(61 days)
No
The document describes a system for collecting, transmitting, and displaying physiological data for review by a healthcare professional. There is no mention of automated analysis, interpretation, or decision-making based on the data, which would typically indicate the presence of AI/ML. The analysis is explicitly stated to be performed by the HCP.
No
The device is described as a "non-invasive ambulatory patient monitoring system" that collects and transmits physiological data for display, monitoring, and storage. It explicitly states, "The Nexsystem is not for use as a critical care monitoring system" and "The Nexsystem is not an apnea monitor," indicating it is for observation and data collection, not for providing therapy or active treatment.
No
The device collects and monitors physiological parameters like ECG, respiratory data, skin temperature, blood pressure, and lung function. While this data can be used to inform a diagnosis by a healthcare professional, the device itself is described as a "monitoring system" and does not state that it performs a diagnostic function or provides a diagnosis. It explicitly states it is "not for use as a critical care monitoring system" nor an "apnea monitor."
No
The device description explicitly lists multiple hardware components: patient-worn sensor (Nexisensor), signal transfer unit (Nexender), communications module (Nextation), auxiliary sensors (spirometer and blood pressure monitor), and a Call Discriminator Unit. While it includes software (Nexoft application), it is not solely software.
Based on the provided information, the Nexsystem ambulatory patient monitoring system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Nexsystem directly monitors physiological parameters from the patient's body (ECG, respiratory data, skin temperature, blood pressure, PEF, FEV1) using sensors attached to the patient. It does not analyze samples like blood, urine, or tissue.
- The intended use and device description focus on monitoring and transmitting physiological data. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- The performance studies and key metrics relate to the accuracy of physiological measurements, not the performance of a test on a biological specimen.
Therefore, the Nexsystem falls under the category of a medical device for patient monitoring, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
74DPS, 73BZQ, 80FLL, 74DRG, MWJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest (for sensor band)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professional (HCP) at the TMS, home or alternate care settings
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)
Non-clinical performance data for equivalence:
- ANSI/AAMI EC12: Compliance testing of the Nexisensor to ANSI/AAMI EC12 Disposable ECG Electrodes has been conducted. The Nexisensor is compliant with ANSI/AAMI EC12, subject to the understanding that the 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.
- ANSI/AAMI EC38: Compliance testing of the Nexystem to ANSI/AAMI EC38 Ambulatory Electrocardiographs has been conducted. The Nexystem is a Type I ambulatory electrocardiograph and is compliant with ANSI/AAMI EC38, 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.
Clinical performance data for equivalence: Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K980619, K951246, K974149, K943278, K951902, K964408
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.
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
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
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 |
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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.
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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.
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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 | ||||
| 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 | ||||
| '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 |
| Nexoft at any time | ||||
| ECG sensing electrodes | Ag / AgCl custom | n/a | Any Ag / AgCl electrode is | |
| recommended. | ||||
| Alarms on low / high heart rate | No | No | Yes | Events outside pre-set thresholds can |
| be logged for review. | ||||
| Wireless operation | Yes | No | No | Provides greater operational patient |
| 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 | |
| recommended | ||||
| Temperature | ||||
| Thermistor | Alpha Sensors: medical 400 series | |||
| for skin surface (disposable) | n/a | Arbo: 400 series for skin | ||
| 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 |
| trend analysis. | ||||
| Non Invasive Blood Pressure | Omron IC (HEM725CIC) | AND Medical | Unit meets ANSI-AAMI SP10- | |
| 1992 performance standard | Nexystem uses a legally marketed | |||
| device | ||||
| 510K # | K913523 | K871720 | n/a | |
| Spirometer | Micromedical MicroPlus | n/a | n/a | Nexystem uses a legally marketed |
| device | ||||
| 510K# | K963035 | n/a | n/a | |
| Nextation General | ||||
| Communications capability | up to 2 external devices at any one | |||
| time | up to 10 external devices | n/a | 2 auxiliary sensors considered | |
| 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 | |||
| patient auxiliary measurements | ||||
| and communicate system faults | Audio and visual patient | |||
| 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 |
| 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 |