MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM

K040581 · Vitel Net · DQA · May 27, 2004 · Cardiovascular

Device Facts

• Record ID: K040581
• Device Name: MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
• Applicant: Vitel Net
• Product Code: DQA · Cardiovascular
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MedVizer™ ViTelCare Patient Monitoring System is intended to be a tool for an in-home patient that acquires, accumulates, and transmits a continuous or intermittent collection, self-assessment of physical condition, and other physiological vital signs information to a healthcare practitioner located remotely from the patient. The patient data is sent 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.

Device Story

PC-based telemedicine system; collects, manages, and transmits patient monitoring data and video images from home/group care environments. Inputs include physiological vital signs and patient self-assessments; transmitted via public telecommunications/Internet to a remote MedVizer™ ViTelCare Call Center. Operated by patients at home and healthcare practitioners at the call center. Practitioners review data and conduct videoconferences to assess patient condition. Output consists of displayed/printed patient data and video, facilitating clinical decision-making by professionals. Benefits include remote access to patient status, enabling timely clinical intervention.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technical comparison to the predicate device.

Technological Characteristics

PC-based telemedicine system; utilizes standard public telecommunications and Internet connectivity for data transmission. Functions as a communication and management platform for physiological data and video. No specific materials or energy sources beyond standard computing hardware described.

Indications for Use

Indicated for in-home patients requiring remote monitoring of physiological vital signs and physical condition assessment. Intended for use by healthcare practitioners to review patient data and conduct videoconferencing for clinical decision-making. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• MedVizer™ PACS (K000557)

Submission Summary (Full Text)

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## MAY 27 2004

K040581

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. [phone] Fax: [phone]

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.

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Public Health Service

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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

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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 [phone] or [phone] 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

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## 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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