VITELCARE TURTLE, MODEL 400

K043368 · Visual Telecommunications Network, Inc. · MWI · Feb 1, 2005 · Cardiovascular

Device Facts

• Record ID: K043368
• Device Name: VITELCARE TURTLE, MODEL 400
• Applicant: Visual Telecommunications Network, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

ViTelCare™ Turtle 400 is a PC-based telemedicine system for home and group care environments; collects, manages, and transmits patient vital signs and self-assessment data. System functions as communication tool; acquires physiological data from patient; transmits via public telecommunications/Internet to MedVizer™ ViTelCare Call Center. Healthcare practitioners access stored data at remote call center; review information to support clinical decision-making. Device facilitates remote patient monitoring; enables practitioner oversight of patient health status; supports diagnosis and treatment planning by qualified professionals.

Clinical Evidence

No clinical data provided; substantial equivalence based on technical comparison to predicate device.

Technological Characteristics

PC-based telemedicine system; utilizes standard public telecommunications and Internet for connectivity. Functions as a physiological patient monitor (Product Code MWI).

Indications for Use

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

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)

Submission Summary (Full Text)

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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. [phone] Fax: [phone]

- 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

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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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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