DASH 3000 PATIENT MONITOR

K992929 · General Electric Medical Systems Information Techn · MHX · Nov 26, 1999 · Cardiovascular

Device Facts

• Record ID: K992929
• Device Name: DASH 3000 PATIENT MONITOR
• Applicant: General Electric Medical Systems Information Techn
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Dash 3000 Patient 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. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care. This information can be displayed, trended, stored, and printed.

Device Story

Dash 3000 is a bedside, portable, and transport patient monitor. Inputs: ECG, invasive/noninvasive blood pressure, pulse oximetry, temperature, impedance respiration, and end-tidal CO2. Device processes signals to provide real-time display, trending, storage, and printing of physiologic data. Includes advanced analysis features: arrhythmia detection, ST analysis, cardiac/pulmonary calculations, and 12SL interpretive ECG analysis. Used by clinicians in hospitals, clinics, and transport vehicles (ground/air). Network interface allows data transfer to clinical information systems via Unity network. Output assists clinicians in patient assessment and clinical decision-making; provides continuous monitoring to improve patient safety in critical care and transport environments.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including requirements specification review, code inspections, software and hardware testing, safety testing, and environmental testing, followed by final validation.

Technological Characteristics

Bedside/portable patient monitor. Measures ECG, BP, SpO2, temp, cardiac output, respiration, CO2. Features include arrhythmia, ST analysis, and 12SL interpretive ECG. Connectivity via Unity network for data transfer. Software-based analysis for physiologic calculations and interpretive ECG. Sterilization not specified; intended for professional clinical environments.

Indications for Use

Indicated for monitoring physiologic parameter data (ECG, BP, pulse, temp, cardiac output, respiration, SpO2, CO2) in adult, pediatric, and neonatal patients under direct supervision of licensed healthcare practitioners in clinical and transport settings.

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

• Eagle 4000 Patient Monitor (K964750)
• Marquette SL Series Transport Remote Acquisition Module (K921669)

Submission Summary (Full Text)

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NOV 2 6 1999

K442929

## 510(k) Summary of Safety and Effectiveness

Date:

Submitter:

August 24, 1999

GE Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223 USA

Contact Person:

David Wahlig Sr. Regulatory Affairs Specialist GE Marquette Medical Systems Phone: [phone] Fax: [phone]

Device: Trade Name:

Dash 3000 patient Monitor Common/Usual Name:

Patient monitor

Classification Names:

21 CFR 868.1400 Analyzer, Gas, Carbon Dioxide, 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:

K964750 Eagle 4000 Patient Monitor

K921669 Marquette SL Series Transport Remote Acquisition Module

Device Description:

The Dash 3000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, noninvasive blood pressure, oxygen saturation, temperature, impedance respiration, and end-tidal carbon dioxide. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). Additionally, the network interface allows for the display and transfer of network available patient data. Intended Use:

The Dash 3000 Patient 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. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional

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medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response.

Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual.

The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.

This information can be displayed, trended, stored, and printed.

## Technology:

The Dash 3000 employs the same functional technology as the predicate devices.

## Test Summary:

The Dash 3000 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 Dash 3000:

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

## Conclusion:

The results of these measurements demonstrated that the Dash 3000 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

NOV 26 1999

Mr. David Wahliq Corporate Regulatory Affairs GE Marquette Medical Systems 8200 W. Tower Ave. Milwaukee, WI 53223

K992929 Re: Dash 3000 Patient Monitor Regulatory Class: III (three) Product Code: MHK August 24, 1999 Dated: Received: August 31, 1999

Dear Mr. Wahlig:

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, Drug, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. David Wahlig

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 t.oll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

A.H. Cordons L.

J. Celia M. Witten, Ph.D., M.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Unknown: 510(k) filed on August 24, 1999

Device Name: Dash 3000 Patient Monitor

Indications For Use:

The Dash 3000 Patient 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.

The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response.

Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL).

The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data 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)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

A.H.A. Lackland.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_K992929