ClearVision ExamVue Flat Panel Detector

K160143 · Jpi Healthcare, Inc. · MQB · Oct 28, 2016 · Radiology

Device Facts

• Record ID: K160143
• Device Name: ClearVision ExamVue Flat Panel Detector
• Applicant: Jpi Healthcare, Inc.
• Product Code: MQB · Radiology
• Decision Date: Oct 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The ClearVision ExamVue Flat Panel detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The ClearVision ExamVue Flat Panel detector is not indicated for use in mammography.

Device Story

ClearVision ExamVue Flat Panel Detector consists of three solid-state x-ray detector models (tethered and wireless cassette-sized panels, fixed panel); designed for radiologists and technicians. Device captures digital x-ray images by converting x-rays to electronic signals via a Cesium Iodide (CsI) scintillator and amorphous Silicon (aSi) TFT array; eliminates film/chemical processing. ExamVueDR software performs image processing, presentation, and storage in DICOM format. Used in clinical settings; interfaces with x-ray generators via hard-wired control signals or Automatic Exposure Detection (AED). Output is a digital image for clinical review; assists in diagnostic decision-making and treatment planning. Benefits include improved workflow efficiency and digital image availability.

Clinical Evidence

Clinical images provided to supplement laboratory performance data; not required to establish equivalence due to identical detector technology. Bench testing included safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility for patient-contacting surfaces.

Technological Characteristics

Solid-state x-ray imager using aSi TFTD technology with CsI scintillator. Models: 14x17in tethered, 14x17in wireless (with AED), 17x17in tethered. Connectivity: Gigabit Ethernet or wireless. DICOM compliant. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for general radiology, including podiatry, orthopedic, and other specialties, and mobile x-ray systems. Not indicated for mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Predicate Devices

• ATAL-8 (K113812)
• DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A (K090742)

Submission Summary (Full Text)

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

October 28, 2016

JPI Healthcare, Inc. % Mr. William Little Senior Product Manager JPI Healthcare Solutions, Inc. 52 Newtown Plaza PLAINVIEW NY 11803

Re: K160143

Trade/Device Name: ClearVision Exam Vue Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 12, 2016 Received: September 13, 2016

Dear Mr. Little:

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

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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

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### Indications for Use

510(k) Number (if known) K160143

Device Name

ClearVision ExamVue Flat Panel Detector

Indications for Use (Describe)

The ClearVision ExamVue Flat Panel detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.

The ClearVision ExamVue Flat Panel detector is not indicated for use in mammography.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510 (k) Summary

August 10, 2016.

- 1. Company and Correspondant Making the Submission:
Name: JPI Healthcare Co., LTD Address: Woolim e-BIZ center #608 170-5, Kuro-3-dong, Kuro-gu Seoul, 152-769 Telephone: [phone] - 2580 (Ext. 500-504) Fax: [phone] Contact: John Lim Website: http://www.jpi.co.kr/

- 2. Identification of Device

| Classification Name: | Solid State X-ray Imager (flat panel/digital imager) |
|-------------------------|------------------------------------------------------|
| Common Name: | Solid State X-ray Imager |
| Trade/Proprietary Name: | ClearVision ExamVue Flat Panel Detector |

#### 3. Predicate Device

| Manufacturer: | Atlaim |
|----------------------|------------------------------------------------------|
| Device: | ATAL-8 |
| 510(k) Number: | K113812 |
| Classification Name: | Solid State X-ray Imager (flat panel/digital imager) |
| Common Name: | Solid State X-ray Imager |
| Regulatory Number: | 21 CFR 892.1680 |
| Regulatory Class: | II |
| Product Code: | 90 MQB |

| Manufacturer: | Samsung Mobile Display |
|----------------------|----------------------------------------------------------|
| Device: | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL<br>LTX240AA01-A |
| 510(k) Number: | K090742 |
| Classification Name: | Solid State X-ray Imaging Device |
| Common Name: | Digital Flat Panel Xray Detector |
| Regulatory Number: | 21 CFR 892.1680 |
| Regulatory Class: | II |
| Product Code: | 90 MQB |

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- Product Classification Names and Citations 4.
Regulatory Number: 21 CFR 892.1680 Regulatory Class: II Product Code: 90 MQB

#### 5. Description:

The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format.

All models of the ClearVision ExamVue Flat Panel Detector use aSi TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are:

- a. A 14x17in (35x43cm) tethered cassette sized panel
- b. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detection
- c. A 17x17in (43x43cm) tethered panel for fixed installations.

#### 6. Indication for use

The ClearVision ExamVue Flat Panel Detector is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.

The ClearVision ExamVue Flat Panel Detector is not indicated for use in mammography.

### 7. Comparison with Predicate Device:

JPI Healthcare Co., Ltd, believes that the ClearVision ExamVue Flat Panel Detector is substantially equivalent to the ATAL-8 detector of Atlaim and the LTX240AA01-A of Samsung Mobile Display, Ltd.

The ClearVision ExamVue Flat Panel Detectors have similar or superior characteristics to the predicate devices, including:

- The same aSi TFTD technology, converting visible light from a a. scintillator into a digital image.
- b. Similar pixel pitch (140um-143um for the Clear Vision Exam Vue Flat

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Panels vs 139um-143um for the predicate devices)

- Exclusively CsI scintillators, compared to the option of CsI or the lower C. performance Gadolinium Oxide scintillator in the predicate devices.
- d. Similar indications for use, focused on general radiography and excluding mammography.
- Have been integrated to function with the same image acquisition e. software, ExamVueDR, for final processing and presentation.

Clinical images were provided; these images were not necessary to establish equivlance based on the modifications to the device (x-ray detector technology identical to predicate devices) but they provide further evidence in addition to the laboratory performance data to show that the subject device works as intended.

The image acquisition control interface testing was performed as part of laboratory and clinical testing. This control interface consists of hard wired control signal to the x-rav generator (all models) or AED (FDX3543RPW). The software control interface for exposure settings on selected generators had been previously tested in the notification of the ExamVueDR software as a stand-alone product (K142930).

- 8. Safety, EMC and Performance Data
Bench tests reports have been provided, detailing the safety and EMC testing, as well as non-clinical performance data for the ClearVision ExamVue Flat Panel Detector.

Biocompatibility data has been provided for patient-contacting surfaces of the device, demonstrating that there are no known adverse reactions to skin contact with the device.

We have also provided clinical testing of the hardware, showing comparison images using identical software, as recommended by the FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"

- 9. Conclusions:
In accordance with the Federal Food. Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification JPI Healthcare Co., Ltd. concludes that The ClearVision ExamVue Flat Panel Detector is safe and effective and substantially equivalent to predicate devices as described herein.

A detailed comparison supporting this conclusion can be found in Exhibit 1, Substantial Equivalence Chart.

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# EXHIBIT 1

## SUBSTANTIAL EQUIVALENCE CHART

| Device Name | ExamVue<br>FPD<br>FDX3543RP | Examvue FPD<br>FDX3543RPW | Examvue<br>FPD<br>FDX4343R | ATAL-8 | LTX240AA01-<br>A |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Toshiba | Toshiba | Toshiba | ATLAIM | Samsung<br>Mobile Display |
| FDA 510(k)<br>K# | K160143 | K160143 | K160143 | K113812 | K090742 |
| Intended use. | The ClearVision ExamVue Flat Panel detector<br>is indicated for use in general radiology,<br>specialist radiology including podiatry,<br>orthopedic, and other specialties, and in mobile<br>x-ray systems.<br>The ClearVision ExamVue Flat Panel detector<br>is not indicated for use in mammography. | The ClearVision ExamVue Flat Panel detector<br>is indicated for use in general radiology,<br>specialist radiology including podiatry,<br>orthopedic, and other specialties, and in mobile<br>x-ray systems.<br>The ClearVision ExamVue Flat Panel detector<br>is not indicated for use in mammography. | The ClearVision ExamVue Flat Panel detector<br>is indicated for use in general radiology,<br>specialist radiology including podiatry,<br>orthopedic, and other specialties, and in mobile<br>x-ray systems.<br>The ClearVision ExamVue Flat Panel detector<br>is not indicated for use in mammography. | The ATAL 8<br>and ATAL 8C<br>are indicated<br>for use in<br>general<br>radiographic<br>images of<br>human<br>anatomy. It is<br>intended to<br>replace<br>radiographic<br>film/screen<br>systems in all<br>general-<br>purpose<br>diagnostic<br>procedures,<br>excluding<br>fluoroscopic,<br>angiographic,<br>and<br>mammographic<br>applications. | LTX240AA01-<br>A digital flat<br>panel X-ray<br>detector is<br>indicated for<br>digital imaging<br>solution<br>designed for<br>providing<br>general<br>radiographic<br>diagnosis of<br>human<br>anatomy<br>targeting both<br>adult and<br>children. It is<br>intended to<br>replace film<br>based<br>radiographic<br>diagnostic<br>systems and<br>provide a case<br>diagnosis and<br>treatment<br>palnning for<br>physicians and<br>other health<br>care<br>professionals.<br>Not to be used<br>for<br>mammography. |
| Configuration | | This submission is for the digital panel and | | This | This |

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| | software only, no generator or stand provided. | | | submission is<br>for the digital<br>panel only, no<br>generator or<br>stand provided. | submission is<br>for the digital<br>panel only, no<br>generator or<br>stand provided. |
|-----------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Detector Type | Amorphous Silicon (a-Si) Photodiode | | | SAME | SAME |
| Pixel Pitch | 143um | 140um | 143um | 139um | 143um |
| Limiting<br>Resolution | 3.7lp/mm | 3.7lp/mm | 3.7lp/mm | Over 3lp/mm | 3lp/mm |
| A/D<br>Conversion | 16 bit | 14 bit | 14 bit | 14 bit | 14 bit |
| Active Area | 14x17 inch | 14x17 inch | 16.9x17.3 inch | 17x17 inch | 17x17 inch |
| Dimensions<br>(mm) | 384(w) x<br>460(D) x<br>15(H) | 384(w) x<br>460(d) x 15(h) | 512(w) x<br>495(d) x<br>43(h) | 500(w) x<br>500(1) x 25(h) | 500(w) x<br>497(1) x 44mm<br>(H) |
| Weight | 3kg | 3kg | 9kg | 7.8kg | 13.4kg |
| Pixels | 2448x2984<br>(7.3Mpx) | 2466x3040<br>(7.5Mpx) | 3008x3072<br>(9.2Mpx) | 3072x3072<br>(9.4Mpx) | 3072x3072<br>(9.4Mpx) |
| DQE @ 1<br>lp/mm | 57% | 60% | 58% | 33% Gadox /<br>46% CsI | 45% Gadox /<br>65% CsI |
| MTF @ 1<br>lp/mm | 63% | 68% | 65% | 63% Gadox /<br>72% CsI | 57% Gadox /<br>59% CsI |
| DICOM | Yes | Yes | Yes | Yes | Yes |
| Scintillator | CsI | CsI | CsI | CsI/Gadox | CsI/Gadox |
| Interface | Gigabit<br>Ethernet | Gigabit<br>Ethernet or<br>Wireless | Gigabit<br>Ethernet | Gigabit<br>Ethernet | Gigabit<br>Ethernet |
| Automatic<br>Exposure<br>Detection | No | Yes | No | Yes | No |
| Generator<br>Exposure<br>Trigger or<br>Sensor | Yes | Yes | Yes | Yes | Yes |
| Power Source | AC Line | AC Line | AC Line | AC Line | AC Line |
| Standards | Electrical<br>Safety per<br>IEC 60601-1<br>and EMC per<br>IEC 60601-<br>1-2. | Electrical<br>Safety per IEC<br>60601-1 and<br>EMC per IEC<br>60601-1-2. | Electrical<br>Safety per<br>IEC 60601-1<br>and EMC per<br>IEC 60601-<br>1-2. | Electrical<br>Safety per IEC<br>60601-1 and<br>EMC per IEC<br>60601-1-2. | Electrical<br>Safety per IEC<br>60601-1 and<br>EMC per IEC<br>60601-1-2. |
| Acquisition<br>and Control<br>Software | Exclusively<br>ExamVueDR<br>(K142930) | Exclusively<br>ExamVueDR<br>(K142930) | Exclusively<br>ExamVueDR<br>(K142930) | *Option for<br>ExamVueDR<br>(K142930) | *Option for<br>ExamVueDR<br>(K142930) |

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*: The ExamVueDR software 510(k) notification (K149230) includes the indicated detector as one of the detectors the software can be integrated with to form a retrofit solution. The ExamVueDR software is not referenced in the 510(k) notification for the detector itself.

The intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. The image acquisition and user interface software in the device has been previously 510(k) notified for use with the predicate devices. For this reason, we believe it is substantially equivalent to the predicate devices.