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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

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