MODIFICATION TO DASH 3000/4000 PATIENT MONITOR

K040458 · Ge Medical Systems Information Technologies · MHX · Jun 3, 2004 · Cardiovascular

Device Facts

• Record ID: K040458
• Device Name: MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Jun 3, 2004
• 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 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, 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 BP, pulse, temperature, cardiac output, respiration, pulse oximetry, CO2, O2, and anesthetic agents. Device processes signals to provide real-time monitoring, arrhythmia detection, ST analysis, and interpretive 12-lead ECG (12SL). Used by clinicians in hospitals, clinics, and transport vehicles. Outputs displayed on-screen, trended, stored, printed, or transmitted via Unity network to clinical information systems. Supports third-party peripheral integration via serial output. Facilitates clinical decision-making by providing continuous physiological data and automated diagnostic calculations.

Clinical Evidence

Bench testing only. Compliance with voluntary standards: ANSI/AAMI EC13, ANSI/AAMI SP10:1992, IEC 60601-1 (and amendments), IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-27, IEC 601-2-30, IEC 601-2-34, and UL 2601. No clinical data presented.

Technological Characteristics

Physiological patient monitor; supports ECG, BP, pulse, temperature, cardiac output, respiration, pulse oximetry, CO2, O2, and anesthetic agents. Features arrhythmia detection, ST analysis, and 12SL interpretive ECG. Network-enabled via Unity network. Complies with IEC 60601 series and ANSI/AAMI standards for electrical safety and performance.

Indications for Use

Indicated for monitoring physiologic parameters (ECG, invasive/non-invasive BP, pulse, temperature, cardiac output, respiration, pulse oximetry, CO2, O2, anesthetic agents) in adult, pediatric, and neonatal patients under direct supervision of licensed healthcare practitioners in professional medical facilities and transport environments.

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 (K033304)

Submission Summary (Full Text)

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JUN 0 3 2004

K040458

# 510(k) Summary of Safety and Effectiveness

May 7, 2004 Date: GE Medical Systems Information Technologies Submitter: 8200 West Tower Avenue USA Milwaukee, WI 53223 Melissa Robinson Contact Person: Phone: [phone] Fax: [phone] DASH 3000/4000 Patient Monitor Trade Name: Device: Physiological Patient Monitor Common/Usual Name: 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)

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### 21 CFR 870.2770 Plethysmograph, Impedance

K033304 DASH 3000/4000 Patient Monitor Predicate Device:

The DASH 3000/4000 Patient Monitor is a device that is Device Description: 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). Additionally, the network interface allows for the display and transfer of network available patient data.

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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 prehospital emergency response.

data includes but is is not restricted to: Physiologic 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.

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

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#### Test Summary: The DASH 3000/4000 Patient Monitor complies with the following voluntary standards: ANSVAAMI EC13, ANSVAAMI SP10:1992; IEC 60601-1, 60601-1-am1, 60601-1-am2; IEC 60601-1-1, 60601-1-1-am1; IEC 60601-1-2; IEC 60601-2-27; IEC 601-2-30; IEC 601-2-34; UL 2601. The following quality assurance measures were applied to the development of the system:

- . Requirements specification review
- 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 0 3 2004

Ms. Melissa Robinson Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Ave. Milwaukee, WI 53223

Re: K040458

Trade/Device Name: GE Dash 3000/4000 Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX Dated: May 7, 2004 Received: May 11, 2004

Dear Ms. Robinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf have roviowed your becamed the device is substantially equivalent (for the indications ferenced above and have ure to legally marketed predicate devices marketed in interstate for use stated in the encreative in the enactment date of the Medical Device Amendments, or to conninered prior to rits) 2011-12-11 in accordance with the provisions of the Federal Food, DDVA de vices that have been receasined in quire approval of a premarket approval application (PMA). and Cosmotion (110) that the device, subject to the general controls provisions of the Act. The I va may, merelore, manel of the Act include requirements for annual registration, listing of goneral volt. on the virus wing, 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 may be subjoct to back access a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that 1 DX has made a Lotto made in administered by other Federal agencies. You must or uny I oderal statues and seguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Ms. Melissa Robinson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Actived in your Section 2 product radiation control provisions (Sections 55 in the simple in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will anow you to ocgin hanceing your aveness of your device of your device to a legally premarket nothication. The PDA miding of ouosantal experies 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 If you desire specific advice for your do 1,601, 594-4646. Also, please note the regulation entitled, Contact the Office of Complaned at (301) 37 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 1 - - 1 - - 1 - - 1 - - 1 - - 1 - - 1 - - - - - - - - " Misbranding by reference to premanse nothead.incernedations of Small other general information on your responsibilities and its toll-free mumber [phone] or 1 [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Ques

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 The Dash 3000/4000 Patient Molition in the intended use of the system is to monitor physiologic
licensed healthcare practitioner. The intended use of the Dash is designed as licensed healthcare practitioner. The lifent son and patients. The Dash is designed as a
parameter data on adult, pediatio and necessor and necessional medical parameter data on adult, pediatic and nechanter in all professional medical bedside, portable, and transport modes including but not limited to: emergency
facilities and medical transport modes including but not limited to: surgical intensive facilities and medical transport intodes into recovery, critical care, surgical intensive department, operating from, post anestileste recovery, tensive care, pediatric intensive
care, respiratory intensive care, coronary care, medical intensive care, pediations f care, respiratory Intensive care, colonal y care, incultals, outpatient clinics, freestanding
care, or neonatal intensive care areas located in hospital catient transport, in care, or neonatal intensive care areas located in nospital patient transport, intersurgical centers, and other alternate care facilities, intro noopical particles and rotary nospital patient transpe-hospital emergency response.

Wingsa are includes but is not restricted to: electrocardiogram, invasive blood Physiologic data Includes but is not resure, pulse, temperature, cardiac output, respiration,
pressure, noninvasive blood pressure, pulse, temperations summarized in the pressure, noninvasive blood pressure, pulse, temporaters, we summarized in the operator's manual.

oper the on
The Dash 3000/4000 Patient Monitor is also intended to provide physiologic data at The Dash 3000/4000 Patient Monitor is also intended to provide provides
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.

Prescription Use X (Part 21 CFR 801 Subpart D) And/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Dexice

Division Sian-Off n of Anesthesiology, General Hospital,

510(k) Number: K040438