DASH 2500 PATIENT MONITOR

K080157 · Ge Medical Systems Information Technologies · MHX · Mar 24, 2008 · Cardiovascular

Device Facts

• Record ID: K080157
• Device Name: DASH 2500 PATIENT MONITOR
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Dash 2500 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of this device is a portable (intrahospital) multiparameter unit designed for monitoring adult, pediatric, and neonate patient vital signs in a hospital subacute care environments, such as same-day surgery, emergency rooms, recovery/PACU, progressive care, interventional radiology, special care units, and GI/endoscopy. The Dash 2500 Patient Monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, temperature with an reusable electronic thermometer (predictive mode for oral and rectal temperature measurement, monitor mode for axillary temperature measurement), and functional oxygen saturation (SpO2) and pulse rate via spot checking and continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion. The Dash 2500 also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.

Device Story

Portable, multi-parameter patient monitor for intra-hospital use; monitors adult, pediatric, and neonate vital signs. Inputs: ECG, NIBP, SpO2, respiration, and temperature sensors. Device processes physiological signals to display real-time data, detect alarm limit conditions, and record up to two waveforms. Operated by clinicians in subacute hospital settings; can be shelf, table, or wall-mounted. Provides continuous monitoring and spot-checking capabilities; supports data recall and interface with central stations or servers. Benefits include real-time patient status awareness and timely alarm notification for clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including risk analysis, requirements/design reviews, module verification, system integration testing, performance testing, safety testing, and environmental testing.

Technological Characteristics

Portable multi-parameter monitor; powered by AC or battery. Parameters: oscillometric NIBP, ECG, SpO2, respiration, and temperature (predictive/monitor modes). Connectivity: standalone or interface to central station/server via host communications protocol. Mounting options: wall, pole, bed rail, or head/foot board. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for adult, pediatric, and neonate patients in hospital subacute care environments (e.g., same-day surgery, ER, PACU, progressive care, interventional radiology, special care, GI/endoscopy) for monitoring vital signs including NIBP, heart/pulse rate, respiration rate, ECG, temperature, and SpO2.

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

• DINAMAP PRO 1000 V3 MONITOR (K031376)

Submission Summary (Full Text)

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K080157

## Section 5: 510(k) Summary or 510(k) Statement

| | MAR 24 2008<br>510(k) Summary of Safety and Effectiveness |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 21, 2008 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, Wisconsin 53223 |
| Contact Person: | Sharon Untz<br>Quality and Regulatory Affairs Manager<br>GE Medical Systems Information Technologies<br>Telephone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device: | |
| Trade Name: | Dash 2500 Patient Monitor |
| Common/Usual Name: | Physiological Patient Monitor (Multi-parameter Module) |
| Classification Names: | 21 CFR 870.1025 Physiologic Patient Monitor (with arrhythmia<br>detection or alarms) |
| Predicate Device: | K031376 DINAMAP PRO 1000 V3 MONITOR |
| Device Description: | The Dash 2500 Patient Monitor is a portable (intra-hospital) multi-<br>parameter monitor designed for monitoring adult, pediatric, and neonate<br>patient vital signs.<br>The Dash 2500 Patient Monitor is self-contained and can be powered<br>by batteries or AC. The Monitor has a carrying handle and can be<br>operated on a shelf or table. It can also be mounted in a variety of ways<br>(e.g., wall, pole, bed rail, or head/foot board) using a mounting plate<br>located on the bottom of the Monitor. The Monitor can be used as a<br>stand-alone monitor with the capability to interface to a central station,<br>a server or any other device capable of receiving data using the host<br>communications protocol. |
| Intended Use: | The Dash 2500 Patient Monitor is intended for use under the direct<br>supervision of a licensed healthcare practitioner. The intended use of<br>this device is a portable (intra-hospital) multiparameter unit designed<br>for monitoring adult, pediatric, and neonate patient vital signs in a<br>hospital subacute care environments, such as same-day surgery,<br>emergency rooms, recovery/PACU, progressive care, interventional<br>radiology, special care units, and GI/endoscopy.<br>The Dash 2500 Patient Monitor monitors and displays oscillometric<br>non-invasive blood pressure (systolic, diastolic and mean arterial<br>pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation<br>(SpO2) by non-invasive pulse oximetry, and temperature with an<br>reusable electronic thermometer (predictive mode for oral and rectal<br>temperature measurement, monitor mode for axillary temperature<br>measurement). |

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The Dash 2500 also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.

Technology: The Dash 2500 employs the same functional technology as the predicate devices.

Test Summary: The Dash 2500 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:

- � 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 2500 is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Ms. Sharon Untz Quality Assurance and Regulatory Affairs Manager 8200 West Tower Avenue Milwaukee, WI 53223

MAR 2 4 2008

Re: K080157

Dash 2500 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: January 21, 2008 Received: January 23, 2008

Dear Ms. Untz:

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 I ou mayy ators 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. Sharon Untz

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/industry/support/index.html.

Sincerely yours,

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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# 1080157

## Section 4: Indications for Use Statement

### Indications for Use

510(k) Number (if known): Device Name: Dash 2500 Patient Monitor

Indications for Use:

The Dash 2500 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of this device is a portable (intrahospital) multiparameter unit designed for monitoring adult, pediatric, and neonate patient vital signs in a hospital subacute care environments, such as same-day surgery, emergency rooms, recovery/PACU, progressive care, interventional radiology, special care units, and GI/endoscopy.

The Dash 2500 Patient Monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, temperature with an reusable electronic thermometer (predictive mode for oral and rectal temperature measurement, monitor mode for axillary temperature measurement), and functional oxygen saturation (SpO2) and pulse rate via spot checking and continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

The Dash 2500 also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | |
|------------------------|--|
| (21 CFR 801 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Div | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number: | K080057 |

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