TRIO MONITOR MODEL 0998-00-0600

K032338 · Datascope Corp. · MWI · Feb 11, 2004 · Cardiovascular

Device Facts

• Record ID: K032338
• Device Name: TRIO MONITOR MODEL 0998-00-0600
• Applicant: Datascope Corp.
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 11, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Trio monitor is intended for hospital use 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 but is not restricted to: electrocardiogram, invasive blood pressure, heart rate (derived from ECG and SpO2) noninvasive blood pressure, pulse oximetry, respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed.

Device Story

Trio Monitor is a multi-parameter patient monitor for hospital use; operated by clinicians. Inputs include ECG (3/5-lead), temperature, SpO2, invasive blood pressure, non-invasive blood pressure, and respiration. Device processes these signals to provide real-time digital and waveform displays; includes built-in thermal recorder for hard copies of data, waveforms, and trends. Used in clinical environments (rolling stand, wall mount, bed rail, or tabletop). Output allows clinicians to observe patient status, track trends, and make informed clinical decisions. Benefits include continuous physiological monitoring to assist in patient care management.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including requirements specification review, hardware and software testing, code design/reviews, environmental testing, safety testing, performance testing, and risk analysis. Validation confirmed performance equivalent to the predicate device.

Technological Characteristics

Multi-parameter monitor (3 or 4 trace). Parameters: ECG, Temp, SpO2, IBP, NIBP, Respiration. Form factor: rolling stand, wall mount, bed rail, or tabletop. Includes thermal recorder. Software-based processing for digital/waveform display and trend storage. Connectivity: standalone monitor.

Indications for Use

Indicated for adult and pediatric patients in hospital settings under direct supervision of licensed healthcare practitioners for monitoring ECG, invasive/noninvasive blood pressure, heart rate, pulse oximetry, respiration, and temperature. Not intended 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.

Predicate Devices

• GE Medical Systems Dash 2000 Pro Patient Monitor

Submission Summary (Full Text)

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FEB 1 1 2004

## 510(k) Summary of Safety and Effectiveness

| Date: | July 22, 2003 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Patient Monitoring Division<br>Datascope Corp. |
| Contact Person: | Susan E. Mandy<br>Director, Clinical & Regulatory Affairs<br>Patient Monitoring Division<br>Datascope Corp.<br>Telephone: [phone]<br>Fax:[phone] |

Device trade name: Trio Monitor

Common/usual name: Physiological Patient Monitor

## Classification name:

| 21 CFR 870.1100 | Blood pressure alarm |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 21 CFR 870.1130 | Noninvasive blood pressure measurement systems |
| 21 CFR 870.1110 | Blood pressure computer |
| 21 CFR 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm) |
| 21 CFR 870.2340 | Electrocardiograph |
| 21 CFR 870.2700 | Oximeter |
| 21 CFR 880.2910 | Clinical electronic thermometers |
| Predicate Device: | GE Medical Systems Dash 2000 Pro Patient Monitor |
| Device Description: | Mindray Bio-Medical Co. Ltd., previously known as Caymans Mindray<br>Medical Electronic Company of Shenzen, China, manufactures the Trio<br>monitor for Datascope Corp.<br><br>The Trio monitor is a three or four trace patient monitor that can be<br>mounted on a rolling stand, wall mount bracket, bed rail, or operated as a<br>tabletop device. The patient parameters that can be monitored on the Trio<br>are: ECG (3-lead or 5- lead selectable), Temperature, SpO2, Invasive<br>Blood Pressure, Respiration and Non-Invasive Blood Pressure. Digital<br>displays are provided for Heart Rate, Pulse Rate, Pulse Oximetry, Non-<br>Invasive Blood Pressure, Respiration Rate, Invasive Blood Pressure<br>(optional) and Temperature. Waveform displays are provided for ECG, |

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| built-in thermal recorder provides hard copies of all digital data and<br>waveforms, as well as Tabular and Graphic Trend information. | |
|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Trio monitor is intended for hospital use under the direct supervision<br>of a licensed healthcare practitioner. The intended use of the monitor is to<br>monitor physiologic parameter data on adult and pediatric patients.<br>Physiologic data includes but is not restricted to: electrocardiogram,<br>invasive blood pressure, heart rate (derived from ECG and SpO2)<br>noninvasive blood pressure, pulse oximetry, respiration and temperature as<br>summarized in the operating instructions manual. The information can be<br>displayed, stored, trended and printed. |
| Technology: | The Trio monitor employs the same functional technology as the predicate<br>device. |
| Test Summary | The Trio monitor complies with the voluntary standards identified in<br>section six of this submission. During the development process of the Trio<br>monitor, the following activities were completed: |
| | Requirements specification review |
| | Hardware and software testing |
| | Code design and code reviews |
| | Environmental testing |
| | Safety testing |
| | Performance testing |
| | Risk Analysis |
| | Hardware and Software validation |
| Conclusion | The results of these measurements demonstrated that the Trio monitor is as<br>safe, as effective and performs as well as the predicate device. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2004

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

Re: K032338 Trade Name: Trio™ Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: December 23, 2003 Received: December 24, 2003

Dear Ms. Mandy:

We have reviewed your Section 510(k) premarket notification of intent to market the arrived inte we nave reviewed your becamined 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 encrosule) to regally to regally the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the United in AMA devices that have been reclassified in access approval of a premarket approval application (PMA). and Costience Act (Act) that do not require approvial controls provisions of the Act. The You may, therefore, market the devrees, bacjes to the morements for annual registration, listing of general controls provisions of the free, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to such additional controlier 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peacharting your device in the Federal Register.

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Page 2 - Ms. Susan Mandy

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), 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 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 vours.

Dana P. Vochner

( 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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## Indications for Use

510(k) Number (if known): K032338

Device Name:

Indications For Use:

## INDICATION FOR USE STATEMENT

The Trio™ monitor is intended for hospital use 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, noninvasive blood pressure, pulse oximetry, heart rate (derived from ECG or SpO2), 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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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)

Dung R. Laune 1

(Division Sign-Off) Division of Cardiovascular Devices

610(k) Number_K032338

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