•Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adult/pediatric mode.

Heart/pulse rate, respiration rate, ECG

Oxygen saturation (SpO2) by noninvasive pulse oximetry and

Predictive temperature by resistive thermometry.

The Pro 1000 with SuperStat Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using the monitor a clinician can view, record and recall clinical data derived from each parameter.

Device Description

The DINAMAP® Pro 1000 Monitor w/ SuperStat 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

The acceptance criteria for the DINAMAP® Pro 1000 Monitor with SuperStat are tied to its performance in Non-Invasive Blood Pressure (NIBP) measurement, specifically regarding its ability to measure oscillometric NIBP, optimize performance in the presence of artifact, and report NIBP determinations with irregular heart rhythms. The study conducted to demonstrate that the device meets these criteria involved clinical studies following the ANSI/AAMI SP10 Standard.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Able to measure oscillometric non-invasive blood pressure (systolic, diastolic, and mean arterial pressure) in adult, pediatric, and neonate patient populations.	Met: The DINAMAP® Pro 1000 with SuperStat is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic, and mean arterial pressure) for adult, pediatric and neonate patients.
Will optimize performance in the presence of artifact due to vibration and patient motion.	Met: The device "Will optimize performance in the presence of artifact due to vibration and patient motion."
Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adult/pediatric mode.	Met: The device "Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adult/pediatric mode."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size (number of patients) used for the clinical studies. It only states that "Clinical studies were conducted."
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It just refers to "Clinical studies."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The standard referenced, ANSI/AAMI SP10, typically involves a comparison to a reference standard (e.g., intra-arterial blood pressure measurements).

4. Adjudication Method for the Test Set

The document does not describe the adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The focus is on the device's performance against a standard, not on comparing human readers with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the clinical studies describe the performance of the "SuperStat NIBP algorithm" according to the ANSI/AAMI SP10 standard. This implies a standalone evaluation of the algorithm's accuracy in measuring blood pressure, as NIBP devices typically provide automated readings.

7. The Type of Ground Truth Used

The ground truth for the NIBP measurements would typically be established by a reference standard during the clinical studies conducted according to the ANSI/AAMI SP10 standard. This almost certainly involves a direct comparison of the device's NIBP readings to simultaneously obtained, high-fidelity reference blood pressure measurements (e.g., intra-arterial blood pressure measurements performed by a trained professional). The document only states adherence to the standard, not the specific ground truth method.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

9. How the Ground Truth for the Training Set was Established

The document does not provide information on how the ground truth for the training set was established. Given the nature of a 510(k) submission, the primary focus is on the validation of the final algorithm/device, not the specifics of its development or training data.

Summary

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K022834

MAY 1 3 2003

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

April 7, 2003

SUMMARY OF SAFETY AND EFFECTIVENESS

DINAMAP® Pro 1000 Monitor with SuperStat

A. Submitter

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

B. Company Contact

Primary:

Melissa Robinson, Regulatory Affairs Specialist Secondary: Thomas English, Global QA/RA

C. Device Name

Pro 1000 Monitor with SuperStat Trade Name: 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-BZO Recorder, Paper Chart-870.2810-DSF

D. Predicate/Legally Marketed Devices

DINAMAP® Pro 1000 V2 Monitor, K012915 GE Medical Systems Information Technologies

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E. Device Description

F. Intended Use

The DINAMAP® Pro 1000 with SuperStat Monitor is intended to monitor the following adult, pediatric and neonate patient vital signs:

Non-Invasive Blood Pressure:

· Able to measure oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure)

· Will optimize performance in the presence of artifact due to vibration and patient motion.

•Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adult/pediatric mode.

Heart/pulse rate, respiration rate, ECG

Oxygen saturation (SpO2) by noninvasive pulse oximetry and

Predictive temperature by resistive thermometry.

G. Technological Characteristics

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

H. Parameter Technology

The DINAMAP PRO 1000 Monitor with SuperStat has the following parameter technologies:

·SuperStat NIBP algorithm tested according to the ANSI/AAMI SP10 standard.

· Temperature-Same as the PRO 1000 V2 Monitor
·SpO2-Same as the PRO 1000 V2 Monitor
•ECG-Same as the PRO 1000 V2 Monitor

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•Respiration-Same as the PRO 1000 V2 Monitor

I. Testing

Clinical studies were conducted to demonstrate performance (safety and effectiveness) of the DINAMAP PRO 1000 with SuperStat Monitor to the ANSI/AAMI SP10 Standard: American National Standard for Electronic or Automated Sphygmomanometers.

J. Conclusion

The DINAMAP® Pro 1000 with SuperStat Monitor is substantially equivalent to the currently marketed DINAMAP® Pro 1000 V2 Monitor, K012915 cleared 3/21/02.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2003

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

Re: K022834

Trade Name: DINAMAP® Pro 1000 Monitor with SuperStat Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: March 17, 2003 Received: March 19, 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,

Delettu

am D. Zucker rman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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April 7, 2003

510(K) Number (if known):

Device Name: DINAMAP® Pro 1000 Monitor with SuperStat

Indications for Use:

The DINAMAP® Pro 1000 with SuperStat Monitor is intended to monitor the following adult, pediatric and neonate patient vital signs:

Non-Invasive Blood Presure:

· Able to measure oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure)
· Will optimize performance in the presence of artifact due to vibration and patient motion.
•Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adult/pediatric mode.

Heart/pulse rate, respiration rate, ECG

Oxygen saturation (SpO2) by noninvasive pulse oximetry and

Predictive temperature by resistive thermometry.

(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

DeleTu

510(k) Number

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.