Multi-Parameter Patient Monitor
Device Facts
| Record ID | K211619 |
|---|---|
| Device Name | Multi-Parameter Patient Monitor |
| Applicant | Shenzhen Comen Medical Instruments Co.,Ltd |
| Product Code | MHX · Cardiovascular |
| Decision Date | Dec 29, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, alarming and storing of multiple physiological parameters These parameters include ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient. All parameters can be monitored on single adult, pediatric, and neonatal patients except: - BIS monitoring is intended for adult and pediatric patients only; - C.O. monitoring is restricted to adult patients only; - Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population. - When using COMEM SpO2, the monitor is intended to be used on adult patients only. - NIBP measurement continual mode is not applicable to neonates. The monitors are to be used in general healthes by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for helicopter transport, hospital ambulance, or home use. The monitors do not measure, display, or trend changes in the ST segment. The monitors do not intend for use as apnea monitors. The monitors are not intended for use in MRI or CT environments. The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.
Device Story
Multi-parameter patient monitors (NC10/NC12) for clinical settings; operated by physicians/medical staff. Inputs: ECG leads, temperature probes, SpO2 sensors, NIBP cuffs, IBP transducers, C.O. catheters, CO2/AG sampling lines, BIS sensors. Device processes signals to display real-time waveforms and numeric values; triggers alarms for physiological thresholds. Output: visual display of patient status; aids clinical decision-making regarding patient stability. Benefits: continuous monitoring of vital signs; early detection of physiological changes. NC10/NC12 differ only in display size (10.4" vs 12.1").
Clinical Evidence
Clinical validation performed for NIBP, SpO2, and respiratory rate. SpO2 accuracy validated via controlled desaturation study per ISO 80601-2-61. NIBP accuracy validated per ISO 81060-2. Respiratory rate validated by comparing device measurements against clinician-scored capnography (EtCO2) per ISO 14155:2020.
Technological Characteristics
Color TFT LCD display; rechargeable Li-ion battery (11.1V, 2200/4400mAh) or AC power. Parameters: ECG (3/5/12-lead), trans-thoracic impedance (RR), thermal resistance (Temp), red/infrared light (SpO2), oscillometry (NIBP), invasive pressure (IBP), thermodilution (C.O.), infrared absorption (CO2/AG). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 60601-2-34, ISO 80601-2-56, ISO 80601-2-61, ISO 80601-2-55, IEC 80601-2-49, IEC 60601-2-26.
Indications for Use
Indicated for monitoring, displaying, alarming, and storing physiological parameters (ECG, RR, Temp, SpO2, PR, NIBP, IBP, C.O., CO2, AG, BIS) in adult, pediatric, and neonatal patients. Arrhythmia analysis, BIS, and COMEM SpO2 restricted to adults; C.O. restricted to adults; BIS also for pediatrics. Contraindicated for patients with known VT, Accelerated Idioventricular rhythm, or Torsades de Pointes. Not for MRI/CT, transport, or home use.
Regulatory Classification
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Predicate Devices
- C50 and C80 Multi-parameter Patient Monitors (K191106)
Submission Summary (Full Text)
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December 29, 2022
Shenzhen Comen Medical Instruments CO., LTD. Charlotte Lin Jingfang International Registration Engineer FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-District, Guangming District Shenzhen, Guangdong 51806 China
Re: K211619
Trade/Device Name: 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, NHQ, NHO, NHP, OLW, GXY Dated: December 2, 2022 Received: December 2, 2022
Dear Charlotte Lin Jingfang:
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.
# Shruti N. Mistry -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K211619
Device Name
Multi-parameter Patient Monitor, model: NC10, NC12
Indications for Use (Describe)
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, alarming and storing of multiple physiological parameters These parameters include ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
- · BIS monitoring is intended for adult and pediatric patients only;
- · C.O. monitoring is restricted to adult patients only;
· Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
- · When using COMEM SpO2, the monitor is intended to be used on adult patients only.
- · NIBP measurement continual mode is not applicable to neonates.
The monitors are to be used in general healthes by clinical physicians or appropriate medical staff under the direction of physicians.
The monitors are not intended for helicopter transport, hospital ambulance, or home use.
The monitors do not measure, display, or trend changes in the ST segment.
The monitors do not intend for use as apnea monitors.
The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.
| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="display:inline-block;"> <span style="font-size:1.2em; vertical-align:middle;">☒</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> |
| <span style="display:inline-block;"> <span style="font-size:1.2em; vertical-align:middle;">☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |
[X] Prescription Use (Part 21
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# Section 5 - 510 (k) Summary
# NC10 and NC12 Multi-parameter Patient Monitor
This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.
| Date: | 2nd December, 2022 | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------------------------------------------------------------------------------|
| Submitter | SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD | | |
| Address | Floor 10, 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 | Chuanqing Zhu | | |
| Telephone | +86-18252006698 | | |
| Facsimile | +86-755-3431232 | | |
| Ee-mail | zhuchuanqing@szcomen.com | | |
| Device<br>trade<br>name | NC10 and NC12 Multi-parameter Patient Monitor | | |
| Common name | Multi-parameter Patient Monitor | | |
| | Classification Regulation, Classification name and Product Codes | | |
| Device Panel | Regulation<br>Classification<br>number | Product<br>code | Description |
| Cardiovascular | §870.1025, II | MHX | Arrhythmia detector and alarm (including<br>ST-segment measurement and alarm) |
| Cardiovascular | §870.1025, II | DSI | Arrhythmia detector and alarm (including<br>ST-segment measurement and alarm). |
| Cardiovascular | §870.1025, II | MLD | Arrhythmia detector and alarm (including<br>ST-segment measurement and alarm). |
| Cardiovascular | §870.2300, II | DRT | Monitor, Cardiac (Including<br>Cardiotachometer & Rate Alarm) |
| Cardiovascular | §870.1100, II | DSJ | Alarm, Blood-Pressure |
| Cardiovascular | §870.1130, II | DXN | System, Measurement, Blood-Pressure,<br>Non-Invasive |
| Cardiovascular | §870.1110, II | DSK | Computer, Blood-Pressure |
| Cardiovascular | §870.2340, II | DPS | Electrocardiograph |
| Cardiovascular | §870.1435, II | DXG | Computer, Diagnostic, Pre-Programmed,<br>Single-Function |
| Cardiovascular | §870.2770, II | DSB | Plethysmograph, Impedance |
| General<br>Hospital | §880.2910, II | FLL | Thermometer, Electronic, Clinical |
| Anesthesiology | §870.2700, II | DQA | Oximeter |
| Anesthesiology | §868.1400, II | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-<br>Phase |
| Anesthesiology | §868.1500, II | CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase<br>(Anesthetic Concentration) |
| Anesthesiology | §868.1620, II | CBS | Analyzer, Gas, Halothane, Gaseous-Phase<br>(Anesthetic Conc.) |
| Anesthesiology | §868.1700, II | CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous<br>Phase (Anesthetic Conc.) |
| Anesthesiology | §868.1720, II | CCL | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Anesthesiology | §868.1500, II | NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase<br>(Anesthetic Concentration) |
| Anesthesiology | §868.1500, II | NHO | Analyzer, Gas, Desflurane, Gaseous-Phase<br>(Anesthetic Concentration) |
| Anesthesiology | §868.1500, II | NHP | Analyzer, Gas, Sevoflurane, Gaseous-<br>Phase (Anesthetic Concentration) |
| Neurology | §882.1400, II | OLW | Index-Generating Electroencephalograph<br>Software |
| Neurology | §882.1320, II | GXY | Electrode, Cutaneous |
| Predicate<br>Device: | K191106, C50 and C80 Multi-parameter Patient Monitors, SHENZHEN COMEN<br>MEDICAL INSTRUMENTS CO., LTD | | |
| Device<br>description: | The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying,<br>reviewing, alarming and storing multiple physiological parameters. These parameters<br>include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)),<br>Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood<br>pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide<br>(CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.<br>All parameters can be monitored on single adult, pediatric, and neonatal patients except:<br>BIS monitoring is intended for adult patients only; C.O. monitoring is restricted to adult patients only; Arrhythmia analysis is intended for use with adult patients only and is not intended<br>and shall not be used on pediatric and neonatal population. When using COMEM SpO2, the monitor is intended to be used on adult patients only. NIBP measurement continual mode is not applicable to neonates. Both models are designed with:<br>Same system framework and components<br>Same hardware design principle<br>Same software platform<br>Same parameters measurement subsystems (including parameters modules and accessories)<br>The only difference between NC10 and NC12 is the display size. | | |
| Indications for<br>Use: | The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying,<br>reviewing, alarming and storing of multiple physiological parameters. These parameters<br>include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), | | |
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| | Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood<br>pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide<br>(CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.<br>All parameters can be monitored on single adult, pediatric, and neonatal patients except:<br>• BIS monitoring is intended for adult and pediatric patients only;<br>• C.O. monitoring is restricted to adult patients only;<br>Arrhythmia analysis is intended to use on adult patients only and is not intended and shall<br>not be used on pediatric and neonatal population.<br>• When using COMEM SpO2, the monitor is intended to be used on adult patients only.<br>• NIBP measurement continual mode is not applicable to neonates. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The monitors are to be used in general healthcare facilities by clinical physicians or<br>appropriate medical staff under the direction of physicians.<br>The monitors are not intended for helicopter transport, hospital ambulance, or home use.<br>The monitors do not measure, display, or trend changes in the ST segment.<br>The monitors do not intend for use as apnea monitors. |
| | The monitors are not intended for use in MRI or CT environments.<br>The monitors are not used on patients who have a demonstrated need for cardiac monitoring<br>known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes. |
| Technological<br>Comparison to | Both the subject devices and the predicate device provide a means for monitoring one<br>patient, collecting specific physiological data, processing the data for alarm conditions and |
| Predicate | display of numeric values and waveforms. |
| Devices: | In terms of indications for use, basic operation and performance specifications, the NC10 |
| | and NC12 Multi-parameter Patient Monitor is equivalent to C50 and C80 multi-parameter |
| | Patient Monitors (K191106). All devices can provide monitoring such as ECG(3-lead , 5- |
| | lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate(RR), |
| | Temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive |
| | blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG) and |
| | Bispectral index (BIS)for a single patient. |
| | NC10 and NC12 restricted the arrhythmia analysis, BIS monitoring and COMEN SpO2 on |
| | adults only, which is a subset of C50 and C80 multi-parameter patient monitor. These do |
| | not affect the substantial equivalence of subject device and predicate device. |
| | Table below compares the key technological feature of the subject devices (NC10 and NC12 |
| | patient monitors) to the predicate device (K191106, C50 and C80 multi-parameter patient |
| | monitor). The features in gray are features that are different between the predicate devices…
