(219 days)
No
The document describes a standard patient monitoring system that displays physiological data and waveforms. There is no mention of AI or ML algorithms for data analysis, interpretation, or prediction. The functions described are typical of traditional patient monitors.
No.
The "Marquette Solar 9000 Anesthesia Information Monitor" is a patient monitoring system designed to display physiological data and does not provide therapy or treatment.
Yes.
The device is a patient monitoring system that displays physiological data (ECG, heart rate, blood pressure, respiratory rate, pulse oximetry, temperature, etc.) which is used by medical professionals for assessing a patient's condition. While it doesn't provide a definitive diagnosis on its own, the data it presents is critical for diagnostic purposes.
No
The device description explicitly states it is a "patient monitoring system" that receives data from "data acquisition modules" and displays it on a "color display device." This indicates the presence of hardware components beyond just software.
Based on the provided text, this device 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 Marquette Solar 9000 Anesthesia Information Monitor is a patient monitoring system that displays physiological data acquired directly from the patient (e.g., ECG, pressure, respiratory rate, temperature, pulse oximetry). It does not analyze samples taken from the patient.
- Intended Use: The intended use describes monitoring patients in various clinical settings, not performing laboratory tests on patient samples.
Therefore, the device falls under the category of a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Use of the Marquette Solar 9000 Anestheaia Information Monitor is intended for operating room (OR), post ansethesia 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.
Product codes
73CCK, 73CBQ, 73CBS, 73CCI, 73CBR, 73CCL, 73BZQ, 74DSI, 74CAA, 74BXD, 74KFN, 80BWX, 74DRT, 74BWS
Device Description
The Marquette Solar 9000 Anesthesia Information Monitor is a patient monitoring system that is designed to display patient physiciosical data that is received from the Marquette Electronic's Tram-Net (Unity) network, Tram individual and multi-parameter data acquisition modules (K900540). and other compatible modules, as referenced within the Premarket Notification Submission.
The data and information these modules acquire includes. but is not limited to: Electrocardlingraphy (ECG) information. QRS and antivitymia detection. heart rate calculation, ST-segment analysis, cardiac output, wedge determination, and systolic, diastolic, and mean pressure measurements. Additional data and information that these modules acquire includes: respiratory rate detection and computation, detection of a no breath (or apneic) period. respiratory and ansethesia gas perameters, ventilation perameters, pulse oximetry values, piethysmograph values, and temperature measurements. The Solar 9000 Anesthesia Information Monitor is designed to display ECG and pressure and respiratory waveforms generated from the network and the various acquisition modules.
The operator uses the system to interact with the scauired data via a color display device. This interaction includes: selecting which waveforms or parameters are displayed, display and review of trended data, silencing alarms, adjusting parameter alarm levels, or printing selected data.
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
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)
Not Found
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.
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.
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 Effectiveness
- Manufacturer/ Submitter 1.
Marquette Electronics, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 U.S.A.
Establishment Registration Number: 2124823
Contact Nama/ Telephone Number:
Dianne Schmitz Corporate Regulatory Affairs Marquette Electronics, Inc.
Phone: (414) 382-3230
Date: October 17, 1995
General Device Information 2.
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 Solar 9000 Anesthesia Information Monitor.
Classification Name(s)
The Marquette Solar 9000 Anesthesia Information Monitor's classification names, classification panels, and regulation citations include:
| * 21 CFR 868.1400 Analyzer, Gas, Carbon- Dioxide, Gaseous-Phase | 73CCK |
|---|---|
| * 21 CFR 868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Conc.) | 73CBQ |
| * 21 CFR 868.1620 Analyzer, Gas, Halothane, Gaseous-Phase, (Anesthetic Conc.) | 73CBS |
| * 21 CFR 868.1690 Analyzer, Gas, Nitrogen Gaseous-Phase | 73CCI |
| * 21 CFR 868.1700 Analyzer, Gas, Nitrous- Oxide, Gaseous-Phase, (Anesthetic Conc.) | 73CBR |
| * 21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase | 73CCL |
| * 21 CFR 868.2375 Monitor, Breathing Frequency | 73BZQ |
| * 21 CFR 870.1025 Detector and Alarm, Arrhythmia | 74DSI |
| * 21 CFR 870.1100 Monitor, Blood Pressure, Indwelling | 74CAA |
| * 21 CFR 870.1130 Monitor, Blood Pressure, Non-Indwelling | 74BXD |
bor
1
| * 21 CFR 870.1435 Cardiac Output, Thermal
| (Balloon Type Catheter) | 74KFN |
|---|---|
| * 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, except the "Detector and Alarm, Arrhythmia" parameter, have been determined to be Class II devices according to the Anesthesiology and/ or Cardlovascular Device Classification Panels. The "Detector and Alarm, Arrhythmia" parameter is a Class III parameter. Because the Marquette Solar 9000 Anesthesia Information Monitor may acquire and display data from a module that may include this Class !!! parameter, it is belleved that FDA may classify the system as 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.
Legally Marketed Predicate Device s
The Marquette Solar 9000 Anesthesia Information Monitor is substantially equivalent, with similar indications for use to the following devices which are currently legally marketed and in commercial distribution:
· K900598 Tramscope Svstem
4. Device Description
The Marquette Solar 9000 Anesthesia Information Monitor is a patient monitoring system that is designed to display patient physiciosical data that is received from the Marquette Electronic's Tram-Net (Unity) network, Tram individual and multi-parameter data acquisition modules (K900540). and other compatible modules, as referenced within the Premarket Notification Submission.
The data and information these modules acquire includes. but is not limited to: Electrocardlingraphy (ECG) information. QRS and antivitymia detection. heart rate calculation, ST-segment analysis, cardiac output, wedge determination, and systolic, diastolic, and mean pressure measurements. Additional data and information that these modules acquire includes: respiratory rate detection and computation, detection of a no breath (or apneic) period. respiratory and ansethesia gas perameters, ventilation perameters, pulse oximetry values, piethysmograph values, and temperature measurements. The Solar 9000 Anesthesia Information Monitor is designed to display ECG and pressure and respiratory waveforms generated from the network and the various acquisition modules.
The operator uses the system to interact with the scauired data via a color display device. This interaction includes: selecting which waveforms or parameters are displayed, display and review of trended data, silencing alarms, adjusting parameter alarm levels, or printing selected data.
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603
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Intended Use 6.
Use of the Marquette Solar 9000 Anesthesia Information Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal.
Use of the Marquette Solar 9000 Anesthesia Information 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 personnel.
Use of the Marquette Solar 9000 Anestheaia Information Monitor is intended for operating room (OR), post ansethesia 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.
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