REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE

{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 {1}------------------------------------------------ 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. \\\DC - 85021/0001 - 1737304 v1 {2}------------------------------------------------ ## 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; - 3. 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 | <span style="text-decoration: overline;">X</span> | 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 | | |---------------|--| |---------------|--| \\\DC - 85021/0001 - 1737304 v1