COLIN PRESS MATE, MODEL BP S510

K063690 · Omron Healthcare, Inc. · MHX · May 9, 2007 · Cardiovascular

Device Facts

• Record ID: K063690
• Device Name: COLIN PRESS MATE, MODEL BP S510
• Applicant: Omron Healthcare, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: May 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Colin Press Mate, Model BP S510 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), body temperature (Temp), invasive blood pressure (IBP) and capnography (EtCO2 and InCO2 ). The intended patient populations are: adults and pediatrics of at least 14 years of age and weighing more than 35 kg and infants can only be monitored with the oscillometric cuff. Environment of use: All areas of a hospital and hospital type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.

Device Story

Colin Press Mate BP S510 is a multi-parameter patient monitor; inputs include ECG leads, NIBP cuffs, SpO2 sensors, temperature probes, IBP transducers, and capnography sampling lines. Device processes physiological signals to provide real-time monitoring of vital signs; outputs displayed on integrated screen for clinical review. Used in hospital environments (OR, ICU, general care) and hospital-type facilities (sleep labs, surgical centers) by doctors, nurses, or technicians. Provides continuous monitoring to assist clinicians in assessing patient status and making timely clinical decisions; benefits include early detection of physiological changes and improved patient safety through continuous surveillance.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Multi-parameter monitor for ECG, NIBP, SpO2, PR, RR, Temp, IBP, and capnography. Features oscillometric NIBP measurement. Form factor is a bedside monitor unit. Connectivity and specific software architecture details not provided.

Indications for Use

Indicated for monitoring ECG, HR, NIBP, SpO2, PR, RR, Temp, IBP, and capnography in adults and pediatrics ≥14 years old and >35 kg; infants limited to oscillometric cuff monitoring. Used in hospitals and hospital-type facilities by skilled clinicians.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2007

Mr. Ranndy Kellogg Vice President Marketing and Medical Sales Omron Healthcare, Incorporated 1200 Lakeside Drive Bannockburn, Illinois 60015

Re: K063690

Trade/Device Name: Colin Press Mate, Model BP S510 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia, Detector and Alarm (including ST-Segment Measurement and Alarm) Regulatory Class: II Product Code: MHX, DSK, DPS, DXN, DQA and CCK Dated: April 12, 2007 Received: April 13, 2007

Dear Mr. Kellogg:

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. Kellogg

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 vour 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

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## Indications for Use Statement

Page 1 of 1

510(k) Number:

K063690

Device Name:

Colin Press Mate, Model BP S510

Indications for Use:

The Colin Press Mate, Model BP S510 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), body temperature (Temp), invasive blood pressure (IBP) and capnography (EtCO2 and InCO2 ).

The intended patient populations are: adults and pediatrics of at least 14 years of age and weighing more than 35 kg and infants can only be monitored with the oscillometric cuff.

Environment of use: All areas of a hospital and hospital type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.

Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.

Prescription Use XX (Part 21 CFR 801 Subpart D) Over-the-counter use __ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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