(4 days)
The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device.
The EPSI is a video integration system that uses a video splitter to take the original source image from a device and send it out to a variety of locations, such as the original intended monitor, a hemodynamics recording system in the control room, etc. The split image is then sent into the EPSI system (Flat Panel LCD monitor) and a Keyboard-Video-Mouse (KVM) switch. The display on the LCD at any time is controlled by a touchpad panel.
The provided 510(k) summary for the Electrophysiology Systems Integrator (EPSI) describes a device that integrates video outputs from various medical instruments into a single display. However, it does not contain specific acceptance criteria, a detailed study protocol, or performance metrics that would typically be reported for a medical device that makes a diagnostic claim or provides quantitative results.
Based on the information provided, the EPSI device is categorized as a "Display, Cathode-Ray, Medical" (Product Code DXJ, Regulatory Class II). Its function is to display existing video outputs, not to generate new diagnostic information or to interpret medical images. Therefore, the "acceptance criteria" and "device performance" in this context are likely related to its operational functionality, electrical safety, and ability to display images accurately as provided by the source devices, rather than clinical efficacy or diagnostic accuracy.
Here's an attempt to structure the information based on your request, highlighting where information is not present in the provided document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from device type and regulatory standards) | Reported Device Performance (from 510(k) summary) |
|---|---|
| Electrical Safety and Electromagnetic Compatibility (EMC) (Compliance with IEC 60601-1 and collateral standards for medical electrical equipment) | "all electrical safety testing necessary to meet the IEC 60601-1 and its collateral standard IEC 60601-1-1 was completed by an experienced medical device electrical testing facility." |
| Integration and Display Functionality (Ability to receive, split, route, and display video from various medical instruments on a single LCD screen) | "The EPSI is a video integration system that uses a video splitter to take the original source image from a device and send it out to a variety of locations... The split image is then sent into the EPSI system (Flat Panel LCD monitor)." "Control of the video sources is accomplished using a touchpad device." "The system allows for numerous overlapping images from existing medical instrumentation to be viewed on the same large screen..." |
| Data Archiving and Retrieval (Ability to record and archive data from multiple sources and facilitate easy retrieval) | "records and archives data from multiple sources that are accessible on a single station and provides easy retrieval and control of all onscreen data via touchpad controls." |
| Substantial Equivalence to Predicate Devices (Technological characteristics and intended use are similar to legally marketed predicate devices) | "Based on an analysis of the technology and intended use of the predicate devices cited, SystemsOne, LLC, believes that the EPSI system is substantially equivalent to several devices currently on the market." |
| General Functionality and Operational Reliability (Device operates as intended during development and installation) | "SystemsOne, LLC, has conducted extensive testing of the EPSI system during development and installation." |
Missing Information:
- Specific numerical or objective performance metrics for image quality (e.g., resolution, latency, color accuracy), reliability (e.g., MTBF), or user interface responsiveness are not provided in this summary.
- The 510(k) summary focuses on the system's ability to perform functions and its compliance with safety standards, rather than quantitative measurements of its performance. This is typical for devices that are primarily display or interface components without diagnostic algorithms.
Study Details
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "extensive testing...during development and installation" and "all electrical safety testing," but no specific number of test cases, images, or operational hours are provided for the functional or safety tests.
- Data Provenance: Not applicable in the context of clinical data for a display device. The testing described appears to be engineering verification and validation testing, not clinical studies involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The device's function is to display existing video, not to make a diagnostic interpretation where expert ground truth would be required for a test set. The validation would instead involve verifying that the display accurately reproduces the input signal.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or adjudication process is described for this type of device. Testing would likely involve technical verification against requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not relevant for this device. An MRMC study evaluates the diagnostic performance of human readers, with and without AI assistance, typically for devices that produce or interpret diagnostic images. The EPSI system is a video integrator and display, not a diagnostic aid or an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was done
- No. This device is a hardware and software system for display integration and control. It does not employ a standalone algorithm that would be evaluated for performance akin to an AI or diagnostic algorithm. Its "standalone" function refers to its ability to process and display video signals, which would have been validated through engineering tests.
7. Type of Ground Truth Used
- Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data, expert consensus). For electrical safety, the ground truth is compliance with the IEC 60601 series of standards. For display functionality, the ground truth would be the accurate reproduction of the input video signal and the proper functioning of the control interface.
8. Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI that requires a "training set" of data in the conventional sense. Its functionality is based on pre-programmed logic for video signal processing and control.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this type of device.
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.P.
510(k) Summary or Statement
DEC 0 7 2007
| Submitted by: | SystemsOne, LLC6130 Blackberry Street, Suite BAnchorage, AK 99502Phone: 907.250.1797 |
|---|---|
| Contact Person: | M. W. (Andy) Anderson, Ph.D., RACPrincipal AdvisorRegulatory and Clinical Research Institute, Inc.5353 Wayzata Boulevard, Suite 505Minneapolis, MN 55416 |
| Summary Date: | November 8, 2007 |
| Proprietary Name: | Electrophysiology Systems Integrator (EPSI) |
| Common Name: | Display, Cathode-Ray, Medical |
| CFR Reference: | 21CFR§870.2450 |
| Class: | II |
| Product Code: | DXJ |
| Equivalent Marketed Device(s): | CIC Pro Clinical Information Center CentralStation, GE Medical, K053356HP CareVue 9000, Hewlett-Packard, K992636Medical Multi-Disclosure Workstation,SpaceLabs, K962811 |
| Device Description: | The EPSI is a video integration system that usesa video splitter to take the original source imagefrom a device and send it out to a variety oflocations, such as the original intended monitor,a hemodynamics recording system in the controlroom, etc. The split image is then sent into theEPSI system (Flat Panel LCD monitor) and aKeyboard-Video-Mouse (KVM) switch. Thedisplay on the LCD at any time is controlled by atouchpad panel. |
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K073372 p. 2/2
Intended Use: The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device. Technological Characteristics: The EPSI system integrates multiple technologies available "off-the-shelf" from
different manufacturers so they can be easily managed with less equipment. The system allows for numerous overlapping images from existing medical instrumentation to be viewed on the same large screen; records and archives data from multiple sources that are accessible on a single station and provides easy retrieval and control of all onscreen data via touchpad controls.
Substantial Equivalence Rationale: Based on an analysis of the technology and intended use of the predicate devices cited, SystemsOne, LLC, believes that the EPSI system is substantially equivalent to several devices currently on the market.
Test Conclusions: SystemsOne, LLC, has conducted extensive testing of the EPSI system during development and installation. In addition, all electrical safety testing necessary to meet the IEC 60601-1 and its collateral standard IEC 60601-1-1 was completed by an experienced medical device electrical testing facility.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
DEC 0 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SystemsOne, LLC c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K073372
Electrophysiology Systems Integrator (EPSI) Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode Ray Tube Display Regulatory Class: Class II (two) Product Code: DXJ Dated: November 30, 2007 Received: December 3, 2007
Dear Mr. Job:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Mark Job
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); 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. 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 Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bfimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Indications for Use
073372
510(k) Number (if known):
n/a
Device Name: Electrophysiology Systems Integrator (EPSI)
Indications for Use:
The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhimmerma
(Division Sign-Off)
Division of Cardiovascular Devices
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).