The Sabratek Patient Home Monitoring System (PHMS), is a physiological data monitoring and communications system intended for use predominately in alternate care settings.

Device Description

The system consists of three major components as shown in Fig.1. 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 caregivers. The program can also control the functions of the APM-2000 and monitor the functions of other devices connected to the VHRC.

AI/ML Overview

The Sabratek Patient Home Monitoring System (PHMS) is a physiological data monitoring and communications system. The device itself is not a diagnostic tool but gathers various physiological data. Therefore, the "acceptance criteria" discussed here relate to the device's technical specifications and engineering performance rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (Sabratek PHMS)
Respiration
Measure respiration rate	Yes	Yes
Range	2-150 RPM	4-40 RPM
Accuracy	± 2 RPM or 2%	± 2 RPM or 2%
Sensor	Pro-Tech 1246 (K#960851)	Pro-Tech 1246 (K#960851)
Electrocardiogram
Records and stores monitor bandwidth ECG	Yes	Yes
Single lead (2 active electrodes + ground)	Yes	Yes
5 lead selectable leads	Yes	No
Defibrillator-protected input leads	Yes	No
Defib Sync.	Yes	No
Pacemaker spike detection	Yes	No
QRS or arrhythmias detection	Yes	No
QRS Tone	Yes	No
Detects electrode lead off	Yes	Yes
Alarms on low/high rate	Yes	No
Wireless operation	Optional	No
ECG Electrodes	Lead-Lok, Inc LLE306BX, P-6 (K#911529)	Lead-Lok, Inc LLE306BX, P-6 (K#911529)
Patient Weight Scale	AND Medical UC-300	AND Medical UC-300
K#	Class I Exempt device 880.2700	Class I Exempt device 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
VHRC - General
Communications capability	Up to 10 external devices	Up to 10 external devices
Display	LCD 45.75 X 67.56 mm	4 row 20 character LCD
Display backlight	Yes	Yes
Keypad	Separate keys	5 row by 5 column custom
Voice synthesizer	No	Yes
Malfunction audio	No	Yes
Speaker phone	No	Optional
Patient alarm notification	Audio and visual	Audio and visual
Size	9.6" X 8.2" X 7.6"	≈12" x 12" x 4"
Weight	12.68 Lbs	≈10 lb
Operating temperature	0 to 40 C	0 to 60 C
Humidity	15% to 95% non-condensing	0 to 95% non-condensing
Operating altitude	-2000 to 15000 Ft.	-200 to 15,000 ft
Shipping/storage temperature	-20 to +60 C	-20 to +60 C
Drip proof	Unknown	IEC 529 level IPX1
VHRC power
115/230 VAC 50/60 Hz	100-120 VAC, 50-60 Hz	Yes
Internal battery pack operation	Yes 2.5 + Hrs.	Yes, >1 hour
Internal battery charger	Yes	Yes
Battery recharge time	8-12 Hrs.	≈8 hours
Double insulation	Yes	Yes
Power input	Unknown	<40 watts

Study Proving Acceptance Criteria:

The document states: "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."

This indicates that the Sabratek PHMS underwent Engineering bench testing Verification and Validation testing to demonstrate its equivalence in safety and efficacy to predicate devices. The details of these tests are not provided in the summary.

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in detailed verification and validation reports, which are not included in this summary.

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention the use of experts to establish ground truth for a test set. This is consistent with the nature of the device, which is for physiological data monitoring rather than diagnostic interpretation. The acceptance criteria focus on technical performance metrics (e.g., accuracy of respiration rate, ECG recording capability).

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the reported testing appears to be non-clinical engineering bench testing focusing on technical specifications rather than human interpretation or diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The device is a monitoring system and does not involve human readers interpreting data from the device in a comparative effectiveness study scenario to improve diagnostic accuracy.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

The evaluation described as "Engineering bench testing Verification and Validation testing" implies a standalone performance assessment of the device's ability to accurately measure and record physiological data according to its specifications, without human intervention in the primary data acquisition and processing steps that define these metrics. However, the document does not explicitly state "standalone performance."

7. Type of Ground Truth Used:

The ground truth for the device's performance, such as respiration rate accuracy or ECG recording capability, would have been established through calibrated instruments and reference standards during the engineering bench testing. For example, a known, precisely controlled respiration rate would be used to test the device's respiration rate measurement, or a calibrated signal generator for ECG. The document implicitly relies on the technical specifications and performance of the listed component sensors (e.g., Pro-Tech 1246 for respiration, Nonin OEM II for pulse oximetry, AND Medical for NIBP) which themselves would have been validated against their respective ground truths.

8. Sample Size for the Training Set:

The document does not refer to a "training set" as the device is a hardware system for physiological monitoring, not an AI/machine learning algorithm requiring a separate training set.

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

Summary

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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.The device performs the functions of Monitor, Cardiac(incl. Cardiotachometer & rate alarm), 870.23.00,Monitor, Breathing Frequency, 868.2375, Monitor,Electrocardiographic, 870.2340, Monitor Pulse-Rate,870.2300, and Monitor, Temperature Clinical ElectronicThermometer, 880.2910.41
COMMON/USUAL NAME:	Ambulatory Patient Monitor
PROPRIETARY NAME:	Sabratek Patient Home Monitoring System (PHMS)
CLASSIFICATION:	21 CFR Monitor, Cardiac (incl. Cardiotachometer & ratealarm), 870.23.00, Monitor, Breathing Frequency,868.2375, Monitor, Electrocardiographic, 870.2340,Monitor Pulse-Rate, 870.2300, and Monitor,Temperature Clinical Electronic Thermometer,880.2910.41
PERFORMANCE STANDARDS:	No Performance Standards are in effect for thisdevice.
INDICATIONS	The Sabratek Patient Home Monitoring System (PHMS),is a physiological data monitoring and communicationssystem intended for use predominately in alternate caresettings. It consists of an ambulatory monitor (the APM-2000), a communications module located in the patientcare setting (the Virtual Hospital Room Communicator),and personal-computer-based data display and storagesoftware (Remote Device Access Software, RDAS)located in the healthcare provider facility. The APM-2000 is a physiological data recorder which stores ECGwaveform data, temperature, respiration rate, arterialblood oxygen saturation, and pulse from non-invasivesensors. It alerts the patient of sensor and system errors.It has an alarm system which alarms whenever measureddata violates prescribed limits. The VHR Communicator

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is a PC-based module which communicates with the APM-2000 to download, store and transfer physiological

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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.

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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

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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 HomeMonitoring System (PHMS)	Predicate Device
Respiration
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)
Electrocardiogram
Records and stores monitorbandwidth electrocardiogram	Yes	Yes
Single lead (2 active electrodesplus a "ground" electrode)	Yes	Yes
5 lead selectable leads	No	Yes
Defibrillator-protected inputleads	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 offcondition	Yes	Yes
Alarms on low/high rate	No	Yes
Wireless operation	No	Optional
ECG Electrodes	Lead-Lok, Inc LLE306BX,P-6 (K#911529)	Lead-Lok, Inc LLE306BX,P-6 (K#911529)
Patient Weight Scale	AND Medical UC-300	AND Medical UC-300
K#	Class I Exempt device880.2700	Class I Exempt device880.2700
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

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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

、

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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

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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

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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)

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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

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.