(55 days)
Not Found
No
The summary describes a system for collecting and transmitting patient data, but there is no mention of AI, ML, or any related technologies for data analysis or interpretation.
No.
The device is described as a "communication tool" and a "Telemedicine system" for acquiring, accumulating, and transmitting patient data to a remote healthcare practitioner. It explicitly states that "Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals," indicating that the device itself is not providing therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals," indicating that the device itself is not intended for diagnostic purposes but rather for data transmission and communication to support healthcare professionals in their diagnostic and treatment decisions.
No
The device description explicitly states it is a "PC based Telemedicine system," indicating it includes hardware components (a PC) in addition to software.
Based on the provided information, the ViTelCare™ Turtle 400 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.
- Device Function: The description clearly states the device's purpose is to "acquire, accumulate, and transmit vital signs information, selfassessment of physical condition, and other physiological data" from a patient to a remote healthcare practitioner. This involves collecting data from the patient's body (like vital signs), not analyzing samples taken from the body.
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples.
The device is a telemedicine system focused on remote patient monitoring and communication of physiological data.
N/A
Intended Use / Indications for Use
ViTelCare™ Turtle 400 Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, self-assessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. 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
MWI
Device Description
The ViTelCare™ Turtle 400 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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-home patient; healthcare practitioner; MedVizer™ ViTelCare Call Center
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
K043368
p.1/2
FEB = 1 2005
Attachment 4
510(k) Summary As Required by 807.92 For ViTelCare™ Turtle 400 Patient Monitoring System Prepared on November 22nd, 2004
Submitted By: ViTel Net 8201 Greensboro Drive, Suite 600 McLean, VA 22102
Tel. (703) 448-0999 Fax: (703) 749-9559
- Contact Person: Allen Izadpanah President and Chief Executive Officer
Device Trade Name:ViTeICare™ Turtle 400 Patient Monitoring System
Common Name: Turtle 400 Patient Monitoring System
Classification: Not Classified
ViTelCare™ Patient Monitoring System (K040581) Predictive Device:
- Manufactured By: ViTel Net 221 Elizabeth Street Utica, NY 13501
Description of The Device: The ViTelCare™ Turtle 400 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 This Device: Indications for Use: ViTelCare™ Turtle 400 Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, selfassessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning
1
Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "0-3363", with the first character possibly being "K". Below this, the text "p 2/2" is written, indicating a page number. The handwriting appears somewhat rough and uneven.
diagnosis and treatment are to be performed by qualified healthcare professionals.
Substantial Equivalence to Predicate Device: The ViTelCare™ Turtle 400 Patient Monitoring System is virtually identical to the ViTelCare™ Patient Monitoring System. There are no technical differences with any implications for safety and effectiveness. The labeling of ViTelCare™ Turtle 400 Patient Monitoring System includes extensive protocols for monitoring patients with medical conditions. These have been derived from guidelines published by the VA, DoD, and other national organizations.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.
FEB - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Visual Telecommunications Network c/o Mr. Allen Izadpanah 8201 Greensboro Drive Suite 600 McLean VA 22102
Re: K043368
Trade Name: VitelCare™ Turtle Patient Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Number: 21 CFN 870.2500
Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MWI Dated: January 11, 2005 Received: January 12, 2005
Dear Mr. Izadpanah:
We have reviewed your Section 510(k) premarket notification of intent to market the device ti we nave reviewed your Section 9 rotty premained is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate for use stated in the enclosure) the development of the devices marketed in interstate for use stated in the encrosule) to regally manation in the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 20, 1970, the encordance with the provisions of the Federal Food, Drug, devices that have been icclassified in accessor who a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act . T and Cosmetic Act (Act) that do not require approvins of the general controls of the Act. The You may, therefore, market the devices, seejos, so the may be annual registration, listing of the general controls provisions of the Fee 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 if your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controller Entroling may of the 200 to 898. In addition, FDA may be found in the Code of Peachar Region Registering your device in the Federal Register.
3
Page 2 – Mr. Allen Izadpanah
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri s issuation of a complies with other requirements of the Act that I DA has Inade a decommancia an administered by other Federal agencies. You must of any redelal statutes and regulations and limited to: registration and listing (21 Compry with an the Act 81equirements, as a manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forni in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control provisions (ovetice as described in your Section 510(k) This letter will anow you to begin manical equivalence of your device of your device to a legally premits thousandin. The PDF maining of castination 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 advice for Jour ac (301) 594-4648. Also, please note the regulation entitled, Colliation of Compulation and (21 the Part 807.97). You may obtain Missionaling of Icrelected to promance robilities under the Act from the Division of Small other 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,
B. Zimmer for
D. Z. Zimmerman, M.D.
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2
Indications for Use
510(k) Number (if known): K043368
Device Name: ViTelCare TM Turtle 400 Patient Monitoring System
Indications for Use: ViTelCare™ Turtle 400 Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, self-assessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
B. Simmons
Division of Cardio 510(k) Number