The ATI Medical, Inc. IsoRod Pd-103 Radionuclide Brachytherapy Source is intended for permanent interstitial implantation for the treatment of selected localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, neck, lung, intra-abdominal, pancreas, prostate, and unresectable tumors, or for residual disease after excision of primary or secondary tumors. IsoRod Pd-103 implants may be used concurrently with or following treatment with other interventions, such as external beam therapy or chemotherapy.

Device Description

The IsoRod implant is a permanently implanted, radioactive device, designed for the treatment of deep- seated tumors. IsoRod implants are comprised of base metallic rods that are coated with radioactive palladium. The radioactive palladium is then encapsulated with a metallic coating.

The base rod is composed of a palladium/cobalt alloy. The rod is 1 millimeter and 10 millimeters in length. The thin layer (0.2 micron) that comprises the radioactive layer is a combination of radioactive and non-radioactive palladium (Pd-103 and Pd-102 respectively). The encapsulation layer of 6-8 microns is pure palladium, a metal that is utilized in permanent implants based on its favorable biocompatibility characteristics.

The activity of each IsoRod implant is between 0.5 mCi and 3.0 mCi. The source is exceptionally isotropic based on the fact that the radioactive material is evenly deposited on the source and is shielded in every direction only by the thin layer of non-radioactive palladium.

AI/ML Overview

The provided text, K020683, is a 510(k) summary for the IsoRod Pd-103 Implant Brachytherapy Source. This document describes a medical device rather than an AI/ML device, and thus the requested information regarding acceptance criteria, study details, and AI/ML-specific metrics (like human reader improvement with AI, standalone algorithm performance, training set details) is not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through:

Intended Use: Showing the same indications for use as predicate devices.
Technological Characteristics: Highlighting similar isotope, apparent activity, and device description.
Biocompatibility Testing: Confirming the device is biocompatible for its intended use.
Dosimetry: Mentioning Monte Carlo analysis for dosimetry, with physical dose measurements to be completed.

Therefore, many of the specific questions asked are not relevant to this type of device submission.

However, I can extract the information that is present:

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

Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices)	Reported Device Performance
Intended Use: Same as predicate devices	Intended for permanent interstitial implantation for localized tumors (head, neck, lung, intra-abdominal, pancreas, prostate, unresectable tumors, or residual disease after excision). May be used concurrently with or following external beam therapy, hyperthermia, or chemotherapy.
Technological Characteristics: Similar isotope, apparent activity	- Isotope: Palladium-103 (Pd-103)- Activity: 0.5 mCi to 3.0 mCi per implant- Design: Base metallic rods coated with radioactive palladium and encapsulated with pure palladium. Rod is 1mm x 10mm.
Biocompatibility: Safe for permanent implantation	Biocompatibility tests (summarized in Appendix 7) indicate the device is biocompatible under conditions of intended use. (Specific criteria and results not detailed in the summary).
Dosimetry: Appropriate for brachytherapy	Dosimetry determined by Monte Carlo analysis at UCLA using MCNP4C code. Physical dose measurements in a phantom to be completed prior to marketing. (Specific values or ranges not detailed in the summary).

2. Sample size used for the test set and the data provenance:

Not applicable. This submission performs no "test set" evaluation in the context of an AI/ML study. The evaluation focuses on comparison to predicate devices and engineering/biocompatibility testing, not clinical performance data from a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. No test set or adjudication method 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:

Not applicable. The device is a brachytherapy source, not an AI-assisted diagnostic or prognostic tool.

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

Not applicable. The device is a physical radioactive implant, not an algorithm.

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

For biocompatibility: Ground truth would be established through standardized biocompatibility testing protocols defined by relevant ISO standards (e.g., ISO 10993) which determine material safety for implantation. The summary states these tests were performed, but not the specific "ground truth" method.
For dosimetry: Ground truth would be established through physical measurements and validated Monte Carlo simulations demonstrating accurate radiation dose distribution.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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Ko20683

510(k) SUMMARY

DEC 1 7 2002

Name of 510(k) sponsor: Address:

ATI Medical, Inc. 10954-A Via Frontera San Diego, CA 92129

Telephone: 858 487-7243 Fax: 858 487-7763

Contact information:

Michael Wienholt, RAC Regulatory Affairs Manager ATI Medical, Inc.

Telephone: 858 487-7243, ext. 28 Fax: 858 487-7763 E-mail: mwienholt@atimedical.com

Date summary prepared:	March 2, 2002
Proprietary name of device:	IsoRod Pd-103 Implant
Generic/classification name:	Brachytherapy Source
Product code (classification):	Source, Radionuclide, Brachytherapy21 C.F.R. § 892.5730

Legally Marketed Predicate Devices:

GENETRA (K013660) TheraSeed Palladium (K010283) InterSeed (K973328)

Device Description and Technological Characteristics:

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Intended Use

The ATI Medical, Inc. IsoRod Pd-103 Radionuclide Brachytherapy Source is intended for permanent interstitial implantation for the treatment of selected localized turnors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, neck, lung, intra-abdominal, pancreas, prostate, and unresectable turnors, or for residual disease after excision of primary or secondary tumors. IsoRod Pd-103 implants may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy.

Testing

The dosimetry of the IsoRod implants was determined by Monte Carlo analysis at UCLA using the MCNP P version 4C Monte Carlo code developed at Los Alamos National Laboratory. Physical dose measurements in a phantom will be completed prior to marketing.

The results of the biocompatibility tests are summarized at Appendix 7 and indicate that the IsoRod Pd-103 implant is biocompatible under the conditions of intended use.

Conclusions

The ATI Medical, Inc. IsoRod Pd-103 Implant has the same indications for use and similar technological characteristics (e.g., isotope; apparent activity) as the predicate devices. Biocompatibility testing has established that IsoRod implants are biocompatible under the conditions of intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2002

Mr. Michael Wienholt, RAC Director, Regulatory Affairs & QA ATI Medical, Inc. 10954 Via Frontera, Suite A SAN DIEGO CA 92127

Re: K020683 Trade/Device Name: IsoRod Pd-103 Implant Brachytherapy Source .. Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: September 17, 2002 Received: September 18, 2002

Dear Mr. Wienholt:

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); 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.

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Page 2 . . .

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

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Snydor

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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ATI Medical, Inc. Premarket Notification 510(k) - IsoRod Pd-103 Implants

INDICATIONS FOR USE STATEMENT

Applicant:	ATI Medical, Inc.
510(k) Number:	K020683
Device Name:	IsoRod Pd-103 Radionuclide Brachytherapy Source (implant)

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

Over-the Counter Use

Daniel h. Lagemann

(Division Sign-Off)

Division of Reproduct and Radiological Devi 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.