TRIO MONITOR

K051897 · Datascope Corp. · MWI · Aug 12, 2005 · Cardiovascular

Device Facts

• Record ID: K051897
• Device Name: TRIO MONITOR
• Applicant: Datascope Corp.
• Product Code: MWI · Cardiovascular
• Decision Date: Aug 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Trio™ monitor is intended for use in healthcare settings under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, non-invasive blood pressure (NIBP), pulse oximetry, heart rate (derived from ECG, SpO2 or NIBP), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor

Device Story

Trio Monitor is a multi-parameter physiologic monitor for clinical settings; operated by licensed healthcare practitioners. Inputs include ECG leads, blood pressure cuffs (invasive/non-invasive), SpO2 sensors, and temperature probes. Device processes these signals to derive heart rate, respiration, and vital signs; displays, stores, trends, and prints data for clinician review. Output assists clinicians in real-time patient assessment and monitoring. Benefits include continuous physiologic tracking to support clinical decision-making in hospital environments.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Physiologic monitor for ECG, IBP, NIBP, SpO2, heart rate, respiration, and temperature. Class II device (21 CFR 870.2300). Product code MWI. Designed for clinical/hospital use; not for home use.

Indications for Use

Indicated for adult and pediatric patients in healthcare settings requiring monitoring of ECG, invasive/non-invasive blood pressure, pulse oximetry, heart rate, respiration, and temperature. Not indicated for home use or as an apnea monitor.

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.

Submission Summary (Full Text)

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AUG 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Datascope Corp. c/o Ms.Susan E. Mandy Director, Clinical and Regulatory Affairs 800 MacArthur Blvd. Mahwah, NJ 07430

Re: K051897 Trade Name: Trio Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Monitor, Physiologic, Patient (without Arrhythmia) Regulatory Class: Class II (two) Product Code: MWI Dated: July 12, 2005 Received: July 13, 2005

Dear Ms. Mandy,

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becares and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to connisted pror to they 2011-12-11 accordance with the provisions of the Federal Food, Drug, de necs that have been resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, therefore, mains of the Act include requirements for annual registration, listing of general controls proficiouring 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 may oc subject to back access as a 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 – Ms. Susan E. Mandy

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must or any I odotal 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 CI K rut 0077, accems (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) I ma letter notification. The FDA finding of substantial equivalence of your device to a legally promation hoticated wice 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 other Economics 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,

B. Zimmtman for

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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## Indication for Use

Kos1897 510(k) Number (if known):

Trio Monitor Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

## INDICATION FOR USE STATEMENT

The Trio™ monitor is intended for use in healthcare settings under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, non-invasive blood pressure (NIBP), pulse oximetry, heart rate (derived from ECG, SpO2 or NIBP), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed.

The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blommer

(Division Sign-Off) Division of Cardloyascular Devices 510(k) Number