The Pd-103 Seed Implant Kits will be offered using TheraSeed® Palladium-103 Implants, which are produced and marketed commercially by Theragenics, Inc. under the 510(k) K010283. There is no change to the seeds produced by Theragenics and marketed under the name TheraSeed® Palladium-103 devices. These seeds will be packaged in various sterile and non-sterile configurations. These configurations are the same as the predicate described in K043246.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Palladium-103 Seed Implant Kits." This summary is a regulatory document submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission for this type of device (radionuclide brachytherapy source) typically does not include detailed clinical studies with acceptance criteria for device performance in the same way that a diagnostic AI device or a new therapeutic device would.

Instead, the core of this submission focuses on demonstrating substantial equivalence to an existing approved device. This means showing that the new device has the same intended use, technological characteristics, and principles of operation as a predicate device that is already on the market. The "performance data" referred to in Section G typically relates to engineering and manufacturing tests to ensure the seeds meet established specifications, not clinical outcomes from a study proving efficacy or diagnostic accuracy.

Therefore, many of the requested points in your prompt are not applicable to this specific document as they pertain to clinical performance studies, which are not usually required or presented for a 510(k) of this nature.

Here's an attempt to answer your questions based on the provided text, highlighting what is and isn't available:

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

This information is not provided in the 510(k) summary. For a brachytherapy seed, acceptance criteria would typically involve physical and radiological specifications (e.g., activity, dose rate, seed dimensions, uniformity) and the performance would be measured against these. However, this document states: "The principles of operation and fundamental scientific technology have not changed. Reference K043246 and K010283 for a detailed description." and "The appropriate testing for the Palladium-103 Seed Implant Kits was conducted." This implies that the device meets the same specifications as the predicate devices, but the specific criteria and performance values are not detailed in this summary.

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

This information is not applicable/not provided. This 510(k) does not describe a clinical test set or clinical study comparing the new device against a ground truth for diagnostic or therapeutic efficacy. It relies on substantial equivalence to predicate devices that have prior approval and established safety and effectiveness.

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/not provided. There is no clinical test set described where ground truth would need to be established by experts.

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

This information is not applicable/not provided. No clinical test set or adjudication method is described.

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

This information is not applicable/not provided. This device is a brachytherapy seed, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.

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

This information is not applicable/not provided. This is not an algorithmic device.

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

This information is not applicable/not provided. No clinical studies with ground truth are described in this 510(k) summary. The "ground truth" for this device's approval is its substantial equivalence to previously approved devices and compliance with established manufacturing and performance specifications for brachytherapy seeds.

8. The sample size for the training set

This information is not applicable/not provided. This device does not use machine learning or AI that would require a "training set."

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

This information is not applicable/not provided. This device does not use machine learning or AI that would require a "training set."

Summary regarding K060636:

The 510(k) summary for the Palladium-103 Seed Implant Kits primarily establishes substantial equivalence to existing predicate devices (TheraSeed® Palladium-103 Implants and BrachySource® Brachytherapy Seed Implants). The key arguments are:

Identical intended use: The indications for use for the Palladium-103 Seed Implant Kits are explicitly stated to be unchanged from the predicate device (Theragenics 510(k), K010283).
Identical design and fundamental scientific technology: The device uses the same TheraSeed® Palladium-103 Implants produced by Theragenics, Inc., and the configurations for packaging are the same as another predicate (K043246).
"Appropriate testing" was conducted: This refers to engineering and manufacturing tests to confirm the new device (specifically, the kits and configurations) meets established specifications for brachytherapy seeds, confirming it is not different in terms of safety and efficacy from the predicate.

In essence, the study that "proves the device meets the acceptance criteria" in this context is the comparison to the predicate devices and the internal quality testing, rather than a clinical trial with a defined test set, ground truth acquisition, or human reader performance metrics.

Summary

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K060636

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

APR 1 9 2006

Image /page/0/Picture/3 description: The image shows the word "BARD" in a stylized, bold font. The letters are thick and have a rounded appearance. The "A" in "BARD" is designed with a unique shape, resembling a triangle with a horizontal line across the middle. The overall design of the word gives it a modern and distinctive look.

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:

Contact Person's Fax:

Date of Preparation:

Submitter's Name:	C. R. Bard, Inc.
	Bard Urological Division
Address:	13183 Harland Dr.
	Covington, GA 30014
Contact Person:	Julie J. Bassett
Contact Person's Telephone Number:	678-342-4921

B. DEVICE NAME:

Trade Name(s):	Palladium-103 Seed Implant Kits
Common/Usual Name:	Brachytherapy seed implants
Classification Names:	90KXK - Source, Brachytherapy, Radionuclide21 CFR 892.5730

770-788-5517

March 9, 2006

C. PREDICATE DEVICE NAME:

Trade Name(s): TheraSeed® Palladium-103 Implants and BrachySource® Brachytherapy Seed Implants

D. DEVICE DESCRIPTION:

The principles of operation and fundamental scientific technology have not changed. Reference K043246 and K010283 for a detailed description.

TheraSeed® is a registered trademark of Theragenics Corporation®

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E. INTENDED USE:

TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following characteristics:

. Localized,
Unresectable,
Low to moderate radiosensitivity.

The tumors may be of the following types:

. Superficial;
. Intrathoracic;
. Intra-abdominal;
트 Lung, pancreas, prostate, head and neck;
. Residual following external beam or excision of primary tumor;
. Recurrent.

The intended use has not changed from Theragenics 510(k), K010283.

ﺎﻧﺎ TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject device, Palladium-103 Implant Kits, has the same intended use, design and fundamental scientific technology as the predicate devices.

G. PERFORMANCE DATA SUMMARY:

The appropriate testing for the Palladium-103 Seed Implant Kits was conducted.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 1 9 2006

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

Re: K060636

Trade/Device Name: Palladium-103 Seed Implant Kits Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: March 9, 2006 Received: March 10, 2006

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006". The logo is circular and contains the letters "FDA" in a bold font. The text "Protecting and Promoting Public" is also visible in the image.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease of a rison 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); 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.

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 promated 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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C.R. Bard, Inc., Bard Urological Division Palladium-103 Seed Implant Kits Premarket Notification [510(k)]

1.3 Indications for Use Statement

510(k) Number (if known):

Device Name: Palladium-103 Seed Implant Kits_

Indications for Use:

TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following characteristics:

. Localized,
l Unresectable,
Low to moderate radiosensitivity. 트

The tumors may be of the following types:

l Superficial:
. Intrathoracic;
일 Intra-abdominal;
1 Lung, pancreas, prostate, head and neck;
발 Residual following external beam or excision of primary tumor;
지 Recurrent.

Prescription Use	X
(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)

David A. Segrim

(Division Sign-Off) V
Division of Reproductive, Abdominal,
anır Radiological Devices K060636

(Recommended Format 11/13/2003)

TheraSeed® is a registered trademark of Theragenics Corporation®.

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.