MODIFICATION TO DASH 3000/4000 PATIENT MONITOR

K030431 · Ge Medical Systems Information Technologies · MHX · Feb 26, 2003 · Cardiovascular

Device Facts

• Record ID: K030431
• Device Name: MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Dash 3000/4000 Patient Monitor 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, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000 Patient Monitor 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. The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

Device Story

Dash 3000/4000 Patient Monitor; bedside/portable/transport device. Inputs: ECG, invasive/non-invasive BP, pulse, temp, cardiac output, respiration, SpO2, CO2, O2, anesthetic agents. Processes signals for display, trending, storage, printing, and network transmission via Unity network. Used in hospitals, clinics, and transport (ground/air) by clinicians. Features include arrhythmia detection, ST analysis, 12SL interpretive ECG analysis, cardiac/pulmonary/dose calculations. Interfaces with third-party serial devices. Output allows real-time monitoring, clinical decision support, and data integration into hospital information systems. Benefits: continuous patient status awareness, improved clinical response, and centralized data access.

Clinical Evidence

Bench testing only. No clinical data presented. Compliance with voluntary standards and quality assurance measures (requirements review, code inspections, software/hardware/safety/environmental testing, final validation) used to demonstrate substantial equivalence.

Technological Characteristics

Bedside/portable/transport monitor. Parameters: ECG, BP, SpO2, temp, cardiac output, respiration, CO2, O2, anesthetic agents. Connectivity: Unity network interface, serial data output for third-party peripherals. Software: 12SL interpretive ECG analysis, arrhythmia detection, ST analysis, cardiac/pulmonary/dose calculations. Standards: Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for monitoring physiologic parameters (ECG, BP, pulse, temp, cardiac output, respiration, SpO2, CO2, O2, anesthetic agents) 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.

Submission Summary (Full Text)

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FEB 26 2003

## 510(k) Summary of Safety and Effectiveness

| Date: | February 7, 2003 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Karen M. Lunde<br>Sr. Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA<br>Phone: [phone]<br>Fax: [phone] |
| Device: | Trade Name: Dash 3000/4000 Patient Monitor |
| Common/Usual Name: | Physiological 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 |
| 21 CFR 870.1025 | Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) |
| 21 CFR 870.2770 | Plethysmograph, Impedance |

atient Monito Device Description: The Dash 3000/4000 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, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations. PA wedge. ST analysis, and interpretive 12 lead ECG analysis (12SL).

network available patient data.

Intended Use: The Dash 3000/4000 Patient Monitor 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

Additionally, the network interface allows for the display and transfer of

GE Medical Systems Information Technologies Confidential

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K030431
page 2 of 2

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. blood pressure, noninvasive blood pressure, pulse. invasive temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.

The Dash 3000/4000 Patient Monitor 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.

The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

Technology: The Dash 3000/4000 Patient Monitor employs the same functional technology as the predicate devices.

- Test Summary: The Dash 3000/4000 Patient Monitor 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 Dash 3000/4000 Patient Monitor is as safe, as effective, and performs as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Ms. Karen M. Lunde Sr. Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K030431

Trade Name: Dash 3000/4000 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: February 7. 2003 Received: February 10, 2003

Dear Ms. Lunde:

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. Iisting 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 - Ms. Karen M. Lunde

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 forth in the quality systems (OS) 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,

N. O'Dell Miller, M.D.

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 February 7, 2003

Dash 3000/4000 Patient Monitor Device Name:

Indications For Use:

The Dash 3000/4000 Patient Monitor 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, interhospital 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, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.

The Dash 3000/4000 Patient Monitor 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.

The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

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

Concurrence of CDRH/Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K05043/

Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use*_*_

(Optional Format 1-2-96)