C50 and C80 Multi-parameter Patient Monitor

K191106 · Shenzhen Comen Medical Instruments Co.,Ltd · MHX · Dec 13, 2019 · Cardiovascular

Device Facts

• Record ID: K191106
• Device Name: C50 and C80 Multi-parameter Patient Monitor
• Applicant: Shenzhen Comen Medical Instruments Co.,Ltd
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index). All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: · The ICG monitoring is applicable to the adult patients of 122~229cm in height and 30~159Kg (67~341 pounds) in weight only; · NIBP measurement continual mode is not applicable to neonates; · Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients; The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for home use.

Device Story

Multi-parameter patient monitors (C50/C80) collect physiological signals via patient-connected sensors/accessories; inputs include ECG, SpO2, NIBP, IBP, Temp, CO2, AG, C.O., and (for C80) ICG and BIS. Device processes signals to display real-time waveforms and numeric values, perform arrhythmia analysis, and trigger alarms. Used in general healthcare facilities by clinicians. Output allows continuous patient status assessment, aiding clinical decision-making. Benefits include real-time monitoring and early detection of physiological abnormalities.

Clinical Evidence

Clinical validation performed for NIBP and SpO2. NIBP study (25 adults/children; 20 neonates/infants) followed ISO 81060-2; results showed consistency and accuracy. SpO2 study (30 subjects: 24 adults, 6 neonates) followed ISO 80601-2-61; demonstrated safety and accuracy. No adverse events reported.

Technological Characteristics

Multi-parameter monitor with color TFT LCD (10.4" C50, 12.1" C80). Powered by AC or internal Li-ion battery. Sensing principles: ECG (electrodes), SpO2 (red/IR light), NIBP (oscillometry), IBP (direct), CO2/AG (infrared absorption), Temp (thermal resistance), ICG (impedance), BIS (EEG signal processing). Connectivity via standard patient interfaces. Software-based alarm and analysis systems. Complies with IEC 60601-1, IEC 60601-1-2, and various parameter-specific standards (e.g., ISO 80601-2-61, IEC 80601-2-30).

Indications for Use

Indicated for monitoring, displaying, alarming, and storing physiological parameters (ECG, RR, SpO2, PR, NIBP, Temp, IBP, CO2, AG, C.O.) in adult, pediatric, and neonatal patients. C80 additionally monitors ICG (adults 122-229cm, 30-159kg) and BIS (not for neonates). NIBP continual mode not for neonates. For use in healthcare facilities by medical staff.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Passport Series Patient Monitors (Passport 12m and Passport 17m) (K170876)

Reference Devices

• Masimo CO2 module (K123043, K103604)
• Respironics CO2 module (K040183, K053174)
• BIS module and sensor (K040183, K002734)
• ICG electrode cable and sensors (K110645)

Submission Summary (Full Text)

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December 13, 2019

Shenzhen Comen Medical Instruments Co., Ltd. Hongbo Yan Regulation Engineer Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 To Floor 5 of Building 2, FIYTA Timepiece Bldg, Nanhuan Ave. Shenzhen, 518106 China

Re: K191106

Trade/Device Name: C50 and C80 Multi-parameter Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DSJ, DXN, DSK, DPS, DXG, DSB, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, NHO, NHP, OLW, GXY Dated: November 15, 2019 Received: November 15, 2019

Dear Hongbo Yan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K191106

#### Device Name

C50 and C80 Multi-parameter Patient Monitor

#### Indications for Use (Describe)

The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

· The ICG monitoring is applicable to the adult patients of 122~229cm in height and 30~159Kg (67~341 pounds) in weight only;

· NIBP measurement continual mode is not applicable to neonates;

· Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;

The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for home use.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <div style="display:inline-block;"><b>X</b></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;"></div> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Section 5 - 510 (k) Summary

## C50 and C80 Multi-parameter Patient Monitor

This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.

| Date: | September 26, 2019 | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Submitter | SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD | | | |
| Address | Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, | | | |
| | FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, | | | |
| | Shenzhen, 518106, Guangdong, China. | | | |
| Contact | Hongbo Yan | | | |
| Telephone | [phone] | | | |
| Facsimile | [phone] | | | |
| Device trade<br>name | C50 and C80 Multi-parameter Patient Monitor | | | |
| Common name | Multi-parameter Patient Monitor | | | |
| | Classification Regulation, Classification name and Product Codes | | | |
| Device Panel | Regulation<br>&Classification | number | Procode | Description |
| Cardiovascular | §870.1025, II | | MHX | Arrhythmia detector and alarm (including<br>ST-segment measurement and alarm) |
| Cardiovascular | §870.1025, II | | DSI | Arrhythmia detector and alarm (including<br>ST-segment measurement and alarm). |
| Cardiovascular | §870.1025, II | | MLD | Arrhythmia detector and alarm (including<br>ST-segment measurement and alarm). |
| Cardiovascular | §870.2300, II | | DRT | Monitor, Cardiac (Incl.<br>Cardiotachometer& Rate Alarm) |
| Cardiovascular | §870.1100, II | | DSJ | Alarm, Blood-Pressure |
| Cardiovascular | §870.1130, II | | DXN | System, Measurement, Blood-Pressure,<br>Non-Invasive |
| Cardiovascular | §870.1110, II | | DSK | Computer, Blood-Pressure |
| Cardiovascular | §870.2340, II | | DPS | Electrocardiograph |
| Cardiovascular | §870.1435, II | | DXG | Computer, Diagnostic, Pre-Programmed,<br>Single-Function |
| Cardiovascular | §870.2770, II | | DSB | Plethysmograph, Impedance |
| General<br>Hospital | §880.2910, II | | FLL | Thermometer, Electronic, Clinical |
| Anesthesiology | §870.2700, II | | DQA | Oximeter |
| Anesthesiology | §868.1400, II | | CCK | Analyzer, Gas, Carbon-Dioxide,<br>Gaseous-Phase |
| Anesthesiology | §868.1500, II | | CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase<br>(Anesthetic Concentration) |
| Anesthesiology | §868.1620, II | CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | |
| Anesthesiology | §868.1700, II | CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | |
| Anesthesiology | §868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | |
| Anesthesiology | §868.1500, II…