(15 days)
The Cardio-View system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device.
Cardio-View is a very large screen monitor for integrating the outputs from multiple video sources onto a single display. This unit is ideally suited for training labs where physicians and medical technologists can simultaneously view the disparate systems in use in the procedure rooms for complex procedures such as electrophysiology and heart surgery. The single display can be set up with customized views of many different procedure room activities to emphasize a particular area of interest while still providing the ability to monitor many others. For example, the display might simultaneously show the information being provided by an anesthesiology monitoring system, an EKG monitoring system, a CAT/MRI simulator, and fluoroscope; with each optimally-positioned for the type of procedure underway. While the display is primarily designed as an integrator and repeater of the many individual monitors typically in use in the procedure room; there is really no limit as to where it can actually be used.
The provided document is a 510(k) summary for a medical device called "Cardio-View." This document does not describe acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for algorithms or AI-driven diagnostic devices.
The Cardio-View device is described as a "very large screen monitor for integrating the outputs from multiple video sources onto a single display" intended for use by healthcare professionals in a medical procedure laboratory. It functions as a display and integrator, not a diagnostic or AI-powered analytical tool.
Therefore, the requested information elements related to algorithm performance, sample sizes for test and training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this device and its 510(k) submission.
The "Test Conclusions" section states:
"CuriView IGT, LLC, has conducted extensive testing of the Cardio-View 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."
This indicates that the testing focused on the electrical safety and functional performance of a display and integration system, rather than diagnostic accuracy or algorithmic performance.
In summary, based on the provided text, the device is a medical monitor/integrator, and the 510(k) submission does not contain the type of performance study details requested for AI/algorithm-driven devices.
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TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | CurlView IGT, LLC1242 Chestnut StreetNewton, MA 02464Phone: 617-340-3188 |
|---|---|
| Contact Person: | Ward Sparacio, CEO |
| Summary Date: | November 3, 2008 |
| Proprietary Name: | Cardio-View |
| Common Name: | Display, Cathode-Ray, Medical |
| CFR Reference: | 21CFR§870.2450 |
| Class: | II |
| Product Code: | DXJ |
| Equivalent MarketedDevice(s): | Electrophysiology Systems Integrator (EPSI)SystemsOne, LLC (K073372) |
| Device Description: | Cardio-View is a very large screen monitor for integrating theoutputs from multiple video sources onto a single display.This unit is ideally suited for training labs where physiciansand medical technologists can simultaneously view thedisparate systems in use in the procedure rooms for complexprocedures such as electrophysiology and heart surgery.The single display can be set up with customized views ofmany different procedure room activities to emphasize aparticular area of interest while still providing the ability tomonitor many others.For example, the display might simultaneously show theinformation being provided by an anesthesiology monitoringsystem, an EKG monitoring system, a CAT/MRI simulator,and fluoroscope; with each optimally-positioned for the typeof procedure underway.While the display is primarily designed as an integrator andrepeater of the many individual monitors typically in use inthe procedure room; there is really no limit as to where it canactually be used. |
| intended Use: | The Cardio-View system is intended to be used by healthcare professionals to integrate the video outputs from severalcommercially-available instruments commonly used in amedical procedure laboratory into a single video display.Control of the video sources is accomplished using atouchpad device. |
| TechnologicalCharacteristics: | The Cardio-View system integrates multiple technologiesavailable "off-the-shelf" from different manufacturers so theycan be easily managed with less equipment. The systemallows for numerous overlapping images from existingmedical instrumentation to be viewed on the same largescreen; records and archives data from multiple sources thatare accessible on a single station and provides easy retrievaland control of all onscreen data via touchpad controls. |
| Substantial EquivalenceRationale: | Based on an analysis of the technology and intended use ofthe predicate device cited, CurlView IGT, LLC, believes thatthe Cardio-View system is substantially equivalent to thedevice currently approved and on the market. |
| Test Conclusions: | CuriView IGT, LLC, has conducted extensive testing of theCardio-View system during development and installation. Inaddition, all electrical safety testing necessary to meet theIEC 60601-1 and its collateral standard IEC 60601-1-1 wascompleted by an experienced medical device electricaltesting facility. |
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Image /page/1/Picture/1 description: The image shows a handwritten note with the text "KCK3321 pg 2 of 2". Below the handwritten note, there is a printed line that says "Page 5-2 of 2". The handwritten note appears to be a page number or identifier, possibly related to the printed page number.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Curlview IGT, LLC c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313
NOV 2 6 2008
Re: K083321
Trade/Device Name: Cardio-View Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: November 11, 2008 Received: November 12, 2008
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 cquivalent (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. 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
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Page 2 - Mr. Mark Job
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
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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K083321 pg 1 of 1
Page 4-1 of 1
4.0 INDICATIONS FOR USE STATEMENT
510(k) Number: N/A
Device Name: Cardio-View
Indications For Use:
The Cardio-View system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device.
Prescription Use: YES
AND/OR
Over-the-Counter Use: NO
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | for B Zuckerman |
|---|---|
| 11/26/08 | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K083321 |
§ 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).