K Number
K961165
Device Name
HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A
Date Cleared
1996-10-10

(199 days)

Product Code
Regulation Number
870.1025
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to provide ambulatory and nonambulatory monitoring of ECG and SpO2 parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use.
Device Description
The Hewlett-Packard HP M2600A OmniCare Telemetry System consists of a pocket sized digital synthesized transmitter, synthesized receiver, and a mainframe that accommodates up to eight receiver channels. Patient physiological parameter information is displayed on HP M2350A/60A, a central station device. Patient physiological parameter displays, controls, recordings and alarms are controlled from an HP M2350A/60A Component Central Monitor. Recordings can also be initiated from the transmitter. System functions such as bedside overview, remote arthythmia monitoring, remote data management and remote clinical data access are available to the user at the central station. No changes were made to the ST or arrhythmia monitoring algorithms. The addition of SpO2 monitoring is a new feature compared to the HP telemetry predicate device and is the most significant change. Two changes were made to ECG monitoring. A third lead was added and pace pulse detection is now done in software as opposed to hardware with similar performance. The new system utilizes synthesized tuning as opposed crystal module replacement to select a new channel. An infra-red serial port was added to the transmitter for communication with an external service tool to facility tuning. The new system leverages heavily off of Hewlett-Packard devices previously cleared. The system is a digital UHF system that uses the same antenna devices, and much of the same transmitter and receiver design as the predicate device. The SpO2 capability is based on existing cleared devices. The HP M1020A SpO2 electronics were modified to work in the transmitter. New patient studies for SpO2 were done as part of the validation work for the new sy stem .
More Information

Not Found

No
The document explicitly states "No changes were made to the ST or arrhythmia monitoring algorithms" and does not mention any AI or ML technologies in the device description or in the sections specifically looking for mentions of AI, DNN, or ML.

No.
The device is described as a monitoring system for ECG and SpO2 parameters, which provides diagnostic information without delivering any therapeutic treatment.

No

Explanation: The device is described as a telemetry system for monitoring physiological parameters (ECG and SpO2). While it displays information, its stated purpose is monitoring, not diagnosing a condition.

No

The device description clearly outlines multiple hardware components including a transmitter, receiver, mainframe, central station device, and modified SpO2 electronics. While software is mentioned for pace pulse detection, the system is fundamentally a hardware-based monitoring system with integrated software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for "ambulatory and nonambulatory monitoring of ECG and SpO2 parameters of adult, and pediatric patients". This describes monitoring physiological parameters within the patient's body, not analyzing samples outside the body.
  • Device Description: The description details a system for monitoring ECG and SpO2, which are direct measurements of the patient's physiological state. It involves a transmitter, receiver, and central station for displaying and managing this data. This aligns with patient monitoring, not in vitro testing.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Reagents or assays
    • Laboratory testing
    • Diagnosis based on analysis of samples

Therefore, the device described is a patient monitoring system, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The device is intended to provide ambulatory and nonambulatory monitoring of ECG and SpO2 parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use.

Product codes

Not Found

Device Description

The Hewlett-Packard HP M2600A OmniCare Telemetry System consists of a pocket sized digital synthesized transmitter, synthesized receiver, and a mainframe that accommodates up to eight receiver channels. Patient physiological parameter information is displayed on HP M2350A/60A, a central station device. Patient physiological parameter displays, controls, recordings and alarms are controlled from an HP M2350A/60A Component Central Monitor. Recordings can also be initiated from the transmitter. System functions such as bedside overview, remote arthythmia monitoring, remote data management and remote clinical data access are available to the user at the central station. No changes were made to the ST or arrhythmia monitoring algorithms. The addition of SpO2 monitoring is a new feature compared to the HP telemetry predicate device and is the most significant change. Two changes were made to ECG monitoring. A third lead was added and pace pulse detection is now done in software as opposed to hardware with similar performance. The new system utilizes synthesized tuning as opposed crystal module replacement to select a new channel. An infra-red serial port was added to the transmitter for communication with an external service tool to facility tuning. The new system leverages heavily off of Hewlett-Packard devices previously cleared. The system is a digital UHF system that uses the same antenna devices, and much of the same transmitter and receiver design as the predicate device. The SpO2 capability is based on existing cleared devices. The HP M1020A SpO2 electronics were modified to work in the transmitter.

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

adult, and pediatric patients

Intended User / Care Setting

trained health care personnel, professional health care facility

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

New patient studies for SpO2 were done as part of the validation work for the new sy stem .

Key Metrics

Not Found

Predicate Device(s)

K894277

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K961165

[510(K)] SUMMARY OF SAFETY AND EFFECTIVENESS

This submission notifies the FDA of a our intention to replace the HP M1403A Telementy Monitoring System, K894277 with a new system. The new system will be marketed as the HP M2600A OmniCare Telemetry System. The new system is very similar to the replaced system except for several added features. The design was leveraged off of development work (RF, ECG, and SpO2) done on previously cleared devices to give the user the added capability as well as a better value.

Description

The Hewlett-Packard HP M2600A OmniCare Telemetry System consists of a pocket sized digital synthesized transmitter, synthesized receiver, and a mainframe that accommodates up to eight receiver channels. Patient physiological parameter information is displayed on HP M2350A/60A, a central station device.

Patient physiological parameter displays, controls, recordings and alarms are controlled from an HP M2350A/60A Component Central Monitor. Recordings can also be initiated from the transmitter. System functions such as bedside overview, remote arthythmia monitoring, remote data management and remote clinical data access are available to the user at the central station. No changes were made to the ST or arrhythmia monitoring algorithms.

The addition of SpO2 monitoring is a new feature compared to the HP telemetry predicate device and is the most significant change.

Two changes were made to ECG monitoring. A third lead was added and pace pulse detection is now done in software as opposed to hardware with similar performance.

The new system utilizes synthesized tuning as opposed crystal module replacement to select a new channel. An infra-red serial port was added to the transmitter for communication with an external service tool to facility tuning.

The new system leverages heavily off of Hewlett-Packard devices previously cleared. The system is a digital UHF system that uses the same antenna devices, and much of the same transmitter and receiver design as the predicate device. The SpO2 capability is based on existing cleared devices. The HP M1020A SpO2 electronics were modified to work in the transmitter. New patient studies for SpO2 were done as part of the validation work for the new sy stem .

INTENDED USE

The device is intended to provide ambulatory and nonambulatory monitoring of ECG and SpO2 parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use.

SUBSTANTIAL EQUIVALENCE

HP M2600A OmniCare Telemetry System is a replacement for the present telemetry system. The device was compared to predicate devices to show equivalence with respect to safety, intended use, and efficacy. The comparison shows the device to be substantially equivalent in safety, effectiveness, and intended use to legally marketed devices. The discussion of similarities and differences shows that there are no significant differences between the modified device and the predicate devices.

HP Confidential