(85 days)
Marquette Eagle 3000 Patient Monitor
No Reference Devices Found
No
The document describes a standard patient monitor with basic physiological parameter monitoring and signal processing, with no mention of AI or ML technologies.
No
The device is a patient monitor used to measure physiological parameters, not to treat a condition or restore health.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a disease or condition. This device is a patient monitor, which is used to monitor basic physiological parameters. While monitoring can be part of patient management, it is primarily for observation and tracking, not for diagnosing a condition itself. The document states its use is to "monitor a patient's basic physiological parameters," which is distinct from providing a diagnosis based on these parameters.
No
The device description explicitly states it is a "patient monitoring system" and a "microprocessor-based, software-driven device," indicating the presence of hardware components for signal acquisition and processing, in addition to software. The mention of optional "printing of information by a paper recorder" further confirms hardware involvement.
Based on the provided information, the Marquette Eagle 1000 (DASH 1000) Patient Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the Marquette Eagle 1000 monitors physiological parameters directly from the patient (ECG, blood pressure, oxygen saturation, temperature). It does not analyze samples taken from the patient.
- Intended Use: The intended use is for monitoring patients in various clinical settings, not for performing laboratory tests on patient samples.
Therefore, the Marquette Eagle 1000 Patient Monitor falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Marquette Eagle 1000 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 1000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal.
Use of the Marquette Eagle 1000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport outside the hospital, or when it has not been ordered by a physician or other qualified medical personnel.
Use of the Marquette Eagle 1000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care and 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.
The Marquette Eagle 1000 (DASH 1000) Patient Monitor is a patient monitor 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, and temperature.
Optionally, the printing of information by a paper recorder may be added to the basic monitor configuration.
Use of this device is intended for patient populations including: adult, pediatric, and/or neonatal.
Product codes (comma separated list FDA assigned to the subject device)
74CAA, 74BXD, 80BWX, 74DRT, 74BWS, 74DSI
Device Description
The Marquette Eagle 1000 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, and temperature.
The Eagle 1000 Patient Monitor is a microprocessor-based, software-driven 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 1000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care and 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)
Testing was performed on the Eagle 1000 Patient Monitor and its predicate devices. Precision, accuracy, as well as safety testing was performed. Test results indicate that the Eagle 1000 Patient Monitor provides an equivalent level or better in performance, when compared to the legally marketed predicate device(s) 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.
Marquette Eagle 3000 Patient Monitor
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K9705545
8 1997
MAY
510(k) Summary of Safety and Effectiveness
February 7, 1997 Date:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
| Submitter: | Marquette Medical Systems
8200 West Tower Avenue
Milwaukee, WI 53223 U.S.A. |
| ------------ | ----------------------------------------------------------------------------------- |
|---|
Dianne Schmitz Contact Person: Corporate Regulatory Affairs Marquette Medical Systems Phone: (414) 362-3230 Fax: (414) 355-3790
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 domestically within the United States is the DASH 1000 Patient Monitor. Marquette Hellige's trade/ proprietary name internationally is the Eagle 1000 Patient Monitor.
Classification Name(s)
The Marquette Eagle 1000 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 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 |
| * 21 CFR 870.1025 | Detector and Alarm, Arrhythmia | 74DSI |
Device Classification
Devices monitoring similar parameters have been determined to be Class II devices according to the Cardiovascular Device Classification Panel. Therefore, it is believed that the system will be considered a Class II device.
However, due to ongoing discussions between the Agency and Industry on the definition of 21 CFR 870.1025, Arrhythmia detector and alarm, which is a Class III parameter, Marquette Medical Systems has included the additional information that would be required for a Class III device within the premarket notification submission. This is being provided should the Agency determine the Eagle 1000 Patient Monitor is a Class III device.
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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.
| Predicate Device: | Marquette Eagle 3000 Patient Monitor |
|---|---|
| Device Description: | The Marquette Eagle 1000 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, and temperature. | |
| Intended Use: | The Marquette Eagle 1000 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 1000 Patient Monitor is intended for | |
| patient populations including: adult, pediatric, and/ or neonatal. | |
| Use of the Marquette Eagle 1000 Patient Monitor is not | |
| recommended for use in patient's home or residence, during | |
| patient transport outside the hospital, or when it has not been | |
| ordered by a physician or other qualified medical personnel. | |
| Use of the Marquette Eagle 1000 Patient Monitor is intended for | |
| operating room (OR), post anesthesia recovery, critical care and | |
| 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. | |
| Conclusions: | The Eagle 1000 Patient Monitor is a microprocessor-based, |
| software-driven device. The signal-acquisition and -processing | |
| technologies and the basic parts of the device software were re- | |
| used from former devices. | |
| Testing was performed on the Eagle 1000 Patient Monitor and its | |
| predicate devices. Precision, accuracy, as well as safety testing | |
| was performed. Test results indicate that the Eagle 1000 Patient | |
| Monitor provides an equivalent level or better in performance, | |
| when compared to the legally marketed predicate device(s) when | |
| tested to the accuracy requirements as specified in the contents | |
| of the premarket notification submission. | |
| The Eagle 1000 Patient Monitor passed the EC type- | |
| examination, and thus bears the CE mark. | |
| Marquette Medical Systems has demonstrated that the Eagle | |
| 1000 (DASH 1000) Patient Monitor is as safe and effective, and | |
| performs substantially equivalent to the predicate device. |
Klaus Rudolf /des Jan. 97
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dianne Schmitz Marquette Medical Systems 8200 West Tower Avenue Milwaukee, Wisconsin 53223
K970545 Re :
Eagle 1000 (DASH 1000) Series Patient Monitor with Model numbers: Eagle Model 1001 (Software Version 1.0); Eagle Model 1002 (Software Version 1.0); Eagle Model 1003 (Software Version 1.0); Eagle Model 1004 (Software Version 1.0); Eagle Model 1005 (Software Version 1.0); Eagle Model 1006 (Software Version 1.0); Eagle Model 1007 (Software Version 1.0); Eagle Model 1008 (Software Version 1.0); Eaqle Model 1009 (Software Version 1.0); Eaqle Model 1010 (Software Version 2.0); Eagle Model 1011 (Software Version 2.0); Eagle Model 1014 (Software Version 2.0); and Eagle Model 1015 (Software Version 2.0) Requlatory Class: III (three) Product Code: 74 DSI Dated: February 11, 1997 Received: February 12, 1997
Dear Ms. Schmitz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 2 -
3
Page 2 - Ms. Dianne Schmitz
inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any -obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Unknown; 510(k) fi'ed February 11, 1997
Device Name: Eagle 1000 (DASH_1000) Patient Monitor
Indications For Use:
MAY - 1997
The Marquette Eagle 1000 (DASH 1000) Patient Monitor is a patient monitor 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, and temperature.
Optionally, the printing of information by a paper recorder may be added to the ..... basic monitor configuration.
Use of this device is intended for patient populations including: adult, pediatric, and/or neonatal.
| EAGLE 1002
| (101 123 02) | Battery | ECG | |||||
|---|---|---|---|---|---|---|---|
| EAGLE 1003 | |||||||
| (101 124 02) | Battery | ECG | Recorder | ||||
| EAGLE 1004 | |||||||
| (101 123 03) | Battery | ECG | SpO₂ | ||||
| EAGLE 1005 | |||||||
| (101 124 03) | Battery | ECG | SpO₂ | Recorder | |||
| EAGLE 1006 | |||||||
| (101 123 04) | Battery | ECG | NBP | ||||
| EAGLE 1007 | |||||||
| (101 124 04) | Battery | ECG | NBP | Recorder | |||
| EAGLE 1008 | |||||||
| (101 123 05) | Battery | ECG | SpO₂ | NBP | |||
| EAGLE 1009 | |||||||
| (101 124 05) | Battery | ECG | SpO₂ | NBP | Recorder | ||
| EAGLE 1010 | |||||||
| (101 123 06) | Battery | ECG | SpO₂ | NBP | TEMP | ||
| EAGLE 1011 | |||||||
| (101 124 06) | Battery | ECG | SpO₂ | NBP | TEMP | Recorder | |
| EAGLE 1014 | |||||||
| (101 123 07) | Battery | ECG | SpO₂ | NBP | TEMP | 2 x IBP | |
| EAGLE 1015 | Battery | ECG | SpO₂ | NBP | TEMP | 2 x IBP | Recorder |
mim size Rhad Press
Software Version 1.0 for Engle Models 1002, 1003, 1004, 1005, 1006, 1007, 1008, HOUP
Softiivne Version 2.0 for Eagle Models 1010, 1014, 1011, +1015
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON AN,OTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K970545 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)