(15 days)
083321
Not Found
No
The description focuses on integrating and displaying existing video feeds, with no mention of analysis, processing, or interpretation of the video content using AI/ML techniques.
No
The device integrates and displays video outputs from other medical systems; it does not directly treat or diagnose a medical condition.
No
The device is described as an integration system for video outputs from various electrophysiology equipment onto a single display, primarily for organizational and observational purposes during procedures. Its function is to consolidate existing video feeds, not to analyze data, make diagnoses, or provide new diagnostic information.
No
The device description explicitly states the system uses a 56-inch LCD display monitor and a touchpad device for control, indicating the inclusion of hardware components beyond just software.
Based on the provided information, the VantageView™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to integrate video outputs from other medical systems for display during electrophysiology procedures. It's a display and control system for existing medical imaging and data, not a device that performs tests on biological samples to diagnose or monitor a condition.
- Device Description: The description focuses on integrating and displaying video feeds from other medical devices. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of biomarkers or analytes
- Diagnostic or monitoring claims based on sample analysis
The VantageView System is a display and control system designed to improve workflow and visualization for healthcare professionals during medical procedures. It relies on the outputs of other medical devices, which may or may not be IVDs themselves, but the VantageView System itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The VantageView™ System is indicated for use during electrophysiology procedures, and is intended to be used by healthcare professionals to integrate the video outputs from several commercially-available systems 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 (comma separated list FDA assigned to the subject device)
DXJ
Device Description
The VantageView System uses a 56 inch, high definition (HD), LCD display monitor that is able to integrate up to 8 video displays from up to 16 video sources. The video inputs are typically from common electrophysiology (EP) equipment used in an EP Lab (e.g. Fluoroscopy, the EP-WorkMate System, the EnSite Velocity System, MediGuide Technology, etc.) This technology creates one focused observation point for monitoring the selected displays simultaneously.
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
healthcare professionals, medical procedure laboratory
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)
Bench testing was performed to confirm that the product met design requirements and did not affect the safety or effectiveness of the product. The following non-clinical tests were performed: system verification testing, standard based testing, simulated clinical testing, and Instructions for Use (IFU) validation.
In addition, all electrical safety necessary to meet the IEC 60601-1 and 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
083321
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AN 2: 6 2011
One St. Jude Medical Drive St. Paul, MN 55117-9913
K110085 /
Date Prepared: December 21, 2010
Establishment Address and Registratio St. Jude Medical One St. Jude Medical Drive t. Paul, MN 55117-9913 stablishment Registration Number: 218414
12.2 Submitter's Name/Contact Pers
Kris Miller St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117-9913
Device Classific.
Trade Name: Common Name: Classification Name:
VantageView System Medical cathode-ray tube display 870.2450, display, cathode-ray tube, medical
12.4 Predicate Device
Cardio-View Manufactured by: Carrot Medical-CurlView (083321-
12.5 Indications for Us
- 12 12 12 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 1 2 2 2 2 1 1 2 2 2 1 1 2 2 2 1 1 2 2 1 1 1 2 2 1 1 1 1 2
he VantageView™ System is indicated for use during electrophysiology procedures, and is intended to be used by healthcare professionals to integrate the video outputs from several commercially-available systems commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device
Traditional 510(k) VantageView System
1
One St. Jude Medical Drive St. Paul, MN 55117-9913
12.6 Device Description
The VantageView System uses a 56 inch, high definition (HD), LCD display monitor that is able to integrate up to 8 video displays from up to 16 video sources. The video inputs are typically from common electrophysiology (EP) equipment used in an EP Lab (e.g. Fluoroscopy, the EP-WorkMate System, the EnSite Velocity System, MediGuide Technology, etc.) This technology creates one focused observation point for monitoring the selected displays simultaneously. ಿಗೆ ಮಾಡಿ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರಮುಖ ಪ್ರ
12.7 Summary of Non-Clinical Testing
SJM has conducted extensive testing of the VantageView System during development and installation.
Bench testing was performed to confirm that the product met design requirements and did not affect the safety or effectiveness of the product. The following non-clinical tests were performed: system verification testing, standard based testing, simulated clinical testing, and Instructions for Use (IFU) validation.
In addition, all electrical safety necessary to meet the IEC 60601-1 and collateral standard IEC 60601-1-1 was completed by an experienced medical device electrical testing facility.
12.8 Summary of Design Control Activities
The development of the VantageView System was performed in accordance with St. Jude Medical's Quality System requirements and in compliance with Quality System Regulations design controls requirements documented in 21 CFR 820.30.
Traditional 510(k) VantageView System
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
JAN 26 Car
.
Re: K110085
Trade/Device Name: Vantage View System Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode Ray Tube Display Regulatory Class: Class II (two) Product Code: DXJ Dated: January 10, 2011 Received: January 11, 2011
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), if your device is elabilities not about of . 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 – St. Jude Medical c/o 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); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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.
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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Image /page/4/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of nine squares on the left and the text "ST. JUDE MEDICAL" on the right. Below the text is the phrase "MORE CONTROL LESS RISK" in a smaller font.
One St. Jude Medical Drive St. Paul, MN 55117-9913
- ട് Indications for Use
510(k) Number (if known):
Device Name: VantageView System
Indications for Use:
The VantageView™ System is indicated for use during electrophysiology procedures, and is intended to be used by healthcare professionals to integrate the video outputs from several commercially-available systems 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______________________________________________________________________________________________________________________________________________________________
(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)
Division of Cardiovascular Devices
510(k) Number K161652
Traditional 510(k) VantageView System