EAGLE PATIENT MONITOR

K960418 · Marquette Electronics, Inc. · DSI · Oct 2, 1996 · Cardiovascular

Device Facts

• Record ID: K960418
• Device Name: EAGLE PATIENT MONITOR
• Applicant: Marquette Electronics, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Oct 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Marquette Eagle 3000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for the printing of information by a paper recorder. Use of the Marquette Eagle 3000 Patient Monitor is intended for patient populations including: adult, pediatric, and/or neonatal. Use of the Marquette Eagle 3000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel. Use of the Marquette Eagle 3000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

Device Story

Eagle 3000 Patient Monitor is a fixed-parameter bedside monitoring system; inputs include ECG leads, blood pressure transducers, and temperature probes. Device processes physiological signals to display real-time data and perform arrhythmia analysis; provides audible/visual alarms for parameter violations; optional paper recorder for data output. Used in hospital departments (OR, ICU, recovery) and outpatient clinics by trained clinicians (physicians, nurses, anesthetists). Output allows clinicians to track patient status and respond to alarm conditions; benefits include continuous physiological surveillance and timely clinical intervention. Device is non-modular and lacks battery power for transport.

Clinical Evidence

Bench testing only. Comparative precision and accuracy testing performed against predicate devices. Results demonstrate equivalent or superior performance to legally marketed predicates.

Technological Characteristics

Fixed-parameter patient monitor; non-modular design. Parameters: ECG, invasive/non-invasive blood pressure, temperature, arrhythmia analysis. Line-powered (no battery). Includes optional integrated paper recorder. Software-based alarm management and signal processing.

Indications for Use

Indicated for adult, pediatric, and neonatal patient populations requiring monitoring of ECG, invasive/non-invasive blood pressure, temperature, and arrhythmia analysis in clinical settings (OR, ICU, recovery, clinics). Not for home use or patient transport.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Marquette Eagle Monitor (K920790)
• Eagle 3000 Patient Monitor (K952474)

Submission Summary (Full Text)

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OCT-01-1996 9:03 FROM MARGUETTE ELECTRONICS TO 913014804204 P.002
K960 418

# 510(k) Summary of Safety and Effectiveness

OCT - 2 1996

1. Manufacturer/ Submitter
Marquette Electronics, Inc.
8200 West Tower Avenue
Milwaukee, WI 53223 U.S.A.

Establishment Registration Number: 2124823

Contact Name/ Telephone Number:
Dianne Schmitz
Corporate Regulatory Affairs
Marquette Electronics, Inc.

Phone: [phone]

Date: October 1, 1996

2. General Information

Common/ Usual Name
This device is commonly known as a patient monitoring system.

Trade/ Proprietary Name
Marquette Electronics, Inc.'s trade/ proprietary name for this device is the Eagle 3000 Patient Monitor.

Classification Name(s)
The Marquette Eagle 3000 Patient Monitor's classification names, classification panels, and regulation citations include:

* 21 CFR 870.1025 Arrhythmia detector and alarm 74DSI
* 21 CFR 870.1110 Monitor, Blood Pressure, Indwelling 74CAA
* 21 CFR 870.1130 Monitor, Blood Pressure, Non-Indwelling 74BXD
* 21 CFR 880.2910 Monitor, Temperature (with probe) 80BWX
* 21 CFR 870.2300 Monitor, Cardiac (Incl. cardiotachometer & rate alarm) 74DRT

Device Classification
Devices monitoring similar parameters have been determined to be Class II or III devices according to the Cardiovascular Device Classification Panel. FDA has determined this to be a Class III device.

Performance Standards
Performance standards (Section 514 of the Act) have not yet been established for the device that is the subject of this premarket notification submission.

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OCT-01-1996 9:03 FROM MARQUETTE ELECTRONICS TO 913014 04204 P.003

## 3. Legally Marketed Predicate Device(s)

The Marquette Eagle 3000 Patient Monitor is substantially equivalent, with similar indications for use to the following devices which are currently legally marketed and in commercial distribution:

Marquette Eagle Monitor K920790
Eagle 3000 Patient Monitor K952474

## 4. Device Description

The Marquette Eagle 3000 Patient Monitor is a patient monitoring system that is designed to be used to monitor a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, temperature, and arrhythmia analysis.

The Eagle 3000 Patient Monitor is a factory configured or fixed-parameter patient monitoring device.

Options which allow for the monitoring of invasive blood pressure and the printing of information by a paper recorder may be added to the basic monitor configuration at the factory prior to shipment to the customer.

The Eagle 3000 Patient Monitor has **NOT** been designed as a modular patient monitoring device which allows the addition and deletion of monitoring parameters at the point-of-use.

The Eagle 3000 Patient Monitor has **NOT** been designed as a transport monitor. Therefore, no battery power feature or option has been included with this device.

## 5. Intended Use

The Marquette Eagle 3000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs.

The option is provided for the printing of information by a paper recorder.

Use of the Marquette Eagle 3000 Patient Monitor is intended for patient populations including: adult, pediatric, and/or neonatal.

Use of the Marquette Eagle 3000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel.

{2}

OCT-01-1996 9:03 FROM MARQUETTE ELECTRONICS TC 913014904204 P.004

Use of the Marquette Eagle 3000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

## 6. Conclusion

Comparative testing was done on the Eagle 3000 Patient Monitor and its predicate devices. Precision and accuracy testing was also performed. Test results indicate that the Eagle 3000 Patient Monitor provides an equivalent level or better in performance, when compared to the legally marketed predicate devices when tested to the accuracy requirements as specified in the contents of the premarket notification submission.

Marquette Electronics, Inc. has demonstrated that the Eagle 3000 Patient Monitor is as safe and effective, and performs substantially equivalent to the predicate devices.