TRUSCOPE SERIES PATIENT MONITOR

{0}------------------------------------------------ ## K131763 b 1/5 # JUL 1 5 2013 # Section 3 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) Number: - 1. Date of Prepared: May. 15, 2013 - Sponsor 2. Guangdong Biolight Meditech Co., Ltd Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China Establishment Registration Number: 3007305624 Contact Person: Mr. Tianbao Li, Chief Engineer T: +86-756-3399963 F:+86-756-3399989 E:li_tb@blt.com.cn - 3. Submission Correspondent Diana Hong & Tarzan. Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net {1}------------------------------------------------ #### K131763 P 2/5 #### Proposed Device Identification 4. Proposed Device Name: Truscope Patient Monitors Device Common Name: Patient Monitors Proposed Device Model: Truscope Elite A8, Truscope Elite A6, Truscope Elite A5, Truscope Elite A3, Truscope Classic, Truscope II, and Truscope MINI; Classification: | Regulation No. | Classification Name. | Product Code | Device Class | |--------------------------|----------------------------------------------------------------------------|--------------|--------------| | Main Code | | | | | 21 CFR 870.1025 | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | DSI | Class II | | Subsequent Product Codes | | | | | 21 CFR 870.1025 | Detector and Alarm, Arrhythmia | DSI | Class II | | 21 CFR 870.1025 | Monitor, ST Segment with Alarm | MLD | Class II | | 21 CFR 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm) | DRT | Class II | | 21 CFR 870.1130 | Non-invasive blood pressure measurement system | DXN | Class II | | 21 CFR 870.1110 | Blood pressure computer | DSK | Class II | | 21 CFR 880.2910 | Clinical Electronic Thermometers - Temperature Monitor with Probe | FLL | Class II | | 21 CFR 870.2700 | Oximeter, Pulse | DQA | Class II | | 21 CFR 868.1400 | Carbon Dioxide Gas Analyzer | CCK | Class II | | 21 CFR 868.1500 | Enflurane gas analyzer | CBQ | Class II | | 21 CFR 868.1620 | Halothane gas analyzer | CBS | Class II | | 21 CFR 868.1700 | Nitrous Oxide gas analyzer | CBR | Class II | | 21 CFR 868.1720 | Oxygen gas analyszer | CCL | Class II | | 21 CFR 882.1400 | Electroencephalograph | GWQ | Class II | | 21 CFR 870.2770 | Impedance plethysmograph | DSB | Class II | #### Table I-1 Classification of Truscope Patient Monitors Intended Use Statement: #### Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3 The Truscope series patient monitors (Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead {2}------------------------------------------------ K131763 P 3/5 selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG) and Cerebral State Index (CSI). The arrhythmia detection, ST segment analysis only applied to a single adult patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use. #### Truscope II and MINI Truescope Series Patient Monitor (Truscope II and MINI) is intended to be used for monitoring. displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. Truescope Series Patient Monitor (Truscope II and MINI) is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance. Note: Truscope MINI does not have functions of Invasive Blood Pressure and Carbon Dioxide #### Truscope Classic Truescope Series Patient Monitor (Truscope Classic) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2). Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance. - Predicate Device Identification 5. 510(k) Number: K120193 {3}------------------------------------------------ #### K 131763 P 4/5 #### Predicate Device Name: ANY VIEW PATIENT MONITORS ANY VIEW A6, ANY VIEW A8, ANYVIEW A3, ANY VIEW A5 Manufacturer: Guangdong Biolight Meditech Co., Ltd 510(k) Number: K102040 Predicate Device Name: PATIENT MONITOR ANY VIEW A6, ANY VIEW A8, M9500 Manufacturer: Guangdong Biolight Meditech Co., Ltd 510(k) Number: K100046 Predicate Device Name: M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 Manufacturer: Guangdong Biolight Meditech Co., Ltd #### Device Description 6. The proposed device Truscope Patient Monitor is change from the Paitent Monitor manufactured by Guangdong Biolight Meditech Co., Ltd, all models included in this submission has exactly same design, materials, and manufacture process with their original model, only different is the model name and device name. The relationship between with the Truscope Patient Monitor and their original model matrix table list as following: | Truscope Patient Monitor Model | Original Patient Monitor Model | |--------------------------------|--------------------------------| | Truscope Elite A8 | ANY VIEW A8 (K120193) | | Truscope Elite A5 | ANY VIEW A6 (K120193) | | Truscope Elite A6 | ANY VIEW A5 (K120193) | | Truscope Elite A3 | ANY VIEW A3 (K120193) | | Truscope Classic | M9500 (K102040) | | Truscope II | M69 (K100046) | | Truscope MINI | M7000 (K100046) | #### 7. Non-Clinical Test Conclusion Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: {4}------------------------------------------------ K131763 P 5/5 - IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; a) Amendment 1, 1991-11, Amendment 2, 1995. - b) IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests. - AAMI EC13:2002, Cardiac monitors, heart rate meters, and alarms; c) - AAMI EC57:1998/(R) 2008, Testing and reporting performance results of cardiac rhythm and d) ST-segment measurement algorithms. - AAMI SP10:2002/ A1:2003 (R) 2008, Manual, electronic or automated sphygmomanometers; e) - () ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use; - 8. Technological Characteristics Comparison There are any differences between proposed device and predicate except model name. - 9. Substantially Equivalent Conclusion The proposed device, Truscope Patient Monitors, are determined to be Substantially Equivalent (SE) to the predicate device, ANY VIEW PATIENT MONITORS (K120193), PATIENT MONITOR ( K102040) and M SEIRES PATIENT MONITOR (K100046) in respect of safety and effectiveness. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the bird. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 July 15, 2013 Guangdong Biolight Meditech Co., Ltd. c/o Ms. Diana Hong General Manager P.O. Box 120-119 Shanghai. 200120 CH Re: K131763 > Trade/Device Name: Truscope Series Patient Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (With Arrhythmia Detection Or Alarms) Regulatory Class: Il (two) Product Code: MHX, DSI, MLD, DRT, DXN, DSK, FLL. DQA, CCK, CBQ, CBR. CBS, CCL, CWQ. DSB Dated: June 9, 2013 Received: June 17, 2013 Dear Ms. Diana Hong: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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. {6}------------------------------------------------ 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, OwenPFAaris-S for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### K131763 #### b 1/3 # Indication for Use Statement 510(k) Number: Device Name:Truscope Patient Monitor/Model: Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3 Indications for Use: Truscope Elite A8, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3 The Truscope series patient monitors (Truscope Elite A6, Truscope Elite A6, Truscope Elite A5 and Truscope Elite A3) is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG (3-lead or 12-lead selectable), arthythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG) and Cerebral State Index (CSI). The arrhythmia detection, ST segment analysis only applied to a single adult patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use. XPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------------------| | Digitally signed by Owen P. | | | Date: | 2013.07.15 10:39:59 | | | -04'00' | II-1 {8}------------------------------------------------ Project #:M0162012B Page I of 3 K131763 P 2/3 #### 510(k) Number: Device Name: Truscope Patient Monitor/Model: Truscope II and MINI Indications for Use: #### Truscope II and MINI Truescope Series Patient Monitor (Truscope II and MINI) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. Truescope Series Patient Monitor (Truscope II and MINI) is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance. Note: Truscope MINI does not have functions of Invasive Blood Pressure and Carbon Dioxide #### ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) - ## OVER-THE-COUNTER USE (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) #### Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by Owen Paris Date: 2013.07.15 10:40:28 -04'00' Page 2 of 3 II-2 {9}------------------------------------------------ K 131763 P 3/3 510(k) Number: Device Name:Truscope Patient Monitor/Model: Truscope Classic Indications for Use: Truscope Classic Truescope Series Patient Monitor (Truscope Classic) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance. OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) ### OVER-THE-COUNTER USE (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by Owen . R. Faris: S Date: 2013.07.15 10:40:49 -04'00' Page 3 of 3