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.

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.

AI/ML Overview

Here’s an analysis of the provided text, focusing on the acceptance criteria and the study (performance test) that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Predicate Devices)	Reported Device Performance (AOS Orion Ir-192 Source Cable)
Mechanical Compatibility: Must be compatible with Nucletron microSelectron HDR V2 and V3 Remote Afterloaders	Successfully completed various tests demonstrating worst-case scenarios, confirming compatibility with Nucletron microSelectron V2 and V3 HDR Remote Afterloaders.
ISO 2919 and ISO 9978 Compliance: Meet standards for sealed radioactive sources.	The device has been tested and meets acceptance criteria outlined in ISO 2919 and ISO 9978 standards.
Cable Strength: ≥ 200 Newtons	≥ 200 Newtons
Weld Strength: Able to withstand 15 Newtons for 3 minutes	Able to withstand 15 Newtons for 3 minutes
Range of Motion: Radius of ≥ 15mm (predicate)	Radius of ≥ 12mm
Tested Transfer Cycles: 100,000 cycles	100,000 cycles
Certified Cycles: 25,000 cycles	25,000 cycles
Recommended Cycles: 5,000 cycles	5,000 cycles

Note on Range of Motion: While the predicate requires a radius of ≥ 15mm, the new device reports ≥ 12mm. The document states that the new cable design "provides the same strength and flexibility as the 2 piece predicate cable," implying that the different radius is considered an acceptable, equivalent performance characteristic due to the design change.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of individual units. The performance tests refer to "series of tests" and "the Orion Cable" (singular), suggesting that a sufficient number of cables were tested to demonstrate compliance with the specified criteria. Specific numbers for units tested are not provided.
Data Provenance: The document does not specify the country of origin for the test data nor explicitly state whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these would typically be internal, prospective performance tests conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The "ground truth" for a physical medical device like an Ir-192 source cable is established by objective, measurable engineering and performance standards (e.g., ISO, tensile strength tests, cycle tests), not by expert consensus on clinical data or images.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of data (e.g., medical images) where there can be inter-reader variability. For objective performance tests of a physical device, the results are typically directly measured against a predetermined standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable. An MRMC study is designed to evaluate the performance of human readers, often with and without AI assistance, in interpreting medical images or data. The AOS Orion Ir-192 Source Cable is a physical brachytherapy source, and its performance is assessed through engineering and physical property tests, not through human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. Standalone performance (algorithm-only) applies to software algorithms (like AI) that perform a task without immediate human intervention. The device in question is a physical medical device, not a software algorithm. Its "standalone" performance is simply its inherent physical and mechanical properties.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on objective engineering and material standards, specifically:

ISO 2919 and ISO 9978: International standards for sealed radioactive sources.
Predicate device performance: The performance characteristics of the legally marketed predicate devices (MicroSelectron HDR Version 2 and MicroSelectron V3) serve as a benchmark for equivalence. This includes specific numerical values for dimensions, strength, and cycle testing.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning or AI models. This device is a physical product, and its development and testing do not involve a training set in the AI sense. Its design is based on engineering principles and materials science.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as in point 8.

Summary

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510(k) Summary

1. General Information

510(k) Owner:	Alpha-Omega Services, Inc.9156 Rose StreetBellflower, California 90706Tel: (562) 804-0604Fax: (562) 804-0610
Contact Person:	Bob A. RobnettDirector 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 Source21 CFR 892.5730, Class II, Product Code: KXK
Establishment Registration Numbers:	2022694, 3003660614
Special Controls	None
Substantial Equivalence:	K092804 MicroSelectron HDR Version 2K061354 MicroSelectron V3

2. Device Description

3. Intended Use

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

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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 CablePatent 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. Awaiting510(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 a6 Wire Crosslaid Stainless SteelOuter Wrap	Section 1: 19 Stands CrosslaidSection 2: 7x7 Stranded	Section 1: 19 Stands CrosslaidSection 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 Newtonsfor 3 minutes	Able to withstand 15 Newtonsfor 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

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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)_

Regulation Number and Section

§ 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.