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 Description

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, 5-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;
Those monitors provide patient monitoring capabilities by using corresponding accessories.
The multi-parameter Patient monitor, model: C50 and C80 have same design principle and technical characteristics:
But the software in the host and modules and components are different.
The differences between C50 and C80 are ICG, BIS and size of monitor.

AI/ML Overview

The provided document describes the acceptance criteria and a study proving the C50 and C80 Multi-parameter Patient Monitor meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established through adherence to recognized international standards and clinical performance metrics. The document details a comparison with a predicate device (K170876, Passport Series Patient Monitors). While explicit "acceptance criteria" for each parameter are not always separately listed with a single performance value from the new device, the "Comparison" column in the table below infers if the new device meets or exceeds the predicate's performance or if sufficient justification is provided for differences.

Feature	Predicate Device (K170876) Performance	Subject Device (C50 & C80) Performance	Comparison to Acceptance Criteria (Predicate) & Justification
Monitor Size	Passport 17m: 400x370x193mm; Passport 12m: 297x336x187mm	C80: Approx. 344x291x165mm; C50: Approx. 291.7x250x187mm	The monitor size of the subject device is smaller than the predicate device, but it "won't affect the safety and effectiveness of the subject device." Implied acceptance: smaller size is acceptable if safety/effectiveness are not compromised.
Integrated display & touch screen	Color TFT LCD (17-inch, 1280x1024 pixels for 17m; 12-inch, 800x600 pixels for 12m)	Color TFT LCD (C80: 12.1-inch, 800x600 pixels; C50: 10.4-inch, 800x600 pixels)	Screen size is smaller, but resolution for C80/C50 is the same as Passport 12m. "Same. The screen of Subject device is smaller than predicate device. Complying with IEC 60601-1 and IEC 62366-1 also indicates the clinical use is safe and effective." Implied acceptance: smaller screen size is acceptable due to compliance with relevant IEC standards for safety and usability.
Power supply	Two rechargeable Lithium-ion batteries or AC for Passport 17m; One rechargeable Lithium-ion battery or AC for Passport 12m	C50 and C80: Powered either by built-in battery or external AC.	"Same, both powered by battery and AC." Implied acceptance: functional equivalence.
Battery	11.1V, 4500mAh	11.1V, 2200mAh/4400mAh	"The battery capacity is different. The batteries of C50/C80 have complied with IEC 62133. C50 and C80 have conformed to IEC 60601-1." Implied acceptance: different capacity is acceptable as long as safety (IEC 62133, IEC 60601-1) is maintained.
ECG	3-lead, 5-lead and 12-lead selectable, heart rate (HR)	3-lead, 5-lead and 12-lead selectable, heart rate (HR)	"Same." Implied acceptance: functional equivalence.
ECG (Arrhythmia Analysis)	Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy, Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, Ron T, Run PVCs, PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac, Pause, Irr. Rhythm, AFib (24 types)	Asystole, ventricular fibrillation, R ON T, VT >2, Couplet, PVC, Bigeminy, Trigeminy, Brady (Bradycardia), PNC (Pacer Not Capture), PNP (Pacer Not Pace), Missed Beats, IHB (Irregular Heart Beat), VTAC (Ventricular Tachycardia), Tachy (Tachycardia), PVC Too High, Extreme Tachycardia, Extreme Bradycardia, Ventricular Rhythm, Heart Pause (20 types)	"C50/C80 has 20 types of arrhythmias in total, 18 of which is same as the predicate device. The other two (underline) is supported by compliance with EC57." Implied acceptance: fewer types are acceptable as long as key arrhythmia detections are present and supported by EC57 compliance.
Respiration	Method: Trans-thoracic impedance. Range: adult:0-120 rpm; pediatrics:0-150rpm; neonate:0-150rpm. Accuracy: 7 to 150rpm: ± 2rpm or ± 2%, whichever is greater. 0 to 6rpm: not specified.	Method: Trans-thoracic impedance. Range: adult:0-120 rpm; pediatrics:0-150rpm; neonate:0-150rpm. Accuracy: 7 to 150rpm: ± 2rpm or ± 2%, whichever is greater. 0 to 6rpm: not specified.	"Same." Implied acceptance: functional and performance equivalence.
Pulse oxygen saturation (SpO2)	Method: red and infrared light method. Masimo SpO2: Range:1~~100%. Accuracy: No motion: 70-100% ±2%(adult/pediatric), ±3%(neonate); Motion: 70-100% ±3%. Nellcor SpO2: Range:0~~100%. Accuracy: 70-100% ±2%(adult/pediatric), ±3%(neonate). Mindray SpO2: Range:0~100%. Accuracy: 70-100% ±2%(adult/pediatric), ±3%(neonate).	Method: same. Masimo SpO2: same range & accuracy. Nellcor SpO2: same range & accuracy. Comen SpO2: Range: 0%-100%. Accuracy: 70-100% ±2%(adult/pediatric, non-motion), ±3%(neonate, non-motion).	"Same." (for Masimo and Nellcor modules). For their own Comen SpO2 module, it shows equivalent accuracy. Implied acceptance: performance equivalence with predicate's different OEM modules and new Comen module meets similar accuracy.
Pulse rate (PR)	From Mindray SpO2 (Range 20-254 bpm, Acc ±3 bpm), Masimo SpO2 (Range 25-240 bpm, Acc ±3 bpm no motion, ±5 bpm motion), Nellcor SpO2 (Range 20-300 bpm, Acc ±3 bpm for 20-250 bpm), IBP sensor (Range 25-350 bpm, Acc ±1 bpm or ±1%).	From Masimo SpO2 (Range 25-240 bpm, Acc ±3 bpm no motion, ±5 bpm motion), Nellcor SpO2 (Range 20-300 bpm, Acc ±3 bpm for 20-250 bpm), Comen SpO2 (Range 20-254 bpm, Acc ±2 bpm), IBP sensor (Range 25-350 bpm, Acc ±1 bpm or ±1%), NIBP sensor (Range 40-240 bpm, Acc ±3 bpm or ±3%).	"The PR from Comen SpO2 is more accuracy than the PR form Mindray SpO2. The PR form Masimo SpO2, Nellcor SpO2 and IBP sensor of C50 and C80 are the same with the predicate device. In addition, C50 and C80 have one more PR data source (NIBP) than predicate device. C50 and C80 have complied with ISO 80601-2-61." Acceptance criteria met or exceeded; added NIBP source (improvement). Adherence to ISO 80601-2-61.
Non-invasive blood pressure (NIBP)	Method: Oscillometry. Range: Adult (systolic 25-290mmHg, diastolic 10-250mmHg), pediatric (systolic 25-240mmHg, diastolic 10-200mmHg), neonate (systolic 25-140mmHg, diastolic 10-115mmHg). Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg.	Method: same. Range: Adult (systolic 40-270mmHg, diastolic 10-215mmHg), pediatric (systolic 40-200mmHg, diastolic 10-150mmHg), neonate (systolic 40-135mmHg, diastolic 10-100mmHg). Accuracy: 0-300mmHg: ±3mmHg.	"The NIBP measure range for adult/pediatric/neonate in C50 and C80 is smaller than that in predicate device. The C50 and C80 is more accuracy than predicate device. C50 and C80 have conformed to IEC 80601-2-30." Acceptance criteria met or exceeded in accuracy, and justification for smaller range implicitly accepted by meeting IEC 80601-2-30.
Temperature (Temp)	Method: Thermal resistance. Range: 0 ~ 50°C. Accuracy: ±0.1°C.	Method: Thermal resistance. Range: 0 ~ 50°C. Accuracy: ±0.2°C.	"The predicate device is more accuracy than C50 and C80. C50 and C80 have complied with ISO 80601-2-56." Implied acceptance: slightly lower accuracy is acceptable as long as it complies with ISO 80601-2-56.
Carbon dioxide (CO2)	Method: Infrared absorption. Masimo CO2: Sidestream 0-99mmHg, AwRR 0-120rpm. Microstream 0-99mmHg, AwRR 0-150rpm. Accuracy: Sidestream 0-40mmHg ±2mmHg, 41-76mmHg ±5%, 77-99mmHg ±10%, AwRR ±2rpm. Microstream 0-38mmHg ±2mmHg, 39-99mmHg ±5% +0.08%, AwRR 0-70rpm ±1rpm, 71-120rpm ±2rpm, 121-150rpm ±3rpm.	Method: same. Masimo CO2: Sidestream 0-190mmHg, 0-25% (760mmHg), AwRR 0-150rpm. Mainstream 0-190mmHg, 0-25% (760mmHg), AwRR 0-150rpm. Respironics CO2: Sidestream 0-150mmHg, 0-19.7%, AwRR 0, 2-150rpm. Mainstream 0-150mmHg, 0-19.7%, AwRR 0, 2-150rpm. Accuracy (Masimo): ±(2.25mmHg +reading x 4%), AwRR ±1rpm. Accuracy (Respironics): 0-40mmHg ±2mmHg, etc., AwRR ±1rpm.	"The C50 and C80 are more accuracy and measured wider than predicate device. For C50 and C80, Masimo CO2 module (K123043 and K103604) and Respironics CO2 module (K040183 and K053174) have been cleared. Both modules have complied with ISO 80601-2-55." Acceptance criteria met or exceeded; wider range and higher accuracy; existing modules previously cleared and comply with ISO 80601-2-55.
Invasive blood pressure (IBP)	Method: Direct invasive measurement. Range: -50 to 300 mmHg. Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor).	Method: Direct invasive measurement. Range: -50 to 300 mmHg. Accuracy: ±2% or ±1 mmHg, whichever is greater (without sensor).	"Same." Implied acceptance: functional and performance equivalence.
Cardiac output (C.O.)	Method: Thermodilution method. Range: 0.1 to 20 L/min. Accuracy: ±5% or ±0.1 L/min, whichever is greater.	Method: Thermodilution method. Range: 0.1 to 20 L/min. Accuracy: ±5% or ±0.1 L/min, whichever is greater.	"Same." Implied acceptance: functional and performance equivalence.
Anesthetic gas (AG)	Method: Infrared absorption. Range (CO2, N2O, Hal, Enf, Iso, Sev, O2, AwRR). Accuracy (CO2 ±0.3% ABS, N2O ±(8%REL+2%ABS), Other AG 8%REL).	Method: same. Range (CO2, N2O, Hal, Enf, Iso, Sev, O2, AwRR). Accuracy (CO2 0-15%: ±(0.2kPa+readingx2%), N2O ±(2 kPa+readingx2%), Hal/Enf/Iso 0-8%: ±(0.15%+readingx5%), Sev 0-10%: ±(0.15%+readingx5%), Des 0-22%: ±(0.15%+readingx5%), O2 ±(1%+readingx2%), Masimo AG AwRR ±1rpm).	"For CO2/Enf/Hal/Iso/Sev/Des, The measurement range of C50 and C80 is smaller than the predicate device. For awRR, the measurement range of C80 is better than the predicate device. The C50 and C80 are more accuracy than predicate device. The measurement range of C50 and C80 is enough for most environments; it won't affect the safety and effectiveness. The C50 and C80 supports two AG modules: MASIMO ISA AX+ Sidestream module and Masimo IRMA AX+ Mainstream module, both of them have been cleared in K103604." Acceptance criteria: different ranges are acceptable with justification of sufficient range for most environments and high accuracy. Utilizes previously cleared and compliant modules.
BIS (C80 only)	Range: BIS, BIS L, BIS R: 0-100; SQI, SQI L, SQI R: 0-100%; EMG, EMG L, EMG R: 0-100 Db; SR, SR L, SR R: 0-100%; SEF, SEF L, SEF R: 0.5-30.0 Hz; TP, TP L, TP R: 40-100 Db; BC, BC L, BC R: 0-30; sBIS L, sBIS R: 0-10.0; Semg L, Semg R: 0-10.0; ASYM: 0-100%. Accuracy: 1% for BIS, SQI, EMG, ESR (implied).	Range and Accuracy: BIS: same; accuracy: 1%. SQI: same; accuracy: 1%. EMG: same; accuracy: 1%. ESR: 0-100%; accuracy: 1%.	"The underline parameters are what C50 and C80 doesn't have. The BIS module and sensor have been cleared by FDA and its 510k numbers are K040183 and K002734." Acceptance criteria for essential parameters are met by using previously cleared FDA modules.
ICG (C80 only)	Method: Indirect impedance cardiograph measurement. Range: SV: 5-250 ml; HR: 44-2m; C.O. 1.4-15 L/min. Accuracy: SV: Not specified; HR: ±2 bpm; C.O. Not specified.	Method: Indirect impedance cardiograph measurement. Range: HR: 40-250bpm; SV: 0-250mL; C.O.:0-30L/min; TFC: 5-150 /KΩ; SVR:0-3500 dyn・s ・ cm-5. Accuracy: SV: Not specified; HR: ±2 bpm; C.O. Not specified.	"The underline parameter is what C50 and C80 doesn't have. The ICG electrode cable and sensors are all cleared by FDA, 510(k) number of which is K110645." Acceptance criteria for essential parameters are met by using previously cleared FDA components.

Study that Proves the Device Meets Acceptance Criteria

The essential studies to prove the device meets acceptance criteria are divided into Non-Clinical Performance Data and Clinical Studies.

Non-Clinical Performance Data:

Software Verification and Validation Testing: Conducted in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Risk analysis was performed, and the software was deemed a "major" level of concern.
Electrical safety and Electromagnetic Compatibility (EMC): Testing conducted according to:
- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 Edition 4: 2014-02
Bench Testing: Functional and system-level tests were performed, showing the devices meet specifications and perform equivalently to the predicate.
Biocompatibility Testing: Performed for patient-contacting components (ECG cable, SpO2 probes, temperature probes) that were not previously cleared. Cytotoxicity, sensitization, and irritation testing were conducted based on ISO 10993-1 and FDA's 2016 biocompatibility guidance.
Conformance with Applicable Standards: The device demonstrated compliance with numerous recognized consensus standards, in addition to those listed above for specific modules (e.g., ISO 80601-2-55 for Respiratory Gas Monitors, ISO 80601-2-56 for Thermometers, ISO 80601-2-61 for Pulse Oximeter Equipment, ANSI AAMI EC57:2012 for Cardiac Rhythm and ST-Segment measurement algorithms).

Clinical Studies:

1. NIBP Clinical Study - for adults and children

Device Parameter: Non-invasive Blood Pressure (NIBP)
Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
Sample Size: 25 patients (19 adults, 6 children).
- Demographics: 10 men, 15 women. 6 patients aged 3-12, 2 aged 12-40, 10 aged 40-60, 7 above 60.
Data Provenance: Retrospective or Prospective not explicitly stated, but implies prospective data collection from "The Second Affiliated Hospital of Guangzhou Medical University and The First Affiliated Hospital of Guangzhou Traditional Chinese Medical University" from 2012 to 2013 (China).
Ground Truth: Implicitly referent method (e.g., auscultation by trained observers) as required by ISO 81060-2.
Adjudication Method: Not specified, but standard practice for NIBP clinical validation involves multiple observers for reference measurements.
Results: "The results are accurate and reliable, and the repeated measurement consistency is in good condition, within the measurement range. Moreover, No adverse events and side effects were found in clinical trials."

2. NIBP Clinical Study - for neonate and infants

Device Parameter: Non-invasive Blood Pressure (NIBP)
Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
Sample Size: 20 subjects.
- Demographics: 10 males, 10 females. 13 subjects <29 days, 4 subjects 29 days to 1 year, 3 subjects 1 to 3 years old.
- Data Points: 10 groups of data collected for each subject, totaling 200 groups.
Data Provenance: Retrospective or Prospective not explicitly stated, but implies prospective data collection from "The First Affiliated Hospital of Guangxi Medical University and The First Affiliated Hospital of Xinxiang Medical University" from 2012 to 2013 (China).
Ground Truth: Implicitly referent method (e.g., auscultation by trained observers) as required by ISO 81060-2.
Adjudication Method: Not specified.
Results: "The results are accurate and reliable, and the repeated measurement consistency is in good condition, within the measurement range. Moreover, No adverse events and side effects were found in clinical trials."

3. SpO2 Clinical Study

Device Parameter: Oxygen saturation (SpO2)
Acceptance Criteria/Standard: Complies with FDA Certification Guidance Document of Photoelectric Oximeter and ISO 80601-2-61 "Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment."
Sample Size: 30 subjects (24 adult subjects, 6 neonates).
- Demographics (Adults): 24 subjects (7 males, 17 females) aged 24-44 years old (20 yellows, 4 blacks).
- Demographics (Neonates): 6 neonates (5 males, 1 female) aged 1-24 days.
Data Provenance: Implies prospective data collection from "the Affiliated Hospital of Guilin Medical University" from January 20, 2016 to June 10, 2016 (China).
Ground Truth: Implicitly a controlled desaturation study where arterial blood gas samples are taken and analyzed for SaO2, which is compared to the pulse oximeter readings.
Adjudication Method: Not specified.
Results: "Per the clinical test analysis result, there is no adverse events, the oxygen saturation module and probe are safe and effective for the intended use, as well as demonstrating accurate pulse measurement."

Additional Requested Information:

2. Sample size for the test set and the data provenance:
- NIBP (Adult/Children): 25 patients from China (2012-2013).
- NIBP (Neonate/Infants): 20 subjects (200 data groups) from China (2012-2013).
- SpO2: 30 subjects (24 adults, 6 neonates) from China (Jan-June 2016).
- All clinical data appears to be prospective as it describes clinical trials "conducted in" specific hospitals during specific periods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts (e.g., radiologists) for establishing ground truth in clinical studies. For NIBP validation against ISO 81060-2, ground truth typically involves at least two trained observers performing auscultatory measurements. For SpO2, ground truth is established by laboratory CO-oximetry measurements of arterial blood, usually managed by laboratory technicians in a controlled setting, not interpretation by "experts" in the sense of image analysis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify the adjudication method for any of the clinical or non-clinical tests. For NIBP, ISO 81060-2 dictates specific statistical analysis methods (e.g., Bland-Altman) for comparing device readings to reference measurements, often requiring two or more observers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a multi-parameter patient monitor measuring physiological parameters (ECG, SpO2, NIBP, Temp, etc.). It does not describe an AI-powered diagnostic imaging device or an AI-assistance feature for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone patient monitor that provides automated measurements and alarms. The performance of its modules (e.g., NIBP, SpO2 algorithms) was evaluated independently against reference standards (clinical validation) and through bench testing. So, yes, standalone performance of the underlying algorithms and hardware was demonstrated through the clinical and non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- NIBP: Likely comparative measurements against a reference standard method (e.g., auscultatory measurements by trained observers) as specified by ISO 81060-2.
- SpO2: Involves laboratory arterial blood gas analysis (CO-oximetry) during controlled desaturation studies, comparing the device's SpO2 readings to the directly measured SaO2 values.
- Other Parameters (ECG, Temp, IBP, CO2, AG, BIS, ICG): Performance is primarily verified through bench testing against calibrated simulators and reference equipment and adherence to respective ISO/IEC standards.
8. The sample size for the training set:
- The document describes pre-market notification (510k) for a patient monitor, not an AI/machine learning device that typically involves a training set. The clinical studies performed are for validation of the device's performance against human subjects, not for training internal algorithms. Therefore, there is no explicit "training set" mentioned in the context of machine learning.
9. How the ground truth for the training set was established:
- As there is no explicit mention of an AI/machine learning training set, this question is not applicable. The ground truth for validation was established by reference standard methods in clinical trials and bench testing as described in point 7.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)
X Prescription Use (Part 21 CFR 801 Subpart D)	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	+86-13424152596
Facsimile	+86-755-23431232
Device tradename	C50 and C80 Multi-parameter Patient Monitor
Common name	Multi-parameter Patient Monitor
	Classification Regulation, Classification name and Product Codes
Device Panel	Regulation&Classification	number	Procode	Description
Cardiovascular	§870.1025, II		MHX	Arrhythmia detector and alarm (includingST-segment measurement and alarm)
Cardiovascular	§870.1025, II		DSI	Arrhythmia detector and alarm (includingST-segment measurement and alarm).
Cardiovascular	§870.1025, II		MLD	Arrhythmia detector and alarm (includingST-segment measurement and alarm).
Cardiovascular	§870.2300, II		DRT	Monitor, Cardiac (Incl.Cardiotachometer& Rate Alarm)
Cardiovascular	§870.1100, II		DSJ	Alarm, Blood-Pressure
Cardiovascular	§870.1130, II		DXN	System, Measurement, Blood-Pressure,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,Single-Function
Cardiovascular	§870.2770, II		DSB	Plethysmograph, Impedance
GeneralHospital	§880.2910, II		FLL	Thermometer, Electronic, Clinical
Anesthesiology	§870.2700, II		DQA	Oximeter
Anesthesiology	§868.1400, II		CCK	Analyzer, Gas, Carbon-Dioxide,Gaseous-Phase
Anesthesiology	§868.1500, II		CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase(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	NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
Anesthesiology	§868.1500, II	NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
Anesthesiology	§868.1500, II	NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Neurology	§882.1320, II	GXY	Electrode, Cutaneous
Predicate Device:	K170876, Passport Series Patient Monitors (Passport 12m and Passport 17m), ShenzhenMindray Bio-medical Electronics Co., LTD
Device description:	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, 5-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;Those monitors provide patient monitoring capabilities by using corresponding accessories.The multi-parameter Patient monitor, model: C50 and C80 have same design principle and technical characteristics:But the software in the host and modules and components are different.The differences between C50 and C80 are ICG, BIS and size of monitor.
Indications for 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, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature
TechnologicalComparison toPredicateDevices:	Both the subject devices and the predicate devices provide a means for interfacing with apatient, collecting parameter and specific physiological data, and processing the data foralarm generation and display of numeric values and waveforms.The device respecting indications for use, basic operation and performance specificationsof the C50 and C80 Multi-parameter Patient Monitor is equivalent to Passport SeriesPatient Monitors (K170876). Those devices all can provide monitoring such as ECG(3-lead , 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respirationrate (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 (impedancecardiography) and BIS (bispectral index).All the parameters can be monitored on single adult, pediatric, and neonatal patients withthe exception of the following:• The ICG monitoring is applicable to the adult patients of 122~~229cm in height and30~~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 forneonatal patients;
Table below compares the key technological feature of the subject devices (C50 and C80patient monitors) to the predicate device (K170876, Passport 12m and Passport 17m).The features in yellow are the features that are same with the predicate device.
Device Comparison Table
	Feature	Predicatedevice(K170876)Passport 12m/17m	Subject devicesC50 and C80	Comparison
	Monitor Size	Passport 17m: 400 mm×370 mm×193mmPassport 12m:297 mm × 336 mm × 187mm	C80: About 344mm×291 mm×165mmC50: About 291.7mm × 250 mm × 187mm	The monitor size of subject device is smaller than predicate device, but it won't affect
		mm × 146.5mm	the safety andeffectiveness ofsubject device.
Integrated displayand touch screen	color TFT LCDPassport 17m: 17 InchPassport 12m:12 Inch	color TFT LCDC80: Size: 12.1 InchC50: Size: 10.4 Inch	sameThe screen ofSubject device issmaller thanpredicate device,Complying withIEC 60601-1 andIEC 62366-1 alsoindicates theclinical use is safeand effective..
	Passport 17m:1280×1024 pixelsPassport 12m: 800×600pixels	C80 Pixel :800×600C50 Pixel :800×600
Power supply	Passport 17m:Two rechargeableLithium-ion battery orAC power supplyPassport 112m:One rechargeableLithium-ion batteryor AC power supply	C50 and C80:Powered either bybuilt-in battery orexternal AC.	Same, bothpowered bybattery and AC.
Battery	11.1V, 4500mAh	11.1V,2200mAh/4400mAh	The batterycapacity isdifferent.The batteries ofC50/C80 havecomplied withIEC 62133.C50 and C80 haveconformed to IEC60601-1.
ECG	3-lead, 5-lead and12-lead selectable, heartrate (HR)	3-lead, 5-lead and12-lead selectable,heart rate (HR)	Same
ECG (ArrhythmiaAnalysis)	Asystole,VFib/VTac, Vtac,Vent. Brady,Extreme Tachy,Extreme Brady,PVC, Couplet,Bigeminy, Trigeminy,Ron T, Run PVCs,PVCs, Tachy, Brady,	Asystole,ventricularfibrillation, R ONT, VT $>2$ , Couplet,PVC, Bigeminy,Trigeminy, Brady(Bradycardia), PNC(Pacer NotCapture), PNP	C50/C80 has 20types ofarrhythmias intotal, 18 of whichis same as thepredicate device.The other two(underline) issupported by

	Missed Beats,	(Pacer Not Pace),	compliance with
	Vent. Rhythm, PNP,	Missed Beats, IHB	EC57.
	PNC, Multif. PVC,	(Irregular HeartBeat), VTAC
	Nonsus. Vtac,
	Pause, Irr. Rhythm,	(VentricularTachycardia), Tachy(Tachycardia), PVCToo High,
	AFib	ExtremeTachycardia,
		ExtremeBradycardia,
		Ventricular Rhythm,Heart Pause
Respiration	Method: Trans-thoracicimpedanceRange: adult:0-120 rpm;pediatrics:0-150rpm;neonate:0-150rpmAccuracy: 7 to 150rpm:$\pm$ 2rpm or $\pm$ 2%,whichever is greater.0 to 6rpm: not specified	Method:Trans-thoracicimpedanceRange: adult:0-120 rpm;pediatrics:0-150rpm;; neonate:0-150rpmAccuracy: 7 to 150rpm: $\pm$ 2rpm or $\pm$ 2%, whichever isgreater.0 to 6rpm: notspecified	same
Pulse oxygensaturation (SpO2)	Method:red and infraredlight methodMasimo SpO2:Range:1~~100%Accuracy:No motion Conditions:70 to 100%: $\pm$ 2%(inadult/pediatric mode)70 to 100%: $\pm$ 3% (inneonate mode)Motion conditions:70%~~100%: $\pm$ 3%1%~~ 69%: Notspecified.Nellcor SpO2:Range: 0~~100%Accuracy:70% to	Method: sameMasimo SpO2:Range: sameAccuracy: sameNellcor SpO2:Range: sameAccuracy: sameComen SpO2:Range: 0%-100%Accuracy: 70 to100%: $\pm$ 2%(adult/pediatric, innon-motion )70 to 100%: $\pm$ 3%(neonate, innon-motion)0% to 69%: Not	same
	100%: ±2%(adult/pediatric)	specified.
	70 to 100%: ±3%(neonate)
	0% to 69%: Not specified.
	Mindray SpO2:Measurement range: 0 to 100%Accuracy:70 to 100%:±2% (adult/pediatric mode)70 to 100%: ±3%(neonate mode)0% to 69%: Not specified.
Pulse rate(PR)	PR from Mindray SpO2 ModuleMeasurement range: 20 to 254 bpmAccuracy: ±3 bpm	PR FROM Masimo SpO2:Range: 25~240bpmAccuracy:±3bpm (without motion)±5bpm (with motion)	The PR from Comen SpO2 is more accuracy than the PR form Mindray SpO2. The PR form Masimo SpO2, Nellcor SpO2 and IBP sensor of C50 and C80 are the same with the predicate device. In addition, C50 and C80 have one more PR data source (NIBP) than predicate device. C50 and C80 have complied with ISO 80601-2-61.
	PR FROM Masimo SpO2:Range: 25~240bpmAccuracy:±3bpm (without motion)±5bpm (with motion)	PR FROM Nellcor SpO2:Range: 20~~300bpmAccuracy:20~~250bpm: ±3bpm251~300bpm: not specified.
	PR FROM Nellcor SpO2:Range:20~~300bpmAccuracy:20~~250bpm: ±3bpm251~300bpm: not specified.	PR FROM Comen SpO2:Range:20bpm~254bpmAccuracy: ±2bpm
	PR FROM IBP sensor:Range:25-350bpmAccuracy:±1bpm or ±1%, whichever is greater	PR FROM IBP sensor:Range: 25-350bpmAccuracy: ±1bpm or ±1%, whichever is greaterPR FROM NIBP
Non-invasiveblood pressure(NIBP)	Method: OscillometryRange:Adult:systolic:25 ~ 290mmHgdiastolic:10~~250mmHgpediatrics:systolic:25 ~ 240mmHgdiastolic:10~~200mmHgNeonate:systolic:25 ~ 140mmHgdiastolic:10~115mmHgAccuracy:Max mean error: ±5 mmHgMax standard deviation:8 mmHg	sensor:Range:40bpm~~240bpm;Accuracy: ±3bpm or ±3%, whichever is greater.Method: sameRange:Adult:systolic:40-270mmHgdiastolic:10-215mmHgpediatrics:systolic:40~~200mmHgdiastolic:10-150mmHgNeonate:systolic:40~~135mmHgdiastolic:10~~100mmHgAccuracy:0~300mmHg:±3mmHg	The NIBP measure range for adult/pediatric/neonate in C50 and C80 is smaller than that in predicate device. The C50 and C80 is more accuracy than predicate device. C50 and C80 have conformed to IEC 80601-2-30.
Temperature(Temp)	Method: Thermal resistanceRange: 0 ~ 50°CAccuracy: ±0.1°C	Method: Thermal resistanceRange: 0 ~ 50°CAccuracy: ±0.2°C	The predicate device is more accuracy than C50 and C80.C50 and C80 have complied with ISO 80601-2-56.
Carbon dioxide (CO2)	Method:Infrared absorptionMasimo CO2:Range:Sidestream CO2 Module:0~~99mmHgAwRR:0~~120rpmMicrostream CO2 Module:	Method: sameMasimo CO2Range:Sidestream CO2 Module 0mmHg~~190mmHg , 0~~25% (at 760mmHg)AwRR:0~150rpmMainstream CO2	The C50 and C80 are more accuracy and measured wider than predicate device For C50 and C80, Masimo CO2 module (K123043 and K103604) and Respironics CO2

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0~~99mmHgAwRR:0~~150rpm	Module0mmHg~~190mmHg , 0~~25% (at 760mmHg)AwRR:0~~150rpmRespironics CO2:Range:Sidestream CO2 Module0~~150mmHg0%~~19.7%(0~~20.0k Pa)AwRR: 0 , 2rpm~~150rpmMainstream CO2 Module0~~150mmHg0%~~19.7% (0~~20.0kPa)AwRR: 0 , 2rpm~150rpm	module (K040183 and K053174) have been cleared.Both modules have complied with ISO 80601-2-55.
Accuracy:Sidestream CO2 Module:0 to 40 mmHg: ±2mmHg41 to 76mmHg: ±5% of the reading77 to 99mmHg: ±10% of the readingAwRR: ±2 rpmMicrostream CO2 Module0 to 38 mmHg: ±2mmHg39 to 99mmHg: ±5% of the reading+0.08% of (the reading-38)AwRR:0-70rpm: ±1 rpm71-120rpm: ±2 rpm121-150rpm: ±3 rpm	Accuracy:MasimoSidestream CO2 ModuleAll environment:±(2.25mmHg +reading×4%)AwRR: ±1 rpmMasimoMainstream CO2 ModuleAll environment:±(2.25mmHg +reading×4%)AwRR: ±1 rpmRespironicsSidestream CO2 Module0~~40mmHg:±2mmHg41~~70mmHg:±5% ×reading
		71~~100mmHg:±8%×reading101~~150mmHg:±10%×readingAwRR: ±1 rpmRespironicsMainstream CO2Module0~~40mmHg:±2mmHg41~~70mmHg:±5%×reading71~~100mmHg:±8%×reading101~~150mmHg:±10%×readingAwRR: ±1 rpm
invasive bloodpressure(IBP)	Method: Direct invasivemeasurementRange: -50 to 300 mmHgAccuracy: ±2% or ±1 mmHg, whichever isgreater (without sensor)	Method: DirectinvasivemeasurementRange: -50 to 300 mmHgAccuracy: ±2% or±1 mmHg,whichever is greater(without sensor)	same
cardiac output(C.O.)	Method:Thermodilution methodRange: 0.1 to 20 L/minAccuracy: ±5% or ±0.1L /min, whichever isgreater	Method:ThermodilutionmethodRange: 0.1 to 20L/minAccuracy: ±5% or±0.1 L /min,whichever is greater	same
anesthetic gas(AG)	Method:Infrared absorptionRange:CO2 0%~30%N2O 0%~100%Hal 0%~30%Enf 0%~30%Iso 0%~30%Sev 0%~30%	Method: sameRange:CO2 0%~25%N2O sameHal 0%~25%Enf 0%~25%Iso 0%~25%Sev 0%~25%	For CO2/Enf/Hal/Iso/Sev/Des,The measurementrange of C50 andC80 is smallerthan the predicatedevice.For awRR, themeasurement
	O2 0%~100%	O2same	C80 is better than
	awRR 2~100rpm	awRR0~150rpm	the predicatedevice.
	Accuracy:	Accuracy:
	CO2 ±0.3% ABS	CO20%~15%:$±(0.2kPa+reading×2%)$	The C50 and C80are more accuracythan predicatedevice.
	N2O±(8%REL+2%ABS)	15%~25%:Notdefined.	The measurementrange of C50 andC80 is enough formostenvironments; itwon't affect thesafety andeffectiveness.
	Other anesthetic gases:8%REL	N2O±(2kPa+reading×2%)
		Hal, Enf, Iso:0%~8%:$±(0.15%+reading×5%)$
		Not defined.Sev0%~10%: $±(0.15%+reading×5%)$	The C50 and C80supports two AGmodules:MASIMO ISA
		Not defined.Des0%~22%: $±(0.15%+reading×5%)$	AX+ Sidestreammodule andMasimo IRMA
		Not defined.O2 $±(1%+reading×2%)$	AX+ Mainstreammodule, both ofthem have beencleared inK103604.
		MasimoAGawRR±1rpm
BIS	Range:BIS, BIS L, BISR:0-100	Range andAccuracy:BIS: same;accuracy: 1%.	The underlineparameters arewhat C50 andC80 doesn't have.
	SQI, SQI L, SQI R: 0 to100%	SQI: same;accuracy: 1%.	The BIS moduleand sensor havebeen cleared byFDA and its 510knumbers areK040183 andK002734.
	EMG, EMG L, EMG R:0 to 100 Db	EMG: same;accuracy: 1%.
	SR, SR L, SR R: 0 to100%	ESR: 0~100%;accuracy: 1%.
	SEF, SEF L, SEF R: 0.5to 30.0 Hz
	TP, TP L, TP R: 40 to100 Db
	BC, BC L, BC R: 0 to30
	sBIS L, sBIS R: 0 to10.0
		Semg L, Semg R: 0 to 10.0ASYM: 0 to 100%
	ICG	Method: Indirectimpedance cardiographmeasurement	Method: same	The underlineparameter is whatC50 and C80doesn't have.The ICG electrodecable and sensorsare all cleared byFDA, 510(k)number of whichis K110645.
		Range:SV: 5 to 250 mlHR: 44 to 2mC.O. 1.4 to 15 L/min	Range:HR: 40~~250bpmSV: 0~~250mLC.O.:0~~30L/minTFC: 5~~150 /KΩSVR:0~3500 dyn・s ・ cm-5
		Accuracy:SV: Not specified.HR: ±2 bpmC.O. Not specified	Accuracy:SV: Not specified.HR: ±2 bpmC.O. Not specified.
	Substantial Equivalence Conclusion:
	The above detailed comparison of specifications for each of the modifications to the
	predicate devices (Passport 12m and Passport 17m), and they are different in monitor
	size, touch screen, battery, specification of Arrhythmia analysis, Pulse rate, NIBP,
	Temperature, CO2, anesthetic gas, BIS and ICG function. But the performance testing
	and conformance with applicable standards showed the differences above do not raise
	questions of safety and effectiveness. The detailed analysis for the differences please
	refers to the 3rd column in the above table. Therefore, we declared that the C50 and C80
	Multi-parameter Patient Monitors can be found substantially equivalent to the predicate
	device.
PerformanceData	The following performance data were provided in support of the substantial equivalencedetermination.
	Biocompatibility Testing
	All patient contacting accessories have been previously cleared except for the ECGcable, SpO2 probes and temperature probes. These items are either surface contacting forprolonged durations, or mucosal membrane contacting for limited duration. The
	recommending testing from FDA's 2016 biocompatibility guidance document "Use of
	International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:
	Evaluation and testing within a risk management process" for these contact types include
	cytotoxicity, sensitization, and irritation testing. These three tests were performed for
	each of the patient-contacting components.

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Software Verification and Validation Testing

Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The risk analysis has been developed to identify potential hazards and documents the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements. The software of this device was considered as a "maior" level of concern.

Electrical safety and electromagnetic compatibility(EMC)

Electrical safety and EMC testing were conducted on the C50 and C80 multi-parameter patient monitor, the following standards are found to comply:

ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD), FDA Recognition Number: 19-4
IEC 60601-1-2 Edition 4: 2014-02Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests, FDA Recognition Number: 19-8

Bench Testing

The C50 and C80 Multi-parameter Patient Monitor have been conducted functional and system level tests. The testing results showed that the devices meet specifications requirements and the performance of the device is equivalent to the predicate.

In addition, COMEN have conducted testing to ensure the subject devices meet relevant recognized consensus standards.

IEC 60601-1-8 Edition 2.1 2012-11Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety And Essential Performance - Collateral Standard: General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems, FDA Recognition Number: 5-76
IEC 60601-2-27 Edition 3.0 2011-03Medical Electrical Equipment - Part 2-27: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographic Monitoring Equipment [Including: Corrigendum 1 (2012)], FDA Recognition Number: 3-126
IEC 80601-2-30 Edition 1.1 2013-07Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers, FDA Recognition Number: 3-152
IEC 60601-2-34 Edition 3.0 2011-05Medical Electrical Equipment - Part 2-34: Particular Requirements For The Basic Safety, Including Essential Performance, Of Invasive Blood Pressure Monitoring Equipment, FDA Recognition Number:3-115
ISO 80601-2-55 First Edition 2011-12-15Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of

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Respiratory Gas Monitors, FDA Recognition Number: 1-96
• ISO 80601-2-56 Second Edition 2017-03Medical Electrical Equipment - Part 2-56:Particular Requirements for Basic Safety and Essential Performance of ClinicalThermometers for Body Temperature Measurement, FDA Recognition Number:6-403
• ISO 80601-2-61 First Edition 2011-04-01Medical Electrical Equipment - Part 2-61:Particular Requirements For Basic Safety And Essential Performance Of PulseOximeter Equipment, FDA Recognition Number: 1-85
• IEC 60601-1-6 Edition 3.1 2013-10Medical Electrical Equipment - Part 1-6:General Requirements For Basic Safety And Essential Performance - CollateralStandard: Usability, FDA Recognition Number: 5-89
• IEC 62366-1 Edition 1.0 2015-02Medical Devices - Part 1: Application OfUsability Engineering To Medical Devices [Including CORRIGENDUM 1 (2016)],FDA Recognition Number: 5-114
• ANSI AAMI IEC 62304 First Edition 2006-05Medical Device Software - SoftwareLife Cycle Processes, FDA Recognition Number: 13-32
• ISO 14971 Second Edition 2007-03-01Medical Devices - Application Of RiskManagement To Medical Devices, FDA Recognition Number: 5-40
• ANSI AAMI EC57:2012Testing And Reporting Performance Results Of CardiacRhythm And ST-Segment Measurement Algorithms, FDA Recognition Number:3-118
• ISO 81060-2 Second Edition 2013-05-01 Non-Invasive Sphygmomanometers - Part2: Clinical Validation Of Automated Measurement Type, FDA RecognitionNumber: 3-122
Clinical studies
Non-invasive Blood Pressure (NIBP) clinical tests and oxygen saturation (SpO2)measurement clinical tests were conducted.
NIBP clinical study-for adults and children
Clinical evaluation of the non-invasive blood pressure was performed on adults andchildren. The clinical study complies with the 81060-2 Second Edition 2013-05-01Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of AutomatedMeasurement Type. The studies were conducted in The Second Affiliated Hospital ofGuangzhou Medical University and The First Affiliated Hospital of GuangzhouTraditional Chinese Medical University from 2012 to 2013. 25 patients were enrolled,including 19 adults and 6 children. There are 10 men and 15 women. 6 patients arebetween the ages of 3-12, 2 patients are between the ages of 12-40, 10 patients arebetween the ages of 40-60, and 7 patients are above 60 years old. The results are accurateand reliable, and the repeated measurement consistency is in good condition, within themeasurement range. Moreover, No adverse events and side effects were found in clinicaltrials. Therefore, the non-invasive blood pressure module installed on the patient'smulti-parameter monitor passes this clinical trial and meets the requirements of clinical

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NIBP clinical study-for neonate and infants

Clinical evaluation of the non-invasive blood pressure was also performed on neonate and infants. The clinical study complies with the 81060-2 Second Edition 2013-05-01 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. The studies were conducted in The First Affiliated Hospital of Guangxi Medical University and The First Affiliated Hospital of Xinxiang Medical University from 2012 to 2013. Twenty subjects were enrolled, including ten males and ten females. 10 groups of data were collected for each subject, total of 200 groups of data. There are 13 subjects are less 29 days, 4 subjects are 29 days to 1 years old, 3 subjects are 1 to 3 years old. The results are accurate and reliable, and the repeated measurement consistency is in good condition, within the measurement range. Moreover, No adverse events and side effects were found in clinical trials. Therefore, the non-invasive blood pressure module installed on the patient's multi-parameter monitor passes this clinical trial and meets the requirements of clinical use. As well as being safe, effective and easy to operate.

SpO2 clinical study

Clinical evaluation of the oxygen saturation was performed on adults and neonates. The study complies with the clinical Submissions[510(k)s], FDA Certification Guidance Document of Photoelectric Oximeter and ISO 80601-2-61 Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment. The clinical study was conducted in the Affiliated Hospital of Guilin Medical University from January 20, 2016 to June 10, 2016. Twenty-four adult subjects are included in clinical trial aged from 24 years old to 44 years old (7 males and 17 females, 20 yellows and 4 blacks), With 6 neonates included aged from 1 day to 24 days (5 males and 1 female), there are 30 subjects in total were included in the tests. Per the clinical test analysis result, there is no adverse events, the oxygen saturation module and probe are safe and effective for the intended use, as well as demonstrating accurate pulse measurement.

Summary

Based on the non-clinical and clinical performance above, the C50 and C80 multi-parameter patient monitor was found to have a safety and effectiveness profile that is similar to the predicate device. The C50 and C80 Multi-parameter Patient Monitor are substantially equivalent to the

Conclusion: predicate devices (Passport 12m and Passport 17m, K170876) indications for use, technical characteristics and performance. Performance testing results and conformance with applicable standards demonstrate that the C50 and C80 Multi-parameter Patient Monitor are as safe and effective for the intended use, and perform as well as the predicate device. According to the intended use, the software of C50 and C80 Multi-parameter Patient Monitor was designed and has been verified and validated in accordance with the appropriate test requirements. The accessories contacting with human body has

been proved to be harmless by biocompatibility tests and/or 510(K) reports.

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Manufacturer suggests that the lifetime of the C50 and C80 Multi-parameter Patient
Monitor is 5 years.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.