DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES

K031376 · Ge Medical Systems Information Technologies · MHX · Jul 16, 2003 · Cardiovascular

Device Facts

• Record ID: K031376
• Device Name: DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

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. 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 Story

DINAMAP Pro 1000 V3 is a multi-parameter patient monitor for hospital, outpatient, and clinical settings. Inputs include oscillometric blood pressure cuffs, ECG leads, pulse oximetry sensors, and electronic thermometers. Device processes physiological signals to derive vital signs, detect alarm limit violations, and identify three specific lethal arrhythmias (asystole, v-tach, v-fib). Output is displayed on-screen for clinician review, with capability to record up to two waveforms and recall clinical data. Portable design with internal battery supports intra-hospital transport; networking options include VHF, 900 MHz, or hardwire to central stations. Clinicians use real-time data and alarms to inform patient care decisions and monitor stability.

Clinical Evidence

Bench testing only. Studies included electromagnetic compatibility, electrical safety, and mechanical/environmental testing. No clinical data provided.

Technological Characteristics

Multi-parameter monitor for NIBP, ECG, SpO2, respiration, and temperature. Connectivity via VHF, 900 MHz, or hardwire. Portable, battery-operated. No new technologies compared to predicate.

Indications for Use

Indicated for monitoring non-invasive blood pressure, heart/pulse rate, respiration rate, ECG, SpO2, and predictive temperature in adult, pediatric, and neonatal populations. Includes detection of asystole, ventricular tachycardia, and ventricular fibrillation.

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 V2 (K012915)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### 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

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.

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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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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 [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/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:

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.

(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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Cardiovascular Devices

Division of Cardiovascular Devices
510(k) Number K03376