(4 days)
Not Found
No
The description focuses on video splitting and display control, with no mention of AI/ML terms or functionalities like image analysis, pattern recognition, or automated decision-making based on data.
No.
The device is a video integration system that combines video outputs from other instruments; it does not directly provide therapy or interact with the patient in a therapeutic manner.
No
The device is described as a "video integration system" that takes video outputs from other instruments and displays them. Its purpose is to integrate and display information, not to diagnose conditions itself.
No
The device description explicitly mentions hardware components like a video splitter, Flat Panel LCD monitor, KVM switch, and touchpad panel, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for integrating video outputs from instruments used in procedures like electrophysiology, cardiac catheterization, and fluoroscopy. These are procedures performed on the patient, not tests performed on samples taken from the patient.
- Device Description: The description details a video integration system, a video splitter, and a display. This is focused on managing and displaying visual information from other medical devices, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The EPSI system's function is to manage and display video feeds from other medical devices used during procedures.
N/A
Intended Use / 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.
Product codes
DXJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals / electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
.P.
510(k) Summary or Statement
DEC 0 7 2007
| Submitted by: | SystemsOne, LLC
6130 Blackberry Street, Suite B
Anchorage, AK 99502
Phone: 907.250.1797 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | M. W. (Andy) Anderson, Ph.D., RAC
Principal Advisor
Regulatory and Clinical Research Institute, Inc.
5353 Wayzata Boulevard, Suite 505
Minneapolis, 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 Central
Station, GE Medical, K053356
HP CareVue 9000, Hewlett-Packard, K992636
Medical Multi-Disclosure Workstation,
SpaceLabs, K962811 |
| Device Description: | 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. |
Page 1 OF 2
1
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.
Page 2 of 2
2
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.
3
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
4
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