M SERIES PATIENT MONITOR

{0}------------------------------------------------ ## 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 Title 21, CFR Section 807.92. The assigned 510(k) Number: K131876 l. Date of Submission: 06/08/2013 2. Sponsor Identification > Guangdong Biolight Meditech Co., Ltd. No.2 Innovation First Road, Technical Innovation Coast, Hi-tech Zone, Zhuhai, P.R. China Establishment Registration Number: 3007305624 Contact Person: Jin Liang Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang j@blt.com.cn Submission Correspondent 3. > Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net {1}------------------------------------------------ #### 4. Proposed Device Identification Proposed Device Name: M Series Patient Monitor Proposed Device Model: M66, M69, M7000. M8000 and M9000 Proposed Device Common Name: Patient Monitor Regulatory Information: Classification Name: Monitor, Physiological, Patient; Classification: II: Product Code: MHX: Regulation Number: 21 CFR 870.1025; Review Panel: Cardiovascular; Subsequent Product Code: | Product<br>Code | Regulation<br>Number | Classification Name | Panel | |-----------------|----------------------|--------------------------------------------------------|------------------| | DRT | 870.2300 | Monitor, Cardiac (incl. cardiotachometer & rate alarm) | Cardiovascular | | DXN | 870.1130 | System, Measurement, Blood-pressure, Non-invasive | Cardiovascular | | DSK | 870.1110 | Computer, Blood-pressure | Cardiovascular | | DQA | 870.2700 | Oximeter | Anesthesiology | | BZQ | 868.2375 | Monitor, Breathing Frequency | Anesthesiology | | CCK | 868.1400 | Analyzer, Gas, Carbon-Dioxide, Gaseous-phase | Anesthesiology | | FLL | 880.2910 | Thermometer, Electronic, Clinical | General Hospital | Intended Use Statement: M Series Patient Monitor is intended to be used for monitoring, displaying, 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 monitor 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: M7000 does not have functions of Invasive Blood Pressure and Carbon Dioxide. {2}------------------------------------------------ - Predicate Device Identification 5. 510(k) Number: K100046 Product Name: M Series Patient Monitor Manufacturer: Guangdong Biolight Meditech Co., Ltd. 510(k) Number: K053269 Product Name: MASIMO SET RAD-8 PULSE OXIMETER Manufacturer: Masimo Corporation - 6. Device Description The proposed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000, are modification devices to the existed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000 as cleared in K100046 at 04/08/2010. The proposed devices and the existed devices share same intended use, design principle and technical specifications. The main modification of the proposed devices is adding a SpO2 module, which was designed and manufactured by Masimo Corporation and previously cleared by FDA in K053269 at 12/21/2005. It is an independent module installed within the patient monitor, without any other modifications, and shall be used with the specified accessories, which are listed in following table. | ITEM | Accessory | Reusable/Disposable | Population | Type | |---------------|-----------------|---------------------|------------|------| | DCI / 2501 | SpO2 Sensor | Reusable | Adult | Clip | | DCIP / 2502 | SpO2 Sensor | Reusable | Pediatric | Clip | | Neo / 2514 | SpO2 Sensor | Disposable | Infant | Wrap | | M-LNC1 / 2523 | Extension Cable | N.A. | N.A. | N.A. | Table 3-1 Accessories of Masimo SpO2 Module #### 7. Non-Clinical Test Conclusion Non clinical 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: ISO 14971:2007 Medical devices -- Application of risk management to medical devices; IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995; IEC 60601-1-2, (Edition 2:2001 with Amendment 1:2004), Medical Electrical Equipment - Part 1-2: {3}------------------------------------------------ General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests: ISO 9919:2005: Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. Substantially Equivalent (SE) Conclusion 8. · The following table compares the DEVICE to the predicate device with respect to intended use. technological characteristics and principles of operation, etc. {4}------------------------------------------------ | | Item | Proposed Devices | Predicate Device | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | | Product Code | M Series Patient Monitor | K100046 | | | | MHX | Same | | | Regulation No. | 21 CFR 870.1025 | Same | | | Class | Class II | Same | | | Intended Use | M Series Patient Monitor is intended to be used for<br>monitoring, displaying, reviewing, storing and<br>alarming of multiple physiological parameters<br>including ECG. Heart Rate (HR). Respiration Rate<br>(RESP). Pulse Oxygen Saturation (SpO2), Pulse Rate<br>(PR), Non-invasive Blood Pressure (NIBP), Invasive<br>Blood Pressure (IBP), carbon dioxide (CO2), and<br>Temperature (TEMP) of adult, pediatric and neonatal<br>patient.<br>The monitor is to be used in healthcare facilities by<br>clinical physicians or appropriate medical staff under<br>the direction of physicians. It is not intended for<br>helicopter transport or hospital ambulance.<br>Note: M7000 does not have functions of Invasive<br>Blood Pressure and Carbon Dioxide | Same | | Feature | Display | Colour TFT | Same | | | Alarm | Visual and audio alarming | Same | | | Electrical Safety | The proposed devices were tested to demonstrate to<br>comply with IEC 60601-1. | Same | | | EMC | The proposed devices were tested to demonstrate to<br>comply with IEC 60601-1-2 | Same | | | Patient-contact<br>Material | ECG Electrode: Conductive adhesive<br>SpO2 Sensor: Silicone<br>NIBP Cuff: Polyester fibre<br>EtCO2 Sensor: PVC<br>Temperature Probe: PVC | Same | | | Level of Concern of<br>the Software | Major | Same | | | Label and Labeling | Conforms to FDA Regulatory Requirements | Same | | Item | Proposed Devices | Predicate Devices | | | | M Series Patient Monitor | K100046 | | | ECG Lead Mode | 5-leads ECG input / 3-leads ECG input | Same | | | ECG CMRR | MON ≥105dB / OPS ≥105dB | Same | | | ECG Sweep speed | 12.5mm/s. 25mm/s. 50mm/s | Same | | | HR Range | 10~350 bpm | Same | | | HR Accuracy | ±1% or ±1 bpm, whichever is greater | Same | | | NIBP Method | Oscillometric | Same | | | NIBP Measurement Unit | mmHg / kPa | Same | | | NIBP | Adult 10-270 mmHg | Same | | | Measurement | Pediatric 10-235 mmHg | Same | | | Range | Neonatal 10-135 mmHg | Same | | | | (Static) ±2% or ±3 mmHg. whichever is greater | Same | | | NIBP Accuracy | (Clinical) ±5 mmHg average error<br>≤ 8 mmHg standard deviation | | | | TEMP Range | 0.0~50.0°C | Same | | | TEMP Accuracy | At 45.1°C~50.0°C, ±0.2°C (exclusive of probe)<br>At 25.0°C~45.0°C, ±0.1°C (exclusive of probe)<br>At 0.0°C~24.9°C, ±0.2°C (exclusive of probe) | Same | | | RESP Method | Impedance variation between RA-LL (R-F) | Same | | | RESP Measurement Range | 0~150 rpm | Same | | | RESP Accuracy | ±2 rpm | Same | | | BLT SpO2 Module | | | | | SpO2 Range | 0~100% | Same | | | SpO2 Accuracy | At 70~100%, ±2%<br>At 0~69%, unspecified | Same | | | PR Range | 25~250 bpm | Same | | | PR Accuracy | ±1% or ±1 bpm,<br>whichever is greater | Same | | | Necllor SpO2 Module | | | | | SpO2 Range | 1~100% | Same | | | SpO2 Accuracy | At 70~100%, ±2 digits (Adult)<br>At 70~100%, ±3 digits (Neonate)<br>At 70~100%, ±2 digits (Low Perfusion)<br>At 0~69%, unspecified | Same | | | PR Range | 20~250 bpm | Same | | | PR Accuracy | ±3 digits | Same | | #### Table 3-2 Comparison of General and Safety Characteristics · : {5}------------------------------------------------ #### Table 3-3 Comparison of ECG, NIBP, TEMP, RESP and SpO2 Characteristics {6}------------------------------------------------ | Item | Proposed Devices | Predicate<br>Devices<br>K053269 | Predicate<br>Devices<br>K100046 | |------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------------------------------| | SpO2 Module | MASIMO Module | Same | Similar | | SpO2 Range | 1~100% | Same | Same | | SpO2<br>Accuracy | At 70~100%: $\pm$ 2% (adult/pediatric, non-motion<br>conditions)<br>At 70 ~ 100%: $\pm$ 3% (neonate, non-motion<br>conditions)<br>At 70~100%: $\pm$ 3% (motion conditions)<br>At 0~69%, unspecified | Same | Similar | | PR Range | 25~240 bpm | Same | Similar | | PR Accuracy | $\pm$ 3 bpm (non-motion conditions)<br>$\pm$ 5 bpm (motion conditions) | Same | Similar | | PI Range | 0.02 ~ 20.0% | Same | NA | Table 3-4 Comparison of Masimo SpO2 Characteristics Table 3-5 Comparison of IBP and EtCO2 Characteristics (Inapplicable to M7000) | Item | Proposed Devices | Predicate Devices | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | | M Series Patient Monitor | K100046 | | IBP Measurement Range | -50 ~ +300 mmHg | Same | | IBP Sensitivity of transducer | 5uV/V/mmHg, 2% | Same | | IBP Accuracy | $\pm$ 4mmHg or 4%, whichever is greater | Same | | EtCO2 Method | Infrared Absorption | Same | | EtCO2 Mode | Main Stream / Side Stream | Same | | EtCO₂ Measurement Range | 0~19.7 %(0~150 mmHg) | Same | | EtCO2 Accuracy | 0 ~ 40 mmHg, $\pm$ 2 mmHg<br>41 ~ 70 mmHg, $\pm$ 5% of reading<br>71 ~100 mmHg, $\pm$ 8% of reading<br>101 ~ 150 mmHg, $\pm$ 10% of reading | Same | The proposed device has a Masimo SpO2 Module, while the predicate device M Series Patient Monitor (K100046) docsn't have. The Masimo SpO2 Module was designed and manufactured by Masimo Corporation and previously cleared by FDA in K053269. And Sp02 and pulse rate accuracy of the proposed device with Masimo SpO2 Module has been verified comply with the declaration of specification. Therefore, the difference will not affectiveness of the proposed device. The proposed devices, M Series Patient Monitors, are determined to be Substantially Equivalent (SE) to the predicate devices, M Series Patient Monitors (K 100046), in respect of safety and effectiveness. {7}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of providing health and human services to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. February 27, 2014 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Guangdong Biolight Meditech Co. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA Re: K131876 > Trade/Device Name: M Series Patient Monitor models M66, M69, M7000, M8000, and M9000 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Monitor Regulatory Class: Class II Product Code: MHX Dated: January 29, 2014 Received: January 30, 2014 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. 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 {8}------------------------------------------------ Page 2 - Ms. Diana Hong . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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/Resourcesfor You/Industry/default.htm. Sincerely yours, # Bram D. Zuckerman -S Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # Indications for Use 510(k) Number: K131876 Device Name: M Series Patient Monitor Indications for Use: M Series Patient Monitor is intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters of adult, pediatric and neonatal patient as listed below: | Parameters | M66 | M69 | M7000 | M8000 | M9000 | |------------------------------------|-----|-----|-------|-------|-------| | ECG | x | x | x | x | x | | Heart Rate | x | x | x | x | x | | Respiration Rate (RESP) | x | x | x | x | x | | Pulse Oxygen Saturation (SpO2) | x | x | x | x | x | | Non-Invasive Blood Pressure (NIBP) | x | x | x | x | x | | Invasive Blood Pressure (IBP) | x | x | -- | x | x | | Carbon Dioxide (CO2) | x | x | -- | x | x | | Temperature (TEMP) | x | x | x | x | x | The monitor 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. OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OR 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) **am D. Zuckerman - S** Page 1 of 1 2014.02.27 08:40:56 -05'00' 2-1 2-1