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 Description

The Dash 2500 Patient Monitor is a portable (intra-hospital) multi-parameter monitor designed for monitoring adult, pediatric, and neonate patient vital signs.
The Dash 2500 Patient Monitor is self-contained and can be powered by batteries or AC. The Monitor has a carrying handle and can be operated on a shelf or table. It can also be mounted in a variety of ways (e.g., wall, pole, bed rail, or head/foot board) using a mounting plate located on the bottom of the Monitor. The Monitor can be used as a stand-alone monitor with the capability to interface to a central station, a server or any other device capable of receiving data using the host communications protocol.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a study detailing device performance against those criteria. Instead, it is a 510(k) summary for the GE Dash 2500 Patient Monitor, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics from a specific study with defined acceptance criteria.

The document mentions:

Voluntary standards compliance: "The Dash 2500 complies with the voluntary standards as detailed in Section 9 of this submission." However, Section 9 is not provided in the input, so the specific standards and their associated performance criteria are unknown.
Quality assurance measures: A list of measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, 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." This is a general statement of equivalence, not a report of specific numerical performance against acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information, as this data is not present in the provided submission. The submission confirms a 510(k) clearance based on substantial equivalence, not a detailed performance study against explicit acceptance criteria.

Summary

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K080157

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

	MAR 24 2008510(k) Summary of Safety and Effectiveness
Date:	January 21, 2008
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, Wisconsin 53223
Contact Person:	Sharon UntzQuality and Regulatory Affairs ManagerGE Medical Systems Information TechnologiesTelephone: 414-362-2436Fax: 414-362-2585E-mail: Sharon.Untz@med.ge.com
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 arrhythmiadetection or alarms)
Predicate Device:	K031376 DINAMAP PRO 1000 V3 MONITOR
Device Description:	The Dash 2500 Patient Monitor is a portable (intra-hospital) multi-parameter monitor designed for monitoring adult, pediatric, and neonatepatient vital signs.The Dash 2500 Patient Monitor is self-contained and can be poweredby batteries or AC. The Monitor has a carrying handle and can beoperated on a shelf or table. It can also be mounted in a variety of ways(e.g., wall, pole, bed rail, or head/foot board) using a mounting platelocated on the bottom of the Monitor. The Monitor can be used as astand-alone monitor with the capability to interface to a central station,a server or any other device capable of receiving data using the hostcommunications protocol.
Intended Use:	The Dash 2500 Patient Monitor is intended for use under the directsupervision of a licensed healthcare practitioner. The intended use ofthis device is a portable (intra-hospital) multiparameter unit designedfor monitoring adult, pediatric, and neonate patient vital signs in ahospital subacute care environments, such as same-day surgery,emergency rooms, recovery/PACU, progressive care, interventionalradiology, special care units, and GI/endoscopy.The Dash 2500 Patient Monitor monitors and displays oscillometricnon-invasive blood pressure (systolic, diastolic and mean arterialpressure), heart/pulse rate, respiration rate, ECG, oxygen saturation(SpO2) by non-invasive pulse oximetry, and temperature with anreusable electronic thermometer (predictive mode for oral and rectaltemperature measurement, monitor mode for axillary temperaturemeasurement).

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(08057

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

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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Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.