The Omega R 650 QDASM is an automatic beam limiting device designed for use in diagnostic radiographic/fluoroscopic applications. It includes square field shutters, spectral filters, and an additional lung filter for cardiac application. This device is substantially equivalent to the predicate devices with respect to technological characteristics.

AI/ML Overview

The provided documentation does not contain a study demonstrating the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. The submission is a 510(k) for an X-ray beam-limiting device, focusing on substantial equivalence to predicate devices rather than clinical performance studies.

Therefore, many of the requested details such as acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical or performance study are not applicable or not provided in this specific document.

The document primarily states that the device:

"will comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32" (regulations for diagnostic X-ray systems and their components).
"will comply with the international safety standards IEC 60601-1, IEC 60101-1-2, and IEC 60601-1-3."
"will comply with CE Marking requirements."
"will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90."

These are compliance statements for safety and electrical standards, not performance metrics related to diagnostic accuracy or clinical utility that would require a study with the detailed elements requested.

Summary of available information (and lack thereof based on the request):

Information Requested	Response
1. Table of acceptance criteria and reported performance	Acceptance Criteria (Compliance Statements):- Compliance with 21 CFR 1020.30, 1020.31, 1020.32 (Diagnostic X-ray system regulations)- Compliance with IEC 60601-1, IEC 60101-1-2, IEC 60601-1-3 (International safety standards)- Compliance with CE Marking requirements- Compliance with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 (Safety standards)Reported Device Performance: The document states: "This device is substantially equivalent to the predicate devices with respect to technological characteristics." No specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantitative benefit) are provided as would be expected for an AI/algorithm-based device's clinical performance. The "performance" here refers to its ability to function as a beam-limiting device in accordance with regulatory and safety standards, similar to the predicate devices.
2. Sample size and data provenance for test set	Not applicable. The submission for this device (an X-ray beam-limiting collimator, not an AI diagnostic algorithm) does not include a clinical performance study using a test set of images or patient data. The basis for clearance is substantial equivalence to predicate devices based on technological characteristics and compliance with recognized standards.
3. Number/qualifications of experts for ground truth	Not applicable. No clinical performance study was conducted to establish ground truth for a diagnostic task.
4. Adjudication method for test set	Not applicable.
5. MRMC comparative effectiveness study? Effect size?	No. This device is an automatic beam-limiting device (collimator) for X-ray systems, not an AI or imaging analysis software intended to assist human readers in interpretation or diagnosis. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or would be relevant for this device type.
6. Standalone performance study?	No standalone performance study (in the context of an algorithm's diagnostic accuracy) was reported. The device's "performance" is implicitly its ability to meet the stated technical specifications and safety standards as a physical component of an X-ray system.
7. Type of ground truth used	Not applicable. There is no diagnostic ground truth established for this device's function. The "ground truth" relevant to this submission would be the compliance with engineering and safety standards.
8. Sample size for training set	Not applicable. This is not an AI/ML device that requires a training set of data.
9. How training set ground truth was established	Not applicable.

Summary

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OMEGA MEDICAL IMAGING, INC.

510(k) SUMMARY

KO93572

Company Name:	Omega Medical Imaging, Inc	FEB - 3 2010
Address:	675 Hickman CircleSanford, FL 32771
Telephone No:	407-323-9400
Registration No.:	1052701
Contact person:	James A. Princehorn
Date Prepared:	16 November 2009
Device (trade) name:	Automatic Beam-limiting Device Model R650 QDASM
Common/usual name:	Automatic Radiographic/fluoroscopic Collimator
Classification name:	Diagnostic X-Ray Beam-Limiting Device (21 CFR 892.1610)Class II (Procode: 90 IZW)

Predicate device:

Dunlee automatic "FORMAT A" collimator manufactured by Philips Medical Systems legally . marketed under number K031597.
Omega Model R605 FACS collimators manufactured by RALCO S.R.L legally marketed under � number K050092

Device description:

Intended use:

The Omega R650 QDASM automatic beam limiting device is intended for use in diagnostic . radiographic/fluoroscopic applications.

Safety information:

The Omega R650 QDASM collimator will comply with the applicable requirements of 21 CFR � 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
The Omega R650 QDASM collimator will comply with the international safety standards IEC . 60601-1, IEC 60101-1-2, and IEC 60601-1-3.
The Omega R650 QDASM will comply with CE Marking requirements. .
The Omega R650 QDASM will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 .

Conclusion:

The Omega R650 QDASM collimator does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Omega considers the R650 QDASM collimator to be substantially equivalent with the predicate devices.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

FEB - 3 2010

Mr. James A. Princehorn President Omega Medical Imaging, Inc. Cardiac and Vascular Imaging Systems 675 Hickman Circle SANFORD FL 32771

Re: K093572

Trade/Device Name: R650 QDASM Beam Limiting Device Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW Dated: November 16, 2009 Received: November 18, 2009

Dear Mr. Princehorn:

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 Found, Or vo 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 provisiopp of the I 1 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 (reportion 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.

Donald J. Trump

St.Pierre Donald J. Acting 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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Indications for Use Form

510(k) Number (if known): K093572

Device Name: R650 QDASM Beam Limiting Device

Indications for Use:

The Omega R650 QDASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.

Prescription Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093572

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Regulation Number and Section

§ 892.1610 Diagnostic x-ray beam-limiting device.

(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.