(85 days)
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.
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. The signal-acquisition and -processing technologies and the basic parts of the device software were re-used from former devices.
The provided 510(k) summary for the Marquette Eagle 1000 Patient Monitor primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria for specific alarm detection or diagnostic functions. The device is a patient monitoring system, and the submission emphasizes its ability to monitor basic physiological parameters and raise alarms.
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria for each monitored parameter (like ECG accuracy, blood pressure accuracy, SpO2 accuracy, etc.) nor does it report specific device performance against such criteria. Instead, it makes a general statement:
General Statement on Performance:
"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."
Since no specific acceptance criteria or quantitative performance data are given, a table of acceptance criteria and reported device performance cannot be generated from the provided text.
Additional Requested Information:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for the test set or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. Given that this is a patient monitor for basic physiological parameters, ground truth would typically be established by validated reference devices, not human experts in the diagnostic sense (e.g., a highly accurate ECG machine as a reference for ECG, or an arterial line for invasive blood pressure).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not provided. Adjudication methods are typically used when subjective interpretations are involved, which is not the primary function of a physiological monitor measuring objective parameters.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting images or complex data in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a standalone device in the sense that it collects and displays physiological data. Its performance would inherently be "standalone" in that it performs its functions without direct human intervention in the signal processing. However, the document does not detail specific "algorithm only" performance metrics separate from the integrated device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. For a physiological monitor, ground truth is typically established by validated reference devices known for their high accuracy in measuring the specific physiological parameter (e.g., a highly accurate reference thermometer for temperature, an arterial line for invasive blood pressure, or a gold-standard oximeter for SpO2).
8. The sample size for the training set
The document does not mention a "training set" as this device predates the common application of machine learning with distinct training and test sets in medical device submissions. The device is described as "microprocessor-based, software-driven" and that "signal-acquisition and -processing technologies and the basic parts of the device software were re-used from former devices." This implies that the design and performance were likely based on established engineering principles and validation against known physiological signals, rather than iterative machine learning training.
9. How the ground truth for the training set was established
Not applicable, as a distinct "training set" in the modern machine learning sense is not indicated. The software and signal processing were re-used from former devices, suggesting that their development and validation would have followed standard engineering practices for medical devices at the time, likely involving comparisons to established reference measurements.
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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 Systems8200 West Tower AvenueMilwaukee, 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 monitoringsystem that is designed to be used to monitor a patient's basicphysiological parameters including: electrocardiography (ECG),invasive blood pressure, non-invasive blood pressure, oxygensaturation, and temperature. |
| Intended Use: | The Marquette Eagle 1000 Patient Monitor is designed to monitorand display patient data. Its design allows the operator to adjustparameter alarm settings that would audibly and visually notifythe operator when a violation occurs. The option is provided forprinting of information by a paper recorder. |
| Use of the Marquette Eagle 1000 Patient Monitor is intended forpatient populations including: adult, pediatric, and/ or neonatal. | |
| Use of the Marquette Eagle 1000 Patient Monitor is notrecommended for use in patient's home or residence, duringpatient transport outside the hospital, or when it has not beenordered by a physician or other qualified medical personnel. | |
| Use of the Marquette Eagle 1000 Patient Monitor is intended foroperating room (OR), post anesthesia recovery, critical care andintensive care. These departments are typically located inhospitals or may be located in outpatient clinics or free standingsurgical centers. It is intended for use by physicians, physicianassistants, registered nurses, certified registered nurseanesthetists, or other hospital personnel trained in the use of theequipment. | |
| Conclusions: | The Eagle 1000 Patient Monitor is a microprocessor-based,software-driven device. The signal-acquisition and -processingtechnologies and the basic parts of the device software were re-used from former devices. |
| Testing was performed on the Eagle 1000 Patient Monitor and itspredicate devices. Precision, accuracy, as well as safety testingwas performed. Test results indicate that the Eagle 1000 PatientMonitor provides an equivalent level or better in performance,when compared to the legally marketed predicate device(s) whentested to the accuracy requirements as specified in the contentsof 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 Eagle1000 (DASH 1000) Patient Monitor is as safe and effective, andperforms substantially equivalent to the predicate device. |
Klaus Rudolf /des Jan. 97
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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 -
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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
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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)
§ 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.