SOLAR 8000M SYSTEM

K012467 · General Electric Medical Systems Information Techn · DSI · Feb 11, 2002 · Cardiovascular

Device Facts

• Record ID: K012467
• Device Name: SOLAR 8000M SYSTEM
• Applicant: General Electric Medical Systems Information Techn
• Product Code: DSI · Cardiovascular
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Solar 8000M System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in the use of the equipment. The Solar 8000M is a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment. The Solar 8000M System is capable of monitoring electrocardiogram, non-invasive pressure, pulse, invasive blood pressure, blood temperature, cardiac output, respiration, pulse oximetry, venous O2 saturation, Transcutaneous O2 and CO2 respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O2 and CO2 concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices. The Solar 8000M System is also intended to provide physiologic data over the UNITY network. The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

Device Story

Multiparameter physiological patient monitor; processes inputs from ECG, blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous O2 saturation, transcutaneous O2/CO2, respiratory mechanics, anesthetic agents, impedance cardiography, EEG, and bispectral index. System includes processing unit, display, TRAM-rac housing, acquisition modules, and remote controls. Used in hospital/facility settings by trained clinicians. Provides real-time physiologic data display, trending, and storage; interfaces with third-party devices via serial/analog outputs; transmits data over UNITY network. Supports clinical decision-making by providing continuous patient status updates; enables monitoring of vital signs and specialized parameters to improve patient care and safety.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including unit-level module verification, system-level integration testing, performance testing, safety testing, environmental testing, and clinical use validation.

Technological Characteristics

Multiparameter physiological monitor; modular design with TRAM-rac housing and acquisition modules. Supports networked connectivity via UNITY network and serial/analog interfaces for third-party devices. Performs signal processing for various physiological parameters (ECG, pressure, gas, etc.).

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospital or facility environments for multiparameter physiological monitoring, including ECG, blood pressure (invasive/non-invasive), pulse, temperature, cardiac output, respiration, pulse oximetry, venous O2 saturation, transcutaneous O2/CO2, respiratory mechanics, anesthetic agents, impedance cardiography, EEG, and bispectral index.

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 7/8000 System (K993757)

Submission Summary (Full Text)

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FEB 1 1 2002

# Section 2 Summary and Certification

K012467

| | 510(k) Summary of Safety and Effectiveness |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | July 31, 2001 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Karen Webb<br>Sr. Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device: | |
| Trade Name: | Solar 8000M System |
| Common/Usual Name: | Physiological Patient Monitor |
| Classification Names: | Physiological Patient Monitor |
| Predicate Devices: | K993757 Solar 7/8000 System |
| Device Description: | The Solar 8000M System includes the following basic components:<br>Solar 8000M processing unit a display TRAM-rac housing acquisition module(s) keypad and/or remote control Additional, optional components include: Clinical Information Center (central station) Remote display digital writer or printer TRAM-Net interface adapter(s) Octanet connectivity device Remote Alarm Box |
| Intended Use: | The Solar 8000M System is intended for use under the direct<br>supervision of a licensed healthcare practitioner or by personnel trained<br>in the use of the equipment. The Solar 8000M is a multiparameter<br>physiological patient monitoring system intended for use on adult,<br>pediatric and neonatal patients, within a hospital or facility environment.<br>The Solar 8000M System is capable of monitoring electrocardiogram |

n, non-invasive pressure, pulse, invasive blood pressure, blood temperature, cardiac output, respiration, pulse oximetry, venous O2 saturation, Transcutaneous O2 and CO2 respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O2 and CO2 concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices.

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K012467

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The Solar 8000M System is also intended to provide physiologic data over the UNITY Tu network.

The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

### Technology:

The Solar 8000M System employs the same functional scientific technology as its predicate devices.

### Test Summary:

The Solar 8000M System and its host patient monitoring system comply 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 8000M System:

- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Final acceptance testing (Validation) .
- Performance testing .
- Safety testing .
- . Environmental testing
- Clinical use validation .

#### Conclusion:

The results of these measurements demonstrated that the Solar 8000M System are as safe, as effective, and perform as well as the predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Ms. Karen M. Webb Senior Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223

Re: K012467

> Trade Name: Solar 8000M System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: November 9, 2001 Received: November 13, 2001

Dear Ms. Webb:

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 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

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Page 2 - Ms. Karen M. Webb

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Aus. R. D. Zeller, M.D.

am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012467; 510(k) filed on July 31, 2001 510(k) Number (if known):

Solar 8000M System Device Name:

Indications for Use:

The Solar 8000M System is intended for use under the direct supervision of a licensed healthcare The Solar Books System is meet in the use of the equipment. The Solar 8000M is a practilioner of Dy personnel trained in their system intended for use on adult, pediatio and neonatal patients, within a hospital or facility environment.

The Solar 8000M System is capable of monitoring electrocardiogram, invasive blood pressure, The Schall blood pressure, pulse, temperature, cardiac output, respiration, pdlse oximetry, venous O2 saturation, Transcutaneous O2 and CO2 respiratory mechanics, and/or (for adult and/or pediatic patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O2 and CO2 concentrations are available for electroencephalography and the can be displayed, trended and stored in the monitor from a variety of peripheral devices.

The Solar 8000M System is also intended to provide physiologic data over the UNITY™ network.

The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

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# 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)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012467