MODIFICATION TO SOLAR 9500 INFORMATION MONITOR

K030575 · Ge Medical Systems Information Technologies · MHX · Mar 21, 2003 · Cardiovascular

Device Facts

• Record ID: K030575
• Device Name: MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

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 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.

Device Story

Solar 9500 is a patient monitoring system; displays physiological data from Tram-net network and data acquisition modules. Components: processing unit, color display, Tram modules, Tram-rac housing; optional remote display. Inputs: ECG, invasive/noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, CO2, O2, anesthetic gases, mixed venous O2 saturation. System interfaces with third-party peripherals via serial/analog outputs. Connectivity: Unity Ethernet LAN for clinical information/cardiology products; additional Ethernet for hospital Enterprise Network. Embedded web browser allows point-of-care access to patient history, lab results, and cath reports via hospital intranet. Used in high-acuity areas (OR, ICU, PARR) by clinicians. Output: real-time physiological data display, trending, storage, and printing. Benefits: centralized patient data management, improved clinical information access at point-of-care, and support for clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Quality assurance measures included requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation.

Technological Characteristics

System comprises processing unit, color display, Tram modules, and Tram-rac housing. Connectivity via Unity Ethernet LAN and Enterprise Network. Supports serial/analog data outputs from third-party peripherals. Embedded web browser for intranet access. Complies with voluntary standards for patient monitoring systems.

Indications for Use

Indicated for monitoring physiologic parameters in adult, pediatric, and neonatal patients in high-acuity clinical settings (OR, PARR, critical care, various ICUs) under licensed healthcare practitioner supervision.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Solar 9500 Information Monitor (K990068)

Submission Summary (Full Text)

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K030575
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## 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: [phone] Fax: [phone]

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
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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.

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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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 [phone]. 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 [phone] or [phone] 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