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.

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.

The Nexystem comprises a number of system components identified below.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Nexystem based on the provided K993643 Premarket Notification:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria in terms of numerical thresholds for all evaluated parameters. Instead, it relies heavily on compliance with recognized standards (ANSI/AAMI EC12 and EC38) and direct comparison to predicate devices, highlighting where the Nexystem meets or exceeds predicate performance.

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance (Nexystem)
ECG	Compliance with ANSI/AAMI EC12 for disposable electrodes. Compliance with ANSI/AAMI EC38 for ambulatory electrocardiographs (Type I). Consistent with predicate device performance (Sabratek, Propaq Encore).	Compliant with ANSV/AAMI EC12. Compliant with ANSUV/AAMI EC38 (Type I, single lead, no ECG analysis). Records and stores extended monitor bandwidth (0.05 - 85 Hz). QRS detection. Heart rate range: 30 - 250 BPM. Heart rate accuracy: $\pm$ 3 BPM. Ag/AgCl custom sensing electrodes.
Respiration	Consistent with predicate device performance (Propaq Encore). Compliance with relevant standards for respiration monitoring (not explicitly stated for Nexystem, but predicates set a benchmark).	Measures respiration rate by impedance. Range: 0 - 72 BPM. Not an apnoea monitor. Accuracy: $\pm$ 2 BPM. Ag/AgCl custom sensor.
Temperature	Consistent with predicate device performance (Propaq Encore).	Thermistor: Alpha Sensors medical 400 series. Range: 25.0 - 45.0 °C. Accuracy: $\pm 0.2 °C$.
Blood Pressure	Uses a legally marketed device (Omron IC) with established 510(k) clearance (K913523).	Omron IC (HEM725CIC) - Non-invasive blood pressure.
Spirometry	Uses a legally marketed device (Micromedical MicroPlus) with established 510(k) clearance (K963035).	Micromedical MicroPlus.
Wireless Operation	Provides greater patient convenience than non-wireless predicates.	Yes (Nexisensor to Nexender, Nexender to Nextation).
Safety	Compliance with IEC 60601-1 for drip proofing. General electrical safety (Class I device, earthed).	Tested to IEC 60601-1 (drip proofing). Nextation is Class I device and earthed.
Communications	Uses standard protocols (TCP/IP, PPP, Windows dial-up). Modem meets V34 standards.	Nexender to Nextation radio link: Digital, frequency-shift keying. Power output: 50 mV/m at 3 m. Frequency: 433 MHz or 916 MHz. Nextation to Nexoft: V34 modem, TCP/IP and PPP protocol.
Functionality	Provides ability to view raw data, display a list of patient events, log events outside pre-set thresholds.	Nexoft displays a list of all patient events; users can view raw data for each event. Events outside pre-set thresholds can be logged for review.

2. Sample Size Used for the Test Set and Data Provenance

The submission explicitly states: "14.7 Clinical performance data for equivalence: Not applicable". This indicates that no separate clinical test set of patient data was used to demonstrate the performance of the Nexystem in a clinical setting compared to a ground truth established from patient data. The primary method of demonstrating equivalence was through non-clinical testing against standards and direct comparison of specifications with predicate devices.

Therefore, for a clinical test set:

Sample size: Not applicable.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Since no clinical test set was utilized for demonstrating performance against a "ground truth" derived from patient data, this information is not applicable. The "ground truth" for the non-clinical tests was defined by the requirements of the standards (ANSI/AAMI EC12 and EC38) and the specifications of the predicate devices.

4. Adjudication Method for the Test Set

As no clinical test set with human-established ground truth was used, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The submission explicitly states "Clinical performance data for equivalence: Not applicable". Therefore, no MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The performance evaluation primarily involved standalone testing of the device's technical specifications and compliance with recognized standards. This is akin to standalone performance for the various physiological data acquisition and transmission functions. For example:

Compliance testing of the Nexisensor to ANSI/AAMI EC12 for disposable ECG electrodes.
Compliance testing of the Nexystem to ANSI/AAMI EC38 for ambulatory electrocardiographs.
Verification of heart rate range and accuracy, respiration range and accuracy, and temperature range and accuracy based on the device's internal functionality.
The use of legally marketed and separately cleared devices for blood pressure (Omron IC) and spirometry (Micromedical MicroPlus) implies their standalone performance was relied upon.

However, it's important to note this is not a standalone performance of an AI algorithm, as this device does not appear to incorporate AI for diagnostic purposes. It's a standalone performance demonstration of monitoring hardware and software capabilities.

7. The Type of Ground Truth Used

The ground truth used in this submission is multifaceted and based on:

Industry Standards: The requirements and specifications outlined in ANSI/AAMI EC12 (Disposable ECG Electrodes) and ANSI/AAMI EC38 (Ambulatory Electrocardiographs).
Predicate Device Specifications: The technical parameters and performance characteristics of the legally marketed predicate devices (Sabratek PHMS, Propaq Encore, Mortara Ambulatory X-12 Telemetry Module, Reynolds Tracker/Pathfinder, Instromedix Poseidon Cardiac Monitoring System). The Nexystem demonstrated "substantial equivalence" by meeting or exceeding these established benchmarks.
Functional Testing: The inherent design specifications and measured performance of the Nexystem components (e.g., heart rate accuracy, temperature accuracy) as validated by engineers/testers against known input signals or reference devices.

8. The Sample Size for the Training Set

This information is not applicable. The Nexystem is an ambulatory patient monitoring system that primarily collects and transmits physiological data; it is not described as an AI-powered diagnostic or analysis device that would require a "training set" in the context of machine learning. The focus is on hardware and software functionality and compliance with performance standards for data acquisition and transmission.

9. How the Ground Truth for the Training Set Was Established

As no training set (in the context of machine learning/AI) was used, this information is not applicable.

Summary

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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

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14.4 Device Description

14.4.1 System Overview

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.

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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 monitorbandwidth 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 viaNexoft at any time
ECG sensing electrodes	Ag / AgCl custom	n/a	Any Ag / AgCl electrode isrecommended.
Alarms on low / high heart rate	No	No	Yes	Events outside pre-set thresholds canbe logged for review.
Wireless operation	Yes	No	No	Provides greater operational patientconvenience
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 isrecommended
Temperature
Thermistor	Alpha Sensors: medical 400 seriesfor skin surface (disposable)	n/a	Arbo: 400 series for skinsurface (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 fortrend analysis.
Non Invasive Blood Pressure	Omron IC (HEM725CIC)	AND Medical	Unit meets ANSI-AAMI SP10-1992 performance standard	Nexystem uses a legally marketeddevice
510K #	K913523	K871720	n/a
Spirometer	Micromedical MicroPlus	n/a	n/a	Nexystem uses a legally marketeddevice
510K#	K963035	n/a	n/a
Nextation General
Communications capability	up to 2 external devices at any onetime	up to 10 external devices	n/a	2 auxiliary sensors consideredadequate 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 promptpatient auxiliary measurementsand communicate system faults	Audio and visual patientalarm 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 levelof 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;users can view raw data for each event (ordownload data for any event).	In Pathfinder, a summary table includes the totalnumber of patient events; user can tab throughraw ECG data for each event in turn.

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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:

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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 andcorrection)	CEN 231, SCP Digital TransmissionError detection/correction	Nexystem uses standard Windows dialup.
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

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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.

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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

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Page 1 of 1

510(k) Number: K993643

Device Name: Nexsystem Ambulatory Patient Monitor

Indications For Use:

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

Regulation Number and Section

§ 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).