DASH 3000/4000 PATIENT MONITOR

K020290 · General Electric Medical Systems Information Techn · MHX · Aug 14, 2002 · Cardiovascular

Device Facts

• Record ID: K020290
• Device Name: DASH 3000/4000 PATIENT MONITOR
• Applicant: General Electric Medical Systems Information Techn
• Product Code: MHX · Cardiovascular
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Traditional
• 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 blood pressure, SpO2, temperature, impedance respiration, EtCO2, O2, N2O, anesthetic agents. Processing: arrhythmia detection, cardiac/pulmonary calculations, dose calculations, PA wedge, ST analysis, 12SL interpretive ECG analysis. Outputs: real-time physiologic data display, trends, storage, printouts. Used in hospitals, clinics, surgical centers, ambulances, aircraft. Operated by clinicians. Network interface (Unity network) allows data transfer to clinical information systems; supports third-party serial peripheral devices. Benefits: continuous patient monitoring, data integration at point-of-care, support for clinical decision-making.

Clinical Evidence

Bench testing only. Quality assurance measures included risk analysis, requirements reviews, design reviews, module verification, system integration testing, final validation, performance testing, safety testing, and environmental testing.

Technological Characteristics

Physiologic patient monitor; bedside/portable form factor. Sensing: ECG, pressure, pulse oximetry, gas analysis. Connectivity: Unity network interface, serial data output for third-party peripherals. Software: includes arrhythmia detection, ST analysis, 12SL interpretive ECG analysis. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for monitoring physiologic parameters in adult, pediatric, and neonatal patients under direct supervision of licensed healthcare practitioners in professional medical facilities, transport modes, and pre-hospital emergency response 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 (K001359)

Submission Summary (Full Text)

{0}------------------------------------------------

K 020290
F "/=-

AUG 1 4 2002

# Section 2 Summary and Certification

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 23, 2002 |
| 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: | Dash 3000/4000 Patient Monitor |
| Common/Usual Name: | Physiological Patient Monitor |
| Classification Names: | 21 CFR 870.1025 Detector and Alarm, Arrhythmia |
| Predicate Devices: | K001359 Dash 3000/4000 Patient Monitor |
| Device Description: | The Dash 3000/4000 Patient Monitor is a device that is designed to be<br>used to monitor, display, and print a patient's basic physiological<br>parameters including: electrocardiography (ECG), invasive blood<br>pressure, non-invasive blood pressure, oxygen saturation, temperature,<br>impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide<br>and anesthetic agents. Other features include arrhythmia, cardiac<br>output, cardiac and pulmonary calculations, dose calculations, PA<br>wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL).<br>Additionally, the network interface allows for the display and transfer of<br>network available patient data. |
| Intended Use: | The Dash 3000/4000 Patient Monitor is intended for use under the<br>direct supervision of a licensed healthcare practitioner. The intended<br>use of the system is to monitor physiologic parameter data on adult,<br>pediatric and neonatal patients. The Dash is designed as a bedside,<br>portable, and transport monitor that can operate in all professional<br>medical facilities and medical transport modes including but not limited<br>to: emergency department, operating room, post anesthesia recovery,<br>critical care, surgical intensive care, respiratory intensive care, coronary<br>care, medical intensive care, pediatric intensive care, or neonatal<br>intensive care areas located in hospitals, outpatient clinics, freestanding<br>surgical centers, and other alternate care facilities, intra-hospital patient<br>transport, inter-hospital patient transport via ground vehicles (i.e.,<br>ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital<br>emergency response.<br>Physiologic data includes but is not restricted to: electrocardiogram,<br>invasive blood pressure, noninvasive blood pressure, pulse,<br>temperature, cardiac output, respiration, pulse oximetry, carbon<br>dioxide, oxygen, and anesthetic agents as summarized in the |

{1}------------------------------------------------

0700

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 scientific technology as its 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 Dash 3000/4000 Patient Monitor:

- 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 .

#### Conclusion:

The results of these measurements demonstrated that the Dash 3000/4000 Patient Monitor are as safe, as effective, and perform as well as the predicate device.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2002

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

Re: K020290

> 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: May 21, 2002 Received: May 23, 2002

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.

{3}------------------------------------------------

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 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,

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

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

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, surqical 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, intrahospital 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-ofcare.

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)

| Prescription Use | X | OR | Over-The-Counter Use | ____ |
|----------------------|---|----|--------------------------|------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |

_________________________________________________________________

(Division Sign-Off) for Ban Juhur 8/14/92

Division of Cardiovascular

and Respiratory Devices

| 510(k) Number. | K020290 |
|----------------|---------|
|----------------|---------|