(24 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 text is a 510(k) summary for the GE Medical Systems Information Technologies Solar 9500 Information Monitor. It describes the device, its intended use, and states that its safety and effectiveness are based on demonstrating substantial equivalence to predicate devices and compliance with voluntary standards.
However, the document does not contain specific acceptance criteria, numerical performance metrics, or details of a study that directly proves the device meets such criteria. Instead, it relies on the concept of "substantial equivalence" to predicate devices and adherence to general quality assurance measures and safety/environmental testing.
Therefore, most of the requested information cannot be extracted from this document as it does not detail a specific performance study with quantitative results, ground truth establishment, or sample sizes for testing or training sets.
Here's what can be extracted based on the provided text, with clear indications where information is not available:
Acceptance Criteria and Study Details for Solar 9500 Information Monitor
| Information Category | Details from Document (if available) |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Not explicitly stated as numerical acceptance criteria for a new performance test. 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 implies that the 'acceptance criteria' were met by demonstrating substantial equivalence to predicate devices and compliance with voluntary standards. No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the Solar 9500 itself for each physiological parameter. |
| 2. Sample size and data provenance (test set) | Not available. The document does not describe a specific clinical performance test with a defined test set sample size or data provenance. The assessment relies on substantial equivalence and general safety/performance testing. |
| 3. Number of experts and qualifications (ground truth for test set) | Not applicable/available. No specific expert-adjudicated ground truth for a test set is described. The device's performance is assumed to be equivalent to predicate devices which would have undergone their own validation. |
| 4. Adjudication method (test set) | Not applicable. No specific adjudication method is described for a test set. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study | No, not described. The document does not mention an MRMC study or any comparison of human readers with/without AI assistance. The device is a patient monitor, not an AI diagnostic tool for image interpretation. |
| 6. Standalone (algorithm only without human-in-the-loop) performance study | Not explicitly described as a standalone performance study with quantitative metrics. The document states "Software and hardware testing" and "Safety testing" were done, which would involve the device operating in a standalone capacity, but no detailed performance results are provided. The device's function is to display physiological data, not provide an automated diagnosis. |
| 7. Type of ground truth used | Not applicable/available. The document does not refer to a specific "ground truth" as would be used in a diagnostic algorithm performance study (e.g., pathology, outcomes data). The device measures and displays physiological parameters, whose accuracy would be validated against established medical reference standards or predicate devices. |
| 8. Sample size for the training set | Not applicable/available. This device is a patient monitor, not a machine learning model that undergoes a "training set" in the common sense of AI development. |
| 9. How ground truth for the training set was established | Not applicable/available. (See point 8). |
Summary of Study Described:
The document describes the "Solar 9500 Information Monitor," a patient monitoring system. The overarching "study" or assessment demonstrating its safety and effectiveness is primarily based on substantial equivalence to legally marketed predicate devices. This means that the device's technological characteristics, intended use, and performance are considered equivalent to devices already approved by the FDA (specifically, the Solar 9500 Information Monitor, K030575, is listed as a predicate device, although this seems to be a typo and likely refers to its own 510(k) rather than a separate predicate device).
The document states that the Solar 9500 "employs the same functional technology as the predicate devices." In addition, the device underwent various quality assurance measures during its development:
- Requirements specification review
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation
The conclusion drawn from these activities is that the Solar 9500 "is as safe, as effective, and performs as well as the predicate devices." This avoids the need for a de novo clinical trial with specific performance metrics and dedicated ground truth establishment for each measurable parameter, as the equivalence to already-approved devices serves as the basis for clearance.
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JAN 1 5 2004
510(k) Summary of Safety and Effectiveness
| Date: | December 19, 2003 | |
|---|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA | |
| Contact Person: | Andrew KluessendorfRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: 414-362-3063Fax: 414-362-2585 | |
| Device: | Trade Name: Solar 9500 Information Monitor | |
| 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 |
- 21 CFR 870.2700 Oximeter, Pulse
K030575 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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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 Solar® 9500 Information Monitoring System is intended for use Intended 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.
- The Solar 9500 complies with the voluntary standards as detailed in Test Summary: The following quality assurance Section 9 of this submission. measures were applied to the development of the system:
- 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 Conclusion: is as safe, as effective, and performs as well as the predicate devices.
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare.
JAN 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Mr. Andrew Kluessendorf Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K033964
Trade Name: Solar 9500 Information Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: MHX Dated: December 19, 2003 Received: December 22, 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.
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Page 2 – Mr. Andrew Kluessendorf
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any I edetar who a c'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 CI K Fart 677, Mooning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product for 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 premance notinetation on "ce 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,
CTeffert Mape
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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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510(k) Number (if known):
510(k) filed on December 19, 2003
Solar 9500 Information Monitor Device Name:
Indications For Use:
The Solar® 9500 Information Monitoring System is intended for use under the direct supervision The Solar® 9500 Information wontoring oystem is the system is to monitor physiologic
of a licensed healthcare practitioner. The intended use of the system is one qualing one of a licensed healthcare practitioner. The intents, in high scality as the operating parameter data on addit, pediathe and fleonatar putical intensive care, respiratory
room (OR), post anesthesia recovery (PARR), critical care, surginalise asse, or popparty room (OR), post anesthesia recovery (r ART), childa bare, barger minsive care, or neonatal
intensive care, coronary care, medical intensive care, pediatio intensive blood, pr Unary care, medioal includes electrocardiogram, invasive blood pressure, intensive care. Intensive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximenty, nonlivasive blood pressure, pulse, temperature, carelas ourpen 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 Solars 9500 finomation wonkomy Oystem is also interest to provinced in province in 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)
RH, Office of Device Evaluation (ODE)
Cmmyr to DDz
(Division Sign-Off)
(Division Sign Off)
Division of Cardiovascular Devices
510(k) Number K033964
Prescription Use_X (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.