VITELCARE C-TURTLE PATIENT MONITORING SYSTEM

K060712 · Visual Telecommunications Network, Inc. · MWI · Apr 19, 2006 · Cardiovascular

Device Facts

• Record ID: K060712
• Device Name: VITELCARE C-TURTLE PATIENT MONITORING SYSTEM
• Applicant: Visual Telecommunications Network, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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 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.

Device Story

PC-based telemedicine system for home/group care environments; collects, manages, and transmits patient vital signs, physiological data, and self-assessments. Inputs: patient-provided physiological data and self-reports. Operation: data transmitted via public telecommunications/Internet to MedVizer™ ViTelCare Call Center; enables remote review by healthcare practitioners and optional videoconferencing. Output: stored patient data for practitioner review. Used by patients at home and practitioners at remote clinical sites. Facilitates remote clinical oversight; supports practitioner-led diagnosis and treatment decisions; improves access to care for home-bound patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological similarity to predicate devices.

Technological Characteristics

PC-based system; utilizes standard public telecommunications and Internet for data transmission. Integrates data acquisition, storage, and videoconferencing capabilities. No specific materials or hardware standards cited.

Indications for Use

Indicated for in-home patients requiring remote monitoring of vital signs, physiological data, and self-assessments of physical condition by healthcare practitioners.

Regulatory Classification

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.

Predicate Devices

• ViTelCare™ Patient Monitoring System (K040581)
• ViTelCare™ Turtle 800 Patient Monitoring System (C040283)
• ViTelCare™ Turtle 400 Patient Monitoring System (K043368)

Submission Summary (Full Text)

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K060712

## 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 Net<br>8201 Greensboro Drive, Suite 600<br>McLean, VA 22102 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tel. [phone] | Fax: [phone] |
| Contact Person: | Allen Izadpanah<br>President 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)<br>ViTelCare™ Turtle 800 Patient Monitoring System<br>(C040283)<br>ViTelCare™ Turtle 400 Patient Monitoring System<br>(K043368) |
| Manufactured By: | ViTel Net<br>221 Elizabeth Street<br>Utica, 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

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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 [phone]. 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 [phone] or [phone] 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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