SOLAR 9500 INFORMATION MONITOR

K033964 · Ge Medical Systems Information Technologies · MHX · Jan 15, 2004 · Cardiovascular

Device Facts

• Record ID: K033964
• Device Name: SOLAR 9500 INFORMATION MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Jan 15, 2004
• 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 modular patient monitoring system; processes physiological data from Tram-net network and multi-parameter acquisition modules; components include processing unit, color display, Tram modules, and Tram-rac housing. Used in high-acuity hospital areas (OR, ICU, etc.) by clinicians; provides real-time display, trending, storage, and printing of vital signs. Integrates with GE Unity Ethernet LAN for communication with clinical/cardiology products; includes embedded web browser for hospital intranet access (lab results, patient history, cath reports) at point-of-care. Supports third-party peripheral devices via serial/analog outputs. Enables clinicians to view patient status and clinical data to support bedside decision-making.

Clinical Evidence

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

Technological Characteristics

Modular patient monitor; processing unit, color display, Tram modules, Tram-rac housing. Connectivity: Unity Ethernet LAN, hospital Enterprise Network, serial/analog interfaces. Embedded web browser for intranet access. Complies with voluntary standards (Section 9 of submission).

Indications for Use

Indicated for adult, pediatric, and neonatal patients in high-acuity clinical settings (OR, PARR, critical care, surgical/respiratory/coronary/medical/pediatric/neonatal intensive care) requiring monitoring of physiologic parameters including ECG, blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, CO2, O2, anesthetic gases, and mixed venous oxygen saturation.

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 (K030575)

Submission Summary (Full Text)

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JAN 1 5 2004

## 510(k) Summary of Safety and Effectiveness

| Date: | December 19, 2003 | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA | |
| Contact Person: | Andrew Kluessendorf<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] | |
| 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 [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,

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:

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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.

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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__________________________________________________________________________________________________________________________________________________________

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