(232 days)
No
The summary describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities. The performance studies and metrics are typical for this type of device and do not suggest the use of AI/ML.
No
Explanation: The device is described as a "patient monitor" intended for "monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters." It provides data but does not administer treatment or directly affect the patient's physiological state.
No
This device is described as a patient monitor intended for "monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters." While it provides data, its stated purpose is observation and alarming, not the diagnosis of disease.
No
The device description explicitly states that the C50 and C80 are "patient monitors" and mentions the use of "corresponding accessories" and "modules and components," indicating the presence of hardware beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters". These parameters are measured directly from the patient's body (ECG, SpO2, NIBP, temperature, etc.) using sensors and probes applied to the patient.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of Specimen Analysis: The description of the C50 and C80 patient monitors does not mention the analysis of any biological specimens (blood, urine, tissue, etc.). The device directly measures physiological signals from the patient.
Therefore, the C50 and C80 patient monitors fall under the category of patient monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / 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 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 122229cm in height and 30159Kg (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.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI, MLD, DRT, DSJ, DXN, DSK, DPS, DXG, DSB, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, NHO, NHP, OLW, GXY
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 122229cm in height and 30159Kg (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients.
ICG monitoring is applicable to adult patients.
NIBP continual mode is not applicable to neonates.
Anesthetic depth (BIS) is not intended for neonatal patients.
Intended User / Care Setting
General healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing:
All patient contacting accessories have been previously cleared except for the ECG cable, SpO2 probes and temperature probes. These items are either surface contacting for prolonged 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.
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 "major" 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 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 Clinical Thermometers 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 Pulse Oximeter 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 - Collateral Standard: Usability, FDA Recognition Number: 5-89
- IEC 62366-1 Edition 1.0 2015-02Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices [Including CORRIGENDUM 1 (2016)], FDA Recognition Number: 5-114
- ANSI AAMI IEC 62304 First Edition 2006-05Medical Device Software - Software Life Cycle Processes, FDA Recognition Number: 13-32
- ISO 14971 Second Edition 2007-03-01Medical Devices - Application Of Risk Management To Medical Devices, FDA Recognition Number: 5-40
- ANSI AAMI EC57:2012Testing And Reporting Performance Results Of Cardiac Rhythm And ST-Segment Measurement Algorithms, FDA Recognition Number: 3-118
- ISO 81060-2 Second Edition 2013-05-01 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type, FDA Recognition Number: 3-122
Clinical studies:
- NIBP clinical study-for adults and children: Clinical evaluation of the non-invasive blood pressure was performed on adults and children. 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 Second Affiliated Hospital of Guangzhou Medical University and The First Affiliated Hospital of Guangzhou Traditional 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 are between the ages of 3-12, 2 patients are between the ages of 12-40, 10 patients are between the ages of 40-60, and 7 patients are above 60 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K123043, K103604, K040183, K053174, K002734, K110645
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
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.
1
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
2
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 122229cm in height and 30159Kg (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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3
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 trade | ||||
| name | 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 (including | |
| ST-segment measurement and alarm) | ||||
| Cardiovascular | §870.1025, II | DSI | Arrhythmia detector and alarm (including | |
| ST-segment measurement and alarm). | ||||
| Cardiovascular | §870.1025, II | MLD | Arrhythmia detector and alarm (including | |
| ST-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 | |
| General | ||||
| Hospital | §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), Shenzhen | |||
| Mindray 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 122229cm in height and 30159Kg (67341 pounds) in weight only;229cm in height and
• 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 | | | |
| Technological
Comparison to
Predicate
Devices: | Both the subject devices and the predicate devices provide a means for interfacing with a
patient, collecting parameter and specific physiological data, and processing the data for
alarm generation and display of numeric values and waveforms.
The device respecting indications for use, basic operation and performance specifications
of the C50 and C80 Multi-parameter Patient Monitor is equivalent to Passport Series
Patient Monitors (K170876). Those devices all can provide monitoring such as 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
30159Kg (67341 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; | | | |
| Table below compares the key technological feature of the subject devices (C50 and C80
patient 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 | Predicate
device(K170876)
Passport 12m/17m | Subject devices
C50 and C80 | Comparison |
| | Monitor Size | Passport 17m: 400 mm×370 mm×193mm
Passport 12m:
297 mm × 336 mm × 187mm | C80: About 344mm×291 mm×165mm
C50: 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 and
effectiveness of
subject device. | |
| Integrated display
and touch screen | color TFT LCD
Passport 17m: 17 Inch
Passport 12m:12 Inch | color TFT LCD
C80: Size: 12.1 Inch
C50: Size: 10.4 Inch | 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.. | |
| | Passport 17m:
1280×1024 pixels
Passport 12m: 800×600
pixels | C80 Pixel :800×600
C50 Pixel :800×600 | | |
| Power supply | Passport 17m:
Two rechargeable
Lithium-ion battery or
AC power supply
Passport 112m:
One rechargeable
Lithium-ion battery
or AC power supply | C50 and C80:
Powered either by
built-in battery or
external AC. | Same, both
powered by
battery and AC. | |
| 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. | |
| ECG | 3-lead, 5-lead and
12-lead selectable, heart
rate (HR) | 3-lead, 5-lead and
12-lead selectable,
heart rate (HR) | Same | |
| ECG (Arrhythmia
Analysis) | Asystole,
VFib/VTac, Vtac,
Vent. Brady,
Extreme Tachy,
Extreme Brady,
PVC, Couplet,
Bigeminy, Trigeminy,
Ron T, Run PVCs,
PVCs, Tachy, Brady, | Asystole,
ventricular
fibrillation, R ON
T, VT $>2$ , Couplet,
PVC, Bigeminy,
Trigeminy, Brady
(Bradycardia), PNC
(Pacer Not
Capture), PNP | 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 | |
| | | | | |
| | Missed Beats, | (Pacer Not Pace), | compliance with | |
| | Vent. Rhythm, PNP, | Missed Beats, IHB | EC57. | |
| | PNC, Multif. PVC, | (Irregular Heart
Beat), VTAC | | |
| | Nonsus. Vtac, | | | |
| | Pause, Irr. Rhythm, | (Ventricular
Tachycardia), Tachy
(Tachycardia), PVC
Too High, | | |
| | AFib | Extreme
Tachycardia, | | |
| | | Extreme
Bradycardia, | | |
| | | Ventricular Rhythm,
Heart Pause | | |
| Respiration | Method: Trans-thoracic
impedance
Range: adult:0-120 rpm;
pediatrics:0-150rpm;
neonate:0-150rpm
Accuracy: 7 to 150rpm:
$\pm$ 2rpm or $\pm$ 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: $\pm$ 2rpm or $\pm$ 2%, whichever is
greater.
0 to 6rpm: not
specified | same | |
| Pulse oxygen
saturation (SpO2) | Method:red and infrared
light method
Masimo SpO2:
Range:1100%100%
Accuracy:
No motion Conditions:
70 to 100%: $\pm$ 2%(in
adult/pediatric mode)
70 to 100%: $\pm$ 3% (in
neonate mode)
Motion conditions:
70%100%: $\pm$ 3% 69%: Not
1%
specified.
Nellcor SpO2:
Range: 0
Accuracy:70% to | Method: same
Masimo SpO2:
Range: same
Accuracy: same
Nellcor SpO2:
Range: same
Accuracy: same
Comen SpO2:
Range: 0%-100%
Accuracy: 70 to
100%: $\pm$ 2%
(adult/pediatric, in
non-motion )
70 to 100%: $\pm$ 3%
(neonate, in
non-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 Module
Measurement range: 20 to 254 bpm
Accuracy: ±3 bpm | PR FROM Masimo SpO2:
Range: 25240bpm240bpm
Accuracy:
±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
Accuracy:
±3bpm (without motion)
±5bpm (with motion) | PR FROM Nellcor SpO2:
Range: 20300bpm250bpm: ±3bpm
Accuracy:
20
251300bpm: not specified. | | |300bpm
| | PR FROM Nellcor SpO2:
Range:20
Accuracy:
20250bpm: ±3bpm300bpm: not specified. | PR FROM Comen SpO2:
251
Range:20bpm254bpm250mmHg
Accuracy: ±2bpm | | |
| | PR FROM IBP sensor:
Range:25-350bpm
Accuracy:±1bpm or ±1%, whichever is greater | PR FROM IBP sensor:
Range: 25-350bpm
Accuracy: ±1bpm or ±1%, whichever is greater
PR FROM NIBP | | |
| Non-invasive
blood pressure
(NIBP) | Method: Oscillometry
Range:
Adult:
systolic:25 ~ 290mmHg
diastolic:10
pediatrics:
systolic:25 ~ 240mmHg
diastolic:10200mmHg115mmHg
Neonate:
systolic:25 ~ 140mmHg
diastolic:10
Accuracy:
Max mean error: ±5 mmHg
Max standard deviation:
8 mmHg | sensor:
Range:40bpm240bpm;200mmHg
Accuracy: ±3bpm or ±3%, whichever is greater.
Method: same
Range:
Adult:
systolic:40-270mmHg
diastolic:10-215mmHg
pediatrics:
systolic:40
diastolic:10-150mmHg
Neonate:
systolic:40135mmHg100mmHg
diastolic:10
Accuracy:
0300mmHg:99mmHg
±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 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. | |
| Carbon dioxide (CO2) | Method:
Infrared absorption
Masimo CO2:
Range:
Sidestream CO2 Module:
0
AwRR:0120rpm190mmHg , 0
Microstream CO2 Module: | Method: same
Masimo CO2Range:
Sidestream CO2 Module 0mmHg25% (at 760mmHg)150rpm
AwRR:0
Mainstream 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 | |
4
5
6
7
8
9
10
| 099mmHg150rpm | Module
AwRR:0
0mmHg190mmHg , 025% (at 760mmHg)
AwRR:0150rpm150mmHg
Respironics CO2:
Range:
Sidestream CO2 Module
0
0%19.7%(020.0k Pa)
AwRR: 0 , 2rpm150rpm150mmHg0%
Mainstream CO2 Module
019.7% (020.0kPa)
AwRR: 0 , 2rpm150rpm | module (K040183 and K053174) have been cleared.40mmHg:
Both modules have complied with ISO 80601-2-55. | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Accuracy:
Sidestream CO2 Module:
0 to 40 mmHg: ±2mmHg
41 to 76mmHg: ±5% of the reading
77 to 99mmHg: ±10% of the reading
AwRR: ±2 rpm
Microstream CO2 Module
0 to 38 mmHg: ±2mmHg
39 to 99mmHg: ±5% of the reading+0.08% of (the reading-38)
AwRR:
0-70rpm: ±1 rpm
71-120rpm: ±2 rpm
121-150rpm: ±3 rpm | Accuracy:
Masimo
Sidestream CO2 Module
All environment:
±(2.25mmHg +reading×4%)
AwRR: ±1 rpm
Masimo
Mainstream CO2 Module
All environment:
±(2.25mmHg +reading×4%)
AwRR: ±1 rpm
Respironics
Sidestream CO2 Module
0
±2mmHg
4170mmHg:100mmHg:
±5% ×reading | | | | |
| | | 71
±8%×reading
101150mmHg:40mmHg:
±10%×reading
AwRR: ±1 rpm
Respironics
Mainstream CO2
Module
0
±2mmHg
4170mmHg:100mmHg:
±5%×reading
71
±8%×reading
101~150mmHg:
±10%×reading
AwRR: ±1 rpm | | | |
| 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 | | |
| 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 | | |
| anesthetic gas
(AG) | Method:
Infrared absorption
Range:
CO2 0%~30%
N2O 0%~100%
Hal 0%~30%
Enf 0%~30%
Iso 0%~30%
Sev 0%~30% | Method: same
Range:
CO2 0%~25%
N2O same
Hal 0%25%3500 dyn・s ・ cm-5 | | |
Enf 0%25%150 /KΩ
Iso 0%25%30L/min
Sev 0%25% | For CO2/Enf/150rpm | the predicate
Hal/Iso/Sev/Des,
The measurement
range of C50 and
C80 is smaller
than the predicate
device.
For awRR, the
measurement | | |
| | O2 0%100% | O2same | C80 is better than | | |100rpm | awRR0
| | awRR 2
device. | | |
| | Accuracy: | Accuracy: | | | |
| | CO2 ±0.3% ABS | CO20%15%:250mL
$±(0.2kPa+reading×2%)$ | The C50 and C80
are more accuracy
than predicate
device. | | |
| | N2O±(8%REL+2%ABS) | 15%25%:Not250bpm
defined. | The measurement
range of C50 and
C80 is enough for
most
environments; it
won't affect the
safety and
effectiveness. | | |
| | Other anesthetic gases:
8%REL | N2O±(2
kPa+reading×2%) | | | |
| | | Hal, Enf, Iso:
0%8%:
$±(0.15%+reading×5%)$ | | | |
| | | Not defined.
Sev0%
10%: $±(0.15%+reading×5%)$ | The C50 and C80
supports two AG
modules:
MASIMO ISA | | |
| | | Not defined.
Des0%22%: $±(0.15%+reading×5%)$ | AX+ Sidestream100%;
module and
Masimo IRMA | | |
| | | Not defined.
O2 $±(1%+reading×2%)$ | AX+ Mainstream
module, both of
them have been
cleared in
K103604. | | |
| | | MasimoAG
awRR±1rpm | | | |
| BIS | Range:
BIS, BIS L, BIS
R:0-100 | Range and
Accuracy:
BIS: same;
accuracy: 1%. | The underline
parameters are
what C50 and
C80 doesn't have. | | |
| | SQI, SQI L, SQI R: 0 to
100% | SQI: same;
accuracy: 1%. | The BIS module
and sensor have
been cleared by
FDA and its 510k
numbers are
K040183 and
K002734. | | |
| | EMG, EMG L, EMG R:
0 to 100 Db | EMG: same;
accuracy: 1%. | | | |
| | SR, SR L, SR R: 0 to
100% | ESR: 0
accuracy: 1%. | | | |
| | SEF, SEF L, SEF R: 0.5
to 30.0 Hz | | | | |
| | TP, TP L, TP R: 40 to
100 Db | | | | |
| | BC, BC L, BC R: 0 to
30 | | | | |
| | sBIS L, sBIS R: 0 to
10.0 | | | | |
| | | Semg L, Semg R: 0 to 10.0
ASYM: 0 to 100% | | | |
| | ICG | Method: Indirect
impedance cardiograph
measurement | Method: same | 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. | |
| | | Range:
SV: 5 to 250 ml
HR: 44 to 2m
C.O. 1.4 to 15 L/min | Range:
HR: 40
SV: 0
C.O.:0
TFC: 5
SVR:0
| | | Accuracy:
SV: Not specified.
HR: ±2 bpm
C.O. Not specified | Accuracy:
SV: Not specified.
HR: ±2 bpm
C.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. | | | | |
| Performance
Data | The following performance data were provided in support of the substantial equivalence
determination. | | | | |
| | Biocompatibility Testing | | | | |
| | All patient contacting accessories have been previously cleared except for the ECG
cable, SpO2 probes and temperature probes. These items are either surface contacting for
prolonged 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. | | | | |
11
12
13
14
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
15
| 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 Clinical |
| Thermometers 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 Pulse |
| Oximeter 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 - Collateral |
| Standard: Usability, FDA Recognition Number: 5-89 |
| • IEC 62366-1 Edition 1.0 2015-02Medical Devices - Part 1: Application Of |
| Usability Engineering To Medical Devices [Including CORRIGENDUM 1 (2016)], |
| FDA Recognition Number: 5-114 |
| • ANSI AAMI IEC 62304 First Edition 2006-05Medical Device Software - Software |
| Life Cycle Processes, FDA Recognition Number: 13-32 |
| • ISO 14971 Second Edition 2007-03-01Medical Devices - Application Of Risk |
| Management To Medical Devices, FDA Recognition Number: 5-40 |
| • ANSI AAMI EC57:2012Testing And Reporting Performance Results Of Cardiac |
| Rhythm And ST-Segment Measurement Algorithms, FDA Recognition Number: |
| 3-118 |
| • ISO 81060-2 Second Edition 2013-05-01 Non-Invasive Sphygmomanometers - Part |
| 2: Clinical Validation Of Automated Measurement Type, FDA Recognition |
| Number: 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 and |
| children. 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 Second Affiliated Hospital of |
| Guangzhou Medical University and The First Affiliated Hospital of Guangzhou |
| Traditional 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 are |
| between the ages of 3-12, 2 patients are between the ages of 12-40, 10 patients are |
| between the ages of 40-60, and 7 patients are above 60 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 |
16
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.
17
| Manufacturer suggests that the lifetime of the C50 and C80 Multi-parameter Patient |
|---|
| Monitor is 5 years. |