NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100

{0}------------------------------------------------ K993643 # 14 Safety and Efficacy - Premarket Notification 510(k) Summary 510(k) Summary as required per 807.92. #### 14.1 Submitter Details Nexan Telemed Ltd The Quorum Barnwell Road Cambridge CB5 8RE United Kingdom Contact: Dr J. D. Place - Operations Director Phone: +44 1223 713500 Fax: +44 1223 713501 Date of submission: 1st September 1999 ## 14.2 Device Name and Classification - 14.2.1 Device name Nexystem #### 14.2.2 Device Common Name Ambulatory Patient Monitor ## 14.2.3 Classification, product code | Class: | II | |----------------|---------------------------------| | Product Codes: | ECG 74DPS CFR: 870.2340 | | | Respiration 73BZQ CFR: 868.2375 | | | Temperature 80FLL CFR: 880.2910 | | | Transmitter 74DRG CFR: 870.2910 | #### 14.3 Predicate Device Information The following predicate devices are considered: | Company | Device | 510(k) | |------------------|------------------------------------|---------| | Sabratek | Patient Home Monitoring System | K980619 | | Protocol Systems | Propaq Encore | K951246 | | Mortara | Ambulatory X-12 Telemetry Module | K974149 | | Reynolds | Tracker Holter Recorder | K943278 | | Reynolds | Pathfinder 7000 Holter Analyser | K951902 | | Instromedix | Poseidon Cardiac Monitoring System | K964408 | {1}------------------------------------------------ ## 14.4 Device Description ## 14.4.1 System Overview The Nexystem is a non-invasive ambulatory patient monitoring system for recording multiple physiological parameters from patients who may be located at home or in an alternate care setting. The Nexystem continuously gathers physiological data from a sensor band attached to the patient and transmits the data wirelessly via a Signal Transfer Unit (Nexender) to a Base Station Unit (Nextation) where the data are recorded and stored. Additionally, the Base Station Unit has interfaces for auxiliary sensors - spirometer and blood pressure monitor - for recording point in time lung function and blood pressure measurements. A Call Discriminator Unit enables incoming telephone calls to be correctly routed to either the Nextation or a telephone handset. The data are transmitted for display, monitoring and storage on a computer (Telemonitoring Station TMS running the Nexoft application software) at a distant location (Telemonitoring Centre). This data transfer is under the control of the Health Care Professional (HCP) at the TMS. Data may be transferred in real time to enable the HCP to check on the quality of the physiological data being recorded and/or the status of the patient. Normally data is transferred at a scheduled time after the end of a patient data recording session. Once transferred to the TMS the data can subsequently be displayed for analysis by the HCP. The Nexystem enables the HCP to print reports of raw or summary data. Image /page/1/Figure/5 description: This image shows a diagram of a telemonitoring system. The system includes a Nexisensor (sensor band) attached to a person's chest, a Nexender (signal transfer unit) attached to the person's waist, and a Nextation (base station unit). The system also includes a telemonitoring center with a telemonitoring station (TMS), a patient's telephone line, and a call discriminator unit. Auxiliary connections for blood pressure monitor and spirometer are also shown. The Nexystem comprises a number of system components identified below. {2}------------------------------------------------ #### 14.4.2 Identification of System Components The Nexystem comprises several distinct components which together form a complete monitoring system. In this section each of these components is separately identified #### 14.4.2.1 Nexisensor The Nexisensor is a disposable, battery powered, adhesive band containing electrodes and sensors, which is attached to a patient's chest. It captures physiological signals, processes and transmits them, via a wireless link, to a Nexender. #### 14.4.2.2 Nexender The Nexender is a portable, battery powered, wireless Signal Transfer Unit either worn by, or in close proximity (within 1.5m) to, the patient. The Nexender receives the physiological data from the Nexisensor and forwards it to the Nextation via a UHF radio link when within operational range (30m). #### 14.4.2.3 Nextation The Nextation is a table-top device, requiring connection to line voltage and direct connection to a hard-wired telephone line. The Nextation acts as a Base Station Unit receiving and recording data from the Nexender. The Nextation has two serial ports for the direct connection of a spirometer and a blood pressure monitor for the recording of point in time measurements. #### 14.4.2.4 Spirometer The spirometer interfaced with the Nexystem is the Micro Medical MicroPlus Spirometer MS03. #### 14.4.2.5 Blood Pressure Monitor The Blood Pressure Monitor interfaced with the Nexystem is the OMRON IC fully automatic blood pressure monitor with inflation pre-set. #### 14.4.2.6 Call Discriminator In situations where a dedicated telephone line is not available at the patient location for use of the Nexystem a telephone call discriminator unit may optionally be utilised to differentiate between incoming voice calls for the patient and data calls from the TMS for the Nextation. The unit utilised is the Viking FAXJ-300 Fax Jack Phone/Fax Switch. #### 14.4.2.7 Telemonitoring Station (TMS) Computer/Nexoft Software The TMS Computer is a standard Windows NT PC located at the HCP's office running the Nexoft application software that is used to download patient data from the Nextation for display, recording and printout of reports for analysis by the Health Care Professional. #### 14.5 Intended Use The Nexystem is an ambulatory patient monitoring system intended for use in the home or alternate care settings. It consists of a patient worn sensor (Nexisensor), signal transfer unit (Nexender), communications module (Nextation), and a telemonitoring station computer based display and storage system (TMS) located at the health care professional's facility. The device stores and transmits ECG data, respiration data, skin temperature, systolic and diastolic blood pressure (non-invasive), and PEF and FEVI. {3}------------------------------------------------ ## 14.6 Non-clinical performance data for equivalence ### 14.6.1 ANSI/AAMI EC12 Compliance testing of the Nexisensor to ANSVAAMI EC12 Disposable ECG Electrodes has been conducted and the detailed Compliance Test Report 100-TR-080 is located in Appendix R. The report concludes that the Nexisensor is compliant with ANSUAAMI EC12. This compliance is subject to the understanding that the Nexisensor electrodes are integral and not wired, and that the Nexisensor is not designed to withstand a defibrillator as it will be removed by paramedics prior to the application of the defibrillator electrodes. ## 14.6.2 ANSI/AAMI EC38 Compliance testing of the Nexystem to ANSVAAMI EC38 Ambulatory Electrocardiographs has been conducted and the detailed Compliance Test Report 100-TR-079 is located in Appendix S. The report concludes that the Nexystem is a Type I ambulatory electrocardiograph and is compliant with ANSUAAMI EC38. This compliance is subject to the understanding that the Nexystem provides only a single lead of ECG and that as ECG analysis is not provided there is only a partial application of the standard. ### 14.7 Clinical performance data for equivalence Not applicable ## 14.8 Predicate Device Comparison The comparison of intended use and technological features of the Nexystem with other legally marketed devices taken together with the validation results, performance tests and other information in this submission indicate the Nexystem is substantially equivalent to legally marketed devices in safety, effectiveness and intended use. {4}------------------------------------------------ のも、その他、その他のアイテムには、日本の中に、日本の中には、日本の中国の中国の中国の中国の中国の中国の中国の中国の中国の中国の中国の ## Predicate Devices: Protocol Systems Propaq Encore ## 510(K)#: K980619 510(K)#: K951246 ## Parameters being compared: Physiological parameters, auxiliary devices, general equipment specification Sabratek Patient Home Monitoring System (PHMS) | Parameter | Nexystem | Sabratek PHMS | PROPAQ Encore | Explanation of Differences | |---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------| | Electrocardiogram | | | | | | Records and stores extended monitor<br>bandwidth electrocardiogram. | Yes, 0.05 - 85 Hz | No | Yes, 0.05 - 40 Hz | 85 Hz gives improved signal fidelity | | Single lead (2 active electrodes plus a<br>'ground' electrode) | Yes | Yes | Yes | | | QRS or arrhythmia detection | QRS detection | No | QRS detection | | | Heart rate range | 30 - 250 BPM | n/a | 25-350 BPM | Nexystem range complies with EC38 | | Heart rate accuracy | $\pm$ 3 BPM | n/a | $\pm$ 3 BPM | | | Detects an electrode lead off condition | No | Yes | Yes | Signal quality can be checked via<br>Nexoft at any time | | ECG sensing electrodes | Ag / AgCl custom | n/a | Any Ag / AgCl electrode is<br>recommended. | | | Alarms on low / high heart rate | No | No | Yes | Events outside pre-set thresholds can<br>be logged for review. | | Wireless operation | Yes | No | No | Provides greater operational patient<br>convenience | | Respiration | | | | | | Measure respiration rate by impedance | Yes | No | Yes | | | Range | 0 - 72 BPM | n/a | 0 (apnoea), 2-150 BPM | Nexystem is not an apnoea monitor. | | Accuracy | $\pm$ 2 BPM | n/a | $\pm$ 2 BPM or 2% | Validation against clinical trial data | | Sensor | Ag / AgCl custom | n/a | Any Ag / AgCl electrode is<br>recommended | | | Temperature | | | | | | Thermistor | Alpha Sensors: medical 400 series<br>for skin surface (disposable) | n/a | Arbo: 400 series for skin<br>surface (disposable) | | | Range | 25.0 - 45.0 °C | n/a | 30.0 - 42.0 °C | Nexystem has extended range. | | Thermistor Accuracy | $\pm 0.2 °C$ | n/a | $\pm 0.1 °C$ | $\pm0.2$ °C is sufficiently accurate for<br>trend analysis. | | Non Invasive Blood Pressure | Omron IC (HEM725CIC) | AND Medical | Unit meets ANSI-AAMI SP10-<br>1992 performance standard | Nexystem uses a legally marketed<br>device | | 510K # | K913523 | K871720 | n/a | | | Spirometer | Micromedical MicroPlus | n/a | n/a | Nexystem uses a legally marketed<br>device | | 510K# | K963035 | n/a | n/a | | | Nextation General | | | | | | Communications capability | up to 2 external devices at any one<br>time | up to 10 external devices | n/a | 2 auxiliary sensors considered<br>adequate for any one patient. | | Display | 2 line x 20 character LCD | 4 line x 20 character LCD | n/a | Adequate for patient messages. | | Display back light | Yes | Yes | n/a | | | Keypad | 3 push buttons | 5 row by 5 column custom | n/a | Keeps system operation simple. | | Patient alerts / notification | Messages displayed to prompt<br>patient auxiliary measurements<br>and communicate system faults | Audio and visual patient<br>alarm notification | n/a | Nexystem not an alarm monitor. | | Size | approx. 24 x 34 x 9 cm | Approx. 30 x 30 x 10cm | 17 x 21 x 13 cm (basic unit) | | | Weight | 3.6 kg / 7.9 lbs. | 4.5 kg / 10 lbs. | 2.8 kg / 6.25 lbs (basic unit) | | | Operating temperature | 0 to 45°C | 0 to 60°C | 0 - 40 °C | | | Storage humidity | 5 to 95% non-condensing | 0 to 95% non-condensing | 15 to 95% non-condensing | | | Shipping/storage temperature | -20 to 65°C | -20 to 60°C | -20 to 65°C | | | Drip proof | Tested to IEC 60601-1 | IEC 529 IPX1 | IEC 529 IPX1 (monitor) | IEC 60601-1 test offers similar level<br>of protection as IEC 529 IPX 1 | | Nextation Power | | | | | | Operation | 110-120V 220-240V 50/60Hz | 115/230 VAC 50/60 Hz | 100-120V 220-240 V 50/60 Hz | | | Current consumption | 250 mA continuous | Not known | 250 mA continuous | | | Operation from internal battery pack | No | Yes, > 1 hour | Yes, > 2.5 hour | 1 hour data buffer in Nexender. | | Double insulation | No | Yes | n/a | Nextation is class I device and earthed | | Power input | < 100 Watts | < 40 Watts. | n/a | | | Ambulatory sensor power | 3 x 1.4 V675AT Zinc Air cells | n/a | n/a | | | Nexender power | 4 x 1.5 V Alkaline cells | n/a | n/a | | | Parameter | Nexystem | Reynolds Holter Recorders and Analyser | Explanation of Differences | | | Event Buttons | | | | | | Number of event buttons | 2 | 1 | Provides more information. | | | Location of event button(s) | On Nexender: worn by patient or placed close by. | On Holter recorder, always worn by patient. | | | | Display of event button presses | In Nexoft, a list of all patient events can be seen;<br>users can view raw data for each event (or<br>download data for any event). | In Pathfinder, a summary table includes the total<br>number of patient events; user can tab through<br>raw ECG data for each event in turn. | | | Page 121 of 125 {5}------------------------------------------------ Page 122 of 125 {6}------------------------------------------------ 510(K)#: K974149 #### Mortara Ambulatory X-12 Telemetry Module Predicate: Parameters being compared: Nexender to Nextation radio link parameters #### Explanation of Differences Nexender to Nextation Mortara X-12 Telemetry Module Parameter Radio Link Digital, frequency-shift keying Digital, frequency-shift keying Transmission scheme 80 kHz (915 MHz) and 320 kHz (2.15 GHz) Nexystem is a single channel system Radio channel spacing n/a 50 mV/m at 3 m Power output 50 mV/m at 3 m 433 MHz is European frequency band Frequency 433 MHz or 916 MHz 915 MHz or 2.45 GHz 915/916 are the same approved band. ### Predicate: ## Reynolds Tracker Holter Recorders Reynolds Pathfinder 7000 Holter Analyser ## 510(K)#: K943278 510(K)#: K951902 Event buttons Parameters being compared: {7}------------------------------------------------ #### 510(K)#: K964408 Poseidon™ Cardiac Monitoring System Predicate: Nextation to TMS communications and Nexoft features Parameters being compared: | Parameter | Nexystem | Poseidon™ Cardiac Monitoring System | Explanation of Differences | |------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------| | Nextation to Nexoft Communications | | | | | Modem | Meets V34 fax/data modem speeds and standards. | Meets V34 fax/data modem speeds and standards. | | | Protocol | TCP/IP and PPP (including error detection and<br>correction) | CEN 231, SCP Digital Transmission<br>Error detection/correction | Nexystem uses standard Windows dial<br>up. | | Nexoft Features | | | | | Operating system | Windows NT | Windows NT | | | Print out | Yes | Yes | | | Storage | Magnetic hard drive | Magnetic disk | | | Back up | Yes - Optical disc | Yes | | | Alarms | No | No | | | Data triggers | Yes | Yes | | Page 124 of 125 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 8 1999 Nexan Telemed Ltd. c/o Quintiles, Inc. Kenneth A. Palmer, Ph.D. 15825 Shady Grove Road, Suite 130 Rockville, MD 20850-4008 Re: K993643 Nexsystem Abulatory_Parient Monitor Model Nex Regulatory Class: II (two) Product Code: MWJ October 28, 1999 Dated: Received: October 28, 1999 Dear Dr. Palmer: 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 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). 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {9}------------------------------------------------ Page 2 - Kenneth A. Palmer, Ph.D. 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, elia M., Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological·Health Enclosure {10}------------------------------------------------ Page 1 of 1 510(k) Number: K993643 Device Name: Nexsystem Ambulatory Patient Monitor Indications For Use: The Nexsystem ambulatory patient monitoring system is intended for use in the home or alternate care settings. It consists of a patient-worn sensor (Nexisensor), signal transfer unit (Nexender), communications module (Nextation), and a telemonitoring station computer based display and storage system (TMS) located at the health care professional's facility. The device stores and transmits ECG data, respiratory data, skin temperature, systolic and diastolic blood pressure (Non-invasive), and PEF and FEV1. The Nexsystem is not for use as a critical care monitoring system. The Nexsystem is not an apnea monitor. なんて (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) Walter Tikh (Division Sign-Division of Cardiovascular. Respiratory. and Neurological Devic 510(k) Number