Aos Interstitial Templates, Needles & Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062823 FDA 510(k)
- FDA Product Code
- JAQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5700 FDA 510(k)
- Regulation Number
- 892.5700 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AOS Interstitial Templates, Needles, and Accessories are a System, Applicator, Radionuclide, Remote-Controlled designed for interstitial brachytherapy procedures. These devices consist of silicone templates with precisely spaced needle holes, template needles, and associated accessories to facilitate precise placement of radioactive sources in target tissues such as the cervix, prostate, rectum, or vagina.
The system is intended for single-use in radiology settings and is supplied sterile. Templates are available in various sizes to accommodate different anatomical treatment sites, with needle spacing standardized at 1 cm (center-to-center). The device is regulated under FDA 510(k) clearance (K062823) and falls under the Radiology medical specialty, adhering to regulatory requirements outlined in 892.5700. No reusable components are specified.
Frequently asked questions
What anatomical sites are these interstitial templates and needles designed to assist with during brachytherapy procedures?
The AOS Interstitial Templates, Needles, and Accessories are specifically designed for precise placement of radioactive sources in target tissues such as the cervix, prostate, rectum, or vagina. The templates come in various sizes to accommodate these different anatomical treatment sites while maintaining a standardized 1 cm center-to-center needle spacing for accuracy.
Are the AOS Interstitial Templates and Needles intended for reuse, or are they meant for single-use only?
These devices are explicitly designed for single-use only in radiology settings. The manufacturer does not specify any reusable components, ensuring sterility and safety for each procedure.
How are the templates and needles supplied, and what should I expect in terms of sterility?
The system is supplied sterile and ready for immediate use in radiology procedures. Each package is intended for one-time use, eliminating the need for reprocessing or sterilization between patients.
What regulatory pathway was followed for FDA clearance of this device, and which medical specialty does it fall under?
The AOS Interstitial Templates, Needles, and Accessories received FDA 510(k) clearance under the traditional review pathway, classified as Substantially Equivalent (SESE). The device falls under the Radiology medical specialty, adhering to regulatory requirements outlined in 21 CFR 892.5700.
What needle spacing is standard across the templates, and how does this benefit treatment planning?
The templates feature a standardized 1 cm center-to-center needle spacing, which ensures consistent and reproducible placement of radioactive sources. This uniformity aids in precise treatment planning and delivery, particularly for complex anatomical sites like the cervix, prostate, or rectum.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Alpha-Omega Services, Inc. July 10, 2024 Bob Robnett Director ..., PDF 510(k) Summary AOS Interstitial Templates, Needles & Accessories, AOS Interstitial Templates, Needles, and Accessories (K233628) — FDA ..., Aos Interstitial Templates, Needles & Accessories (K062823) — Fda 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062823 | Class II | Active |
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Manufacturer
- Manufacturer
- Alpha-Omega Services, Inc.
Sources (1)
- FDA 510(k) K062823 24 fields · synced Sep 19, 2026