(87 days)
No
The summary describes a standard patient monitor with physiological parameter monitoring and ECG analysis. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Not Found" entries for AI/ML mentions and training/test set descriptions further support this conclusion.
No
The device is a patient monitor designed to display patient data and monitor physiological parameters, not to provide therapy or treatment.
No
A diagnostic device is used to identify a condition or disease. This device is a patient monitor that displays and monitors physiological parameters, but it is not intended for diagnosis of a disease.
No
The device description explicitly states it is a "patient monitoring system" designed to monitor various physiological parameters, implying the inclusion of hardware components to acquire these signals. The mention of "printing of information by a paper recorder" further indicates hardware.
Based on the provided text, the Marquette Eagle 4000 Patient Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The description of the Marquette Eagle 4000 clearly states it is a "patient monitoring system" that monitors "basic physiological parameters" directly from the patient (ECG, blood pressure, oxygen saturation, temperature, respiration, etc.). It does not examine specimens in vitro.
- Intended Use: The intended use describes monitoring patients in various clinical settings and providing real-time data and alarms. This is consistent with a patient monitoring device, not an IVD.
Therefore, the Marquette Eagle 4000 Patient Monitor is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for 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 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, 73BZQ, 73FLS, 74CAA, 74BXD, 80BWX, 74KFN, 74DRT, 74DQA
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).
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 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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary of Safety and Effectiveness
FEB 2 | 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: (414) 362-3230
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 |
1
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
2
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.