EAGLE 4000 PATIENT MONITOR

K964750 · Marquette Electronics, Inc. · LOS · Feb 21, 1997 · CV

Device Facts

• Record ID: K964750
• Device Name: EAGLE 4000 PATIENT MONITOR
• Applicant: Marquette Electronics, Inc.
• Product Code: LOS · CV
• Decision Date: Feb 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Attributes: Pediatric

Intended Use

The Marquette Eagle 4000 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 printing of information by a paper recorder. Use of the Marquette Eagle 4000 Patient Monitor is intended for patient populations including: adult, pediatric, and/or neonatal. Use of the Marquette Eagle 4000 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 4000 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

Patient monitoring system; inputs include ECG, invasive/non-invasive blood pressure, SpO2, temperature, respiration, and cardiac output signals. Device processes physiological data to display real-time values and waveforms; includes 12-lead ECG analysis (12 SL program) for arrhythmia detection. Outputs include visual/audible alarms for parameter violations and printed reports via paper recorder. Used in hospital departments (OR, ICU, recovery) and outpatient clinics; operated by physicians, nurses, and trained medical personnel. Assists clinicians in patient status assessment and clinical decision-making; provides continuous monitoring to improve patient safety in critical care environments.

Clinical Evidence

Bench testing only. Verification and validation testing performed comparing the Eagle 4000 to predicate devices. Results demonstrate equivalent or superior performance in accuracy for all monitored physiological parameters.

Technological Characteristics

Multi-parameter patient monitor; includes 12-lead ECG analysis (12 SL program). Parameters: ECG, invasive/non-invasive BP, SpO2, temperature, respiration, apnea, pulse, cardiac output. Connectivity: paper recorder output. Form factor: bedside monitor unit. Software: 12 SL ECG analysis algorithm.

Indications for Use

Indicated for monitoring physiological parameters (ECG, invasive/non-invasive BP, SpO2, temperature, respiration, apnea, pulse, cardiac output, arrhythmia) in adult, pediatric, and neonatal patients in clinical settings (hospitals, clinics, surgical centers). Not for home use or patient transport.

Predicate Devices

• Marquette Eagle Monitor (K920790)
• Marquette SL Series Tram Module (K921669)

Submission Summary (Full Text)

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K964750

# 510(k) Summary of Safety and Effectiveness

FEB 21 1997

## 1. Manufacturer/ Submitter

Marquette Medical Systems
8200 West Tower Avenue
Milwaukee, WI 53223 U.S.A.

Establishment Registration Number: 2124823

Contact Name/ Telephone Number:

Dianne Schmitz
Corporate Regulatory Affairs
Marquette Medical Systems

Phone: [phone]

Date: November 15, 1996

## 2. General Information

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

Trade Proprietary Name
Marquette's trade/ proprietary name for this device is the Eagle 4000 Patient Monitor.

Classification Name(s)
The Marquette Eagle 4000 Patient Monitor's classification names, classification panels, and regulation citations include:

* 21 CFR 870.1025 Detector and Alarm, Arrhythmia 74DSI
* 21 CFR 868.2375 Monitor, Breathing Frequency 73BZQ
* 21 CFR 868.2375 Monitor, (Apnea Detector) Ventilatory Effort 73FLS
* 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 870.1435 Monitor, Cardiac Output, Thermal (Balloon Type Catheter) 74KFN
* 21 CFR 870.2300 Monitor, Cardiac (Incl.) 74DRT

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cardiotachometer & rate alarm)

* 21 CFR 870.2700 Oximeter, Pulse 74DQA

## Device Classification

Both of the main predicate devices included parameters which are Class III parameters, and both devices were cleared to market via the 510(k) notification route. The modified device that is the subject of this 510(k) submission remains in Class III.

## 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.

## 3. Legally Marketed Predicate Device(s)

The Marquette Eagle 4000 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
Marquette SL Series Tram Module K921669

## 4. Device Description

The Marquette Eagle 4000 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, oxygen saturation, temperature, respiration, apnea detection, pulse rate, cardiac output, and full arrhythmia analysis. The device now includes Marquette's 12 lead ECG Analysis program (commonly referred to as 12 SL).

## 5. Intended Use

The Marquette Eagle 4000 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 printing of information by a paper recorder.

Use of the Marquette Eagle 4000 Patient Monitor is intended for patient populations including: adult, pediatric, and/or neonatal.

Use of the Marquette Eagle 4000 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 4000 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

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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

Verification and validation testing was done on the Eagle 4000 Patient Monitor and its predicate devices. Test results indicate that the Eagle 4000 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 Medical Systems has demonstrated that the Eagle 4000 Patient Monitor is as safe and effective, and performs substantially equivalent to the predicate devices.

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