(187 days)
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No
The document describes a standard patient monitoring system that displays physiological data and provides network connectivity. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
Explanation: The device is described as an "Information Monitoring System" intended to "monitor physiologic parameter data" and "display patient physiological data." It does not mention delivering any therapy or treatment, only collecting and displaying patient information.
No
Explanation: The device is described as an "Information Monitoring System" designed to "monitor physiologic parameter data." It displays patient physiological data and provides this data to clinical information systems. Monitoring parameters and displaying data are functions of patient monitoring, not diagnostic assessment for a specific condition.
No
The device description explicitly states that the system is comprised of four basic components: the processing unit, color display, Tram modules(s), and Tram-rac housing, which are hardware components.
Based on the provided information, the Solar® 9500 Information Monitoring System 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 Solar® 9500 monitors physiologic parameters directly from the patient (ECG, blood pressure, temperature, etc.).
- The description focuses on monitoring and displaying real-time physiological data from the patient. There is no mention of analyzing samples or specimens.
- The intended use and device description clearly state it's a patient monitoring system.
Therefore, the Solar® 9500 falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Solar® 9500 Information Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The Intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. Physiologic data includes electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, anesthetic gas concentrations and mixed venous oxygen saturation, as summarized in the Solar® 9500 Operator's Manual. The monitoring parameters are contained in Appendix B under Technical Specifications.
The Solar® 9500 Information Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital INTRAnet data via a Web Browser at the point-of-care.
Product codes
74 MHX
Device Description
The Solar 9500 is a patient monitoring system that is designed to display patient physiological data that is received from the GE Marquette Medical Systems' Tram-net network and individual and multiparameter data acquisition modules.
The Solar 9500 Information Monitoring System is comprised of four basic components: the processing unit, color display, Tram modules(s), and Tram-rac housing. Optional components include a remote display.
The Solar 9500 utilizes the GE Marquette's Unity Ethernet LAN allowing communication with monitoring, clinical information and cardiology products. An additional Ethernet connection is provided for connection to the hospital Enterprise Network. The Enterprise network connection allows the user access to the hospital INTRAnet, through an embedded Web Browser on the Solar 9500. This web browsing capabliity enables the user to log on to the hospital INTRAnet directly from the monitor allowing access to information such as patient history, up-to-the-minute lab results and cath reports. Data can also be accessed from non-Marquette platforms via the Enterprise network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult, pediatric and neonatal patients
Intended User / Care Setting
under the direct supervision of a licensed healthcare practitioner.
high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Solar 9500 complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Solar 9500:
- Requirements specification review
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation
The results of these measurements demonstrated that the Solar 9500 is as safe, as effective, and performs as well as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '9900', and then the Greek letter 'varphi', and ends with the number '8'. The characters are handwritten and have a slightly irregular appearance.
510(k) Summary of Safety and Effectiveness
Date:
January 7, 1999
GE Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223 USA
Contact Person:
Submitter:
Karen Webb Requiatory Affairs Specialist GE Marquette Medical Systems Phone: (414) 362-3329 Fax: (414) 355-3790
Trade Name: Device:
Solar 9500 Information Monitor
Common/Usual Name:
Patient monitor
Classification Names:
21 CFR 868.1400 Analyzer, Gas, Carbon Dioxide, Gaseous-Phase
21 CFR 868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Conc.) 21 CFR 868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
21 CFR 868.1690 Analyzer, Gas, Nitrogen, Gaseous-Phase (Anesthetic Conc.)
21 CFR 868.1700 Analyzer, Gas, Nitrous Oxide, Gaseous-Phase, (Anesthetic Conc.)
21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase
21 CFR 868.2375 Breathing Frequency Monitor
21 CFR 870.1025 Detector and Alarm, Arrhythmia
21 CFR 870.1100 Monitor, Blood Pressure, Indwelling
21 CFR 870.1130 Noninvasive Blood Pressure Measurement System
21 CFR 870.1100 Blood Pressure Alarm
21 CFR 870.1425 Programmable Diagnostic Computer
21 CFR 870.2340 Electrocardiograph
21 CFR 870.1435 Monitor, Cardiac Output, Thermal (Balloon Type Catheter)
21 CFR 880.2910 Monitor, Temperature (with probe)
21 CFR 870.2300 Monitor, Cardiac (Incl. cardiotachometer & rate alarm)
- 21 CFR 870.2700 Oximeter, Pulse
Predicate Devices:
K954852 Solar 9000 Anesthesia Information Monitor
K921669 Marquette SL Series Transport Remote Acquisition Module
1
Device Description:
The Solar 9500 is a patient monitoring system that is designed to display patient physiological data that is received from the GE Marquette Medical Systems' Tram-net network and individual and multiparameter data acquisition modules.
The Solar 9500 Information Monitoring System is comprised of four basic components: the processing unit, color display, Tram modules(s), and Tram-rac housing. Optional components include a remote display.
The Solar 9500 utilizes the GE Marquette's Unity Ethernet LAN allowing communication with monitoring, clinical information and cardiology products. An additional Ethernet connection is provided for connection to the hospital Enterprise Network. The Enterprise network connection allows the user access to the hospital INTRAnet, through an embedded Web Browser on the Solar 9500. This web browsing capabliity enables the user to log on to the hospital INTRAnet directly from the monitor allowing access to information such as patient history, up-to-the-minute lab results and cath reports. Data can also be accessed from non-Marquette platforms via the Enterprise network.
Intended Use:
The Solar 9500 Information Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive Physiologic data includes electrocardiogram, invasive blood care, care, pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, anesthetic gas concentrations and mixed venous oxygen saturation, as summarized in the Solar 9500 Operator's Manual. The monitoring parameters are contained in Appendix B under Technical Specifications.
The Solar 9500 Information Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital INTRAnet data via a Web Browser at the point-of-care.
This information can be displayed, trended, stored, and printed.
Technology:
The Solar 9500 employs the same functional technology as the predicate devices.
2
Test Summary:
The Solar 9500 complies with the voluntary standards as detailed in The following quality assurance Section 9 of this submission. measures were applied to the development of the Solar 9500:
- Requirements specification review �
- Code inspections .
- Software and hardware testing .
- Safety testing .
- Environmental testing .
- Final validation .
Conclusion:
The results of these measurements demonstrated that the Solar 9500 ls as safe, as effective, and performs as well as the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird, with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 1999
Ms. Karen Webb GE Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223
K990068 Re: Solar 9500 Information Monitor Regulatory Class: III (three) Product Code: 74 MHX Dated: January 7, 1999 Received: January 8, 1999
Dear Ms. Webb:
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 leqally marketed predicate 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. 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.
4
Page 2 - Ms. Karen Webb
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if Known): Unknown; 510(k) filed on January 7, 1999
Solar® 9500 Information Monitor Device Name:
Indications For Use:
The Solar@ 9500 Information Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The Intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal Physiologic data includes electrocardiogram, invasive blood pressure, intensive care. noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, anesthetic gas concentrations and mixed venous oxygen saturation, as summarized in the Solar® 9500 Operator's Manual. The monitoring parameters are contained in Appendix B under Technical Specifications.
The Solar® 9500 Information Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital INTRAnet data via a Web Browser at the point-of-care.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Daula Tiller