DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400

K014255 · Ge Medical Systems Information Technologies · MWI · Jul 2, 2002 · Cardiovascular

Device Facts

• Record ID: K014255
• Device Name: DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DINAMAP® ProCare Series Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

Device Story

Portable vital signs monitor; inputs include NIBP (oscillometric/auscultatory), pulse rate, SpO2, and temperature sensors. Device processes signals via integrated algorithms; outputs vital signs data to integrated printer and display. Used in clinical settings (emergency, recovery, etc.) by healthcare professionals for bedside or intra-hospital transport monitoring. Provides real-time physiological data to assist clinicians in patient assessment and decision-making. Benefits include continuous or spot-check monitoring of patient status.

Clinical Evidence

Bench testing only. Testing included AAMI/ANSI SP10 compliance for NIBP, mechanical and environmental testing, electromagnetic compatibility, battery power, and electrical safety.

Technological Characteristics

Portable monitor with integrated printer; AC or lead-acid battery power. Parameters: NIBP (oscillometric/auscultatory), SpO2 (Masimo technology), thermometry (Alaris technology). Complies with AAMI/ANSI SP10 for NIBP.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring monitoring of vital signs (NIBP, pulse rate, SpO2, temperature) in clinical settings including hospitals, physicians' offices, and alternate care environments.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• DINAMAP® Pro Series Monitor 100-400 (K992638)
• Welch Allyn Vital Signs Monitor (K951193)
• Masimo SET Pulse Oximeter (K992238)
• Alaris Medical System (K955846)

Submission Summary (Full Text)

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K0/4255

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a circle, and there are three stylized swirls or flourishes spaced evenly around the perimeter of the circle.

JUL = 2 2002

GE Medical Systems Information Technologies

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

#### SUMMARY OF SAFETY AND EFFECTIVENESS Dec 21, 2001

# DINAMAP® ProCare Series Monitor

# A. Submitter

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

# B. Company Contact

Thomas J English Director, Regulatory Affairs Phone: [phone] Fax: [phone]

# C. Common Name

Physiological or Vital Signs Monitor, Patient Monitor

| Classification Name | Product Code | 21 CFR |
|--------------------------------------------------|--------------|----------|
| System, Measurement, Blood Pressure, Noninvasive | DXN | 870.1130 |
| Computer, Blood Pressure | DSK | 870.1110 |
| Alarm, Blood Pressure | DSJ | 870.1100 |
| Oximeter | DQA | 870.2700 |
| Oximeter, Ear | DPZ | 870.2710 |
| Thermometer, Clinical Electronic | FLL | 880.2910 |
| Recorder, Paper Chart | DSF | 870.2810 |

## D. Predicate/Legally Marketed Devices

DINAMAP® Pro Series Monitor 100-400-K992638 Critikon Company, LLC

Welch Allyn Vital Signs Monitor-K951193 Welch Allyn Protocol/Tycos Industries Inc.

## E. Device Description

The DINAMAP ProCare Series Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:

- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate ●
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry o
- . DPC XXX: Non-invasive Blood Pressure and Pulse Rate, Temperature
- DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry ● and Temperature.

00010

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This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.

### F. Intended Use

The DINAMAP® ProCare Series Monitor is intended to monitor a single adult. pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

# G. Technological Characteristics

The DINAMAP® ProCare Series Monitor has the same technological characteristics as the predicate device, the DINAMAP® Pro Series 100-400 Monitor. There are no new technologies used on the DINAMAP® ProCare Series Monitor.

## H. Parameter Technology

The DINAMAP® ProCare Series Monitor has the following parameter technologies: •NIBP oscillometric algorithm wholly implemented from the DINAMAP Pro Series 100- 400 Monitor or an NIBP ascultatory algorithm tested according to the ANSI/AAMI SP10 standard..

- · Wholly implemented Alaris thermometry technology
- · Wholly implemented Masimo SpO2 technology

#### I. Testing

Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® ProCare Series Monitor:

- · AAMI/ANSI SP10
- · Mechanical and Environmental
- · Electromagnetic Compatibility
- · Battery Power
- · Electrical Safety

#### K. Substantial Equivalence

| ProCare Series | Predicate Device & Model | 510(k) Numbers |
|----------------|-----------------------------------|----------------|
| Monitor | DINAMAP Pro Series 100-400 | K992638 |
| SpO2 | •Masimo SET Pulse Oximeter | K992238 |
| Temperature | Alaris Medical System | K955846 |
| NIBP | •DINAMAP Pro Series 100-400 | K992638 |
| | • Welch Allyn Vital Signs Monitor | K951193 |

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2002

GE Medical Systems Information Technologies c/o Mr. Thomas English Director, Regulatory Affairs 4502 Woodland Corporate Blvd. Tampa, FL 33614

Re: K014255

Trade Name: DINAMAP® ProCare Series Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without Arrhythmia Detection) Regulatory Class: Class II (two) Product Code: MWI Dated: April 2, 2002 Received: April 3, 2002

Dear Mr. English:

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.

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### Page 2 - Mr. Thomas 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dosen Teh

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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December 21, 2001

Page 1 of 1

510(K) Number (if known): K014255

Device Name: DINAMAP® ProCare Series Monitor

Indications for Use:

The DINAMAP® ProCare Series Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/ surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Or

Over-The Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

DeVittur

510(k) Number

00008