(258 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on basic physiological parameter monitoring without any mention of advanced analytical or learning capabilities.
No.
The device is a patient monitor designed to display patient data and monitor physiological parameters; it does not provide therapy or treatment.
No
This device is a patient monitor that displays patient data and basic physiological parameters. It is intended for monitoring, not for diagnosing conditions.
No
The device description explicitly states it is a "patient monitoring system" that monitors physiological parameters using components like ECG, blood pressure, temperature, and EtCO2. It also mentions options for a paper recorder, indicating hardware components beyond just software.
Based on the provided text, the Marquette Eagle 3000 Patient Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Marquette Eagle 3000 focuses on monitoring physiological parameters directly from the patient (ECG, blood pressure, oxygen saturation, temperature, EtCO2, PA Wedge).
- The intended use and device description clearly state that it monitors patient data and physiological parameters. There is no mention of analyzing biological samples.
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.
Product codes
74CAA, 74BXD, 73CCK, 80BWX, 74DRT, 74BWS
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, oxygen saturation, temperature, and end tidal carbon dioxide (EtCO2). PA Wedge is also available.
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 MOT 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 MQT 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
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
Not Found
Predicate Device(s)
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
510 (k) Summary of Safety and Bifochiveness
OCT - 2 1996
l. Manufacturer/ Submitter Marquette Electronics, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 U.S.A.
Establishment Registration Number: 2124823
Contact Name/ Telephone Mumber: 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 870.1110 | Monitor, Blood Pressure,
Indwelling | 74CAA |
|---|-----------------|-----------------------------------------------------------|-------|
| * | 21 CFR 870.1130 | Monitor, Blood Pressure,
Non-Indwelling | 74BXD |
| * | 21 CFR 870.1400 | Analyzer, Gas, Carbon-
Dioxide, Gaseous-Phase | 73CCK |
| * | 21 CFR 880.2910 | Monitor, Temperature
(with probe) | 80BWX |
| * | 21 CFR 870.2300 | Monitor, Cardiac (Incl.
cardiotachometer & rate alarm) | 74DRT |
| * | 21 CFR 870.2700 | Oximeter, Pulse | 74BWS |
Device Classification
Devices monitoring similar parameters have been determined to be Class II or III devices according to the Cardiovascular and Anesthesiology Device Classification Panels. FDA has determined this to be a Class III device.
1
Performance Standards
Parformance 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 Bagle 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 |
| Carbon Dioxide Module | K904789 |
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, oxygen saturation, temperature, and end tidal carbon dioxide (EtCO2). PA Wedge is also available.
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 MOT 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 MQT 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
2
P.04
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.
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.