic AI/software devices. For a physical medical device like a brachytherapy seed, the "ground truth" would be established through physical and radiological measurements and engineering specifications, often against international or national standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not provided. Adjudication methods are typically relevant for human-interpretable data (e.g., images) where multiple experts might disagree on findings.

5. 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 software or a device that involves human readers interpreting data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a brachytherapy seed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

As discussed in point 3, the concept of "ground truth" in the cognitive sense (like expert consensus on an image or pathology for a diagnosis) doesn't directly apply here. For this type of physical device, the "ground truth" is established by physical and radiological measurement standards (e.g., measurements of activity, dose rate, physical dimensions, material composition, biocompatibility testing standards). The review process by the FDA, including their determination of "substantial equivalence," implies that these standards were met.

8. The sample size for the training set

Not applicable. This device is a physical brachytherapy seed, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K992963

SEP 2 1 1999

510(k) Summary International Isotopes , Inc. International Isotopes Inc. I3RAD 1251 Seed

I. General Information on Submitter:

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

Name of Contact Person:	Rebecca Ellis
	International Isotopes, Inc.
Phone:	(940) 484-9492 ext. 124
Fax:	(940) 484-0877

Date Summary Prepared: 31 August 1999

II. General Information on Device International Isotopes Inc. I3RAD 125I 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

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

Description of the Device: IV.

The I3RAD. 1251 Seeds use 1251 beads encapsulated in a titanium tube.

Intended Use: V.
I3RAD 1251 Seeds 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 of residual disease after excision of the primary tumor or recurring tumors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.

Technological Characteristics of Device Compared to Predicate Device: VI.

The I3RAD 1251 Seed uses the same type of encapsulation of 125T 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 I3RAD 125 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.

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 1999

Ms. Rebecca L. Ellis Manager, Quality & Regulatory Affairs International Isotopes, Inc. 3100 Jim Christal Road Denton, TX 76207

Re:

K992963 13RAD 125I Brachytherapy Seed Dated: August 31, 1999 Received: September 2, 1999 Regulatory Class: II (TWO) Product Code: 90 KXK 21 CFR 892.5730

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 redassified 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 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 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 oblication 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

Dear Ms. Ellis:

Enclosure

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INDICATION FOR USE FORM

Page 【 of I

510 (k) Number (if known):

International Isotopes Inc. I3RAD 125I Seed 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)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K992963

Prescription Use(Per 21 CFR 801.1091	X	OR	Over-The-Counter Use
	(Optional Format 1-2-96)

I3RAD 125I Brachytherapy Seed1 Brachytherapy Seed I3RAD ' International Isotopes, Inc.

31 August 1999

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.