(25 days)
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 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.
The Solar 9500 is a patient monitoring system that is designed to display patient physiological data that is received from the GE Medical Systems' Tram-net network and individual and multi-parameter 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 Medical System'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 capability 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-GE platforms via the Enterprise network.
The Solar 9500 system was developed to interface with third party peripheral devices that support serial and/or analog data outputs.
The provided 510(k) summary for the Solar 9500 Information Monitor does not contain information regarding specific acceptance criteria for performance benchmarks or a detailed study proving the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device based on similar technology and general compliance with voluntary standards and internal quality assurance measures.
Therefore, most of the requested information cannot be extracted directly from the provided text.
Here is a summary of what information is explicitly stated or can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics or specific performance thresholds. | The document states: "The results of these measurements demonstrated that the Solar 9500 is as safe, as effective, and performs as well as the predicate devices." This is a qualitative statement of performance relative to the predicate, rather than precise metrics. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The document mentions "Software and hardware testing," "Safety testing," and "Environmental testing" but does not detail the nature of these tests, including the data used.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The provided information does not describe any MRMC studies or a comparison of human reader performance with or without AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool in the sense of image analysis.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: The document describes "Software and hardware testing" and "Final validation," implying standalone testing of the device's functions. However, specific performance metrics for an "algorithm only" component (like a specific arrhythmia detection algorithm's sensitivity/specificity) are not provided. The device as a whole is tested, which inherently includes its algorithms.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified in detail. The testing mentioned ("Safety testing," "Environmental testing," "Software and hardware testing," "Final validation") typically involves comparing device outputs to known inputs or reference standards, but how the "ground truth" for specific physiological parameters or arrhythmia detection was established is not detailed. For a patient monitor, this would typically involve calibrated measurement devices or expert interpretation of physiological signals.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. The document describes a patient monitoring system, which typically uses established algorithms and signal processing techniques rather than a "training set" in the machine learning sense from a specific dataset. Device development involves engineering, testing against specifications, and validation, not necessarily a machine learning training phase on a large dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable/not specified, as there is no mention of a traditional machine learning "training set."
Summary of Device Rationale and Testing:
The 510(k) summary for the Solar 9500 Information Monitor relies on demonstrating substantial equivalence to a predicate device (K990068, also a Solar 9500 Information Monitor from GE Medical Systems).
The "Test Summary" section states that the device complies with voluntary standards (as detailed in Section 9, which is not provided here) and that the following quality assurance measures were applied:
- Requirements specification review
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation
The conclusion is that these measures "demonstrated that the Solar 9500 is as safe, as effective, and performs as well as the predicate devices." This indicates that the primary "study" proving performance is the comparison to the predicate device and adherence to internal quality assurance processes and relevant voluntary standards. There are no specific quantitative acceptance criteria or detailed performance studies presented in this summary document beyond this qualitative statement of equivalence.
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K030575
page 1 of 2
510(k) Summary of Safety and Effectiveness
February 21, 2003 Date:
GE Medical Systems Information Technologies Submitter: 8200 West Tower Avenue Milwaukee, WI 53223 USA
MAR 2 1 2003
Contact Person: Andrew Kluessendorf Requlatory Affairs Specialist GE Medical Systems Information Technologies Phone: 414-362-3063 Fax: 414-918-8114
Solar 9500 Information Monitor Trade Name: Device:
Common/Usual Name: Patient monitor
Classification Names:
| 21 CFR 870.1025 | Monitor, Physiological Patient (with Arrhythmia Detection or Alarms) | 74MHX |
|---|---|---|
| 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 (Anesthetic Conc.) | 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 | Breathing Frequency Monitor | 73FLS |
| 21 CFR 870.1025 | Detector and Alarm, Arrhythmia | 74DSI |
| 21 CFR 870.1100 | Monitor, Blood Pressure, Indwelling | 74CAA |
| 21 CFR 870.1130 | Noninvasive Blood Pressure Measurement System | 74BXD |
| 21 CFR 870.1100 | Blood Pressure Alarm | 74DSJ |
| 21 CFR 870.1425 | Programmable Diagnostic Computer | 74DQK |
| 21 CFR 870.2340 | Electrocardiograph | 74FYW |
| 21 CFR 870.1435 | Monitor, 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 | 74DQA |
K990068 Solar 9500 Information Monitor Predicate Device:
The Solar 9500 is a patient monitoring system that is designed to Device Description: display patient physiological data that is received from the GE Medical Systems' Tram-net network and individual and multi-parameter 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.
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K030575
page 2 of 2
The Solar 9500 utilizes the GE Medical System'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 capability 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-GE platforms via the Enterprise network.
The Solar 9500 system was developed to interface with third party peripheral devices that support serial and/or analog data outputs.
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. 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 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.
-
The Solar 9500 employs the same functional technology as the Technology: predicate devices.
Test Summary: 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 system: -
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 is as safe, as effective, and performs as well as the predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of a human figure. The figure is composed of three overlapping profiles facing to the right, creating a sense of depth and unity. The overall design is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2003
GE Medical Systems Information Technologies c/o Mr. Andrew Kluessendorf Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K030575
Trade Name: Solar 9500 Information Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: 74 MHX Dated: February 21, 2003 Received: February 24, 2003
Dear Mr. Kluessendorf:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Mr. Andrew Kluessendorf
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Deletuh
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
510(k) filed on February 20, 2003
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 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.
(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) X
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Olen Gortuh
510(k) Number K030575
§ 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.