(74 days)
Not Found
Not Found
No
The summary describes data collection and analysis software, but there is no mention of AI or ML algorithms being used for the analysis. The analysis is described as "viewing and analyzing patient data" and "aid in classifying apneas," which doesn't inherently imply AI/ML.
No.
The device is intended for recording physiological data for later analysis by a physician as an aid to diagnosis and treatment, not for providing therapy.
Yes
The device aids in classifying apneas and displaying heart rate changes, and the data collected is "provided to their physicians as an aid to diagnosis and treatment." This clearly indicates its role in diagnosis.
No
The device description explicitly lists hardware components such as a vest with sensors, a data cable, and a Handspring Visor device, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The Reusable Multiple-Patient LifeShirt is a wearable device that collects physiological data from the patient's body (respiration, ECG, pulse oximetry, blood pressure, body position). It does not analyze samples taken from the body.
- Intended Use: The intended use is to record physiological data for later analysis by a physician as an aid in classifying apneas and displaying heart rate changes. This is a form of physiological monitoring and data collection, not an in vitro diagnostic test.
Therefore, the device falls under the category of physiological monitoring devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The Reusable Multiple-Patient LifeShirt consists of the following components:
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- 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;
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- 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Physician / home (patients may be monitored at home and the data provided to their physicians)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The first line reads 'K031550'. The second line reads 'p 2/4'. The text is written in a simple, slightly uneven style, suggesting it was written quickly or informally.
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
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.
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Technological Characteristics
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 2. 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 4. patient data.
3
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:
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.
(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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