Truscope Ultra Patient Monitor

K162234 · Guangdong Biolight Meditech Co., Ltd. · MWI · Jan 4, 2017 · Cardiovascular

Device Facts

• Record ID: K162234
• Device Name: Truscope Ultra Patient Monitor
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: Jan 4, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

Truscope Ultra Patient monitors are intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead 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), Cerebral Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), Methemoglobin(SpMet). 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.

Device Story

Truscope Ultra Patient Monitors are multi-parameter bedside devices for clinical environments. Inputs include ECG leads, SpO2 sensors, blood pressure cuffs, temperature probes, and gas/anesthetic sensors. Device processes physiological signals to provide real-time monitoring, storage, and alarms for parameters like HR, RESP, NIBP, IBP, CO2, and specialized indices (BIS, CSI, ICG). Operated by physicians or medical staff to track patient status; output displayed on integrated screen for clinical decision-making. Facilitates continuous patient surveillance and timely intervention for physiological abnormalities.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Multi-parameter patient monitor; supports ECG, SpO2, NIBP, IBP, CO2, AG, ICG, CSI, BIS, SpHb, SpCO, SpMet. Connectivity includes wired/wireless interfaces for data review. Software-based signal processing for arrhythmia and ST segment analysis. Class II device.

Indications for Use

Indicated for adult patients in healthcare facilities for monitoring, reviewing, storing, and alarming of physiological parameters including ECG, arrhythmia, ST segment, HR, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2, AG, ICG, CSI, BIS, SpHb, SpCO, and SpMet. Arrhythmia and ST segment analysis limited to single adult patients. Not for home, ambulance, or helicopter use.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 4, 2017

Guangdong Biolight Meditech Co., Ltd. % Diana Hong, General Manager Mid-link Consulting Co., Ltd P.O. box 120-119 Shanghai, 200120 CHINA

Re: K162234

Trade/Device Name: Truscope Ultra Patient Monitors Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: November 30, 2016 Received: December 5, 2016

Dear 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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)

K162234

Device Name Truscope Ultra Patient Monitors

## Indications for Use (Describe)

Truscope Ultra Patient monitors are intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead 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), Cerebral Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), Methemoglobin(SpMet).

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.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:14px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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