The Reusable Multiple-Patient LifeShirt 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, 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 Reusable Multiple-Patient LifeShirt 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 Description

The Reusable Multiple-Patient LifeShirt consists of the following components:

LifeShirt data acquisition system including the vest with inductive plethysmograph sensors, ECG sensors, a data cable and a connected Handspring Visor® device with software for data collection and storage onto a flash memory card;
LifeShirt data transfer software to transmit the data from the user's personal computer to the VivoMetrics Data Center;
VivoMetrics Data Center, a database operated by VivoMetrics personnel which stores and provides an audit trail for collected data; and
VivoLogic data analysis software for viewing and analyzing patient data.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the VivoMetric's Reusable Multiple-Patient LifeShirt:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device can be cleaned for multiple adult patient use.	Cleaning validation performed and demonstrated. The ability of the cleaning process recommended in the Reusable Multiple-Patient LifeShirt User Guide to clean the device was validated.
Device performs as intended following multiple washings.	Functional validation performed and demonstrated. The device performs as intended following multiple washings.
Maintains the same intended use as the predicate device.	The device has the "same intended use" as the predicate device (recording physiological data for later analysis by physician; analysis of breathing patterns as an aid in classifying apneas; displaying heart rate changes; indicated for reuse by multiple adult patients in pharmaceutical studies or general healthcare market).
Maintains the same principles of operation as the predicate device.	The device has "same principles of operation" as the predicate device.
Maintains the same technological characteristics as the predicate device such that the change in use does not affect diagnostic effect.	The device has "same technological characteristics" as the predicate device. The only difference is reuse by multiple vs. single patients, which "does not affect the device's diagnostic effect," which monitors the same physiological parameters (respiration, ECG, pulse oximetry, blood pressure, body position) as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state a specific sample size for a 'test set' in the context of evaluating diagnostic performance or clinical effectiveness. The validation focused on cleaning and functionality. No information on data provenance (country of origin, retrospective/prospective) related to a diagnostic test set is available, as the study was not primarily a diagnostic performance study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not mentioned in the provided 510(k) summary. The submission focuses on showing substantial equivalence concerning changes for multi-patient reuse and the associated cleaning/functional validation, not on evaluating diagnostic accuracy against a ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not mentioned as there was no diagnostic performance study involving interpreting a test set of data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done based on the provided text. The submission focuses on substantial equivalence based on technical characteristics and validation of cleaning/functionality, not on evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of the VivoLogic Analysis Software in terms of its diagnostic accuracy (e.g., classifying apneas) was not explicitly detailed in the context of this 510(k) submission. The submission states the system is "intended to provide analysis of breathing patterns as an aid in classifying apneas," but it focuses on the hardware modification for multi-patient reuse, not the re-validation of the analytical software's standalone performance. The previous 510(k) for the single-patient device might have contained such data, but it is not included here.

7. Type of Ground Truth Used

For the cleaning validation, the "ground truth" would be the successful removal of biological contaminants to a specified level, verifiable through laboratory assays (e.g., microbial counts, protein detection). For functional validation, the "ground truth" would be that the device accurately continues to record physiological data within specified tolerances after multiple washings, which could be measured against a known signal input or by comparison to another validated device. Specific details of these ground truths (e.g., specific assays, tolerance levels) are not provided in this summary. There is no mention of ground truth in the context of diagnostic accuracy from expert consensus, pathology, or outcomes data, as this was not a diagnostic performance study.

8. Sample Size for the Training Set

This information is not applicable/not mentioned for this submission. The 510(k) specifically addresses a modification to allow multi-patient reuse, not the de novo development or re-training of an AI algorithm. The VivoLogic analysis software's training would have occurred prior to the original single-patient device's submission.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not mentioned for this submission. As above, the submission focuses on hardware modification, not AI algorithm training.

Summary

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510(k) SUMMARY

VivoMetric's Reusable Multiple-Patient LifeShirt

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

VivoMetrics, Inc. 121 North Fir Street, Suite E Ventura, California 93001 Phone: 805-667-2225 Facsimile: 805-667-6846

Date Prepared: May 14, 2003

Name of Device and Name/Address of Sponsor

Reusable Multiple-Patient LifeShirt with VivoLogic Analysis Software

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

Common or Usual Name

Programmable Diagnostic Computer

Classification Name

Programmable Diagnostic Computer

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Predicate Devices

LifeShirt with VivoLogic Analysis Software ("Reusable Single-Patient LifeShirt") ويو ويوري ويو

Purpose of 510(k)

The purpose of this Special 510(k) is to modify the LifeShirt. The only difference between the devices is that the new device is for reuse after washing by multiple adult patients while the device is currently marketed for reuse after washing by a single adult patient.

Intended Use

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Technological Characteristics

The Reusable Multiple-Patient LifeShirt consists of the following components:

1. LifeShirt data acquisition system including the vest with inductive plethysmograph sensors, ECG sensors, a data cable and a connected Handspring Visor® device with software for data collection and storage onto a flash memory card;
LifeShirt data transfer software to transmit the data from the 2. user's personal computer to the VivoMetrics Data Center;
1. VivoMetrics Data Center, a database operated by VivoMetrics personnel which stores and provides an audit trail for collected data; and
VivoLogic data analysis software for viewing and analyzing 4. patient data.

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Performance Data

Cleaning validation and functional validation was performed and demonstrate that the Reusable Multiple-Patient LifeShirt can be cleaned for multiple adult patient use and performs as intended following multiple washings.

Substantial Equivalence

The Reusable Multiple-Patient LifeShirt has the same intended use, principles of operation, and technological characteristics as the predicate device. The only difference between the Reusable Multiple-Patient LifeShirt and the Reusable Single-Patient LifeShirt is that the Reusable Multiple-Patient LifeShirt may be reused after washing by multiple adult patients and the Reusable Single-Patient LifeShirt may be reused after washing by a single adult patient. The difference in the number of users of the Reusable Multiple-Patient LifeShirt does not affect the device's diagnostic effect, which is to monitor the same physiological parameters as the predicate device, i.e., respiration, ECG, pulse oximetry, blood pressure, and body position, during activities of daily life and sleep for analysis by a physician. VivoMetrics has validated the ability of the cleaning process recommended in the Reusable Multiple-Patient LifeShirt User Guide to clean the device, as well as validated the functionality of the device after multiple washings. Thus, the Reusable Multiple-Patient LifeShirt is substantially equivalent.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be of moderate resolution.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2003

Hogan & Hartson LLP c/o Mr. Howard M. Holstein Regulatory Counsel 555 Thirteenth Street NW Washington, DC 20004

Re: K031550

Trade Name: Reusable Multiple-Patient LifeShirt with VivoLogic Analysis Software Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: May 16, 2003 Received: May 16, 2003

Dear Mr. Holstein:

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, 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 Code 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 complies with other requirements of the Act

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Page 2 - Mr. Howard M. Holstein

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 (301) 594-4646. 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/cdrh/dsma/dsmamain.html

Sincerely yours,

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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Indications for Use Statement

510(k) Number (if known):

1031550

Device Name:

Reusable Multiple-Patient LifeShirt with VivoLogic Analysis Software

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter
Use (Per 21 C.F.R. 801.109)			(Optional Format 1-2-96)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number
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Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).