Exam Vue PACS

K162868 · Jpi Healthcare Solutions, Inc. · LLZ · Mar 17, 2017 · Radiology

Device Facts

• Record ID: K162868
• Device Name: Exam Vue PACS
• Applicant: Jpi Healthcare Solutions, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ExamVue PACS is an image management system intended to be used by trained professionals, including physicians, radiologists, nurses and medical technicians. The software is a software package used with general purpose computing hardware to receive, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. This device is not indicated for use in mammography. ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CR and DX.

Device Story

ExamVue PACS is a software-based image management system for clinical environments; operated by physicians, radiologists, nurses, and technicians. It functions as a central database/server and viewer application installed on general-purpose PCs. Input consists of DICOM-compliant medical images from CR and DX modalities. The system stores, distributes, and displays these images; provides tools for digital image processing, measurement (distance/angle), window/level adjustment, zoom/magnify, and line profile/histogram analysis. Output is displayed on clinical workstations for diagnostic review and clinical decision-making. The device facilitates efficient image workflow, storage, and communication within a healthcare facility.

Clinical Evidence

Bench testing only. Software verification and validation documentation provided in accordance with IEEE 1012-2012. No clinical data presented.

Technological Characteristics

Software-only PACS; runs on general-purpose computing hardware (Windows 7, 8, or 10). Connectivity via DICOM 3.0 standard for image transfer, query/retrieve, and printing. Features include image archiving, measurement tools, and window/level adjustment. Verification performed per IEEE 1012-2012.

Indications for Use

Indicated for use by trained professionals (physicians, radiologists, nurses, medical technicians) to manage, store, process, and display medical images (CR and DX modalities) in clinical environments. Not indicated for mammography.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• QXLink (K092081)
• Tigerview Professional (K061035)

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

March 17, 2017

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

Re: K162868 Trade/Device Name: Exam Vue PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 3, 2017 Received: March 7, 2017

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) K162868

Device Name ExamVue PACS

#### Indications for Use (Describe)

Exam Vue PACS is an image management system intended to be used by trained professionals, including physicians, radiologists, nurses and medical technicians.

The software is a software package used with general purpose computing hardware to receive, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. This device is not indicated for use in mammography.

ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CR and DX.

| 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)

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# 510 (k) Summary

February 28th, 2017.

- 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: | Imaging Processing System, Radiological |
|-------------------------|---------------------------------------------------|
| Common Name: | Picture Archiving and Communication System (PACS) |
| Trade/Proprietary Name: | ExamVue PACS |

# 3. Predicate Device

| Manufacturer: | Vieworks Co, Ltd |
|----------------------|---------------------------------------------------|
| Device: | QXLink |
| 510(k) Number: | K092081 |
| Classification Name: | Imaging Processing System, Radiological |
| Common Name: | Picture Archiving and Communication System (PACS) |
| Regulatory Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | 90 LLZ |

| Manufacturer: | Televere |
|----------------------|---------------------------------------------------|
| Device: | Tigerview Professional |
| 510(k) Number: | K061035 |
| Classification Name: | Imaging Processing System, Radiological |
| Common Name: | Picture Archiving and Communication System (PACS) |
| Regulatory Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | 90 LLZ |

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- Product Classification Names and Citations 4.

| Classification Name: | Imaging Processing System, Radiological |
|----------------------|---------------------------------------------------|
| Common Name: | Picture Archiving and Communication System (PACS) |
| Regulatory Number: | 21 CFR 892.2050 |
| Regulatory Class: | II |
| Product Code: | 90 LLZ |

#### న్. Description:

The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing. modifying, making measurements on, and displaying the images in the database.

- 6. Indication for use
ExamVue PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

The software is a software package used with general purpose computing hardware to receive, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. This device is not indicated for use in mammography.

ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality type via DICOM: CR and DX.

- 7. Comparison with Predicate Device:
JPI Healthcare Co., Ltd, believes that the ExamVue PACS is substantially equivalent to the predicate devices, TigerView Professional and QXLink

All three devices have the same basic structure (a central server database and associated viewers), function (the storage, display and diagnosis of DICOM images) and follow the DICOM protocol. They have similar intended uses, and provide similar suites of tools to fulfil their function.

The ExamVue PACS differs from the predicate devices is user interface and compatible operating systems. We believe this does not represent a substantial difference between the two devices, as the change in system requirements reflect the change in computer technology since the release of the predicate device, and the user interface presents the same essential data and supports similar workflow as the predicate device.

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### 8. Safety, EMC and Performance Data

Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation.

Software Verification and Validation documentation for ExamVue PACS, as well as bench and clinical testing, have been provided in this submission.

- 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 ExamVue PACS 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 below.

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# EXHIBIT 1

# SUBSTANTIAL EQUIVALENCE CHART

| Characteristics | ExamVue PACS | TigerView<br>Professional | QXLink |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | JPI Healthcare<br>Solutions, Inc | Televere Systems | Vieworks Co, Ltd |
| 510K Number | K162868 | K001035 | K092081 |
| Intended use. | ExamVue PACS is<br>an image<br>management system<br>intended to be used<br>by trained<br>professionals,<br>including<br>physicians,<br>radiologists, nurses<br>and medical<br>technicians.<br>The software is a<br>software package<br>used with general<br>purpose computing<br>hardware to receive,<br>store, distribute,<br>process and display<br>images and<br>associated data<br>throughout a<br>clinical<br>environment. The<br>software performs<br>digital image<br>processing,<br>measurement,<br>communication and<br>storage. This device<br>is not indicated for<br>use in<br>mammography.<br>ExamVue PACS<br>supports receiving,<br>sending, printing, | TigerView<br>Professional is a<br>clinical software<br>application that<br>receives images and<br>data from various<br>imaging sources<br>(eg., radiographic<br>devices, digital<br>video capture<br>device, and generic<br>image devices such<br>as scanners). In<br>addition, TigerView<br>Professional<br>enables the storage<br>of clinical notes and<br>clinical exam data.<br>It is intended to<br>acquire, display,<br>edit(e.g., resize,<br>adjust contrast,<br>crop, annotate, etc.),<br>review, store, print,<br>and distribute<br>images using<br>standard PC<br>hardware | The QXLink is a<br>device that provides<br>one or more<br>capabilities relating to<br>the acceptance,<br>transfer, display,<br>storage, and digital<br>processing of medical<br>images. The software<br>components provide<br>functions for<br>performing operations<br>related to image<br>manipulation,<br>enhancement, or<br>quantification.DICOM<br>3.0 standard. It can<br>transfer images<br>processed in<br>PACS and print<br>images with a film<br>printer compatible<br>with DICOM 3.0 by<br>using DICOM and<br>Network systems. |
| | storing and<br>displaying studies<br>received from the<br>following modality<br>types via DICOM:<br>CR and DX. | | |
| Performance Standard | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Operating System<br>Requirements | Windows 7 or<br>Windows 8 or<br>Windows 10 | Windows Based<br>Operating Systems | Windows Based<br>Operating Systems |
| Image Archive | Yes | Yes | Yes |
| Image Transfer | (DICOM 3.0<br>Standard) | (DICOM 3.0<br>Standard) | (DICOM 3.0<br>Standard) |
| Image Display | Yes | Yes | Yes |
| Patient Search | Yes | Yes | Yes |
| Distance and<br>Angle<br>Measurements | Yes | Yes | Yes |
| Window Level<br>Adjustment | Yes | Yes | Yes |
| Zoom and<br>Magnify Functions | Yes | Yes | Yes |
| Line Profile and<br>Histogram | Yes | Yes | Yes |
| DICOM Directory<br>Reading | Yes | No | Yes |
| DICOM<br>Query/Retrieve | Yes | No | Yes |
| DICOM Import | Yes | Yes | Yes |
| DICOM CD Burn | Yes | Yes | Yes |
| DICOM Print | Yes | Yes | Yes |
| DICOM Tag | Yes | Yes | Yes |
| Display<br>Patient<br>Information<br>Editing | Yes | Yes | Yes |

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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. For this reason, we believe it is substantially equivalent to the predicate devices.