K Number
K960418
Device Name
EAGLE PATIENT MONITOR
Date Cleared
1996-10-02

(247 days)

Product Code
Regulation Number
870.1025
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on basic physiological parameter monitoring without mentioning advanced analytical capabilities.

No.
The device is described as a "patient monitoring system" designed to "monitor and display patient data" and "patient's basic physiological parameters." It does not mention any therapeutic function or intervention.

No

The device is described as a "patient monitoring system" designed to "monitor and display patient data" and "monitor a patient's basic physiological parameters," such as ECG, blood pressure, and temperature. While it provides data that can be used for diagnosis, its primary function is continuous monitoring rather than providing a standalone diagnosis. It alerts operators of parameter violations, which informs clinicians but does not itself diagnose conditions.

No

The device description explicitly states it is a "patient monitoring system" that monitors physiological parameters and includes options for a "paper recorder," indicating it is a hardware device with integrated software, not a software-only device.

Based on the provided text, the Marquette Eagle 3000 Patient Monitor is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use/Indications for Use: The intended use clearly states that the device is designed to "monitor and display patient data" and "monitor a patient's basic physiological parameters." This involves directly monitoring the patient's body, not analyzing samples taken from the body.
  • Device Description: The description lists the parameters monitored (ECG, invasive blood pressure, non-invasive blood pressure, temperature, and arrhythmia analysis). These are all physiological measurements taken from the patient directly.
  • Lack of mention of in vitro analysis: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which is the defining characteristic of an IVD.

Therefore, the Marquette Eagle 3000 Patient Monitor is a patient monitoring device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for 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.

Product codes

74DSI, 74CAA, 74BXD, 80BWX, 74DRT

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.

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, pediatric, and/ or neonatal

Intended User / Care Setting

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.

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)

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.

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.

K920790, K952474

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.

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

P.002
560 418

K960 418

510 (k) Summary of Safety and Effectiveness

    1. Manufacturer/ Submitter Marquette Electronics, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 U.S.A.
      OCT - 2 1996

Establishment Registration Number: 2124823

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

Phone: (414) 362-3230

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.

1

3. Legally Marketed Predicate Device(s)

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

Marquette Eagle MonitorK920790
Eagle 3000 Patient MonitorK952474

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

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.