The DINAMAP® Pro 1000 V3 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 V3 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 DINAMAP® Pro 1000 V3 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 Monitor may be operated from internal batteries making the device portable and suitable for intra-hospital transport.

AI/ML Overview

Here's an analysis of the provided text regarding the DINAMAP® PRO 1000 V3 Monitor, focusing on acceptance criteria and supporting studies:

Based on the provided document (K031376), it is not possible to describe the acceptance criteria and the study that proves the device meets them in detail as requested. The document primarily focuses on the regulatory submission process and establishing substantial equivalence to a predicate device.

Specifically, the document states:

"Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® PRO 1000 V3 Monitor:
- Electromagnetic Compatibility
- Electrical Safety
- Mechanical and Environmental"

However, it does not provide any details on:

Specific quantitative acceptance criteria for any of these studies.
The reported performance of the device against any such criteria.
The methodology, sample sizes, data provenance, ground truth establishment, or any other specifics of these studies.
Any clinical studies, standalone algorithm performance, or multi-reader multi-case studies.

Therefore, many of the requested elements cannot be completed from the provided text.

Here's a table attempting to fill in what can be inferred from the provided text, along with a clear indication where information is not available (N/A):

Table of Acceptance Criteria and Reported Device Performance

Parameter/Characteristic	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
Electromagnetic Compatibility	N/A (Presumed to meet relevant standards)	N/A
Electrical Safety	N/A (Presumed to meet relevant standards)	N/A
Mechanical Safety	N/A (Presumed to meet relevant standards)	N/A
Environmental Performance	N/A (Presumed to meet relevant standards)	N/A
Oscillometric Non-Invasive Blood Pressure	N/A	N/A
Heart/Pulse Rate	N/A	N/A
Respiration Rate	N/A	N/A
ECG Performance	N/A	N/A
SpO2 by Non-Invasive Pulse Oximetry	N/A	N/A
Predictive Temperature	N/A	N/A
Lethal Arrhythmia Detection (Asystole, V-Tach, V-Fib)	N/A	N/A

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: N/A. The document mentions "bench studies" (Electromagnetic Compatibility, Electrical Safety, Mechanical and Environmental) but does not provide any sample sizes or details about data used.
- Data Provenance: N/A. No information is given about the origin or nature of any data used in these bench studies. They are mentioned as general engineering tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Given that the described studies are "bench studies" related to engineering compliance (EMC, electrical, mechanical, environmental), expert input for "ground truth" in a clinical sense would not typically be applicable or detailed in such a summary. No clinical ground truth establishment is mentioned for these engineering tests.
Adjudication method for the test set:
- N/A. No information provided, and not typically relevant for the type of bench studies mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. The document describes a traditional physiological monitor, not an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness analysis would have been performed or reported here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a physiological monitor, not a standalone algorithm. Performance validation would typically involve the device itself (hardware and embedded software) against reference standards or clinical measurements. The document does not detail such performance studies.
The type of ground truth used:
- N/A. For the mentioned "bench studies," the "ground truth" would likely be established by international standards (e.g., for electrical safety, EMC limits) or engineering specifications. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) is discussed for proving the device's functional performance in a clinical setting. The document focuses on substantial equivalence to a predicate device, implying that the predicate's established performance serves as a benchmark rather than new extensive clinical validation.
The sample size for the training set:
- N/A. This device is not described as having an AI component that would require a "training set" in the context of machine learning.
How the ground truth for the training set was established:
- N/A. Not applicable as there is no mention of a "training set" for an AI component.

Conclusion:

The provided document is a 510(k) summary focused on establishing substantial equivalence for a medical device. While it mentions "bench studies" for safety and effectiveness, it lacks the detailed information required to answer most of the questions regarding specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or clinical performance data. The regulatory submission emphasizes that "The DINAMAP® PRO 1000 V3 Monitor has the same technological characteristics as the predicate device, the DINAMAP® PRO 1000 V2 Monitor. There are no new technologies used on the DINAMAP® PRO 1000 V3 Monitor," which is the primary argument for its safety and effectiveness without needing extensive new clinical trials.

Summary

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JUL 16 2003

K031376
p. 112

SUMMARY OF SAFETY AND EFFECTIVENESS

April 29, 2003

DINAMAP® PRO 1000 V3 Monitor

A. Submitter GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard Tampa, FL 33614
B. Company Contact Melissa Robinson Regulatory Affairs Specialist Phone: 813-887-2133 Fax: 813-887-2552

C. Device Name

Trade Name: PRO 1000 V3 Monitor Common Name: Physiological Monitor, Patient Monitor

Classification/Device Product Code:

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

D. Predicate/Legally Marketed Devices

DINAMAP® PRO 1000 V2 - K012915 GE Medical Systems Information Technologies

E. Device Description

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F. Intended Use

The DINAMAP® Pro 1000 V3 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. The Pro 1000 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.

G. Technological Characteristics

The DINAMAP® PRO 1000 V3 Monitor has the same technological characteristics as the predicate device, the DINAMAP® PRO 1000 V2 Monitor. There are no new technologies used on the DINAMAP® PRO 1000 V3 Monitor.

H. Testing

Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® PRO 1000 V3 Monitor:

· Electromagnetic Compatibility
· Electrical Safety
· Mechanical and Environmental

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or eagle with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 16 2003

GE Medical Systems Information Technologies c/o Ms. Melissa Robinson Regulatory Affairs Specialist 4502 Woodland Corporate Boulevard Tampa, FL 33614

Re: K031376

Trade Name: PRO 1000 V3 Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: June 12, 2003 Received: June 17, 2003

Dear Ms. Robinson:

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.

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

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Page 2 – Ms. Melissa Robinson

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 (301) 594-4646. 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 (301) 443-6597 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

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Page 1 of 1

510(k) Number (if known):

K031376

Device Name: DINAMAP® PRO 1000 V3 Monitor

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Cardiovascular Devices

Division of Cardiovascular Devices
510(k) Number K03376

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.