AOS Marker Seeds are used to provide reference positions around a proposed treatment site in order to re-apply a radionuclide source into the body or to the surface of the body for multiple sessions of radiation therapy.

Device Description

AOS Marker Seeds are small, cylindrical pieces of 24k gold or silver, which are easily visible with radiography imaging systems.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the AOS Marker Seeds:

Analysis:

This 510(k) submission for the "AOS Marker Seeds" does not contain a traditional performance study comparing the device against specific acceptance criteria for a new, independent claim. Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed predicate device (also "AOS Marker Seeds," but preamendment and non-sterile).

Therefore, many of the requested fields below will be marked as "Not Applicable" or "Not Provided" because the nature of this 510(k) is a comparison to a predicate, not a de novo performance evaluation with objective acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated as performance criteria for a new claim)	Reported Device Performance (Comparison to Predicate)
Design Equivalence: The new device should have the same design as the predicate.	Met: Both the new and predicate device share the same design.
Material Equivalence: The new device should be constructed of the same materials as the predicate.	Met: Both the new and predicate device are constructed of the same materials.
Single Use: The new device should be single use only.	Met: Both the new and predicate device are Single Use Only.
Sterility: (Implicit improvement/difference)	Met: New device is sterile. (Predicate was non-sterile).
Visibility with radiography imaging systems: (Implicit requirement for intended use)	Met (by statement of intended use and material): AOS Marker Seeds are small cylindrical pieces of 24k gold or silver, which are easily visible with radiography imaging systems. (This is a statement of fact and intended functionality, not a measured performance metric in this submission).
Safety and Efficacy: The new device should be equivalent in safety and efficacy to the predicate.	Met: "The Conclusion drawn from the above is that the Marker Seeds are equivalent in safety and efficacy to their 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 Applicable / Not Provided. This submission does not include a performance study with a test set of data. The equivalence is based on design and material comparison.
Data Provenance: Not Applicable / Not Provided.

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 / Not Provided. No ground truth establishment was conducted as part of a performance study in this submission.

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

Not Applicable / Not Provided. No adjudication of a test set was performed.

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

No, an MRMC study was not done. This device is a passive marker seed, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm performance study was not done. This device is a physical marker, not an algorithm.

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

Not Applicable / Not Provided. No ground truth was established for a performance study. The "ground truth" for this submission is the established safety and efficacy of the predicate device based on its preamendment history and previous FDA clearance.

8. The sample size for the training set

Not Applicable / Not Provided. This submission does not involve machine learning or a training set.

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

Not Applicable / Not Provided. No training set was used.

Summary

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510(k) Summary AOS Marker Seeds

MAY 2 2 2007

K062825

Alpha-Omega Services, Inc. 9156 Rose Street Bellflower, CA 90706 Tel: (800) 346-7894 Fax: (562) 804-0604 Bob A. Robnett July 2006

DEVICE NAME AOS Marker Seeds

PROPRIETARY NAME AOS Marker Seeds

COMMON/USUAL NAME Marker Seeds

CLASSIFICATION 21 CFR 892.5700, Product Code: JAQ, Class II

PREDICATED DEVICES

AOS Marker Seeds (Preamendment, See Appendix A)

DESCRIPTION

AOS Marker Seeds are small, cylindrical pieces of 24k gold or silver, which are easily visible with radiography imaging systems.

INTENDED USE

CONTRAINDICTIONS

Single Use Device

PERFORMANCE STANDARDS

No performance Standards for Brachytherapy Applicators are in effect at this date.

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SUBSTANTIAL EQUIVALENCE

AOS Marker Seeds are substantial equivalence to the AOS Marker Seeds (Preamendment). A comparison summary of technological characteristics is listed below. See Sections 7 Device Description for detailed information.

NEW DEVICE:	AOS Marker Seeds, 24k Gold
PREDICATE:	AOS Marker Seeds, 24k Gold
DESIGN:	Both the new and predicate device share the same design
MATERIAL:	Both the new and predicate device are constructed of the same materials
SINGLE USE:	Both the new and predicate device are Single Use Only.
STERILE:	New device is sterile. Predicate is non-sterile
NEW DEVICE:	AOS Marker Seeds, 24k Silver
PREDICATE:	AOS Marker Seeds, 24k Silver
DESIGN:	Both the new and predicate device share the same design
MATERIAL:	Both the new and predicate device are constructed of the same materials
SINGLE USE:	Both the new and predicate device are Single Use Only.
STERILE:	New device is sterile. Predicate is non-sterile

Conclusions

The Conclusion drawn from the above is that the Marker Seeds are equivalent in safety and efficacy to their predicate devices

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 2 2 2007

Mr. Bob A. Robnett Director, Regulatory Affairs & Quality Alpha-Omega Services, Inc. 9156 Rose Street P.O. Box 789 BELLFLOWER CA 90706

K062825 Re:

Trade/Device Name: AOS Marker Seeds Regulation Number: 21 CFR §892.5730 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: KXK Dated: May 2, 2007 Received: May 3, 2007

Dear Mr. Robnett:

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 is a circular logo commemorating the centennial of the FDA from 1906-2006. The letters FDA are in a bold, stylized font in the center of the logo. Below the letters, the word "Centennial" is written in cursive. Three stars are underneath the word "Centennial". The text "1906-2006" is at the top of the logo.

Protecting and Promoting Public Health

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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.

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 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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Indications For Use

510(k) Number (if known): K062825

Device Name: AOS Marker Seeds

Indications For Use: AOS Marker Seeds are used to provide reference positions around a proposed treatment site in order to re-apply a radionuclide source into the body or to the surface of the body for multiple sessions of radiation therapy.

Alpha-Omega Services (AOS) Marker Seeds are small cylindrical pieces of 24k gold or silver, which are easily visible with radiography imaging systems.

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

Over-The Counter Use: NO (21 CFR 801 Subpart C

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

Concurrence of CDRH, Office or Device Evaluation

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K06 2825

Section 4, page 1 of 1

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.