ETCO2 Sensor

K171828 · Orantech, Inc. · CCK · May 31, 2018 · Anesthesiology

Device Facts

• Record ID: K171828
• Device Name: ETCO2 Sensor
• Applicant: Orantech, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: May 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The intended use of the ETCO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

Device Story

Mainstream ETCO2 sensor (Model CTM-RP01) utilizes non-dispersive infrared (NDIR) spectroscopy to measure CO2 levels in expiratory breath; sensor head contains infrared light source and photo detector; connects to airway adapter placed between patient airway and respirator; transmits raw data to compatible host patient monitor (e.g., General Meditech G3C) for signal processing and screen display; used in clinical settings (ICU, OR, transport) by healthcare professionals; provides real-time CO2 concentration and respiration rate monitoring; aids clinical decision-making regarding ventilation and patient status; benefits include continuous, non-invasive respiratory gas monitoring.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing (ISO 80601-2-55).

Technological Characteristics

Mainstream NDIR infrared spectroscopy sensor; 5.0 VDC power; Lemo Redel 8-pin connector; IPX2 water resistance; complies with IEC 60601-1, IEC 60601-1-2, and ISO 80601-2-55. No direct patient-contacting components.

Indications for Use

Indicated for patients requiring carbon dioxide monitoring during anesthesia, recovery, ICU care, emergency medicine, transport, or respiratory care.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• Capnostat 5 CO2 sensor (K042601)

Submission Summary (Full Text)

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May 31, 2018

Orantech Inc. % Mei Tan RA Consultant Chonconn Medical Device Consulting Co. LTD. 22A, Hai Jing Square, No.18 Taizi Road, Nanshan District, Shenzhen, 51800 China

Re: K171828

Trade/Device Name: ETCO2 Sensor, Model CTM-RP01 Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: April 30, 2018 Received: April 30, 2018

Dear Mei Tan:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K171828

Device Name EtCO2 Sensor, Model CTM-RP01

Indications for Use (Describe)

The intended use of the ETCO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="display:inline-block; margin-right: 5px;">☑</span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="display:inline-block; margin-right: 5px;">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(K) Summary K171828

# 1. Prepared Date: 2018/5/30

### 2. Submitter Information

| Name | Orantech Inc. |
|----------------|------------------------------------------------------------------------------------------------------------------|
| Address | Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community,<br>GongMing, Guangming New District, Shenzhen,China 518106 |
| Contact person | Mr. Hsin Xiong |
| Tel | 0755-23699939 |
| Fax | 0755-23243594 |
| Email | [e-mail] |

# 3. Submission Correspondent

| Name | Chonconn Medical Device Consulting Co.LTD. |
|----------------|----------------------------------------------------------------------------------------|
| Address | 22A,HaiJing Square,No.18 Taizi Road,Nanshan District,<br>Shenzhen,Guangdong,P.R.China, |
| Contact person | Mei(RA consultant) |
| E-mail | [e-mail]/[e-mail] |
| Tel | [phone] |

# 4. Proposed Device Information

| Trade Name | ETCO2 Sensor |
|-----------------------|-------------------------------|
| Model | CTM-RP01 |
| Common name | Carbon Dioxide (CO2) Analyzer |
| Regulatory class | II |
| Production regulation | 21 CFR §868.1400 |
| Product code | CCK |
| Panel | Anesthesiology |

# 5. Predicate Device Information

| 510(K)No. | Trade Name/model | Submitter |
|-----------|------------------------|-----------------------------|
| K042601 | Capnostat 5 CO2 sensor | Respironics Novametrix, LLC |

### 6. Device description

The ETCO2 Sensor is comprised of three main components, a sensor with photo detector and light emitter, cable and connector, The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. The photo ETCO2 Sensor-510(k) Submission Page 1 of 4

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detector and light emitter end of the CO2 sensor is connected to an airway adapter. The airway adapter is connected between the patient airway and the respirator. As the patient completes an expiratory breath the sensor measures the CO2 levels in the expiratory breath and sends that data to the compatible CO2 monitor. The monitor then reads the data and converts the data so it can be displayed on screen.

The ETCO2 sensor are described as follows:

| Model | Description | Compatible Monitor |
|----------|------------------|-------------------------------------------------|
| CTM-RP01 | Mainstream/ 3.0M | General Meditech INC. Patient Monitor model G3C |

# 7. Intended use & Indications for Use

The intended use of the ETCO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

# 8. Comparison to predicate device

The following is provided as a summary of how the technological characteristics of the device compare to the predicate device

| Comparison<br>item | Subject Device | Predicate Device | Comments |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| 510(K) number | Pending application | K042601 | -- |
| Device | CTM-RP01 | Capnostat 5 CO2 sensor | -- |
| Intended use<br>&Indications for<br>Use | The intended use of the ETCO2<br>sensor is to provide carbon<br>dioxide monitoring to a host<br>monitoring system during<br>anesthesia / recovery, in the<br>intensive care unit (ICU), and<br>in Emergency<br>Medicine/Transport or<br>Respiratory care. | The intended use of the<br>Capnostat 5 CO2 sensor is to<br>provide carbon dioxide<br>monitoring to a host monitoring<br>system during anesthesia /<br>recovery, in the intensive care<br>unit (ICU), and in Emergency<br>Medicine/Transport or<br>Respiratory care | Same |
| Environment of<br>Use | Hospitals, clinics, and other<br>healthcare environments | Hospitals, clinics, and other<br>healthcare environments | Same |
| Measurement<br>Technique | Non-dispersive infrared (NDIR)<br>Infrared spectroscopy | Non-dispersive infrared (NDIR)<br>Infrared spectroscopy | Same |
| CO2<br>measurement<br>Range | 0 to 150 mmHg, 0 to 19.7% | 0 to 150 mmHg, 0 to 19.7% | Same |
| CO2 Resolution | 0.1 mmHg 0 to 69 mmHg<br>0.25 mmHg 70 to 150 mmHg | 0.1 mmHg 0 to 69 mmHg<br>0.25 mmHg 70 to 150 mmHg | Same |

Table1 Comparison between CTM-RP01 sensor and Capnostat 5 CO2 sensor

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| CO2 Accuracy | 0 - 40 mmHg ± 2 mmHg | 0 - 40 mmHg ± 2 mmHg | Same |
|------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------|
| | 41 - 70 mmHg ± 5% of<br>reading | 41 - 70 mmHg ± 5% of reading | |
| | 71 - 100 mmHg ± 8% of<br>reading | 71 - 100 mmHg ± 8% of reading | |
| | 101 - 150 mmHg ± 10% of<br>reading | 101 - 150 mmHg ± 10% of reading | |
| | Above 80 breath per minute ±<br>12% of reading | Above 80 breath per minute ±<br>12% of reading | |
| | * NOTE: Gas temperature at<br>25°C | * NOTE: Gas temperature at<br>25°C | |
| Respiration<br>Rate Range | 0 to 150 breaths per minute<br>(bpm) | 0 to 150 breaths per minute<br>(bpm) | Same |
| Respiration<br>Rate Accuracy | ± 1 breaths per minute (bpm) | ± 1 breaths per minute (bpm) | Same |
| Voltage<br>Requirements | 5.0 VDC ±5% | 5.0 VDC ±5% | Same |
| Interconnection | Lemo Redel 8-pin plastic | Lemo Redel 8-pin plastic | Same |
| Temperature<br>and Humidity | Operating: 0 to 40°C, 15 to<br>85% RH, non-condensing<br>Storage: -10 to 40°C, <90%<br>RH, non-condensing | Operating: 0 to 45°C, 10 to 90%<br>RH, non-condensing<br>Storage: -40 to 70°C, <90% RH,<br>non-condensing | Similar |
| | | | |
| Water<br>Resistance | IPX2 – Splash-proof<br>(sensor head only) | IPX4 – Splash-proof<br>(sensor head only) | Similar |
| Compliance | IEC 60601-1(safety)<br>IEC 60601-1-2(EMC)<br>ISO 80601-2-55(Performance) | IEC 60601-1(safety)<br>IEC 60601-1-2(EMC)<br>ISO80601-2-55(Performance) | Same |

From the comparison form above, the subject and predicate devices are based on the following same technological elements:

- Same measurement techniques
- Same intended use & indications for Use
- Same CO2 Resolution & Accuracy
- Same respiration rate range & Accuracy
- Same voltage Requirements
- Both comply to the same FDA recognized standards

The following slightly technological differences exist between the subject and predicate devices:

- Similar temperature and humidity range
- Water Resistance of predicate device is higher than Orantech's ●

These differences do not raise different questions of safety and effectiveness.

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# 9. Clinical test data

Not applicable.

# 10. Non-clinical test data

1)Industry Standards for Electrical Safety, EMC and Essential Performance Testing of the ECO2 Sensor has been completed to verify compliance with FDA recognized national and international standards for electrical safety and performance for medical devices, and particular requirements applicable to this device including:

- IEC 60601-1:2012 Basic safety and essential performance
- IEC 60601-1-2:2007 and 2014 EMC
- ISO 80601-2-55:2011 Respiratory gas monitors

# 2) Biocompatibility

The ETCO₂ Sensor does not contain any direct or indirect patient contacting components. Patient contacting accessories are previously cleared by FDA. Biocompatibility test is not applicable for subject device.

# 3) Software Verification

Software verification and validation testing were conducted and documentation was provided as recommended by FDA Software Guidance.

# 11. Conclusion

The results for testing demonstrate that the ETCO2 Sensor is substantially equivalent to the above listed predicate device.