The DINAMAP® Pro 1000 V2 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO2) by non-invasive pulse oximetry, and predictive temperature with an electronic thermometer in the adult, pediatric and neonate populations. An additional feature is the detection of three lethal arrhythmias- asystole, ventricular tachycardia (v-tach), and ventricular fibrillation (v-fib). The Pro 1000 V2 Monitor 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 DNAMAP® Pro 1000 V2 Monitor is intended to monitor a single patient's vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric, and neonatal. The device's networking capabilities include connection to a central station via VHF, 900 MHz or hardwire communication; host communications for use with other devices. In addition, the DINAMAP Pro 1000 V2 Monitor may be operated from internal batteries making the device portable and suitable for intra-hospital transport.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DINAMAP® Pro 1000 V2 Monitor. It establishes substantial equivalence to a predicate device and mentions a software validation for an arrhythmia detection feature. However, it does not contain a study specifically detailing acceptance criteria and performance results in the manner requested.

Therefore, the following information is not available within the provided text:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set and data provenance for performance evaluation.
Number of experts used to establish ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
If a standalone (algorithm only) performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance evaluation.
Sample size for the training set.
How the ground truth for the training set was established.

Key information from the provided text regarding device validation:

Device: DINAMAP® Pro 1000 V2 Monitor
Intended Use: Monitoring oscillometric non-invasive blood pressure, heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO2), and predictive temperature in adult, pediatric, and neonate populations. An additional feature is the detection of three lethal arrhythmias: asystole, ventricular tachycardia (v-tach), and ventricular fibrillation (v-fib).
Predicate Device: DINAMAP® Pro 1000 Monitor (K002248) and the EkPro ECG algorithm in the DASH 3000/4000 Patient Monitor (K001359).
Technological Characteristics: The DINAMAP® Pro 1000 V2 Monitor has the same technological characteristics as the predicate device. "There are no new technological characteristics. The Pro 1000 Monitor and the Pro 1000 V2 Monitor are both software-driven electronic devices that include the same monitoring parameters."
Testing Mentioned: "A software validation was performed to demonstrate the implementation of the arrhythmia detection feature." This statement indicates that some testing was done specifically for the arrhythmia detection, but the details (acceptance criteria, results, methodology, sample sizes, etc.) are not provided.
Conclusion: The device is deemed substantially equivalent to currently marketed predicate devices. This implies that the device is expected to perform at least as well as the predicate devices, but specific performance metrics are not detailed in this summary.

In summary, while the document confirms that a software validation was performed for the arrhythmia detection feature, it does not provide the detailed acceptance criteria and study data requested related to device performance. The focus of this 510(k) summary is on establishing substantial equivalence rather than presenting granular performance study results against specific criteria.

Summary

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K012915

1/2

MAR 2 1 2002

General Electric Company 4502 Woodland Corporate Blvd., Tampa, FL 33614 813 887-2000

SUMMARY OF SAFETY AND EFFECTIVENESS

DINAMAP® Pro 1000 V2 Monitor

August 28, 2001

A. Submitter

GE Medical Systems Information Technologies. 4502 Woodland Corporate Boulevard Tampa, FL 33614

B. Company Contact

Thomas J English, Director, Regulatory and Quality Affairs Phone: 813-887-2107 Fax: 813-887-2413

C. Device Name

Trade Name:	Pro 1000 V2 Monitor
Common Name:	Physiological Monitor, Patient Monitor
Classification/Device Product Code:

System, Measurement, Blood Pressure, Noninvasive-870.1130-DXN Computer, Blood Pressure-870.1110-DSK Alarm, Blood Pressure-870.1100-DSJ Oximeter-870.2700-DQA Oximeter, Ear-870.2710-DPZ Thermometer, Clinical Electronic-880.2910-FLL Monitor, Cardiac (including cardiotachometer & rate alarm)-870.2300-DRT Electrocardiograph-870.2340-DPS Adapter, Lead Switching, Electrocardiograph-870.2350-DRW Arrhythmia Detection and Alarm-870.1025-DSI Monitor, Breathing Frequency-868.2375-BZQ

Recorder, Paper Chart-870.2810-DSF

D. Predicate/Legally Marketed Devices

DINAMAP® Pro 1000 Monitor, K002248 Critikon Company LLC

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E. Device Description

F. Intended Use

G. Technological Characteristics

The DINAMAP® Pro 1000 V2 Monitor has the same technological characteristics as the predicate device, the DINAMAP® Pro 1000 Monitor. There are no new technological characteristics. The Pro 1000 Monitor and the Pro 1000 V2 Monitor are both software-driven electronic devices that include the same monitoring parameters.

H. Testing

The Pro 1000 V2 Monitor complies with the same regulatory standards as the Pro 1000 predicate device. A software validation was performed to demonstrate the implementation of the arrhythmia detection feature.

I. Conclusion

The DINAMAP® Pro 1000 V2 Monitor is substantially equivalent to the currently marketed DINAMAP® Pro 1000 Monitor, K002248 cleared on 9/21/00 and the EkPro ECG algorithm in the DASH 3000/4000 Patient Monitor, K001359 cleared on 7/18/00.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2002

Mr. Thomas J. English Director, Regulatory and Quality Affairs GE Medical Systems Information Technologies 4502 Woodland Corporate Blvd. Tampa, FL 33614

Re: K012915

Trade Name: DINAMAP® Pro 1000 V2 Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: December 18, 2001 Received: December 21, 2001

Dear Mr. English:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfor to May 28, 1976, the enactment date of the Medical Device Amendments, or to Commerce prior to Milly 20, 1976, are excordance with the provisions of the Federal Food, Drug, de rices that have been recuire 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 may, morelore, mains of the Act include requirements for annual registration, listing of general controll profiterials of ractice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to been awares 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 - Mr. Thomas J. English

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

K Denlon Telleh

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

Enclosure

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Page 1 of 1.

August 24, 2001

510(K) Number (if known): K012915

Device Name: DINAMAP® Pro 1000 V2 Monitor

Indications for Use:

The DINAMAP® Pro 1000 V2 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO22) by non-invasive nears pulse rate, respirative temperature with an electronic thermometer in the pulse onlinery, and pronate populations. An additional feature is the detection of three lethal arrhythmias- asystole, ventricular tachycardia (v-tach), and ventricular thece tethal arrifyininde "tay store, "onitor 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.

(Please Do Not Write Below This Line-Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use : $\checkmark$

Over-The Counter Use

(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K082915

(Optional Format 1-2-96)

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.