The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent or residual, following external beam or excision of primary tumor.

Device Description

The I-Seed Model AgX100 is an Iodine 125 brachytherapy source. A silver rod serves as the substrate for the I-125 and as a radiopaque marker and is contained within a titanium tube sealed at both ends with a laser welded dome. The seed is 4.5 mm long and 0.8 mm in diameter.

AI/ML Overview

The provided text describes the regulatory filing (K103319) for a medical device, the I-Seed Model AgX100, which is an Iodine 125 brachytherapy source. However, the document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets those criteria for an AI/ML-driven device.

The document primarily focuses on the device's physical characteristics, intended use, comparison to predicate devices, and adherence to established manufacturing and safety standards for medical devices (e.g., ISO standards, 21 CFR 820.30 - Design Controls). It describes "Design Verification" and "Design validation and verification testing" to demonstrate compliance with performance specifications, but these are general statements about the physical device, not related to an AI/ML component.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance for an AI/ML model.
Details about a test set (sample size, provenance).
Information on experts used for ground truth establishment.
Adjudication methods.
Any mention of a Multi-Reader Multi-Case (MRMC) study.
Stand-alone algorithm performance.
Type of ground truth (e.g., pathology, outcomes data).
Training set sample size or how its ground truth was established.

The only "acceptance criterion" mentioned is for leak testing of the sealed source, which is "< 4 nCi," and it states that "each source is leak-tested during manufacturing using a validated process." This refers to the physical integrity of the brachytherapy source, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information based on the provided text, as the document is about a physical medical device (a brachytherapy seed) and does not describe any AI/ML components or their validation.

Summary

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HERAGENICS CORPORATION®

K103319

3 2010

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

Device Name:

1-Seed 1-125

AgX100

Device Model Number:

Classification Name:

Device Classification:

Predicate Devices: ·

Radionuclide Brachytherapy Source (KXK), 21 CFR 892.5730

Class II (Radiology)

Theragenics Corporation® 5203 Bristol Industrial Way

Buford, GA 30518

I-Seed I-125 Model 125.506, K021343 OncoSeed Model 6711, K914281

Manufacturer:

Establishment Registration Number:

Official Contact:

1037598

Betsy Cortelloni Corporate Director of Quality and Regulatory Affairs Theragenics Corporation 5203 Bristol Industrial Way Buford, GA 30518 Phone: 770-831-4294 Fax: 770-831-4369 cortellb@theragenics.com

Intended Use: The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors.may be recurrent or residual, following external beam or excision of primary tumor.

Device Description: The I-Seed Model AgX100 is an Iodine 125 brachytherapy source. A silver rod serves as the substrate for the I-125 and as a radiopaque marker and is contained within a titanium tube sealed at both ends with a laser welded dome. The seed is 4.5 mm long and 0.8 mm in diameter.

Comparison of Technological Characteristics: The Model AgX100 is geometrically equivalent to both the Model 125.506 and the Model 6711. The seed design is equivalent to the Model 6711.

Use Type: The brachytherapy source is single patient use. The seeds may be received sterile or non-sterile for loose or magazine loaded configurations. Non-sterile orders . must be sterilized by the user facility. Custom loaded configurations are received sterile.

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THERAGENICS CORPORATION®

Sealed Source Classification: The Model AgX100 is a sealed source classified as C53211 pursuant to ISO 2919:1999E. Additionally, each source is leak-tested during manufacturing using a validated process, in accordance with internal procedures and ISO 9978:1992(E). The internal acceptance criterion for leak testing is less than 4 nCi.

Design Verification: The Model AgX100 was developed in accordance with 21 CFR 820.30 - Design Controls. Design validation and verification testing was conducted to demonstrate compliance with device performance specifications and to establish device safety.

The following standards were used in the development of the AgX100:

. ISO 2919:1999(E), Sealed Radioactive Sources - Classification
ISO 10993-1:2009, Biological evaluation of medical devices Part 1: . evaluation and testing
. ISO 17665-1:2006, Sterilization of healthcare products - moist heat ~ Part 1: . Requirements for the validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006, Sterilization of healthcare products radiation Part 1: . Requirements for the validation and routine control of a sterilization process for medical devices
. ISO 11137-2:2006, Sterilization of healthcare products – radiation – Part 2: establishing the sterilization dose

Conclusion: The results of the V&V testing confirmed that design inputs were achieved and the cumulative test results demonstrated the functionality, safety and effectiveness of the Model AgX100, as well as its substantial equivalence to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Betsy Cortelloni Corporate Director of Quality and Regulatory Affairs Theragenics Corporation, Brachytherapy Division 5203 Bristol Industrial Way BUFORD GA 30518

Re: K103319

JAN - 3 2010

Trade/Device Name: I-Seed Model AgX100 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 10, 2010 Received: November 12, 2010

Dear Ms. Cortelloni:

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); medical device reporting (reporting of medical

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE FORM

510(K) number (if known): K103319

JAN - 3 2010

Device Name:_ _I-Seed Model AqX100

Indications for Use:

Prescription Use × (Per 21 CFR 801 Subpart D) OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K163319

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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.