Multi-parameter Patient Monitor, models C30

K173454 · Shenzhen Comen Medical Instruments Co.,Ltd · MHX · Aug 16, 2018 · Cardiovascular

Device Facts

• Record ID: K173454
• Device Name: Multi-parameter Patient Monitor, models C30
• Applicant: Shenzhen Comen Medical Instruments Co.,Ltd
• Product Code: MHX · Cardiovascular
• Decision Date: Aug 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It's used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker. The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.

Device Story

C30 Multi-parameter Patient Monitor collects physiological signals including ECG, respiration, temperature, SpO2, pulse rate, NIBP, and EtCO2. Device processes these inputs to generate numeric values, waveforms, and alarms. Used in clinical settings by trained physicians and nurses for single-patient monitoring. Output displayed on integrated 4.3-inch touchscreen; enables real-time monitoring, review, and storage of patient data. Clinical decision-making supported by continuous parameter tracking and alarm generation. Benefits include timely identification of physiological changes and patient status monitoring.

Clinical Evidence

Bench testing performed per IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-27, 80601-2-30, 80601-2-56, 80601-2-61, 62366-1, and ISO 80601-2-55. NIBP clinical accuracy verified per ISO 81060-2:2013. Respiration rate (RR) accuracy verified via clinical study comparing device output to capnography. Software verified and validated per IEC 62304.

Technological Characteristics

Multi-parameter monitor with 4.3-inch touchscreen (480x272 pixels). Powered by rechargeable lithium-ion battery or AC. Parameters: ECG (3/5/12-lead), Resp, Temp, SpO2 (Masimo/Nellcor modules), NIBP, EtCO2. Connectivity: Standalone. Software developed per IEC 62304. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 80601-2-56, IEC 80601-2-61, ISO 80601-2-55, ISO 81060-2.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring monitoring of ECG, HR, respiration, temperature, SpO2, pulse rate, NIBP, and EtCO2. Contraindicated for patients with pacemakers. For use by trained healthcare professionals in clinical settings.

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

• BeneView T1 Patient monitor (K123074)
• C80 COMEN Multi-parameter Patient Monitor (K112877)

Submission Summary (Full Text)

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August 16, 2018

Shenzhen Comen Medical Instruments Co., Ltd. Hongbo Yan Registration Engineer South of Floor 7, Block 5 4th Industrial Area of Nanyou Nanshan District Shenzhen, 518052 CN

Re: K173454

Trade/Device Name: Multi-parameter Patient Monitor, Model C30 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: DRT, DPS, DSJ, DSK, DXN, DOA, DSB, FLL Dated: Julv 23, 2018 Received: July 23, 2018

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.

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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

## Jessica E. Paulsen -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K173454

Device Name

Multi-parameter Patient Monitor, Model C30

#### Indications for Use (Describe)

C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It's used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker.

The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510 (k) Summary C30 Multi-parameter Patient Monitor

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

| Date: | Aug 14, 2018 |
|--------------------|----------------------------------------------------------------------------|
| Submitter: | SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD |
| | South of Floor 7, Block 5 4th Industrial Area of Nanyou, Nanshan District, |
| | Shenzhen, Guangdong, 518052, P.R.China |
| | No.2 of FIYTA Timepiece Building, Nanhuan Avenue, Gongming Sub-district, |
| | Guangming New District, Shenzhen, Guangdong, 518106, P.R.China. |
| Contact: | Hongbo Yan |
| | Registration Engineer |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Device Trade Name: | Multi-parameter Patient Monitor, Model C30 |
| Common Name: | Multi-parameter Patient Monitor |

### Device Classification:

| Device Panel | Classification | ProCode | Description | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|---|
| Cardiovascular | §870.2300, II | DRT | Cardiac Monitor (incl. Rate Alarm) | |
| | §870.1110, II | DSK | Computer, Blood Pressure | |
| Devices: | §870.1130, II | DXN | System, Measurement, Blood-Pressure,<br>Non-Invasive | |
| | §870.1100, II | DSJ | Alarm, Blood Pressure | |
| | §870.2300, II | DRT | Monitor, Cardiac (incl.<br>Cardiotachometer& Rate Alarm) | |
| | §870.2340, II | DPS | Electrocardiograph | |
| | §870.2700, II | DQA | Oximeter | |
| | §870.2770, IT | DSB | Plethysmograph, Impedance | |
| General Hospital | §880 .2910, II | FLL | Thermometer, Electronic, Clinical | |
| Predicate Devices: | K123074, BeneView T1 Patient monitor, Shenzhen Mindray Bio-medical<br>Electronics (The primary predicate device) | | | |
| | K112877, C80 COMEN Multi-parameter Patient Monitor, Shenzhen Comen<br>Medical Instruments Co., Ltd | | | |
| Device description: | C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is<br>intended to be used for monitoring, reviewing and storing of multiple physiological<br>parameters as following: ECG, heart rate (HR), respiration (Resp), temperature<br>(Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single<br>patient. Other parameters can be applied to adult, pediatric or neonate. | | | |
| Indications for Use: | C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is<br>indicated for use by health care professionals whenever there is a need for<br>monitoring the physiological parameters of patients. It's used for monitoring,<br>reviewing and storing of multiple physiological parameters as following: ECG,<br>heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR),<br>non-invasive blood pressure (NIBP) of single patient. All parameters can be<br>applied to adult, pediatric or neonate. The Patient Monitor is not intended to be<br>used on the patients with pacemaker. The monitor is used for monitoring the<br>clinical patients, so only the doctors and nurses who are qualified through training<br>can use these monitors. | | | |
| | The table below lists the patient population for each parameter as appropriate: | | | |
| Patient<br>Population<br>Parameter | Adult | Pediatric | Neonate | |
| ECG | √ | √ | √ | |
| RESP | √ | √ | √ | |
| | SpO2 | √ | √ | √ |
| | TEMP | √ | √ | √ |
| | NIBP | √ | √ | √ |
| | Et CO2 | √ | √ | √ |
| | Remark: | 1. The patient population for each parameter as<br>appropriate is marked with '√';<br>2. The neonatal patient type is not included in the<br>patient type of pediatrics for COMEN<br>multi-parameter patient monitors. | | |
| Indications for Use<br>Comparison to<br>Predicate Devices | The C30 and the predicate devices' indications for use are similar. The subject<br>and predicate devices are all patient monitors that are intended to be used in<br>healthcare facilities by physicians or clinical staff. The devices measure similar<br>patient parameters.<br>The device provides single patient monitoring for parameters such as ECG,<br>impedance respiration (Resp), temperature (TEMP),SpO2, pulse rate(PR),<br>noninvasive blood pressure (NIBP), respiration rate (RR) and EtCO2. All<br>parameters can be applied to adult, pediatric or neonate..<br><br>These minor differences between the predicate device and subject devices'<br>indications for use do not constitute a new intended use and are not significant<br>changes in indications for use. | | | |
| Technological<br>Comparison to<br>Predicate Devices: | Both the subject devices and the predicate devices provide a means for<br>interfacing with a patient, collecting parameter and specific physiological data,<br>and processing the data for alarm generation and display of numeric values and<br>waveforms. | | | |

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| Feature | Subject Devices | Predicate Device(primary) K123074 | Predicate Device K112877 | | | |
|------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Dimension | C30 | T1 | C80 | | | |
| | 190×82×105mm | 143×77×102mm | 344.5x291×165 mm | | | |
| Integrated<br>display and<br>touchscreen | 4.3"<br>480*272 pixels | 5"<br>same | 12.1"<br>800*600 pixels | | | |
| | Power<br>supply | One standard<br>rechargeable<br>lithium-ion battery<br>or AC power | Same | Same | | |
| Battery | | 11.1V, 2600mAh | 14.8V, 4400Ah | 12V, 2500mAh | | |
| ECG | | 3-lead, 5-lead or<br>12-lead selectable, | 3-lead, 5-lead or<br>12-lead selectable,<br>arrhythmia<br>detection, ST<br>segment | 3-lead, 5-lead or<br>12-lead<br>selectable | | |
| | | ECG<br>measurement range and<br>accuracy | HR:<br>Neonate /<br>Pediatric: 15 to<br>350bpm<br>Adult: 15 to<br>300bpm<br>Accuracy: ±1% or<br>±1bpm, whichever<br>is the larger. | Same | Same | |
| | Respiration<br>rate (Resp) | | Measurement<br>range: Adult: 7 to<br>120rpm, Neonate:<br>7 to 150rpm.<br>Accuracy: 7 to 150<br>rpm: ±2rpm or<br>±2%, whichever is<br>greater; 0 to 6rpm:<br>Not specified. | Measurement<br>range: Adult: 0 to<br>120rpm, Neonate:<br>0 to 150rpm.<br>Accuracy: same | Measurement<br>range: same<br>Accuracy:<br>7 to 150rpm:<br>±1rpm | |
| | | | Temperature<br>(Temp) | Measurement<br>range: 0 to 50°C (32<br>to 122°F )<br>Accuracy: ±0.1 ℃ or | Same | Same |
| | | | | | ±0.2°F (without probe) | |
| Pulse oxygen saturation (SpO2) | | | | Masimo SpO2 Module:<br>Measurement range: 1 to 100%<br>Accuracy: 70 to 100%: ±2% (measured without motion in adult/pediatric mode)<br>Accuracy: 70 to 100%: ±3% (measured without motion in neonate mode)<br>Accuracy: 70 to 100%: ±3% (measured with motion)<br>1 to 69%: Not specified<br>NellcorSpO2 module:<br>Measurement range: 0 to 100%<br>Accuracy: 70 to 100%: ±2% (adult/pediatric mode)<br>Accuracy: 70 to 100%: ±3% (neonate mode)<br>0 to 69%: Not specified | MindraySpO2 Module:<br>Measurement range: 0 to 100%<br>Accuracy: 70 to 100%: ±2% (adult/pediatric mode)<br>70 to 100%: ±3% (neonate mode)<br>0 to 69%: Not specified<br>Masimo SpO2 Module: Same<br>NellcorSpO2 module: Same | Masimo SpO2 Module: Same<br>NellcorSpO2 module: Same |
| Pulse rate | | | | PR from MasimoSpO2 module:<br>Measurement | PR from MindraySpO2 module:<br>Measurement | / |
| | | | | | | |
| | | range: 25 to 240<br>bpm<br>Accuracy: ±3bpm<br>(measured without<br>motion)<br>±5 bpm (measured<br>with motion)<br><br>PR from<br>NellcorSpO2<br>module:<br>Measurement<br>range: 20 to 300<br>bpm<br>Accuracy: 20 to<br>250bpm: ±3bpm,<br>251 to 300bpm:not<br>specified. | range: 20 to 254<br>bpm<br>Accuracy: ±3bpm<br><br>PR from<br>MasimoSpO2<br>module: Same<br><br>PR from<br>NellcorSpO2<br>module: Same | | | |
| Non-invasive blood<br>pressure<br>(NIBP) | | Measurement<br>range:<br>Adult:<br>Systolic:<br>40-270mmHg<br>Mean: /<br>Diastolic:<br>10-215mmHg<br>Pediatric:<br>Systolic:<br>40-200mmHg<br>Mean: /<br>Diastolic:<br>10-150mmHg<br>Neonate:<br>Systolic:<br>40-135mmHg<br>Mean: /<br>Diastolic:<br>10-100mmHg<br><br>Accuracy:<br>Max mean error: | Measurement<br>range:<br>Adult:<br>Systolic: same<br>Mean: 20-230<br>Diastolic:<br>10-210mmHg<br>Pediatric:<br>Systolic: same<br>Mean:<br>20-165mmHg<br>Diastolic: same<br>Neonate:<br>Systolic: same<br>Mean:<br>20-110mmHg<br>Diastolic:<br>10-110mmHg<br><br>Accuracy: Same | Measurement<br>range:<br>Adult:<br>Systolic: same<br>Mean: 20-235<br>Diastolic: same<br>Pediatric:<br>Systolic: same<br>Mean:<br>20-165mmHg<br>Diastolic:<br>10-100mmHg<br>Neonate:<br>Systolic:<br>40-150mmHg<br>Mean:<br>20-110mmHg<br>Diastolic: same<br><br>Accuracy:<br>Same | | |
| | | | | | | |
| Carbon<br>dioxide<br>(CO2) | ±5mmHg | | / | | | |
| | Max standard<br>deviation: 8mmHg | | | | | |
| | Respironics<br>Novametrix CO2<br>module: | Measurement<br>range: 0-99mmHg | | | | |
| | Measurement<br>range:<br>0-150mmHg, | Accuracy: | | | | |
| | Accuracy: | 0 to 40 mmHg:<br>±2mmHg | | | | |
| | 0-40mmHg:<br>±2mmHg | 41 to 76mmHg:<br>±5% of the reading | | | | |
| | 41-70mmHg: ±5%<br>of the reading | 77 to 99mmHg:<br>±10% of the<br>reading | | | | |
| | 71-100mmHg: ±8%<br>of the reading | awRR<br>measurement<br>range: 0 to 120<br>rpm | | | | |
| | 101-150mmHg:<br>±10% of the<br>reading | awRR<br>measurement<br>accuracy: ±2rpm | | | | |
| | awRR<br>measurement<br>range: 0 to 150 rpm | | | | | |
| | awRR<br>measurement<br>accuracy: ±1rpm | | | | | |
| | | | | | | |
| | Masimo CO2<br>module: | | |…