AOS Marker Seeds (SMG0242-025) by Alpha-Omega Services, Inc.

AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site in adults.

Device Description

AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site.

AI/ML Overview

This document is a 510(k) premarket notification for the AOS Marker Seeds (SMG0242-025), which are 24k gold, 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site.

Based on the provided text, the device is considered substantially equivalent to a legally marketed predicate device (K062825, AOS Marker Seeds). The core of this submission is the claim of identity to the predicate device, rather than new performance data.

Therefore, most of the requested information regarding acceptance criteria and study proving device performance (like accuracy metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this specific 510(k) submission.

Here's how the provided information addresses your questions:

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

Acceptance Criteria: Not explicitly stated in terms of performance metrics for a new device. The "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device. This means the new device must have the same technological characteristics and indications for use as the predicate, or any differences must not raise new questions of safety and effectiveness.
Reported Device Performance: No new performance data is reported as the device is deemed "identical to the predicate device."

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. No new testing was performed; the device is asserting substantial equivalence based on its identity to a previously cleared predicate device.

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

Not Applicable. No new testing was performed.

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

Not Applicable. No new testing 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:

Not Applicable. This device is a physical marker seed, not an AI or imaging diagnostic tool. It does not involve human readers or AI assistance in the context of diagnostic interpretation.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

Not Applicable. No new performance study was conducted. The "ground truth" for this submission relies on the established safety and effectiveness of the identical predicate device.

8. The sample size for the training set:

Not Applicable. This is not a machine learning/AI device, so there is no training set in that context.

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

Not Applicable. As per point 8.

Summary from the document that supports the above responses:

"Nonclinical testing was not performed as device is identical to the predicate device." (Page 4)
"Clinical testing was not performed as device is identical to the predicate device." (Page 4)
"Nonclinical and clinical testing were not performed as device is identical to the predicate device." (Page 5)
"Indications for use have been rephrased for clarity but are the same as the predicate device." (Page 4)
"All other technological characteristics are the same as the predicated device." (Page 4 - referring to the only differences being the discontinued silver version and the change from sterile factory shipment to end-user sterilization).

In conclusion, this 510(k) submission is based on the concept of substantial equivalence, where the new device is considered "identical" to a previously cleared predicate. Therefore, no new performance data or studies (clinical or non-clinical in terms of performance metrics) were required or presented.

Summary

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Alpha-Omega Services, Inc. Bob Robnett Director Regulatory Affairs & Quality Assurance 9156 Rose Street BELLFLOWER, CA 90706

July 2, 2024

Re: K233626

Trade/Device Name: AOS Marker Seeds (SMG0242-025) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: November 10, 2023 Received: November 13, 2023

Dear Bob 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a

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change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K233626

Device Name

AOS Marker Seeds (SMG0242-025)

Indications for Use (Describe)

AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site in adults.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) #:	K233626	510(k) Summary	Prepared on: 2024-06-13

Contact Details	21 CFR 807.92(a)(1)
Applicant Name	Alpha-Omega Services, Inc.
Applicant Address	9156 Rose Street Bellflower CA 90706 United States
Applicant Contact Telephone	562-804-0604
Applicant Contact	Mr. Robnett Bob
Applicant Contact Email	brobnett@alphaomegaserv.com

Device Name	21 CFR 807.92(a)(2)
Device Trade Name	AOS Marker Seeds (SMG0242-025)
Common Name	Remote controlled radionuclide applicator system
Classification Name	System, Applicator, Radionuclide, Remote-Controlled
Regulation Number	892.5700
Product Code	JAQ

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K062825	AOS Marker Seeds	JAQ

Device Description Summary	21 CFR 807.92(a)(4)
AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site.

Intended Use/Indications for Use	21 CFR 807.92(a)(5)
AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site in adults.

Indications for Use Comparison	21 CFR 807.92(a)(5)
Indications for use have been rephrased for clarity but are the same as the predicate device.

Technological Comparison	21 CFR 807.92(a)(6)
The predicate device included gold and silver versions of the device. The silver version is no longer manufactured. The predicate device was marketed as sterile. Sterilization is now completed by the end user. All other technological characteristics are the same as the predicated device.

Non-Clinical and/or Clinical Tests Summary & Conclusions	21 CFR 807.92(b)
----------------------------------------------------------	------------------

Nonclinical testing was not performed as device is identical to the predicate device.

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Clinical testing was not performed as device is identical to the predicate device.

Nonclinical and clinical testing were not performed as device is identical to the predicate device.

Regulation Number and Section

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.