MODIFICATION TO DASH 3000/4000 PATIENT MONITOR

K033304 · Ge Medical Systems Information Technologies · MHX · Nov 12, 2003 · Cardiovascular

Device Facts

• Record ID: K033304
• Device Name: MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 12, 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, 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, noninyasive 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

Bedside/portable/transport patient monitor; inputs include ECG, invasive/non-invasive blood pressure, pulse, temperature, cardiac output, respiration, SpO2, CO2, O2, and anesthetic agents. Device processes physiological signals to provide real-time display, trending, storage, and printing of data. Features include arrhythmia detection, ST analysis, and 12SL interpretive ECG analysis. Used by clinicians in hospitals, clinics, and transport vehicles (ground/air). Integrates with Unity network for data transfer to clinical information systems and interfaces with third-party serial devices. Output assists clinicians in patient assessment and decision-making at point-of-care.

Clinical Evidence

Bench testing only. Compliance with voluntary standards and quality assurance measures (requirements review, code inspections, software/hardware testing, safety/environmental testing, final validation) demonstrated safety and effectiveness equivalent to predicate.

Technological Characteristics

Physiological patient monitor; bedside/portable form factor. Connectivity via Unity network and serial interfaces for third-party devices. Software-based analysis for arrhythmia, ST, and 12SL ECG interpretation. Powered by AC/battery for transport. Sterilization not applicable (external monitoring).

Indications for Use

Indicated for monitoring physiologic parameter data 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

• Dash 3000/4000 Patient Monitor (K030431)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| Date: | October 9, 2003 | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA | |
| Contact Person: | Melissa Robinson<br>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:<br>Trade Name: | Dash 3000/4000 Patient Monitor | |
| Common/Usual Name: | Physiological Patient Monitor | |
| Classification Names:<br>21 CFR 868.1400 Analyzer, Gas, Carbon Dioxide, Gaseous-Phase<br>21 CFR 868.2375 Breathing Frequency Monitor<br>21 CFR 870.1025 Detector and Alarm, Arrhythmia<br>21 CFR 870.1100 Monitor, Blood Pressure, Indwelling<br>21 CFR 870.1130 Noninvasive Blood Pressure Measurement System<br>21 CFR 870.1100 Blood Pressure Alarm<br>21 CFR 870.1425 Programmable Diagnostic Computer<br>21 CFR 870.2340 Electrocardiograph<br>21 CFR 870.1435 Monitor, Cardiac Output, Thermal (Balloon Type Catheter)<br>21 CFR 880.2910 Monitor, Temperature (with probe)<br>21 CFR 870.2300 Monitor, Cardiac (Incl. Cardiotachometer & rate alarm)<br>21 CFR 870.2700 Oximeter, Pulse | | CCK<br>FLS<br>DSI<br>CAA<br>BXD<br>DSJ<br>DQK<br>FYW<br>KFN<br>BWX<br>DRT<br>DQA<br>MHX |
| 21 CFR 870.1025 Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)<br>21 CFR 870.2770 Plethysmograph, Impedance | | DSB |
| Predicate Device: | K030431 Dash 3000/4000 Patient Monitor | |

The Dash 3000/4000 Patient Monitor is a device that is designed to be Device Description: 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). Additionally, the network interface allows for the display and transfer of 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

GE Medical Systems Information Technologies Confidential

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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.

The Dash 3000/4000 Patient Monitor employs the same functional Technology: 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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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2003

GE Medical Systems Information Technologies c/o Ms. Melissa Robinson Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K033304

Trade Name: Dash 3000/4000 Patient Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: October 9, 2003 Received: October 14, 2003

Dear Ms. Robinson:

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 - Ms. Melissa Robinson

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 (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), 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 vours.

Aepasmar

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):

Device Name: Dash 3000/4000 Patient Monitor

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, noninyasive 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Cmman frBDt

(Division Sign-Off)
Division of Cardiovascular Devices

K033304

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)