(15 days)
Not Found
No
The description focuses on integrating and displaying video feeds, with no mention of AI or ML for analysis, interpretation, or decision support.
No
The device is a large screen monitor designed to integrate and display video outputs from various medical instruments for viewing and training purposes. It does not directly provide therapy or therapeutic benefit to a patient.
No
The Cardio-View system is described as a large screen monitor that integrates video outputs from various medical instruments for display. Its purpose is to allow healthcare professionals to view multiple systems simultaneously, particularly in training labs. It does not perform any analysis, interpretation, or diagnosis based on the integrated data; it merely displays information from other diagnostic devices.
No
The device description explicitly states it is a "very large screen monitor" and mentions electrical safety testing (IEC 60601-1), which are characteristics of a hardware device, not software only.
Based on the provided information, the Cardio-View system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to integrate and display video outputs from various medical instruments used during a medical procedure. It's a display and integration system for real-time procedural information.
- Device Description: The description reinforces this by stating it's a large screen monitor for integrating and displaying outputs from existing medical systems. It's used for viewing and training purposes, not for analyzing biological samples or providing diagnostic information based on in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on these samples, or providing diagnostic results based on such analysis. The inputs are video feeds from other medical devices.
In summary, the Cardio-View system is a display and integration tool for procedural information, not a device that performs in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
DXJ
Device Description
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.
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 / medical procedure laboratory, training labs
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
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.
Key Metrics
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
TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | CurlView IGT, LLC
1242 Chestnut Street
Newton, MA 02464
Phone: 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 Marketed
Device(s): | Electrophysiology Systems Integrator (EPSI)
SystemsOne, LLC (K073372) |
| Device Description: | 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. |
| intended 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. |
| Technological
Characteristics: | The Cardio-View 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 device cited, CurlView IGT, LLC, believes that
the Cardio-View system is substantially equivalent to the
device currently approved and on the market. |
| Test Conclusions: | 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. |
1
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.
2
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
3
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
4
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 |