BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants may be used in superficial, intra-abdominal, and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual ournors following completion of a course of external radiation therapy and for recurrent tumors.

Device Description

BrachySource® Seed Implants consist of a welded titanium capsule containing lodine-125 absorbed onto a nickel/copper coated, gold cored aluminum wire. The implants are nominally 4.5mm long by 0.8mm in diameter.

lodine-125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and a 35.5 keV gamma. The tifanium wall of the BrachySource Seed Implant absorbs the electrons.

AI/ML Overview

This document is a 510(k) Summary for a medical device (BrachySource® Brachytherapy Seed Implants). It describes a traditional medical device (brachytherapy seeds for radiation therapy), not an AI/ML-based device. Therefore, the concepts of acceptance criteria for AI performance, clinical study design for AI, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details as requested in the prompt are not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device through bench testing.

Here's a breakdown of the specific aspects requested, as they relate to this non-AI device:

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

Acceptance Criteria (Implied)	Reported Device Performance
Same intended use as predicate device	The subject device has the same intended use.
Same general design as predicate device	The subject device has the same general design.
Same fundamental scientific technology as predicate device	The subject device has the same fundamental scientific technology.
Meets performance requirements for safety and effectiveness (demonstrated via bench testing)	"The appropriate bench testing to determine substantial equivalence was completed." (Specific performance metrics are not detailed in this summary)
Physical characteristics (dimensions, materials)	Nominally 4.5mm long by 0.8mm in diameter, welded titanium capsule, lodine-125 absorbed onto nickel/copper coated, gold cored aluminum wire.
Radioactive properties (half-life, emissions)	Half-life of 59.6 days, decays by electron capture with emission of 27.4 and 31 keV x-rays and a 35.5 keV gamma.

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

Not applicable. This document describes a physical medical device (brachytherapy seeds) and its 510(k) submission. The evaluation was based on "bench testing" to demonstrate substantial equivalence to a predicate device, not on a "test set" of clinical data in the context of an AI/ML study.

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)

Not applicable. See point 2. Ground truth is not established by experts for a physical device's performance in this context. The core evaluation is engineering/physics-based bench testing.

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

Not applicable. See point 2.

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 relates to AI-assisted diagnosis/interpretation, which is not relevant to brachytherapy seeds.

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

Not applicable. There is no algorithm described.

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

For the physical device, the "ground truth" for its performance would be established by physical measurements and engineering specifications (e.g., verifying dimensions, material composition, radioactivity levels, radiation spectrum, dose profile, etc., against manufacturing specifications and safety standards) during the bench testing. This is not clinical ground truth.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train.

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

Not applicable. There is no AI/ML model to train.

Summary

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Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

DEC 2 3 2009

Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, outlined font. The letters are thick and have a textured appearance, possibly due to the image being a scan or a low-resolution graphic. The word is horizontally oriented and appears to be the primary focus of the image.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990,

A. SUBMITTER INFORMATION:

Submitter's-Name:	C. R. Bard, Inc.
	Bard Medical Division
Address:	8195 Industrial Blvd. Covington, GA 30014

Contact Person:	Julie Bassett
Contact Person's Telephone Number:	770-784-6375
Contact Person's Fax:	770-385-4706

B. DEVICE NAME:

Device Name:	Brachytherapy seed implants
Trade Name(s):	BrachySource ® Brachytherapy Seed Implants
Common/Usual Name:	Brachytherapy seed implants
Classification Names:	90KXK - Source, Brachytherapy, Radionuclide
CFR Reference:	21 CFR 892.5730 – Radionuclide BrachytherapySource Class II

C. PREDICATE DEVICE NAME:

Trade Names:	BrachySource® Brachytherapy Seed Implants
	K043246

D. DEVICE DESCRIPTION:

480-06

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E. INTENDED USE:

TECHNOLOGICAL-CHARACTERISTICS-SUMMARY:-

The subject BrachySource® Brachytherapy Seed Implants have the same intended use, general design and fundamental scientific technology as the predicate device.

G. PERFORMANCE DATA SUMMARY:

The appropriate bench testing to determine substantial equivalence was completed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEC 2 3 2009

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

Ms. Julie Bassett Regulatory Affairs Specialist C. R. Bard, Inc. Bard Medical Division 8195 Industrial Blvd. COVINGTON GA 30014

Re: K093663

Trade/Device Name: BrachySource® Brachytherapy Seed Implants Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 23, 2009 Received: November 25, 2009

Dear Ms. Bassett:

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 of medical

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Page 2 -

Enclosure

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ramona M. Mavis

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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C.R. Bard, Inc., Bard Medical Division BrachySource® Brachytherapy Seed Implants Premarket Notification [510(k)]

1.4 Indications for Use Statement

510(k) Number (if known): K093663

Device Name:

Indications for Use:

BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate BrachySource® Seed Implants may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Houn M. Wher

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

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.