SABRATEK PATIENT HOME MANAGEMENT SYSTEM

{0}------------------------------------------------ AUG 20 1998 510(k) Submission, Sabratek Patient Home Monitoring SHINS) Sabratek, Niles, IL 60714 > Section 2 Summary The following is a Summary of the Sabratek Patient Home Monitoring System (PHMS) substantial equivalence and safety and efficacy. | CLASSIFICATION NAME: | The Agency has not specifically classified the device.<br>The device performs the functions of Monitor, Cardiac<br>(incl. Cardiotachometer & rate alarm), 870.23.00,<br>Monitor, Breathing Frequency, 868.2375, Monitor,<br>Electrocardiographic, 870.2340, Monitor Pulse-Rate,<br>870.2300, and Monitor, Temperature Clinical Electronic<br>Thermometer, 880.2910.41 | | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | COMMON/USUAL NAME: | Ambulatory Patient Monitor | | | PROPRIETARY NAME: | Sabratek Patient Home Monitoring System (PHMS) | | | CLASSIFICATION: | 21 CFR Monitor, Cardiac (incl. Cardiotachometer & rate<br>alarm), 870.23.00, Monitor, Breathing Frequency,<br>868.2375, Monitor, Electrocardiographic, 870.2340,<br>Monitor Pulse-Rate, 870.2300, and Monitor,<br>Temperature Clinical Electronic Thermometer,<br>880.2910.41 | | | PERFORMANCE STANDARDS: | No Performance Standards are in effect for this<br>device. | | | INDICATIONS | The Sabratek Patient Home Monitoring System (PHMS),<br>is a physiological data monitoring and communications<br>system intended for use predominately in alternate care<br>settings. It consists of an ambulatory monitor (the APM-<br>2000), a communications module located in the patient<br>care setting (the Virtual Hospital Room Communicator),<br>and personal-computer-based data display and storage<br>software (Remote Device Access Software, RDAS)<br>located in the healthcare provider facility. The APM-<br>2000 is a physiological data recorder which stores ECG<br>waveform data, temperature, respiration rate, arterial<br>blood oxygen saturation, and pulse from non-invasive<br>sensors. It alerts the patient of sensor and system errors.<br>It has an alarm system which alarms whenever measured<br>data violates prescribed limits. The VHR Communicator | | Page 1 is a PC-based module which communicates with the APM-2000 to download, store and transfer physiological {1}------------------------------------------------ 510(k) Submission, Sabratek Patient Home Monitoring System (PHMS) Sabratek, Niles, IL 60714 > data. The VHR Communicator can also collect data of indirect blood pressure, oral temperature, and patient weight using external modules. It communicates with the RDAS through dial-up telephone lines and transfers data to the healthcare facility. The RDAS displays the physiological data to the caregiver and archives it. #### CONTRAINDICATIONS NON-CLINICAL TESTING CONCLUSIONS Engineering bench testing Verification and Validation testing The Sabratek Patient Home Monitoring System (PHMS) is equivalent in safety and efficacy to its predicate devices. . {2}------------------------------------------------ #### System description The system consists of three major components as shown in Fig.1 ## Fig. 1 Patient Home Management System Image /page/2/Figure/4 description: This image shows a diagram of a data collection and transfer system. The system includes an APM-2000 device that collects data from various sources such as a scale, NIBP, and temperature sensors. The data is then stored and transferred via a VHR-Communicator to an alternate care center or patient's home through telephone lines and a POT. Finally, the data is monitored and displayed on an RDAS at the caregiver's office. - . The Ambulatory Patient Monitor (APM-2000) is an ambulatory device that monitors physiological data of the ambulatory patients. - . The Virtual Hospital Room Communicator (VHRC) is a data storage and transfer device that resides in a patient's home or at an alternate care center. The VHRC has the capability to detect and monitor the APM-2000. A number of peripheral devices such as a Scale, Non Invasive Blood Pressure device (NIBP), Oral Temperature probe and other devices can also be connected to the VHRC. Sabratek has selected peripheral devices with current agency rulings of substantial equivalence for use with the VHRC is accessible by a standard telephone line (POT). - . The Remote Device Access Software (RDAS) is a Microsoft Windows 95/NT applications program. The program interacts with the Virtual Hospital Room Communicator (VHRC) via modem and standard telephone line. The program collects the data stored in the VHRC and presents the information for review by the {3}------------------------------------------------ caregivers. The program can also control the functions of the APM-2000 and monitor the functions of other devices connected to the VHRC. # COMPARISON BETWEEN SABRATEK PATIENT HOME MONITORING SYSTEM (PHMS) AND ### PREDICATE DEVICES | Parameter | Sabratek Patient Home<br>Monitoring System (PHMS) | Predicate Device | |----------------------------------------------------------------|---------------------------------------------------|-------------------------------------------| | <b>Respiration</b> | | | | Measure respiration rate | Yes | Yes | | Range | 4-40 RPM | 2-150 RPM | | Accuracy | $\pm$ 2 RPM or 2% | $\pm$ 2 RPM or 2% | | Sensor | Pro-Tech 1246 (K#960851) | Pro-Tech 1246 (K#960851) | | <b>Electrocardiogram</b> | | | | Records and stores monitor<br>bandwidth electrocardiogram | Yes | Yes | | Single lead (2 active electrodes<br>plus a "ground" electrode) | Yes | Yes | | 5 lead selectable leads | No | Yes | | Defibrillator-protected input<br>leads | No | Yes | | Defib Sync. | No | Yes | | Pacemaker spike detection | No | Yes | | QRS or arrhythmias detection | No | Yes | | QRS Tone | No | Yes | | Detects an electrode lead off<br>condition | Yes | Yes | | Alarms on low/high rate | No | Yes | | Wireless operation | No | Optional | | ECG Electrodes | Lead-Lok, Inc LLE306BX,<br>P-6 (K#911529) | Lead-Lok, Inc LLE306BX,<br>P-6 (K#911529) | | Patient Weight Scale | AND Medical UC-300 | AND Medical UC-300 | | K# | Class I Exempt device<br>880.2700 | Class I Exempt device<br>880.2700 | | Temperature Probe | Thermometric MA-200 | Thermometric MA-200 | | K# | Exempt device | Exempt device | | Pulse Oximetry | Nonin OEM II | Nonin OEM II | | Non Invasive Blood Pressure | AND Medical | AND Medical | | K# | K871720 | K871720 | {4}------------------------------------------------ | VHRC - General | | Propaq® Encore | |--------------------------------------|---------------------------|----------------------------| | Communications capability | Up to 10 external devices | Up to 10 external devices | | Display | 4 row 20 character LCD | LCD 45.75 X 67.56 mm | | Display backlight | Yes | Yes | | Keypad | 5 row by 5 column custom | Separate keys | | Voice synthesizer | Yes | No | | Malfunction audio | Yes | No | | Speaker phone | Optional | No | | Patient alarm notification | Audio and visual | Audio and visual | | Size | ≈12" x 12" x 4" | 9.6" X 8.2" X 7.6" | | Weight | ≈10 lb | 12.68 Lbs | | Operating temperature | 0 to 60 C | 0 to 40 C | | Humidity | 0 to 95% non-condensing | 15% to 95% non- condensing | | Operating altitude | -200 to 15,000 ft | -2000 to 15000 Ft. | | Shipping/storage temperature | -20 to +60 C | -20 to +60 С | | Drip proof | IEC 529 level IPX1 | Unknown | | VHRC power | | | | 115/230 VAC 50/60 Hz operation | Yes | 100-120 VAC, 50-60 Hz | | Operation from internal battery pack | Yes, >1 hour | Yes 2.5 + Hrs. | | Internal battery charger | Yes | Yes | | Battery recharge time | ≈8 hours | 8-12 Hrs. | | Double insulation | Yes | Yes | | Power input | <40 watts | Unknown | Sabratek Corporation 5601 West Howard Street Niles, Illinois 60714 847-647-2760 847-647-2382 Facsimile : 、 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 20 1998 Mr. E.F. Waddell Director, Regulatory Affairs Sabratek Corporation 8111 North St. Louis Avenue Skokie, IL 60076 Re : K980619 Sabratek Patient Home Monitoring System Regulatory Class: II (two) Product Code: MHX Dated: July 10, 1998 Received: July 13, 1998 Dear Mr. Waddell: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have {6}------------------------------------------------ under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, ?Misbranding by reference to premarket notification? (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### K980619 ## Device Name: Sabratek Patient Home Monitoring System (PHMS) Indications for use: The Patient Home Monitoring System (PHMS) is a physiological data monitoring and communications system intended for use predominately in alternate care settings. It consists of an ambulatory, patient-worn monitor (the APM-2000), a communications module located in the patient care setting (the Virtual Hospital Room Communicator), and personal-computer-based data display and storage software (Remote Device Access Software, RDAS) located at the healthcare provider facility. The APM-2000 is a patient-worn physiological data recorder which stores ECG waveform data, temperature, respiration rate, arterial blood oxygen saturation, and pulse from non-invasive sensors. Federal law (US) restricts this device to dale by or on the order of a physician. # (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) ### Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X (Per 21 CFR 801.109) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . OR Over-The-Counter Use (Optional Format 1-2-96) Stacey Rodriguez Shart Portnoy Division Sign-C gular, Respiratory, (Division of Cardio) Division of Or Given and Neurological Devi 510(k) Number