The Omega Medical Imaging, LLC CS-series-FP (SSXI) Systems are intended for use in Radiographic/fluroscopic applications including cardiac, vascular, general radiographic/fluroscopic diagnostic, and Interventional x-ray imaging.

Device Description

The Omega Medical Imaging, LLC, CS-series-FP systems currently incorporate a 19.8cm x 19.8cm or 29.8cm x 29.8cm solid-state flat-panel detector (FPD). This 510(k) submission adds a slightly larger 21.7cm x 21.7cm and 30.3cm x 30.3cm solid-state CMOS flat-panel detector as an additional option. The CS-series-FP fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted c-arm and patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The MX CFP 3131 flat-panel image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The captured digital image is processed by the acquisition system (separate from the Flat Panel Detector) which includes image processing, viewing functions, local storage, and DICOM compatibility. The Image Processor does not have the capability to connect to the internet as there is no browser.

Subject Device Flat Panel Detectors MX CFP 2222 / 3131 are to be used only with the Omega CSseries-FP Fluoroscopic Systems

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical imaging device, specifically an X-ray system. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific clinical performance acceptance criteria against a ground truth in the way a diagnostic algorithm would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an X-ray system, specifically an optional detector component), the "acceptance criteria" are related to technical performance benchmarks and compliance with safety standards, rather than clinical diagnostic accuracy. The reported "performance" is the technical testing done to show equivalence.

Acceptance Criteria (Bench Performance)	Reported Device Performance
Equivalence in Low-contrast object visibility	Tested using commercially available Test Objects that include low-contrast objects with varying absorbers simulating different patient sizes. Results indicate equivalence to the existing cleared system.
Equivalence in Spatial Resolution	Tested using commercially available Test Objects to assess spatial resolution. Results indicate equivalence to the existing cleared system.
Equivalence in Temporal Resolution	Tested using commercially available Test Objects to assess temporal resolution. Results indicate equivalence to the existing cleared system.
Equivalence in Dynamic Range	Tested using commercially available Test Objects to assess dynamic range. Results indicate equivalence to the existing cleared system.
Compliance with Safety Standards	The Omega CS-series-FP with the MX CFP 2222 and MX CFP 3131 option systems comply with: - 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32 (Parts related to electronic product radiation control). - IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-2-43 (International safety standards). - UL 60601-1 and CAN/USA C22.2 No.601.1-M90 (Specific safety standards).
Equivalence in Technology	The MX CFP 2222 and 3131 option utilizes the same technology (Cesium Iodide scintillator coupled to a CMOS-light sensitive imaging component) as the predicate device.
No new indications for use	The modified device does not introduce any new indications for use.
No new potential hazards	The modified device does not result in any new potential hazards.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. The "test set" in this context refers to commercially available test objects designed to evaluate technical imaging characteristics, not a clinical dataset of patient images.
Data Provenance: Not applicable, as it's technical bench testing, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for technical performance tests is established by the specifications of the test objects themselves and physical measurements, not by expert consensus on clinical images.

4. Adjudication method for the test set:

Not applicable. Technical measurements do not typically involve adjudication in the way clinical diagnostic performance studies do.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is an X-ray system (hardware component), not an AI algorithm. Therefore, an MRMC study and AI-related effectiveness are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is an X-ray system (hardware component), not a standalone algorithm.

7. The type of ground truth used:

Technical performance benchmarks established by the design of commercially available test objects (e.g., phantoms for low-contrast, spatial resolution, temporal resolution, dynamic range) and compliance with international and national safety standards.

8. The sample size for the training set:

Not applicable. This is an X-ray system; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable.

Summary

{0}------------------------------------------------

February 9, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The Department of Health and Human Services logo is a stylized representation of an eagle. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Omega Medical Imaging, LLC % Mr. John Newman Manager of Regulatory and Quality 675 Hickman Circle SANFORD FL 32771

Re: K171755

Trade/Device Name: CS-series-FP with MX CFP 3131 or MX CFP 2222 Option radiographic/fluoroscopy system Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: January 4, 2018 Received: January 10, 2018

Dear Mr. Newman:

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. 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.

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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171755

Device Name

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic / Fluoroscopy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Omega Medical Imaging. The logo consists of a blue circular symbol on the left, resembling the Greek letter omega. To the right of the symbol, the words "OMEGA MEDICAL" are written in a gray sans-serif font, with the word "IMAGING" below it in a smaller font size and separated by horizontal lines.

Special 510(k) SUMMARY

Company Name:	Omega Medical Imaging, LLC
Address:	675 Hickman Circle, Sanford, Florida 32771
Telephone No:	407-323-9400
Registration No:	1052701
Contact person:	Brian J. Fleming
Date Prepared:	05/26/2017
Device (trade) name:	CS-series-FP with MX CFP 3131 or MX CFP 2222 Optionradiographic/fluoroscopy system
Common/usual name:	Fluoroscopic/Radiographic X-ray system
Classification Name:	Solid State X-ray Imager, Class II, 90 MQB
Classification Panel:	Radiology
CFR section:	892.1650
Device Class:	Class II
Device Code:	90 OWB / JAA

Predicate Device(s):

Omega Medical Imaging CS-series-FP (K121293)

Device description:

Subject Device Flat Panel Detectors MX CFP 2222 / 3131 are to be used only with the Omega CSseries-FP Fluoroscopic Systems

{4}------------------------------------------------

Indications for use:

The Omega Medical Imaging, LLC CS-series-FP with Optional MX CFP 3131 and MX CFP 2222 are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
The intended use of the modified device, as described in the labeling, has not changed as a result of the modification for this filling.

Comparison with Predicate Devices:

· The Omega Medical Imaging MX CFP 2222 and 3131 option the CS-series-FP system utilizes the same technology as the above-mentioned predicate device. The input scintillator is Cesium lodide coupled to a CMOS-light sensitive imaging component. The image processing is achieved with conventional computer based image processing system that is separate from the Flat Panel Detector. The MX CFP 2222 and 3131 Flat Panel Detectors are manufactured by the same company as the Image Processor. It is the opinion of Omega Medical Imaging that the CS-series-FP with the MX CFP 2222 and MX CFP 3131 option is equivalent to the existing Omega Medical Imaging cleared CS-series-FP system.

Substantial Equivalence:

· SE was determined on Bench performance testing. Included in this report is detailed data comparing performance with the existing Omega Medical Imaging CS-series-FP system utilizing the 29.8cm x 29.8cm x 19.8cm x 19.8cm format FPD image acquisition systems. The tests that were performed utilized commercially available Test Object that include lowcontrast objects with varying absorbers simulating different patient sizes, spatial and temporal resolution test objects, and dynamic range test objects.
Guidance for this submission of 510(k) for (SSXID) Solid State X-ray Imaging Devices issued on: September 1, 2016 was used to establish substantial equivalence

Safety information:

The Omega CS-series-FP with the MX CFP 2222 and MX CFP 3131 option systems comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
The Omega CS-series-FP with the MX CFP 2222 and MX CFP 3131 option systems comply with the international safety standards IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-2-43.
· The Omega CS-series-FP with the MX CFP 2121 and MX CFP 3131 option systems comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90

{5}------------------------------------------------

Conclusion:

The Omega CS-series-FP with the MX CFP 2222 and MX CFP 3131 options do not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Omega considers the Omega CS-series-FP with the MX CFP 2222 and MX CFP 3131 Flat panel detectors to be substantially equivalent with the predicate device.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.