(232 days)
Not Found
No
The device description and intended use clearly define the device as passive gold seeds for marking, with no mention of any computational or analytical capabilities, let alone AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device description states its use is to "provide reference positions" which is for marking, not for treatment.
No
The device, AOS Marker Seeds, is described as being used to "provide reference positions around a proposed brachytherapy treatment site." Its function is to mark a location, not to diagnose a condition or disease.
No
The device description explicitly states it is a physical object (24k gold seeds) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the AOS Marker Seeds are used to "provide reference positions around a proposed brachytherapy treatment site." This is a physical marker placed in vivo (within the body) to guide a medical procedure (brachytherapy).
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
Therefore, the function and intended use of the AOS Marker Seeds fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site in adults.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was not performed as device is identical to the predicate device.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
1
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| 1 of 2 | |||
|---|---|---|---|
| 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.
4
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.