(345 days)
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.
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 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.
This document is a 510(k) premarket notification for an ETCO2 Sensor (Model CTM-RP01), not a study report detailing specific acceptance criteria and performance of an AI/ML device. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is not present in this document.
The document focuses on demonstrating substantial equivalence to a predicate device (Capnostat 5 CO2 sensor, K042601) based on similar technological characteristics and performance specifications for a carbon dioxide gas analyzer.
Here's what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides the performance specifications of the subject device (ETCO2 Sensor, Model CTM-RP01) and compares them to the predicate device. These specifications serve as de facto "acceptance criteria" through the lens of substantial equivalence.
| Acceptance Criteria (from Predicate Device Specifications) | Reported Device Performance (ETCO2 Sensor, Model CTM-RP01) | Comments |
|---|---|---|
| CO2 Measurement 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; 0.25 mmHg 70 to 150 mmHg | 0.1 mmHg 0 to 69 mmHg; 0.25 mmHg 70 to 150 mmHg | Same |
| CO2 Accuracy: | Same | |
| 0 - 40 mmHg ± 2 mmHg | 0 - 40 mmHg ± 2 mmHg | |
| 41 - 70 mmHg ± 5% of reading | 41 - 70 mmHg ± 5% of reading | |
| 71 - 100 mmHg ± 8% of reading | 71 - 100 mmHg ± 8% of reading | |
| 101 - 150 mmHg ± 10% of reading | 101 - 150 mmHg ± 10% of reading | |
| Above 80 breath per minute ± 12% of reading | Above 80 breath per minute ± 12% of reading | |
| *NOTE: Gas temperature at 25°C | *NOTE: Gas temperature at 25°C | |
| Respiration Rate Range: 0 to 150 breaths per minute (bpm) | 0 to 150 breaths per minute (bpm) | Same |
| Respiration Rate Accuracy: ± 1 breaths per minute (bpm) | ± 1 breaths per minute (bpm) | Same |
| Voltage Requirements: 5.0 VDC ±5% | 5.0 VDC ±5% | Same |
| Interconnection: Lemo Redel 8-pin plastic | Lemo Redel 8-pin plastic | Same |
| Operating Temperature/Humidity: 0-45°C, 10-90% RH, non-condensing | 0-40°C, 15-85% RH, non-condensing | Similar |
| Storage Temperature/Humidity: -40-70°C, <90% RH, non-condensing | -10-40°C, <90% RH, non-condensing | Similar |
| Water Resistance: IPX4 – Splash-proof (sensor head only) | IPX2 – Splash-proof (sensor head only) | Similar |
| Compliance: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 80601-2-55 (Performance) | IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 80601-2-55 (Performance) | Same |
The following information is NOT available in the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states "Non-clinical test data" were used, including compliance with industry standards. It does not specify a "test set" in the context of data for an AI/ML device, nor does it provide sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as this is a medical device (sensor) and not an AI/ML diagnostic or predictive algorithm based on expert-labeled data. The performance criteria are met through physical measurements and engineering validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device and testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This device is a sensor performing direct measurements, not an AI assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device's performance is inherently standalone in its measurement function, but it's a sensor, not an "algorithm only" device in the AI sense. Its output is displayed by a compatible monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be established by reference gas standards and engineering measurement techniques for CO2 concentration, flow rates, and timing. The document references compliance with ISO 80601-2-55 (Respiratory gas monitors) which would outline such testing methods.
8. The sample size for the training set
- Not applicable. This is a hardware sensor, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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) | |
|---|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) | ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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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,GongMing, Guangming New District, Shenzhen,China 518106 |
| Contact person | Mr. Hsin Xiong |
| Tel | 0755-23699939 |
| Fax | 0755-23243594 |
| Yunxi.xiong@orantech.cn |
3. Submission Correspondent
| Name | Chonconn Medical Device Consulting Co.LTD. |
|---|---|
| Address | 22A,HaiJing Square,No.18 Taizi Road,Nanshan District,Shenzhen,Guangdong,P.R.China, |
| Contact person | Mei(RA consultant) |
| FDA@chonconn.com/Xinmeitan@chonconn.com | |
| Tel | +86-755-33941160 |
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
| Comparisonitem | Subject Device | Predicate Device | Comments |
|---|---|---|---|
| 510(K) number | Pending application | K042601 | -- |
| Device | CTM-RP01 | Capnostat 5 CO2 sensor | -- |
| Intended use&Indications forUse | The intended use of the ETCO2sensor is to provide carbondioxide monitoring to a hostmonitoring system duringanesthesia / recovery, in theintensive care unit (ICU), andin EmergencyMedicine/Transport orRespiratory care. | The intended use of theCapnostat 5 CO2 sensor is toprovide carbon dioxidemonitoring to a host monitoringsystem during anesthesia /recovery, in the intensive careunit (ICU), and in EmergencyMedicine/Transport orRespiratory care | Same |
| Environment ofUse | Hospitals, clinics, and otherhealthcare environments | Hospitals, clinics, and otherhealthcare environments | Same |
| MeasurementTechnique | Non-dispersive infrared (NDIR)Infrared spectroscopy | Non-dispersive infrared (NDIR)Infrared spectroscopy | Same |
| CO2measurementRange | 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 mmHg0.25 mmHg 70 to 150 mmHg | 0.1 mmHg 0 to 69 mmHg0.25 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% ofreading | 41 - 70 mmHg ± 5% of reading | ||
| 71 - 100 mmHg ± 8% ofreading | 71 - 100 mmHg ± 8% of reading | ||
| 101 - 150 mmHg ± 10% ofreading | 101 - 150 mmHg ± 10% of reading | ||
| Above 80 breath per minute ±12% of reading | Above 80 breath per minute ±12% of reading | ||
| * NOTE: Gas temperature at25°C | * NOTE: Gas temperature at25°C | ||
| RespirationRate Range | 0 to 150 breaths per minute(bpm) | 0 to 150 breaths per minute(bpm) | Same |
| RespirationRate Accuracy | ± 1 breaths per minute (bpm) | ± 1 breaths per minute (bpm) | Same |
| VoltageRequirements | 5.0 VDC ±5% | 5.0 VDC ±5% | Same |
| Interconnection | Lemo Redel 8-pin plastic | Lemo Redel 8-pin plastic | Same |
| Temperatureand Humidity | Operating: 0 to 40°C, 15 to85% RH, non-condensingStorage: -10 to 40°C, <90%RH, non-condensing | Operating: 0 to 45°C, 10 to 90%RH, non-condensingStorage: -40 to 70°C, <90% RH,non-condensing | Similar |
| WaterResistance | IPX2 – Splash-proof(sensor head only) | IPX4 – Splash-proof(sensor head only) | Similar |
| Compliance | IEC 60601-1(safety)IEC 60601-1-2(EMC)ISO 80601-2-55(Performance) | IEC 60601-1(safety)IEC 60601-1-2(EMC)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.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).