(183 days)
Not Found
K#960851, K#911529, K871720
No
The description focuses on data collection, storage, transfer, and display, with basic alarming based on prescribed limits. There is no mention of AI or ML algorithms for analysis, interpretation, or prediction.
No
The device is described as a "physiological data monitoring and communications system" that records, stores, and transfers physiological data, and displays it to caregivers. It does not provide treatment or therapy.
Yes.
The device monitors and records physiological data (ECG, temperature, respiration, oxygen saturation, pulse, blood pressure, weight) and alerts when data violates prescribed limits, which is used by caregivers for review, indicating a diagnostic purpose.
No
The device description clearly outlines three major hardware components: the Ambulatory Patient Monitor (APM-2000), the Virtual Hospital Room Communicator (VHRC), and the Remote Device Access Software (RDAS). While the RDAS is software, the system relies on dedicated hardware for data acquisition and communication.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Sabratek Patient Home Monitoring System (PHMS) monitors physiological data directly from the patient using non-invasive sensors (ECG, temperature, respiration, blood oxygen saturation, pulse, blood pressure, weight). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring physiological data and communicating it to a healthcare provider. This aligns with patient monitoring, not in vitro testing.
Therefore, the device described is a physiological monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sabratek 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 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 in the healthcare provider facility. The APM-2000 is a physiological data recorder which stores ECG waveform data, temperature, respiration rate, arterial blood oxygen saturation, and pulse from non-invasive sensors. It alerts the patient of sensor and system errors. It has an alarm system which alarms whenever measured data violates prescribed limits. The VHR Communicator is a PC-based module which communicates with the APM-2000 to download, store and transfer physiological 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.
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
The Sabratek 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 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 in the healthcare provider facility.
The system consists of three major components:
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
predominately in alternate care settings.
healthcare provider facility.
patient's home or at an alternate care center.
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 TESTING
Engineering bench testing Verification and Validation testing
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.
Not Found
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.
Pro-Tech 1246 (K#960851), Lead-Lok, Inc LLE306BX, P-6 (K#911529), AND Medical UC-300 (Class I Exempt device 880.2700), Thermometric MA-200 (Exempt device), Nonin OEM II, AND Medical (K871720)
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
§ 870.1025 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.
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.
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 Electronic
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
alarm), 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 this
device. | |
| INDICATIONS | The Sabratek 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 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 in the healthcare provider facility. The APM-
2000 is a physiological data recorder which stores ECG
waveform data, temperature, respiration rate, arterial
blood oxygen saturation, and pulse from non-invasive
sensors. It alerts the patient of sensor and system errors.
It has an alarm system which alarms whenever measured
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
Monitoring 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 monitor
bandwidth electrocardiogram | Yes | Yes |
| Single lead (2 active electrodes
plus a "ground" electrode) | Yes | Yes |
| 5 lead selectable leads | No | Yes |
| Defibrillator-protected input
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
condition | 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 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 |
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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 |