CS-SERIES-FP

K100102 · Omega Medical Imaging, Inc. · OWB · Aug 31, 2010 · Radiology

Device Facts

• Record ID: K100102
• Device Name: CS-SERIES-FP
• Applicant: Omega Medical Imaging, Inc.
• Product Code: OWB · Radiology
• Decision Date: Aug 31, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

Device Story

CS-series-FP is a fluoroscopy system utilizing a solid-state flat-panel detector (FPD) with a cesium iodide scintillator and amorphous silicon TFT panel. It replaces image intensifier/CCD-based detectors in existing CS-series systems. The system includes a floor-mounted C-arm (dual-plane adds ceiling-suspended C-arm) and a patient table. It captures X-ray signals, processes digital images via an acquisition workstation (MX-200-OMI), and displays them on medical-grade monochrome monitors. Features include pulsed fluoro, spot, and cine modes; edge enhancement; noise reduction with motion correction; and DICOM-compatible storage/networking. Used in clinical settings (e.g., interventional suites) by physicians and technicians. Output allows real-time visualization and review of diagnostic images, supporting clinical decision-making in cardiac and vascular interventions. Benefits include improved imaging performance over traditional intensifiers.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing the CS-series-FP system against the existing Omega CS-series (image-intensifier/CCD-based) and by providing technical specifications and performance data for the Varian PaxScan 2020 flat-panel detector. No clinical data was required or provided.

Technological Characteristics

Solid-state flat-panel detector (amorphous silicon, cesium iodide scintillator); 1024x1024 matrix; 194 μm pixel pitch; 14-bit A/D conversion. Energy range 40-150 kV. Connectivity: Ethernet 10/100, DICOM. Compliance: UL2601-1, IEC60601-1, CSA 22.2 No. 601.1-M90, CE Marked. Software: MX-200-OMI workstation.

Indications for Use

Indicated for radiographic and fluoroscopic imaging in cardiac, vascular, general diagnostic, and interventional procedures. No specific age or gender restrictions provided.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• GE Innova 2000 (K022322)
• Siemens Axiom Artis dFC (K021021)
• Philips Allura Xper FD10 F (K020055)
• Toshiba Infinix CCi/FPD (K052884)
• Omega Medical Imaging CS-series (K070834)

Submission Summary (Full Text)

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# KIDDI02

Omega Medical Imaging, Inc.

## EXECTUTIVE 510(k) SUMMARY

AUG 31 2010

| Company Name: | Omega Medical Imaging, Inc |
|-----------------------|-------------------------------------------------------------------------------------------|
| Address: | 675 Hickman Circle<br>Sanford, FL 32771 |
| Telephone No: | 407-323-9400 |
| Registration No.: | 1052701 |
| Contact person: | James A. Princehorn |
| Date Prepared: | 22 July 2010 |
| Device (trade) name: | CS-series-FP (SSXI) Fluoroscopy system |
| Common/usual name: | Image Intensified Fluoroscopic X-ray System |
| Classification Name: | Solid State X-ray Imager, Class II, 90 MQB<br>Angiographic X-ray System, Class II, 90 IZI |
| Classification Panel: | Radiology |
| CFR Section: | 892.1650 and 892.1600 |
| Device Class: | Class II |
| Device Code: | 90 MQB, 90 IZI OWB, JAA |

### Predicate device(s):

- GE Innova 2000 (K022322) .
- Siemens Axiom Artis dFC (K021021) .
- Philips Allura Xper FD10 F (K020055) .
- . Toshiba Infinix CCi/FPD (K052884)
- . Omega Medical Imaging CS-series (K070834)

#### Device description:

- The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems incorporates a ◆ solid-state flat-panel detector (FPD) as an option to the cleared Omega Medical Imaging, Inc. CS-series fluoroscopy systems (K070834) in lieu of an image intensifier/CCD based imaging detector. The CS-series fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-am and a patient table. The dual plane systems incorporate a ceiling suspended C-arm. The image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The caplured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.
10-1

Section 10

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The following tables indicate the technical specifications of the CS-series-FP option:

| 1. | Flat Panel Detector |
|----|---------------------|
|----|---------------------|

. •

| 1.1 Receptor Type | Amorphous Silicon |
|---------------------------|-------------------------------------------------------|
| 1.2 Conversion Screen | Cesium Iodide |
| 1.3 Pixel Area - Active | 19.8 cm X 19.8 cm |
| 1.4 Pixel Matrix - Active | 1024 X 1024 |
| 1.5 Pixel Pitch | 194 $\mu$ m |
| 1.6 Limiting Resolution | 2.58 lp/mm |
| 1.7 MTF, X-ray | $\geq$ 35% @ 1.30 lp/mm |
| 1.8 Energy Range | 40 - 150 kV |
| 1.9 Fill Factor | 70% |
| 1.10 Dynamic Range | 72 dB |
| 1.11 Contrast Ratio | Large Area (120mm): < 0.8%<br>Small Area (10mm): < 7% |
| 1.12 A/D Conversion | 14-bits |

### 2. Acquisition

| 2.1 Modes | Pulsed Fluoro, Spot, & Cine |
|---------------------------------|--------------------------------|
| 2.2 Pulsed Fluoro Rates | 3.75, 7.5, and 15 pps |
| 2.3 Spot Rates | Single & 2 fps |
| 2.4 Cine Rates | 15 & 30 fps |
| 2.5 Polarity | Positive & Negative |
| 2.6 Edge Enhancement | 5 level |
| 2.7 Noise Reduction | 6 level with motion correction |
| 2.8 Last Image Hold | Yes |
| 2.9 Fluoro Loops | Yes |
| 2.10 Horizontal & Vertical Flip | Yes |

## 3. Acquisition Workstation

| 3.1 Workstation Model | MX-200-OMI |
|--------------------------------|-----------------------------------------------------------|
| 3.2 Monitor, size | 2 X 18.1 inch, Medical Grade,<br>high contrast monochrome |
| 3.3 Grey Levels | |
| 3.4 Review (Fluoro Loops/Cine) | Forward, Reverse, Pause, and Speed |
| 3.5 Window/Level Adjust | Yes |
| 3.6 Annotation | Yes |
| 3.7 Image Invert | Yes |
| 3.8 Horizontal & Vertical Flip | Yes |
| 3.9 Zoom & Roam | Yes (2X) |
| 3.10 Image Storage | Minimum: 117,000 images |
| 3.11 Networking Capabilities | Ethernet 10/100 |
| 3.12 DICOM Store | Yes |
| 3.13 DICOM Print | Yes |

Omega Medical Imaging CS-series-FP 510(k) (revised 7 April 2010)

10-2

.

.

.

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| 3.14 DICOM Worklist Query | Yes |
|---------------------------|----------------------|
| 3.15 DICOM Send | Yes |
| 3.16 Save to DVD/CD | With Embedded Viewer |
| 3.17 Windows Print | Yes |
| 3.18 Image Save | .JPEG & AVI |

## 4. Reference Monitor Identifiers [Review Station]

ﻌﺐ

| 4.1 Patient Name | 64 characters |
|------------------------|---------------------------------------|
| 4.2 Patient I.D. | 64 characters |
| 4.3 Date | 8 characters (05/08/03) |
| 4.4 Time | 4 characters (13::45) |
| 4.5 Window/Level | 0-4096 |
| 4.6 Hospital Name | 64 characters |
| 4.7 Physician Name | 64 characters |
| 4.8 Study I.D. | 16 characters |
| 4.9 Series/Image | 3 characters/3 characters |
| 4.10 Acquisition Mode | PF/DR/Cine |
| 4.11 Image Orientation | Indicated by "R" orientation |
| 4.12 Radiation | Radiation symbol during Live |
| 4.13 Image I.D. | e.g., LIH, Fluoro Loop, Spot, or Cine |

## 5. Live Monitor Identifiers [Image Area]

| 5.1 Patient Name | 64 characters |
|-------------------------|--------------------------------------------------------|
| 5.2 Patient I.D. | 64 characters |
| 5.3 Date | 8 characters (05/08/03) |
| 5.4 Time | 4 characters (13.:45) |
| 5.5 Window/Level | 0-4098 |
| 5.6 Hospital Name | 64 characters |
| 5.7 Physician Name | 64 characters |
| 5.8 Study I.D. | 16 characters |
| 5.9 Series/Image | 3 characters/3 characters |
| 5.10 Image Orientation | Indicated by "R" orientation |
| 5.11 Radiation Symbol | Radiation symbol during Live |
| 5.12 Image I.D. | e.g., FL LIH, FL Loops, Spot Replay, or Cine<br>Replay |
| 5.13 Detector Status | Ready/Not Ready |
| 5.14 Magnification Mode | Normal, MAG 1, MAG 2 |
| 5.15 Loop Replay | Play, Forward, Reverse, Speed, & Pause |
| | |

## GUI [Graphic User Interface on Reference Monitor]

| Patient/Exam Entry | |
|--------------------|-----------------------------------|
| 5.16 Directory | Opens 'Patient Directory' screen |
| 5.17 New | Opens 'Patient Data Entry' screen |
| 5.18 Close | Closes active patient |

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Omega Medical Imaging CS-series-FP 510(k) (revised 7 April 2010)

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| Acquisition | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------|
| 5.19 NR Hi / NR Lo | Selects Noise Reduction Level |
| 5.20 L -> R | Live to Reference (monitor) transfer |
| 5.21 FL @ 15 | Right Click to invoke Fluoro Pulse Rate (15 f/s default, 7.5, & 3.75 f/s) |
| Note: Image Orientation available for Acquisition Mode [from Review ] | |
| Review | |
| 5.22 Edge (enhancement) | Increments from 0, 1, 2, 3, & 4 |
| 5.23 Win./Lev. | Window/Level adjustment |
| 5.24 Split | Invokes 4 on 1 Image display |
| 5.25 Reference - Live | Toggles image between the Reference and Live monitors |
| 5.26 Zoom | Up to 2X zoom with panning |
| 5.27 Polarity | Video white on black or black on white |
| 5.28 Collimate | Invokes electronic shutters |
| 5.29 R [image orientation] | Toggles thru 1 of 4 positions |
| Additional Functions | |
| 5.30 Send | Opens 'DICOM server node selection' |
| 5.31 Print | Sends Image to a Windows compatible printer |
| 5.32 Save | Saves current image to Hard Drive |
| 5.33Text | Invokes the Annotation and Measurement function |

- System Components: This option includes the solid-state x-ray imager (FPD) and . image processor, along with associated mounting hardware and electrical/electronic components. These components are installed in lieu of the image intensifier/CCD camera and its image processor.
- . Materials: The solid-state x-ray imager (FPD) construction and materials comply with UL2601-1, IEC60601-1, CSA 22.2 No. 601.1-M90, and is CE Marked. The imager is classified by Underwriters Laboratories.
- Available Configurations: The CS-series-FP is available in single plane and dual . plane configurations.

#### Intended use:

- . The Omega Medical Imaging, Inc. CS-Series-FP (SSXI) systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
#### Comparison with Predicate Devices:

- It is the opinion of Omega Medical Imaging, Inc. that the CS-series-FP is essentially ● equivalent to the Toshiba Infinix CCi/FPD system (K052884), the GE Innova 2000 (K993037), Philips Alura Xper FD10 F (K020055), and the Siemens Axiom Artis dFC (K021021).

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## DISCUSSION:

Review of the line items in the Comparison Table (Section 10.1) Indicate that all items compared are either similar or the same as the predicate devices. The Flat-Panel Detector manufactured by Varian Medical Systems is utilized in similar FDA cleared fluoroscopic systems and has been in production for several years. All of the major operational features are either similar or the same as the predicate devices and therefore should offer essentially the same performance to the user as the predicate devices.

### Non-Clinical Performance:

- Included in this report is detailed data comparing performance with the existing . Omega Medical Imaging, Inc. CS-series systems utilizing an image-intensifier/CCD based image acquisition system. Also included is detailed specifications and performance of the Varian PaxScan 2020 flat-panel detector.
#### Safety information:

- . The Omega CS-series-FP (SSXI) systems will comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
- The Omega CS-series-FP systems will comply with the international safety . standards IEC 60601-1, IEC 60101-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-2-43.

#### CONCLUSION:

The Omega CS-series-FP (SSXI) systems do not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Omega considers the CSseries-FP (SSXI) systems with the flat-panel detector option to be substantially equivalent with the predicate devices.

Section 10

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## 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

Mr. James Princehorn President Omega Medical Imaging, Inc. 675 Hickman Circle SANFORD FL 32771

JUL 30 2012

Re: K100102

Trade/Device Name: CS-series-FP Fluoroscopy System with optional Solid State X-ray Imaging Device (Flat-Panel Detector)

Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. JAA. and MQB Dated: July 23, 2010 Received: July 29, 2010

Dear Mr. Princehorn:

This letter corrects our substantially equivalent letter of August 31, 2010.

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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Morri 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

510(k) Number (if known): _

Device Name: CS-series-FP (SSXI)

Indications for Use:

17

The Omega Medical Imaging, Inc. CS-series-FP (SSXI) systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

Prescription Use V (Part 21 CFR 801 Subpart D)

WAS AFF Comments on the State Charm Change Charm Ch

Over-The-Counter Use AND/OR (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)

signature

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

510(k) K100162

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AUG 3 1 2010

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