DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N

K022193 · Ge Medical Systems Information Technologies · DQA · Aug 1, 2002 · Cardiovascular

Device Facts

• Record ID: K022193
• Device Name: DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 1, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The DINAMAP® ProCare Series 100N-400N Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intrahospital 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 stepdown. It can also be used in satellite areas, physicians' offices, or alternate care settings.

Device Story

Portable vital signs monitor; provides NIBP, pulse rate, SpO2, and temperature monitoring. Inputs: NIBP cuffs, pulse oximetry sensors, and temperature probes. Operation: utilizes established NIBP algorithms, Alaris IVAC Turbo thermometry, and Nellcor N-595 SpO2 technology. Output: real-time vital signs displayed on screen and via integrated printer. Used in hospital departments (emergency, recovery, etc.) and physician offices by healthcare professionals. Facilitates patient assessment during bedside monitoring or intrahospital transport; supports clinical decision-making through continuous or spot-check vital sign data.

Clinical Evidence

Bench testing only. Studies included electromagnetic compatibility, electrical safety, and mechanical/environmental testing to demonstrate safety and effectiveness.

Technological Characteristics

Portable monitor with integrated printer; AC mains or internal lead-acid rechargeable battery. Parameters: NIBP (proprietary algorithm), Alaris IVAC Turbo thermometry, Nellcor N-595 SpO2. No new technologies compared to predicate. Standalone device.

Indications for Use

Indicated for monitoring vital signs (NIBP, pulse rate, SpO2, temperature) in adult, pediatric, and neonatal patients in clinical settings including bedside, intrahospital transport, emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac stepdown, and physician offices.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• DINAMAP ProCare Series (K014255)
• Nellcor N-595 Pulse Oximeter (K012891)
• Alaris Medical System (K955846)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are decorative swirls or flourishes around the letters, adding a touch of elegance to the design. The logo is in black and white.

K022193

GE Medical Systems Information Technologies

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

#### SUMMARY OF SAFETY AND EFFECTIVENESS July 3, 2002

# DINAMAP® ProCare Series 100N-400N Monitor

#### A. Submitter

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

#### B. Company Contact

Primary: Melissa Robinson Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

#### Secondary:

Tom English Global QA/RA 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® ProCare Series Monitor -K014255 GE Medical Systems Information Technologies

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# E. Device Description

The DINAMAP ProCare Series 100N-400N 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 100N: Non-Invasive Blood Pressure and Pulse Rate .
- DPC 200N: Non-Invasive Blood Pressure and Pulse Rate, Temperature .
- DPC 300N: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry .
- DPC 400N: Non-Invasive Blood Pressure and Pulse Rate. Pulse Oximetry . and Temperature.

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 100N-400N Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intrahospital 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 stepdown. It can also be used in satellite areas, physicians' offices, or alternate care settings.

## G. Technological Characteristics

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

## H. Parameter Technology

The DINAMAP® ProCare Seies 100N-400N Monitor has the following parameter technologies:

- ·NIBP algorithm as implemented on the ProCare Series Monitor
- ·Alaris IVAC Turbo thermometry technology as implemented on the ProCare Series Monitor
- · Wholly implemented Nellcor N-595 SpO2 technology

# I. Testing

Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® ProCare Series 100N-400N Monitor:

- · Electromagnetic Compatibility
- · Electrical Safety
- Mechanical and Environmental

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# K. Substantial Equivalence

| ProCare Series 100N-<br>400N | Predicate Device & Model | 510(k)<br>Numbers |
|------------------------------|------------------------------|------------------------|
| | Monitor | DINAMAP ProCare Series |
| Pulse Oximetry | Nellcor N-595 Pulse Oximeter | K012891 |
| Temperature | Alaris Medical System | K955846 |
| NIBP | DINAMAP ProCare Series | K014255 |

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Image /page/3/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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

AUG 01 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Melissa Robinson Regulatory Affairs Specialist GE Medical Systems Information Technologies 4502 Woodland Corporation Boulevard Tampa, Florida 33614

Re: K022193

Trade/Device Name: DINAMAP® ProCare Series 100-400N Monitor Regulation Number: 870.2700 and 870.2300 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA and MWI Dated: July 3, 2002 Received: July 5, 2002

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 vour 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 or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Ms. Robinson

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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timoth A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

KO22193 510(k) Number (if known):

Device Name: DINAMAP® ProCare Series 100N-400N Monitor

Indications for Use:

The DINAMAP® ProCare Series 100N-400N 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 temperature and/or oxygen saturation (pulse oximetry). 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 (per 21 CFR 801.109

-------------------------

OR

Over-The Counter Use (Optional Format 1-2-96)

A.W. Anderson

(Sivision Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_KOzz193

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