(84 days)
Not Found
No
The summary describes a telemedicine system for data collection, management, and communication, with no mention of AI or ML capabilities for analysis or interpretation of the data.
No.
The device is described as a "patient monitoring system" intended to transmit patient data for review by healthcare practitioners, who then make decisions regarding diagnosis and treatment. It does not directly provide therapy.
No
The "Intended Use / Indications for Use" section states, "Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals," indicating that the device itself is a tool for monitoring and data transmission, not for making diagnostic decisions.
No
The device description explicitly states it is a "PC based telemedicine system adapted to the collection, management, and communication of patient monitoring data," implying the use of hardware (PC) beyond just software. While it facilitates data transmission and communication, it is not solely software.
Based on the provided information, the MedVizer™ ViTelCare Patient Monitoring System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MedVizer™ ViTelCare Function: The description clearly states that the system acquires, accumulates, and transmits a continuous self-assessment of physical condition and other physiological vital signs information. It also involves videoconferencing for communication.
- Lack of Sample Analysis: There is no mention of the system analyzing biological samples. The data collected is related to the patient's physical state and vital signs, not laboratory analysis of bodily fluids or tissues.
- Focus on Monitoring and Communication: The primary function is remote patient monitoring and communication with a healthcare practitioner.
Therefore, the MedVizer™ ViTelCare Patient Monitoring System falls under the category of a patient monitoring and telemedicine system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MedVizer™ ViTelCare Patient Monitoring System is intended for use in the acquisition, communication, storage, display, and printing of video images and patient monitoring data.
MedVizer™ ViTelCare Patient Monitoring System is intended to be included as a tool for an in-home patient that acquires, accumulates, and transmits a continuous self-assessment of physical condition, and other physiological vital signs information to healthcare practitioner located remotely from the patient. The patient data is transmitted to a MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healthcare practitioner can contact the patient directly through a videoconference. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.
Product codes
DQA
Device Description
MedVizer™ ViTelCare Patient Monitoring System is a PC based telemedicine system adapted to the collection, management, and communication of patient monitoring data from home and group care environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-home patient, healthcare practitioner located remotely from the patient, MedVizer™ ViTelCare Call Center, qualified healthcare practitioner
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
MedVizer™ PACS (K000557)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
MAY 27 2004
APPENDIX 6: 510 (K) SUMMARY
510(k) Summary As required by 807.92 For MedVizer™ ViTelCare Patient Monitoring System Prepared on February 16, 2004
Submitted by: ViTel Net 8201 Greensboro Drive, Suite 820 McLean, VA 22102
Tel. (703) 448-0999 Fax: (703) 749-9559
Contact Person: Allen Izadpanah President and Chief Executive Officer
Device Trade Name: MedVizer™ ViTelCare Patient Monitoring System
Common Name: patient monitoring system
Classification: Not classified
Predicate Device: MedVizer™ PACS (K000557)
Manufactured by: ViTel Net 8201 Greensboro Drive, Suite 820 McLean, VA 22102
Description of the Device: MedVizer™ ViTelCare Patient Monitoring System is a PC based telemedicine system adapted to the collection, management, and communication of patient monitoring data from home and group care environments.
Intended Use for the Device: MedVizer™ ViTelCare Patient Monitoring System is intended for use in the acquisition, communication, storage, display, and printing of video images and patient monitoring data.
Substantial Equivalence to Predicate Device: MedVizer™ ViTelCare Patient Monitoring System is virtually identical to MedVizer™ PACS. There are no technical differences with any implications for safety and effectiveness. The labeling of MedVizer™ ViTelCare Patient Monitoring System includes extensive protocols for monitoring patients with specific medical conditions. These have been derived from guidelines published by the VA, DOD, and other national organizations.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or strokes, often referred to as the "Human Services Symbol" or "HHS Symbol."
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 2004
Visual Telecommunications Network, Inc. c/o Mr. Roger Schneider 8201 Greensboro Drive, Suite 820 McLean, VA 22102
Re: K040581
Trade Name: MedVizer ViTclCare Patient Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: DQA Dated: May 07, 2004 Received: May 12, 2004
Dear Mr. Schneider:
We have reviewed your Section 510(k) premarket notification of intent to market the device we neve roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 ass stated in the encreases) in the enactment date of the Medical Device Amendments, or 10 conninered pror to may 2017 31 11:31 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmeter For (110) has the device, subject to the general controls provisions of the Act. The r ou may, are every, mains 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 Codc 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 complics with other requirements of the Act
2
Page 2 - Mr. Roger Schneider
or any Federal statutes and regulations administered by other Federal agencies. You must or any I edelar statutes and equirements, including, but not limited to: registration and listing (21 Comply with an the 11er 01 CFR Part 801); good manufacturing practice requirements as set Cl K Fat 6077; adoning (21 CFR Part 820); and if applicable, the electronic forul in the quints by browisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control to begin marketing your device as described in your Section 510(k) This icher will anow you to ogin maing of substantial equivalence of your device to a legally prematication: "The Presults 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 if you desire specific as not any 101) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Whoordinanting by responsibilities under the Act may be obtained from the Outer general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R.P. Ogden
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ MedVizer™ ViTelCare Patient Monitoring System______
Indications for Use: MedVizer™ ViTelCare Patient Monitoring System is intended to be Includions for Ober in tool for an in-home patient that acquires, accumulates, and transmits a continuneation, self-assessment of physical condition, and other physiological vitar signs mrormationar located remotely from the patient. The patient uala to a 'nealtheare practiceller room the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healthcare practitioner can contact the patient directly through a videoconference noanthears prairies and The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.
Mel R.P. Ogle
(Division Sian-Off Division of Cardiovascular Devices
K 040581 510(k) Number__
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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