AOS MARKER SEEDS

K062825 · Alpha-Omega Services, Inc. · KXK · May 22, 2007 · Radiology

Device Facts

• Record ID: K062825
• Device Name: AOS MARKER SEEDS
• Applicant: Alpha-Omega Services, Inc.
• Product Code: KXK · Radiology
• Decision Date: May 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2

Intended 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.

Device Story

AOS Marker Seeds are small, cylindrical, radiopaque markers composed of 24k gold or silver. They are implanted or placed at or near a radiation treatment site to serve as reference points for imaging systems (radiography). By providing visible landmarks, the seeds assist clinicians in accurately re-applying radionuclide sources for multiple radiation therapy sessions. The device is intended for single use. It is used in clinical settings by radiation oncology staff. The primary benefit is improved precision in targeting radiation therapy across multiple treatment sessions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Cylindrical markers made of 24k gold or silver. Radiopaque for visualization via radiography. Single-use. Sterile.

Indications for Use

Indicated for patients undergoing radiation therapy requiring reference markers for radionuclide source re-application to treatment sites or body surfaces.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AOS Marker Seeds (Preamendment)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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

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.

#### 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 [phone] or [phone] 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

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