(121 days)
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.
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.
This 510(k) summary focuses on modifications to an existing device, the LifeShirt, rather than a standalone study of a new medical device. As such, the information provided primarily addresses the equivalence of the modified device to its predicate, with limited detail on specific performance acceptance criteria and study data in the format requested for a new device's comprehensive performance evaluation.
Here's an analysis based on the provided text, highlighting the limitations due to the nature of this 510(k):
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accurate data transmission and reception (for newly added wireless capabilities) | "Performance testing included verification that data recorded by the LifeShirt recorder is accurately transmitted and received by the PC computer system." (Details on specific metrics or thresholds are not provided.) |
| Electromagnetic Compatibility (EMC) | "In addition, testing was performed to demonstrate electromagnetic compatibility." (Details on specific standards or results are not provided.) |
| Safety and Effectiveness equivalence with predicate device | "Performance data demonstrates that the LifeShirt Real-Time is as safe and effective as the predicate Multiple Patient Use LifeShirt." (Specific quantitative data is not provided.) |
Explanation: The document describes a "Special 510(k)" submission, which is used for modifications to a legally marketed device that do not significantly alter its fundamental scientific technology or intended use. For such submissions, the FDA typically focuses on demonstrating that the changes do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to its predicate. Therefore, the "acceptance criteria" here are largely implied to be maintaining the performance of the predicate device, with specific verification of the new features (wireless communication and temperature probe).
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" sample size in the context of clinical data for performance evaluation. The "performance testing" mentioned refers to engineering verification and validation activities for the new features (wireless data transmission, EMC). There is no mention of a pre-defined subject cohort used for clinical performance testing for the modified features.
Data Provenance: Not explicitly stated for specific clinical tests, as the focus is on engineering verification of new features and equivalence to an already cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in this Special 510(k). The document describes engineering verification testing, not a clinical study requiring expert-established ground truth for a diagnostic outcome.
4. Adjudication method for the test set
Not applicable. There is no mention of a clinical test set requiring expert adjudication for ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned. The device records physiological data for later analysis by a physician.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This Special 510(k) is about a hardware device with software components, not a standalone algorithm in the typical sense of a diagnostic AI. The "VivoLogic analysis and reporting software" is part of the system for "later analysis by a physician," implying a human-in-the-loop workflow. The performance testing focuses on the accuracy of data transmission and fundamental device capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail the type of ground truth used as it relates to clinical diagnostic accuracy, as this was not a primary focus of this Special 510(k). The "ground truth" for the performance testing mentioned (e.g., accuracy of data transmission) would be engineering standards and successful transfer of data files.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning algorithm that requires a training set for its development. The "VivoLogic processing software" likely uses established algorithms for physiological data analysis, not a learning-based approach that requires a training set in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning algorithm.
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<043604
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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: 805-667 -2225 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blsimmons
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_
§ 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).