(34 days)
ViTelCare™ C-Turtle 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 healthcare practitioner can contact the patient directly through a videoconference connection when desired. 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.
The ViTelCare™ C-Turtle 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.
This 510(k) submission (K060712) for the ViTelCare™ C-Turtle Patient Monitoring System does not contain the kind of detailed study information typically found in submissions for AI/ML-driven devices requiring performance metrics and clinical studies.
The submission focuses on demonstrating substantial equivalence to predicate devices (ViTelCare™ Turtle 400 and Turtle 800) primarily based on combining existing functionalities (monitoring data collection and transmission with added videoconferencing). It asserts that there are "no technical differences with any implications for safety and effectiveness" compared to the predicates.
Therefore, many of the requested categories about acceptance criteria, study design, ground truth, and reader studies are not applicable or cannot be extracted from the provided text.
Here's a breakdown of what can be inferred and what is explicitly not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided. The submission states "no technical differences with any implications for safety and effectiveness" between the C-Turtle and its predicate devices, implying that the performance of the C-Turtle is expected to be equivalent to the already cleared predicates without requiring new performance acceptance criteria or a dedicated performance study for this specific device.
2. Sample size used for the test set and the data provenance
Not applicable. No new performance testing is detailed in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new performance testing is detailed in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new performance testing is detailed in this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a patient monitoring system for data collection and communication, not an AI/ML-driven diagnostic aid that would involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not described as having a standalone algorithm for diagnostic or interpretive performance. Its function is to collect, manage, and transmit patient data and facilitate videoconferencing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No new performance testing is detailed in this submission.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in the typical sense.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device requiring a training set and established ground truth in this context.
Summary of Device and Rationale for Limited "Study" Information:
The ViTelCare™ C-Turtle Patient Monitoring System is a telemedicine system designed for collecting, managing, and communicating patient monitoring data (vital signs, self-assessment, other physiological data) from home to a remote healthcare practitioner. Its primary new feature noted in this submission is the addition of videoconferencing functionality, combining features already present in two previously cleared predicate devices (ViTelCare™ Turtle 400 and Turtle 800).
The core argument for clearance is substantial equivalence based on the absence of "technical differences with any implications for safety and effectiveness" compared to its predicates. This means the FDA's review primarily focused on:
- Comparing the intended use of the C-Turtle to the predicates.
- Confirming that the technological characteristics (data collection, transmission, videoconferencing) are similar or leverage already-cleared technologies.
- Ensuring appropriate labeling and protocols (derived from VA, DoD, etc.) are included.
Because this submission is for a device combining existing, cleared functionalities without introducing novel diagnostic algorithms or new risks, a detailed clinical study with performance metrics, ground truth, and reader studies (as one would expect for an AI/ML device) was not required or provided.
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Attachment F
APR 13 2006
510(k) Summary As Required by 807.92 For ViTelCare™ C-Turtle Patient Monitoring System Prepared on March 9th, 2006
| Submitted By: | ViTel Net8201 Greensboro Drive, Suite 600McLean, VA 22102 |
|---|---|
| Tel. (703) 448-0999 | Fax: (703) 749-9559 |
| Contact Person: | Allen IzadpanahPresident and Chief Executive Officer |
| Device Trade Name: | ViTelCare™ C-Turtle Patient Monitoring System |
| Common Name: | C-Turtle Patient Monitoring System |
| Classification: | Not Classified |
| Predictive Device: | ViTelCare™ Patient Monitoring System (K040581)ViTelCare™ Turtle 800 Patient Monitoring System(C040283)ViTelCare™ Turtle 400 Patient Monitoring System(K043368) |
| Manufactured By: | ViTel Net221 Elizabeth StreetUtica, NY 13501 |
Description of The Device: The ViTelCare™ C-Turtle 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™ C-Turtle 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 healthcare practitioner can contact the patient directly through a videoconference connection when desired. The communication connectivity between
ViTel Net 16 March 2006
page 1 of 2
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KokoTin page 2
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.
Substantial Equivalence to Predicate Device: The ViTelCare™ C-Turtle Patient Monitoring System is virtually identical to the ViTelCare™ Turtle 400 Monitoring System with addition of videoconference functionality of the Turtle 800. There are no technical differences with any implications for safety and effectiveness. The labeling of ViTelCare™ C-Turtle 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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
ViTel Net c/o Mr. Allen Izadpanah President and Chief Executive Officer 8201 Greensboro Drive, Suite 600 McLean, VA 22102
Re: K060712
Trade Name: ViTelCare™ C-Turtle Patient Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MWI Dated: March 16. 2006 Received: March 16, 2005
Dear Mr. Izadpanah:
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. Iisting 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.
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Page 2 - Mr. Allen Izadpanah
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); 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Bimemona for
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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Attachment B
Indications for Use
510(k) Number (if known): KO60712
Device Name: ViTelCare ™ C-Turtle Patient Monitoring System
Indications for Use: ViTelCare™ C-Turtle 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 114 ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healtheare practitioner can contact the patient directly through a videoconference connection when desired. The communication connectivity between patient and healtheare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healtheare professionals.
Prescription Use ____________ (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)
D'Annunzio
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Ville: No 16 Mach 11
§ 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).