(247 days)
Not Found
No
The summary describes a radioactive source cable for brachytherapy, a purely mechanical and radioactive component, with no mention of AI or ML in its function or testing.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "a source of nuclear radiation for therapy."
No
Explanation: The device is described as a "sealed radionuclide brachytherapy source... as a source of nuclear radiation for therapy." It is used for therapeutic purposes, not for diagnosing medical conditions.
No
The device is a physical radioactive source cable used in brachytherapy, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "sealed radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy." This describes a therapeutic device used in vivo (within the body) for treatment.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens.
- Device Description: The description confirms it's a "nominal 12 Curie Iridium-192 source cable" for use in remote afterloaders, which are used for delivering radiation therapy.
The information provided consistently points to a therapeutic device used for radiation treatment, not a diagnostic device used for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The AOS Orion Ir-192 Source Cable is a sealed radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. This device is the replaceable Ir-192 source for the Nucletron Corp. MicroSelectron HDR V2 and V3 Afterloaders.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
The AOS Orion Ir-192 Source Cable (Model No. CSO0012-192) is a nominal 12 Curie Iridium-192 source cable for use in the Nucletron microSelectron HDR Version 2 (Model No. 105.99) and the Nucletron microSelectron V3 (Model No. 106.990) Remote Afterloaders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface or into a body cavity or tissue
Indicated Patient Age Range
Not Found
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)
4.1. Compatibility and Mechanical
The mechanical strength and compatibility of the AOS Orion ir-192 Source Cable has been verified through a series of tests demonstrating worst case scenarios. Testing was successfully completed as prescribed and all the acceptance criteria have been met. The Orion Cable has been demonstrated to be compatible for use with the Nucletron microSelectron V2 and Nucletron microSelectron V3 HDR Remote Afterloaders.
4.2.ISO 2919 and Cable/Weld Strength Testing
The AOS Orion Ir-192 Source Cable has been tested and acceptance criteria outlined in the ISO 2919 and ISO 9978 standards. In addition, the Orion Cable's weld and cable strength have been tested and are equivalent to the predicate's performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 892.5730 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.
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510(k) Summary
1. General Information
| 510(k) Owner: | Alpha-Omega Services, Inc.
9156 Rose Street
Bellflower, California 90706
Tel: (562) 804-0604
Fax: (562) 804-0610 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bob A. Robnett
Director Regulatory Affairs & Quality |
| Date: | September 20, 2010 |
| Trade Name: | AOS Orion Ir-192 Source Cable |
| Common/Usual Name: | Radionuclide Brachytherapy Source |
| Classification Name: | Radionuclide Brachytherapy Source
21 CFR 892.5730, Class II, Product Code: KXK |
| Establishment Registration Numbers: | 2022694, 3003660614 |
| Special Controls | None |
| Substantial Equivalence: | K092804 MicroSelectron HDR Version 2
K061354 MicroSelectron V3 |
2. Device Description
The AOS Orion Ir-192 Source Cable (Model No. CSO0012-192) is a nominal 12 Curie Iridium-192 source cable for use in the Nucletron microSelectron HDR Version 2 (Model No. 105.99) and the Nucletron microSelectron V3 (Model No. 106.990) Remote Afterloaders.
3. Intended Use
The AOS Orion Ir-192 Source Cable is a sealed radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. This device is the replaceable Ir-192 source for the Nucletron Corp. MicroSelectron HDR V2 and V3 Afterloaders.
Performance Test বে
4.1. Compatibility and Mechanical
The mechanical strength and compatibility of the AOS Orion ir-192 Source Cable has been verified through a series of tests demonstrating worst case scenarios. Testing was successfully completed as prescribed and all the acceptance criteria have been met. The Orion Cable has been demonstrated to be compatible for use with the Nucletron microSelectron V2 and Nucletron microSelectron V3 HDR Remote Afterloaders.
4.2.ISO 2919 and Cable/Weld Strength Testing
The AOS Orion Ir-192 Source Cable has been tested and acceptance criteria outlined in the ISO 2919 and ISO 9978 standards. In addition, the Orion Cable's weld and cable strength have been
1
tested and are equivalent to the predicate's performance.
5. Substantial Equivalence
| Predicate Information | New Device | Predicate 1 | Predicate 2 | |
|---|---|---|---|---|
| Device Name | AOS Orion Ir-192 Source Cable | |||
| Patent Pending | MicroSelectron HDR Version 2 | MicroSelectron V3 | ||
| Model Number | 510(k) | CSO0012-192 | 105.999 | 106.990 |
| K092804 | K061354 | |||
| Registry of Sealed Source | ||||
| & Device | Not yet submitted. Awaiting | |||
| 510(k) approval. | MD-0497-S-107-S | MD-0497-S-107-S | ||
| Diameter | 0.9mm | 0.9mm | 0.9mm | |
| Length | 2022mm | 2022mm | 2022mm | |
| Cable Type1 | 1x7 Nitinol Inner Core with a | |||
| 6 Wire Crosslaid Stainless Steel | ||||
| Outer Wrap | Section 1: 19 Stands Crosslaid | |||
| Section 2: 7x7 Stranded | Section 1: 19 Stands Crosslaid | |||
| Section 2: 7x7 Stranded | ||||
| Materials2 | Stainless Steel/Nitinol | Stainless Steel | Stainless Steel | |
| Seal Method | Laser Weld | Laser Weld | Laser Weld | |
| Cable Strength | ≥ 200 Newtons | ≥ 200 Newtons | ≥ 200 Newtons | |
| Welds Strength | Able to withstand 15 Newtons | |||
| for 3 minutes | Able to withstand 15 Newtons | |||
| for 3 minutes | Able to withstand 15 Newtons for 3 minutes | |||
| Range of Motion | Radius of ≥ 12mm | Radius of ≥ 15mm | Radius of ≥ 15mm | |
| Isotope | Iridium-192 | Iridium-192 | Iridium-192 | |
| Nominal Activity | 12 Curies | 12 Curies | 12 Curies | |
| Tested Transfer Cycles | 100,000 | 100,000 | 100,000 | |
| Certified Cycles | 25,000 | 25,000 | 25,000 | |
| Recommended Cycles | 5000 | 5000 | 5000 |
1 The AOS Orion Ir-192 Source Cable is a one piece cable constructed of a 1x7 nitinol inner core with a 6 Wire Crosslaid Stainless Steel Outer Wrap. Performance testing has demonstrated that this design provides the same strength and flexibility as the 2 piece predicate cable.
² The addition of nitinol strands provides the required flexibility without the need for a smaller diameter cable attachment as found on the predicate cable.
6. Conclusion
Based on the above information, the AOS Orion Ir-192 Source Cable has been demonstrated to be equivalent to the source cable used in both predicate devices.
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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized depiction of an eagle, with its wings spread. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN - 2 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Bob A. Robnett Director Regulatory Affairs & Quality Alpha-Omega Services, Inc. 9156 Rose Street, P.O. Box 789 BELLFLOWER CA 90706
Re: K102811
Trade/Device Name: AOS Orion Ir-192 Source Cable Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: May 2, 2011 Received: May 3, 2011
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: AOS Orion Ir-192 Source Cable
Indications for Use: The AOS Orion Ir-192 Source Cable is a sealed radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. This device is the replaceable Ir-192 source for the Nucletron Corp. MicroSelectron HDR V2 and V3 Afterloaders.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S Pastle
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K102811 510(k)_