SOLAR 7/8000

K993757 · General Electric Medical Systems Information Techn · DSI · Mar 23, 2000 · Cardiovascular

Device Facts

• Record ID: K993757
• Device Name: SOLAR 7/8000
• Applicant: General Electric Medical Systems Information Techn
• Product Code: DSI · Cardiovascular
• Decision Date: Mar 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Solar 7/8000 System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. Physiologic parameter data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, end tidal CO2, pulse oximetry, venous O2 saturation, Transcutaneous O2 and/or CO2, respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations. O2 and/or 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 7/8000 System is also intended to provide physiologic data over the UNITY™ network. The Solar 7/8000 System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

Device Story

Modular patient monitoring system comprising processing unit, display, TRAM-rac housing, and acquisition modules. Inputs include physiologic signals (ECG, BP, pulse, temp, cardiac output, respiration, CO2, SpO2, venous O2, transcutaneous gases, anesthetic agents). System processes, displays, trends, and stores data; supports network connectivity via UNITY network and TRAM-Net. Used in hospitals/clinical facilities by healthcare practitioners. Output provides real-time physiologic data to clinicians for patient assessment and decision-making. Interfaces with third-party peripheral devices via serial/analog outputs. Benefits include continuous patient surveillance and centralized data management.

Clinical Evidence

Clinical use validation was performed as part of the quality assurance measures. No specific clinical study metrics (e.g., sensitivity, specificity, AUC) are provided in the summary; the device's safety and effectiveness were established through a combination of bench testing, software/hardware verification, and clinical validation.

Technological Characteristics

Modular patient monitor; includes processing unit, display, TRAM-rac housing, and acquisition modules. Supports network connectivity (UNITY network, TRAM-Net). Interfaces with third-party devices via serial/analog outputs. Software-based monitoring system. No specific materials or ASTM standards cited.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospital or clinical settings requiring monitoring of physiologic parameters including ECG, blood pressure (invasive/noninvasive), pulse, temperature, cardiac output, respiration, CO2, pulse oximetry, venous O2 saturation, transcutaneous gases, respiratory mechanics, and anesthetic agents.

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

• Marquette Tramscope System (K900598)
• Marquette SL Series Transport Remote Acquisition Module (K921669)

Reference Devices

• central station (K901072)

Submission Summary (Full Text)

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MAR 2 3 2000

# Section 2 Summary and Certification

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 1, 1999 |
| Submitter: | GE Marquette Medical Systems<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Karen Webb<br>Sr. Regulatory Affairs Specialist<br>GE Marquette Medical Systems<br>Phone: [phone]<br>Fax: [phone] |
| Device: | Trade Name: Solar 7/8000 System |
| Common/Usual Name: | Patient monitor |
| Classification Names: | |

21 CFR 868.1400 Analyzer, Gas, Carbon Dioxide, Gaseous-Phase

21 CFR 868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Conc.)

21 CFR 868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

21 CFR 868.1690 Analyzer, Gas, Nitrogen, Gaseous-Phase (Anesthetic Conc.)

21 CFR 868.1700 Analyzer, Gas, Nitrous Oxide, Gaseous-Phase, (Anesthetic Conc.)

21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase

- 21 CFR 868.2375 Breathing Frequency Monitor
- 21 CFR 870.1025 Detector and Alarm, Arrhythmia
- 21 CFR 870.1100 Monitor, Blood Pressure, Indwelling
- 21 CFR 870.1130 Noninvasive Blood Pressure Measurement System
- 21 CFR 870.1100 Blood Pressure Alarm
- 21 CFR 870.1425 Programmable Diagnostic Computer

21 CFR 870.2340 Electrocardiograph

- 21 CFR 870.1435 Monitor, Cardiac Output, Thermal (Balloon Type Catheter)
- 21 CFR 880.2910 Monitor, Temperature (with probe)
- 21 CFR 870.2300 Monitor, Cardiac (Incl. cardiotachometer & rate alarm)
- 21 CFR 870.2700 Oximeter, Pulse

## Predicate Devices:

K900598 Marquette Tramscope System

K921669 Marquette SL Series Transport Remote Acquisition Module

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Device Description: The Solar 8000 System includes four basic components:

- Solar 8000 processing unit .
- . a display (monochrome or color)
- TRAM-rac housing .
- acquisition module(s) .

The Solar 7000 System includes three basic components:

- Solar 7000 monitor (integrated display and . processing unit) (monochrome or color)
- TRAM-rac housing
- . . acquisition module(s)

Optional Solar 7/8000 components include:

- central station (K901072) .
- . remote display
- . remote control
- writer (Direct Digital Writer/ PRN 50 Thermal . Recorder / Laser Printer)
- . TRAM-Net hub
- TRAM-Net interface adapter(s) .
- SolarView Remote Display Controller .
- Octanet connectivity device .
- . Trend Memory Storage System

#### Intended Use:

The Solar 7/8000 System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained The intended use of the system is to monitor in its proper use. physiologic parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care.

Physiologic parameter data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, end tidal CO2, pulse oximetry, venous O2 saturation, Transcutaneous O2 and/or CO2, respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations. O2 and/or 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 7/8000 System is also intended to provide physiologic data over the UNITY™ network.

The Solar 7/8000 System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

Technology:

The Solar 7/8000 employs the same functional technology as its predicate devices.

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## Test Summary:

The Solar 7/8000 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 Solar 7/8000:

- Requirements specification review .
- . Code inspections
- Software and hardware testing .
- . Safety testing
- Environmental testing .
- Clinical use validation .
- Final validation .

### Conclusion:

The results of these measurements demonstrated that the Solar 7/8000 is as safe, as effective, and perform as well as the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2000

Ms. Karen Webb Sr. Regulatory Affairs Specialist GE Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223

Re: K993757 Trade Name: Solar 7/8000 System Regulatory Class: III Product Code: 74 DSI Dated: February 1, 2000 Received: February 2, 2000

Dear Ms. Webb:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Ms. Karen Webb

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Megas Magneka

Image /page/4/Picture/7 description: The image contains a handwritten word that appears to be "far". The word is written in a cursive style with the letters connected. Below the word, there are two horizontal lines, which could be interpreted as an underline or a simple design element.

James E. Dillard III Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Unknown; 510(k) filed on November 1, 1999 510(k) Number (if known):

Solar 7/8000 System Device Name:

Indications for Use:

The Solar 7/8000 System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care.

Physiologic parameter data includes: electrocardiogram, invasive blood pressure. noninyasive blood pressure, pulse, temperature, cardiac output, respiration, end tidal CO2 pulse oximetry, venous O2 saturation, Transcutaneous O2 and/or CO2, respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations. O2 and/or 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 7/8000 System is also intended to provide physiologic data over the UNITY™ network.

The Solar 7/8000 System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

| | for Jim Dillard |
|---------------------|-----------------|
| (Division Sign-Off) | |

| Division of Cardiovascular, Respiratory, and Neurological Devices | |
|-------------------------------------------------------------------|---------|
| 510(k) Number | K993757 |

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)