10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002
JPI Healthcare Solutions, Inc. March 17, 2017
Ə0U:LOOLDP/LWWOH 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. Page 2— Mr. William Little
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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: January 31, 2017 Indications for Use See PRA Statement below.
510(k) Number (if known)
K162868
Device Name ExamVue PACS
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF 510 (k) Summary February 28th, 2017.
1. Company and Correspondant Making the Submission:
Common Name: Picture Archiving and Communication System (PACS) Regulatory Number: 21 CFR 892.2050 Regulatory Class: II Product Code: 90 LLZ
5. 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.
2 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.
3 EXHIBIT 1
SUBSTANTIAL EQUIVALENCE CHART
Characteristics ExamVue PACS TigerView QXLink
Professional Manufacturer JPI Healthcare Televere Systems Vieworks Co, Ltd Solutions, Inc 510K Number K162868 K001035 K092081
Intended use. ExamVue PACS is TigerView The QXLink is a
an image Professional is a device that provides management system clinical software one or more intended to be used application that capabilities relating to by trained receives images and the acceptance, professionals, data from various transfer, display, including imaging sources storage, and digital physicians, (eg., radiographic processing of medical radiologists, nurses devices, digital images. The software and medical video capture components provide technicians. device, and generic functions for image devices such performing operations The software is a as scanners). In related to image software package addition, TigerView manipulation, used with general Professional enhancement, or purpose computing enables the storage quantification.DICOM hardware to receive, of clinical notes and 3.0 standard. It can store, distribute, clinical exam data. transfer images process and display It is intended to processed in images and acquire, display, PACS and print associated data edit(e.g., resize, images with a film throughout a adjust contrast, printer compatible clinical crop, annotate, etc.), with DICOM 3.0 by environment. The review, store, print, using DICOM and software performs and distribute Network systems. digital image images using processing, standard PC measurement, hardware communication and storage. This device is not indicated for use in mammography.
ExamVue PACS supports receiving, sending, printing, 4 storing and displaying studies received from the following modality types via DICOM: CR and DX.
Standard Operating System Windows 7 or Windows Based Windows Based Requirements Windows 8 or Operating Systems Operating Systems Windows 10 Image Archive Yes Yes Yes Yes Yes Yes Image Transfer (DICOM 3.0 (DICOM 3.0 (DICOM 3.0 Standard) Standard) Standard) Image Display Yes Yes Yes Patient Search Yes Yes Yes Distance and Yes Yes Yes Angle Measurements Window Level Yes Yes Yes Adjustment Zoom and Yes Yes Yes Magnify Functions Line Profile and Yes Yes Yes Histogram DICOM Directory Yes No Yes Reading DICOM Yes No Yes Query/Retrieve DICOM Import Yes Yes Yes DICOM CD Burn Yes Yes Yes DICOM Print Yes Yes Yes DICOM Tag Yes Yes Yes Display Patient Yes Yes Yes Information Editing
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.
