HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM

{0}------------------------------------------------ ## 510(k) Summary ## HomMed Sentry IIIB-F Patient Monitor System - Consultant Contact: Tommie J. Morgan, Ph.D., President Morgan Consultants Inc. 2018 North Durham Drive Houston, TX 77008 713 880-5111 Voice or 713 880-3494 Fax - Company: HomMed. LLC 19275 West Capitol Dr., Suite 200 Brookfield , WI 53045 262 783-5440 Voice or 262 783-5441 Fax HomMed Sentry IIIB-F Patient Monitor System Trade Name: - Patient Vital Signs Monitor with Options Common Name: - Classification Name: Cardiovascular and Respiratory Devices, Class II - Substantial Equivalence Claimed to: HomMed Sentry III Patient Monitor System with Card Reader K014025 - The HomMed Sentry IIIB-F Patient Monitor System (Sentry IIIB-F) is a portable Device Description: patient vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. In addition, the system has optional glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) measuring, and digital image acquisition capabilities. The Sentry IIIB-F acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis. - The HomMed Sentry IIIB-F is intended for in home and/or healthcare facility Indications for Use: applications under physician orders. The use of the system is to allow retrospective review of certain patient physiological functions. The HomMed Sentry IIIB-F can measure and display patient data including noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. Additionally, the patient vital signs data can be communicated to a central review station via a pager network with a backup landline telephone modem for telephone communication with the central pager network if necessary. Sentry IIIB-F provides a noninvasive blood pressure (NIBP) monitor for measurements of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures; pulse oximeter, acquires a pulse rate using an oximeter; oral temperature via an electronic thermometer; weight from an electronic scale. All data collected from these functions as well as optional glucometry, ECG devices, PT/INR monitor and acquired digital images are sent through an internal communication module. The device will provide fast, reliable measurements on patients when using the appropriate blood pressure cuff. Sentry IIIB-F's pulse oximetry works with the 3/8/04 {1}------------------------------------------------ Sentry pulse oximetry probes provided by HomMed, providing Sp02 anc pulse rate on all patients. The electronic thermometry requires use of the Welch Allyn oral thermometry probe and probe covers. It provides only cral temperature information. Comparison with Predicate Devices: This HomMed Sentry IIIB-F allows uncomplicated measurement and remote monitoring of patient vital signs including weight utilizing the existing technologies of the predicate device, HomMed Sentry III Patient Monitor System with Card Reader. Determination of Substantial Equivalence: The performance of each component of the HomMed Sentry IIIB-F has been confirmed to be equivalent to the predicate device HomMed Sentry III Patient Monitor System with Card Reader. Compliance to Standards and Regulations: The HomMed Model Sentry 111B-F complies with the following national and international standards: | Safety | | EN 60601-1 | Medical Electrical Safety | |--------|--|-------------------|---------------------------| | | | IEC 601-1-2 | EMC Compliance | | | | ISO 10993-5,10-11 | Biocompatibility | Performance Data: The HomMed Sentry IIIB-F is utilized within the environments for which it and Sentry III with Card Reader are marketed. The Sentry IIIB-F performs consistent with guidelines and standards found in the FDA reviewer's guides for respiratory devices and electronic thermometers. EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed demonstrating compliance with applicable standards. The test results demonstrated that the Sentry IIIB-F is in compliance with the guidelines and standards referenced in the FDA reviewer's quides and that it performed within its specifications and functional requirements. The HomMed Sentry IIIB-F performance is consistent with the HomMed Sentry III with Card Reader performance. Testing done on the Sentry III IIIB-F assures compliance with applicable electrical, safety and healthcare standards. Thus it is the HomMed position that the HomMed Sentry IIIB-F performs as well as the legally marketed predicate device. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA regarding patient monitors. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes, possibly representing human figures or abstract forms. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 0 2004 HomMed, LLC c/o Tommie J. Morgan, Ph.D. President Morgan Consultants Inc. 2018 North Durham Drive Houston, TX 77008 Re: K040651 Ro40031 Trade Name: HomMed Sentry IIIB-F Patient Monitor System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: II (two) Product Code: DXH Dated: July 29, 2004 Received: July 30, 2004 Dear Dr. Morgan: We have reviewed your Section 510(k) premarket notification of intent to market the device t We have reviewed your Section 9 ro(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manat date of the Medical Device Amendments, or to commerce prior to May 26, 1970, the characters and other of the Federal Food, Drug, devices that have been recalssinod in accessful of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval post of and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The I ou may, merciole, manel the act include requirements for annual registration, listing of general controls provisions of the rise 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 II your device is classified (see above) me existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations ED t may be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I casa announceming your device in the Federal Register. {3}------------------------------------------------ Page 2 - Tommie J. Morgan, Ph.D. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuation of a basean. In other requirements of the Act that FDA has made a decommation administered by other Federal agencies. You must of any I edital statutes and regalations and admited to: registration and listing (21 compry with an the Act 3 requirements, news 801); good manufacturing practice requirements as set CFK Fatt 807), fabeing (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Seting your device as described in your Section 510(k) This letter witi anow you to ogen manies. By premarket notification. The FDA finding of substantial equivalence of your device to a legally prematics notheation: The PDF Intentigation 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 11 you ucate specific advice for your act (301) 594-4646. Also, please note the regulation entitled, Contact the Office of Come of Come are to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oiller general information on your respational 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, Neil R.P. Ogden Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ | 510(k) Number (if known): | K04065 | |---------------------------|--------| |---------------------------|--------| ## Device Name: HomMed Sentry IIIB-F Patient Monitor System ## Indications for Use The HomMed Sentry IIIB-F Patient Monitor System is designed to measure Patient Vital Signs in the home by patients or in clinical environments by health care providers. The HomMed Sentry IIIB-F Patient Monitor System is available with physicians' orders only. The HomMed Sentry IIIB-F Patient Monitor System measures the following parameters: Non-Invasive Blood Pressures (Systolic and Mean Arterial Pressure), Functional Oxygen Saturation (%SpO₂), Peripheral Pulse Rate (PPR), Pulse Strength, Oral Temperature and Patient Weight via an external scale. The HomMed Sentry IIIB-F Patient Monitor System's optional, compatible devices extend those measurements to glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) monitoring and digital image acquisition. The patient parameter data is collected and displayed by the HornMed Sentry IIIB-F Patient Monitor System. Data can be transmitted via the communication module to a central station where the patient data can be viewed and analyzed. Prescription Use X (21 CFR 807 Subpart D) Over-th (21 CE Over-the-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - - CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |------------------------------------|---------| | Division of Cardiovascular Devices | | | 510(k) Number | K040651 | Page 1 of ___