PRESS-MATE ADVANTAGE

K973637 · Colin Medical Instruments Corp. · DXN · Sep 25, 1998 · Cardiovascular

Device Facts

• Record ID: K973637
• Device Name: PRESS-MATE ADVANTAGE
• Applicant: Colin Medical Instruments Corp.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The PressMate Advantage monitors non-invasive blood pressure (NIBP), oxygen saturation (Sp02), ECG, Respiration Rate and Body Temperature of an adult, pediatric, or neonate in a clinical setting

Device Story

PressMate Advantage is a multi-parameter vital signs monitor for clinical use. It acquires physiological data via NIBP cuffs (oscillometric technique), ECG leads, SpO2 sensors (Nellcor technology), and YSI temperature probes. The device processes these inputs to display and optionally print systolic/diastolic/mean blood pressure, pulse rate, oxygen saturation, respiration rate, and body temperature. Operated by clinical staff, the monitor provides real-time physiological data to assist in patient assessment and clinical decision-making. It serves as a comprehensive monitoring solution for various patient populations, including neonates, pediatric, and adult patients.

Clinical Evidence

Bench testing only. The device underwent system-level validation and testing for electrical safety and electromagnetic compatibility (EMC) in accordance with EN 60601 standards. No clinical trial data was provided.

Technological Characteristics

Multi-parameter monitor using oscillometric NIBP, Nellcor SpO2 technology, standard ECG, and YSI temperature probes. System validated for electrical safety and EMC per EN 60601. Form factor is a clinical vital signs monitor with display and optional printer.

Indications for Use

Indicated for monitoring non-invasive blood pressure, SpO2, ECG, respiration rate, and body temperature in adult, pediatric, and neonatal patients in clinical settings.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• PressMate Model 8800 Non-Invasive Blood Pressure Monitor (K951048)
• Escort Model 102 Portable Vital Signs Monitor (K872291)

Submission Summary (Full Text)

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SEP 2 5 1998

K973637

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# 510(K) Summary for The PressMate Advantage

# 1. Date this summary was prepared:

September 15, 1997

#### 2. Submitter's Name and Address:

Colin Medical Instruments Corporation 5850 Farinon Drive San Antonio, Texas 78249

#### 3. Contact Person:

Mr. Mark Rison Senior Director, RA/QA Telephone: [phone] Telefax: 1-210-696-8808

#### 4. Device Name

# Trade/ Proprietary Name:

PressMate Advantage

## Common Name:

Automated Non-Invasive Blood Pressure Monitor / Vital Signs Monitor with / without optional ECG / RR and Sp02

#### Classification Names:

Non- Invasive Blood Pressure Measurement System

#### 5. Predicate Devices

The legally marketed devices to which equivalence is being claimed are:

PressMate Model 8800 Non-Invasive Blood Pressure Monitor K# (K951048) Manufactured by Colin Medical Instruments Corporation

Escort Model 102 K# (K872291) Portable Vital Signs Monitor Manufactured by: Medical Data Electronics Incorporated

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### 6. Device Description

The PressMate Advantage Monitor measures, displays and (optionally) prints the following parameters:

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1. NIBP (systolic, Diastolic, Mean and Pulse Rate)

2. ECG

3. Body Temperature

4. Sp02 ( Oxygen Saturation and Pulse Rate)

#### 7. Intended Use:

The PressMate Advantage monitors non-invasive blood pressure (NIBP), oxygen saturation (Sp02), ECG, Respiration Rate and Body Temperature of an adult, pediatric, or neonate in a clinical setting

### 8. Comparison of Technological Characteristics:

The PressMate Advantage uses the standard oscillometric technique for obtaining. NIBP Nellcor Sp02 technology for Oxygen saturation, standard ECG technology and YSI temperature probes.

## 9. Nonclinical Tests Used in Determination of Substantial Equivalence:

The design of the PressMate Advantage has been thoroughly validated at the unit and system level. Non-clinical tests were conducted to determine the complete system and has been tested to the electrical safety requirements and the Electromagnetic Compatibility requirements of EN 60601.

## 10. Conclusions From Nonclinical Testing:

The testing of the PressMate Advantage demonstrates that the performance is substantially equivalent to predicate devices cited above.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern. The logo is black and white.

SEP 2 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Howard K. Mann Sr. Director QA/RA Colin Medical Instruments Corp. 5850 Farinon Drive University Technology Park San Antonio, TX 78249

Re: K973637 Press-Mate Advantage Requlatory Class: II (Two) Product Code: DXN Dated: June 30, 1998 Received: July 2, 1998

Dear Mr. Mann:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Howard K. Mann

This letter will allow you to begin marketing your device as described in your 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 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Intended Use

Device Name: PressMate Advantage

## Indications For Use:

The PressMate Advantage monitors non-invasive blood pressure (NIBP), Oxygen saturation (Sp02), ECG, Respiration Rate and Body Temperature of an Adult, Pediatric or Neonate in the clinical setting.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Bette E. Cooper Ce

ivision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

OR

Prescription Use 1 (Per 21 CFR 801.109)

Over-the Counter Use