TRIO MONITOR

{0}------------------------------------------------ K041907 page 1 of 3 # JUL 2 3 2004 ## 510(k) Summary of Safety and Effectiveness | Date: | June 10, 2004 | |-----------------|------------------------------------------------| | Submitter: | Patient Monitoring Division<br>Datascope Corp. | | Contact Person: | Susan E. Mandy | | | Director, Clinical & Regulatory Affairs | | | Patient Monitoring Division | | | Datascope Corp. | | | Telephone: (201) 995-8025 | | | Fax: (201) 995-8605 | 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 | - Device Description: Mindray Bio-Medical Co. Ltd., previously known as Caymans Mindray Medical Electronic Company of Shenzen, China, manufactures the Trio monitor for Datascope Corp. {1}------------------------------------------------ ### Background: The FDA cleared the Trio monitor to market under 510(k) K032338 on February 11, 2004. Datascope Corp. has modified the Trio monitor to include Heart Rate derived from Non-Invasive Blood Pressure. Datascope has also made some minor modifications to the Trio monitor as a result of feedback received from both domestic and international customers, and from an October 2002 focus group, referenced on page 228 of K032338, submitted to the FDA on July 28, 2003. These modifications include the replacement of the "Freeze" key with a "Normal Screen" key, minor user interface display formatting modifications, e.g., changes to fonts, colors, screen layout, as well as user preferred default selections. #### Purpose: The ability to derive Heart Rate from the Non-Invasive Blood Pressure parameter is the subject of this 510(k) submission. In the previous Trio submission, Heart Rate was derived from ECG and SpO2. The description of the Trio monitor remains the same as in the original 510(k) K032338, submitted to the FDA, July 28, 2003 and is provided below. Datascope Corp. incorporates by reference Trio monitor 510(k) submission K0323338. The Trio monitor is a three or four trace patient monitor that can be mounted on a rolling stand, wall mount bracket, bed rail, or operated as a tabletop device. The patient parameters that can be monitored on the Trio are: ECG (3-lead or 5- lead selectable), Temperature, SpO2, Invasive Blood Pressure, Respiration and Non-Invasive Blood Pressure. Digital displays are provided for Heart Rate, Pulse Rate, Pulse Oximetry, Non-Invasive Blood Pressure, Respiration Rate, Invasive Blood Pressure (optional) and Temperature. Waveform displays are provided for ECG, Pleth, Invasive Blood Pressure (optional) and Respiration. The optional built-in thermal recorder provides hard copies of all digital data and waveforms, as well as Tabular and Graphic Trend information. #### 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. {2}------------------------------------------------ The Trio monitor employs the same functional technology as the predicate Technology: devices. The Trio monitor complies with the voluntary standards identified in Test Summary: section six of this submission. During the development process of the Trio monitor described in K032338, 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 . Testing and documentation, related to the ability of the Trio monitor to derive Heart Rate from Non-Invasive Blood Pressure, is included in this 510(k) submission, sections five, seven, and eight. #### The results of these measurements demonstrated that the Trio monitor is as Conclusion: safe, as effective and performs as well, as the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 3 2004 Datascope Corp. c/o Mr. Bahram Barzideh Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747 Re: K041907 Trade Name: Trio Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: 21 OF CF 81 8126 including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI -Dated: July 13, 2004 Received: July 15, 2004 Dear Mr. Barzideh: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave usements of a legally marketed predicate devices marketed in interstate for use stated in the encrobate) to regionent date of the Medical Device Amendments, or to commerce phor to may 20, 1978, are excerdance with the provisions of the Federal Food, Drug, devices mat nave been receasined trequire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereloro, manes of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is elassified (600 a00 rols. Existing major regulations affecting your device can Inay be subject to sach adational cegulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 – Mr Bahram Barzideh Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1271 3 lossanted or our device complies with other requirements of the Act that TDA has made a determinations administered by other Federal agencies. You must of ally Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act stequirements, morealing, and manufacturing practice requirements as set CFK Part 807), falcing (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control providens (esting your device as described in your Section 510(k) I ms letter will anow you to oegin maning of substantial equivalence of your device to a legally premarket nothleadon. The PDA mailing of baction 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 If you desire specific advice for Jour act (301) 594-4648. Also, please note the regulation entitled, Colliact the Office of Compilance market notification" (21CFR Part 807.97). You may obtain Misoranumly by reference to prenessibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Neil Ry Ogl for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K041907 # Indication for Use 510(k) Number (if known): K041907 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) Neil L. Ogden ivision of Cardiovascular Devices 510(k) Number K041907