EV Insite System by PSP Corporation is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

Device Description

The EV Insite System is comprised of two pieces of software: EV Insite R and EXtServer. It is a medical image display and processing software product that provides users with capabilities relating to the storage, communication, digital processing and display within the system or across computer networks of medical images. Images can be searched and displayed in a number of layouts as well as stacked. Image and information processing functions include: paging, magnification, gradation, annotation, PET/CT fusion, multiplaner reconstruction (MPR), Maximum Intensity Projection (MIP), superimposing, measurement, multi-display, flip, rotate, and mirror, cine window level adjustment, and comparison display.

The EV Insite system includes features to access and manage medical imaging studies from DICOM 3.0 compliant imaging modalities, and provides information after processing for diagnosis. The EV Insite System software displays image processing results and allows online image search and reading. It does not perform any automatic diagnosis.

The system does not produce any original medical images but can be used for primary diagnosis, except for lossy compressed mammographic images which must not be reviewed for primary image interpretations unless using an FDA cleared display. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. All images located on the EV Insite system have been received from DICOM compliant modalities and/or image acquisition systems.

The EV Insite system allows trained professionals to display and manipulate images stored in DICOM archive devices. These trained professionals include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants.

The EV Insite system is designed to be deployed over conventional networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "EV Insite System" as a Picture Archiving and Communications System (PACS). It details the device's intended use, technological characteristics, and comparison to a predicate device (Centricity PACS-IW).

However, the document specifically states under "10. Clinical Performance Data":
"There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device."

This means that a study proving the device meets acceptance criteria through clinical performance (i.e., involving human subjects, AI assistance, or expert interpretation) was not conducted or required for this 510(k) clearance. The clearance was primarily based on non-clinical performance data and the device's substantial equivalence to a predicate device with established safety and efficacy.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in terms of clinical performance, as such a study was explicitly stated as not being required and thus not present in the provided documentation.

The "Non-Clinical Performance Data" section (Section 9) refers to internal requirements and software verification and validation testing, which indicates the device met engineering and software requirements, not clinical performance metrics tied to human interpretation or AI performance.

To answer your specific points based on the provided document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Non-Clinical/Software): "The EV Insite System meets all the requirements for overall design results confirming that the design output meets the design inputs and specifications for the device." and "The EV Insite System passed all the testing in accordance with internal requirements shown below to support substantial equivalence of the subject device." Specific quantitative criteria for clinical performance are not provided as no clinical study was done.
- Reported Device Performance (Non-Clinical/Software):
  - "Software verification and validation testing were conducted..."
  - "The software for this device was considered as a 'moderate' level of concern, since a malfunction or a latent design flaw in the software device could lead to an erroneous diagnosis that would lead to a minor injury." (This is a risk categorization, not a performance metric).
  - "Verification and validation of the EV Insite System Software consists of unit testing, software testing and system verification and validation."
  - "The EV Insite System software was developed and tested following processes in compliance with IEC 62304: 2006 Medical Device Software - Software Life Cycle."
A table of quantitative clinical performance metrics is not available from this document.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no human clinical testing or test set for clinical performance was used. The focus was on software testing and device functionality.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no human clinical testing or ground truth establishment for clinical performance was specified. The "trained professionals" mentioned are users, not necessarily experts for ground truth generation in a study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no human clinical testing or test set for clinical performance was used.
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: Not applicable. The device is a PACS system for displaying and processing images, not an AI-powered diagnostic aid that assists human readers in a comparative effectiveness study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a PACS system, not an AI algorithm. Its function is to facilitate human interpretation, not to provide standalone diagnoses.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for clinical performance. For software verification, the "ground truth" would be the specified design inputs and expected behavior of the software.
The sample size for the training set: Not applicable, as the device is not an AI/ML model that requires a training set of medical data for learning.
How the ground truth for the training set was established: Not applicable, as the device is not an AI/ML model.

Summary

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

March 24, 2016

PSP Corporation % Ms. Adrienne Lenz Senior Consultant, OA and RA Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 AUSTIN TX 78701

Re: K152716

Trade/Device Name: EV Insite System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 1, 2016 Received: March 3, 2016

Dear Ms. Lenz:

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Robert Ocko

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) K152716

Device Name EV Insite System

Indications for Use (Describe)

EV Insite System by PSP Corporation is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks. Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

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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510(k) Summary

EV Insite System

K152716

1. Submission Sponsor

PSP Corporation

Nishi-azabu 28 Moribldg. Nishi-azabu 4-16-13

Minato-ku,Tokyo 106-0031

JAPAN

Kenji Ishida

Legal Department

Phone number: 03-5485-1028

2. Submission Correspondent

Emergo Global Consulting, LLC

816 Congress Avenue, Suite 1400

Austin, TX 78701

Cell Phone: 262-290-0023

Office Phone: (512) 327.9997

Contact: Adrienne Lenz, Senior Consultant Quality Assurance and Regulatory Affairs

Email: project.management@emergogroup.com

3. Date Prepared

March 1, 2016

4. Device Identification

Trade/Proprietary Name:	EV Insite System
Common/Usual Name:	Picture archiving and communications system (PACS
Classification Name:	Picture archiving and communications system

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Regulation Number:	892.2050
Product Code:	LLZ, System, Image Processing, Radiological
Device Class:	Class II
Classification Panel:	Radiology

5. Legally Marketed Predicate Device(s)

K123174 Centricity PACS-IW with Universal Viewer, manufactured by GE Healthcare

6. Device Description

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7. Indication for Use Statement

EV Insite system by PSP Corporation is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

8. Substantial Equivalence Discussion

The following table compares the EV Insite System to the predicate device with respect to indications for use, principles of operation, and technological characteristics. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	PSP Corporation	GE Healthcare	Significant Differences
Trade Name	EV Insite System	Centricity PACS-IW
510(k) Number	This submission	K123174	None
Product Code	LLZ	LLZ	None
Regulation Number	892.2050	892.2050	None
Indications for Use	EV Insite system by PSP Corporation is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks.Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.Lossy compressed	Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for	None
Manufacturer	PSP Corporation	GE Healthcare	SignificantDifferences
Trade Name	EV Insite System	Centricity PACS-IW
Indications forUse, continued	mammographic images mustnot be reviewed for primaryimage interpretations.Mammographic images mayonly be interpreted using anFDA cleared display that meetstechnical specificationsreviewed and accepted by FDA.	primary image interpretations.Mammographic imagesmay only be interpreted usingan FDA approvedmonitor that offers at least 5Megapixel resolution and meetother technical specificationsreviewed and accepted by theFDA.Typical users of this system aretrained professionals, includingbut not limited to radiologists,physicians,nurses, medical technicians,and assistants.
Mechanism ofAction	Software that runs oncommercially available off-the-shelf computer hardwareplatforms.	Software that runs oncommercially available off-the-shelf computer hardwareplatforms.	None
TechnologyOverview	Medical image display andinterpretation softwareproduct that is part of a picturearchiving and communicationssystem. It provides users withcapabilities relating to theacceptance, transfer, display,storage, and digital processingof medical images (includingdigital mammograms). Thesoftware is run oncommercially availablehardware specified in thelabeling.	Medical image display andinterpretation softwareproduct that is part of a picturearchiving and communicationssystem. It provides users withcapabilities relating to theacceptance, transfer, display,storage, and digital processingof medical images (includingdigital mammograms). Thesoftware is run oncommercially availablehardware specified in thelabeling.	None
Manufacturer	PSP Corporation	GE Healthcare	Significant
Trade Name	EV Insite System	Centricity PACS-IW	Differences
CompatibleImagingModalities	Computed Tomography (CT),Magnetic Resonance (MR),Ultrasound (US), Nuclearmedicine (NM), Computerizedradiography (CR), Digitalmammography (MG), Digital x-ray (DX), Positron EmissionTomography (PET/PT), X-RayAngiography (XA), Digital Intra-oral X-Ray (IO),Radiotluoroscopic X-ray (RF),Secondary Capture Images (SC),Visible Light (VL) Endoscopic,Microscopic and PhotographicImageStorage and otherDICOM imaging modalities.	Computed Tomography (CT),MagneticResonance (MR), Ultrasound(US), Nuclear medicine (NM),Computerized radiography(CR), Digital mammography(MG), Digital x-ray (DX),Positron Emission Tomography(PET/PT), X-Ray Angiography(XA),Digital Intra-oral X-Ray(IO), Radiotluoroscopic X-ray(RF), Secondary Capture Images(SC), Visible Light (VL)Endoscopic, Microscopic andPhotographic ImageStorage, Slide CoordinatesMicroscopic Image Storage,Presentation States (PS), Keyimage Notes (KIN) and otherDICOM imaging modalities.	EV Insite Systemhas fewercompatibleimagingmodalities. Bothsystems arecompatible withthe most widelyused imagingmodalities.
Image Sources	DICOM, JPEG Baseline (Process1), JPEG Extended (Process 2 &4),JPEG Lossless, Non-Hierarchical, First-OrderPrediction (Process 14[Selection Value 1]), RLELossless	DICOM, JPEG and JPEG 2000	EV Insite Systemdoes not supportJpeg2000.
Image andInformationProcessingFunctions	Image Search/listImage Display (number oflayouts)Image stackPaging,MagnificationDemagnification,	Image Search/listImage Display (number oflayouts)Image stackMammography ViewerPaging,Slab ScrollMagnification	Centricity hasmore processingfunctions,including specialprocessing formammograms, 3-D Rendering,UltrasoundMeasurements,Spine Labeling,
Manufacturer	PSP Corporation	GE Healthcare	Significant
Trade Name	EV Insite System	Centricity PACS-IW	Differences
Image andInformation	Windowing (Window leveladjustment),	Demagnification,Sharpen	ortho images,vessel analysis,
ProcessingFunctionscontinued	Annotation,PET-MR/CT Fusion,Multiplaner reconstruction(MPR),Maximum Intensity Projection(MIP),Image overlay,Measurement,Multi-display,Flip, Rotate, and MirrorCineComparison displayConvolution.	Annotation,Image overlay,PET/CT FusionMultiplaner reconstruction(MPR),Maximum Intensity Projection(MIP),3-D RenderingMeasurement,Multi-display,Flip, Rotate, and MirrorCineWindow level adjustment, andComparison displayUltrasound MeasurementsSpine LabelingOrtho toolsVessel AnalysisAdvanced PET/CT	advanced PET/CTand digitalsubtractionangiography. EVInsite System'sfusion functionincludes PET/MRin addition toPET/CT likeCentricity.

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of EV Insite System and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, PSP Corporation completed non-clinical performance tests. The EV Insite System meets all the requirements for overall design results confirming that the design output meets the design inputs and specifications for the device.

The EV Insite System passed all the testing in accordance with internal requirements shown below to support substantial equivalence of the subject device:

. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a malfunction or a latent design flaw in the software device could lead to an erroneous diagnosis that would lead to a minor injury. Verification

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and validation of the EV Insite System Software consists of unit testing, software testing and system verification and validation.

The EV Insite System software was developed and tested following processes in compliance with IEC 62304: 2006 Medical Device Software - Software Life Cycle.

10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

The EV Insite System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).