LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE

K043604 · Vivometrics, Inc. · DQK · Apr 29, 2005 · Cardiovascular

Device Facts

• Record ID: K043604
• Device Name: LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE
• Applicant: Vivometrics, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The LifeShirt Real-Time is intended for use during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, temperature, and body position data may be collected. The system is intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. The LifeShirt Real-Time is indicated for reuse by multiple adult patients in applications that may include pharmaceutical studies in which respiratory information is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.

Device Story

LifeShirt Real-Time is a wearable diagnostic system for recording physiological data (respiration, ECG, pulse oximetry, blood pressure, temperature, body position) during daily activities and sleep. System includes a garment, recorder/transmitter, wireless flash card, and analysis software. Data is recorded on-body and transmitted wirelessly to a networked computer for physician review. Device aids in apnea classification and heart rate monitoring. Used in home or clinical environments; operated by patients or healthcare providers. Physician reviews output to assist in diagnosis and treatment decisions. Wireless transmission capability allows remote data access.

Clinical Evidence

Bench testing only. Testing verified accurate data recording and transmission to the PC system and electromagnetic compatibility.

Technological Characteristics

Components: garment, recorder/transmitter, wireless flash card, VivoMonitor software, VivoLogic analysis software. Optional accessories: pulse oximeter, blood pressure cuff, temperature sensor. Connectivity: wireless transmission to networked computer. Power: battery-operated recorder. Data processing: digital signal recording and analysis.

Indications for Use

Indicated for adult patients in home or clinical settings, including pharmaceutical studies, for monitoring respiration, ECG, pulse oximetry, blood pressure, temperature, and body position during daily activities and sleep to aid in apnea classification and heart rate analysis.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Reusable Multiple-Patient LifeShirt with VivoLogic Analysis Software
• GMP Companies, Inc., LifeSync® Wireless ECG System
• Life Sensing Instrument Company, Teletrens Model TM10 Multi-Parameter Portable Patient Transmitter
• Mortara Instrument Inc., Ambulatory X-12 Telemetry Module

Submission Summary (Full Text)

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### 510(k) SUMMARY

## VivoMetrics, Inc. LifeShirt™ Real-Time

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

VivoMetrics, Inc. 121 North Fir Street, Suite E Ventura, California 93001 Phone: [phone] Facsimile: 805-667 -6846 Contact Person: Keith Gilroy Date Prepared: December 28, 2004

#### Name of Device and Name/Address of Sponsor

LifeShirt Real-Time

VivoMetrics, Inc. 121 North Fir Street, Suite E Ventura, California 93001

#### Common or Usual Name

Programmable Diagnostic Computer

#### Classification Name

Programmable Diagnostic Computer

#### Predicate Devices

Reusable Multiple-Patient LifeShirt with VivoLogic Analysis Software

GMP Companies, Inc., LifeSync® Wireless ECG System

Life Sensing Instrument Company, Teletrens Model TM10 Multi-Parameter Portable Patient Transmitter

Mortara Instrument Inc., Ambulatory X-12 Telemetry Module

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# Purpose of the Special 510(k) notice.

The purpose of this Special 510(k) is to modify the LifeShirt. The only difference between the devices is that the new device is indicated for use with an optional temperature probe, which is supplied, and uses a wireless data card in its recorder to permit the wireless transmission of its recorded data to a networked computer.

## Intended Use

The LifeShirt Real-Time is intended for use during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, temperature, and body position data may be collected. The system is intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. The LifeShirt Real-Time is indicated for reuse by multiple adult patients in applications that may include pharmaceutical studies in which respiratory information is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.

## Technological Characteristics

The LifeShirt Real-Time consists of the following components: the LifeShirt garment, LifeShirt Recorder/Transmitter, a wireless flash card, a data Flash Card, VivoMonitor™ real-time software and VivoLogic® analysis and reporting software. A cleared pulse oximeter, blood pressure cuff, and a temperature sensor are optional accessories provided for use with the device.

## Performance Data

Performance testing included verification that data recorded by the LifeShirt recorder is accurately transmitted and received by the PC computer system. In addition, testing was performed to demonstrate electromagnetic compatibility.

## Substantial Equivalence

LifeShirt Real-Time has the same intended use and similar indications, principles of operation, and technological characteristics as its predicate devices.

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The minor differences in the LifeShirt Real-Time and the cleared LifeShirt which are the optional temperature probe and wireless communication do not raise any new questions of safety or effectiveness as the predicate devices have similar features. Performance data demonstrates that the LifeShirt Real-Time is as safe and effective as the predicate Multiple Patient Use LifeShirt. Thus, the LifeShirt Real-Time is substantially equivalent to its predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a stylized eagle emblem. The eagle is depicted with three stripes forming its body and wing, and the text is written in a sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2005

Vivometrics, Inc. c/o Mr Howard M. Holstein Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109

#### Re: K043604

Trade Name: LifeShirt Rel-Time with Vivo Monitor Software Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: April 15, 2005 Received: April 15, 2005

#### Dear Mr. Holstein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to the enactment date of the Medical Device Amendments, or to conninered pror to they 2011/09/2017 accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r our may, mereleve, 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 If your device is elaborned (over as only of the major regulations affecting your device can inay be subject to such additions, 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 Howard M. Holstein

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease be actived 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 of any I cueral butther and step and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It 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. product in the low you to begin marketing your device as described in your Section 510(k) I mb lotter will and will your he FDA finding of substantial equivalence of your device to a legally prematics notineteem. The 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 a 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 other general micromational 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,

Bhimmafor

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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#### Indications for Use Statement

510(k) Number (if known):___

Device Name: LifeShirt Real-Time with Vivo Monitor Software

Indications for Use:

The LifeShirt Real-Time is intended for use during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a oloop, ior are piration, ECG, pulse oximetry, blood pressure, temperature, and body physiousn. feespirations of the system is intended to provide analysis of possibing patterns as an aid in classifying apneas as well as displaying heart rate broaming patterns as ardiographic waveforms in the wake and sleeping states as onaligos from see of daily living. The LifeShirt Real-Time is indicated for reuse by well about patients in applications that may include pharmaceutical studies in which respiratory information is a useful indicator, or the general healthcare which toopirates may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.

Prescription Use _V (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Blsimmons

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_