(258 days)
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery, in Emergency Medicine/Transport or Respiratory care.
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a monitoring system during anesthesia/recovery in host Emergencv Medicine/Transport or Respiratory care.
The CO2 Mainstream Module is intended 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 CO2 Mainstream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control.
The operation of the CO2 Mainstream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the module'smemory.
The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate the calculation for the concentrations of carbon dioxide, which improves the design accuracy.
The module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). In addition, a CO2 waveform (Capnogram) may be displayed, which is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time interval between detected breaths.
The differences between the Capno M and M+ are only with the intended patient type. The Capno M is intended for use on intubated patients, where the Capno M+ is intended for use with intubated and non-intubated patients. The operating principles, unit of measurement, ETCO2 measurement range, accuracy, respiration rate range, and respiration rate accuracy are the same for both devices.
The CO2 Mainstream Module (Capno-M and Capno-M+) is a device intended 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 device's performance was evaluated through non-clinical studies covering electrical safety, electromagnetic compatibility (EMC), and specific performance criteria in accordance with ISO 80601-2-55. No clinical studies were performed.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Element of Comparison | Acceptance Criteria (Predicate Device K042601) | Reported Device Performance (Subject Device) | Discussion/Compliance |
|---|---|---|---|
| CO2 Response Time | Mainstream: < 60 ms (rise time) | < 70 ms | The 10 ms difference will not influence usage effect. Complies with ISO80601-2-55. |
| EtCO2 Measurement Range | 0 - 150 mmHg, 0 - 20%, 0 - 20 kPa | 0 - 150 mmHg, 0 - 19.7%, 0 - 20 kPa | Complies with ISO80601-2-55. |
| EtCO2 Accuracy | 0~40 mmHg ±2 mmHg | 0~40 mmHg ±2 mmHg | Complies with ISO80601-2-55. |
| (at 760 mmHg, ambient temp 25°C) | 41~70 mmHg ±5% of reading | 41~70 mmHg ±5% of reading | |
| 71~100 mmHg ±8% of reading | 71~100 mmHg ±8% of reading | ||
| 101~150mmHg±10% of reading | 101~150mmHg±10% of reading | ||
| (> 80 bpm, all ranges are ±12% of actual) | |||
| Respiration Rate Measure Range | 2~150 breaths/minute (RPM) | 3 - 150 breaths/minute (RPM) | 2 RPM respiration rate is abnormal. Minimum not critical. Complies with ISO80601-2-55. |
| Respiration Rate Accuracy | ±1 breath per minute | ±1% of reading or ±1 breaths/min (whichever is greater) | Both devices have the same accuracy. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each performance test. The document refers to "bench testing for Inspired CO2 range and accuracy, and Respiration rate range and accuracy." This implies laboratory testing on a device unit or units.
- Data Provenance: The tests conducted appear to be non-clinical bench tests performed by the manufacturer, Beijing Kingst Commercial & Trade Co., Ltd., to demonstrate compliance with international standards. No information regarding country of origin for the data or whether it was retrospective or prospective is provided, as it is non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for the performance tests (e.g., CO2 concentration, respiration rate) would have been established by calibrated laboratory equipment and reference gases/controlled conditions as per the ISO 80601-2-55 standard, not by human expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As this involves non-clinical bench testing for performance and safety, human adjudication methods like 2+1 or 3+1 are not used. Compliance is typically determined by directly comparing device output to known inputs and standard requirements.
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. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a CO2 mainstream module, which is a sensor for measuring carbon dioxide, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The performance data presented is for the device operating as a standalone sensor (without human interpretation or assistance as part of the primary measurement function). The device's accuracy and range in measuring CO2 and respiration rate are intrinsic to the device's technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For CO2 and respiration rate measurements, the ground truth would be established through calibrated reference standards and controlled experimental conditions as specified by the relevant testing standards (e.g., ISO 80601-2-55). This involves using known concentrations of CO2 gases and controlled airflow patterns to simulate breathing.
8. The sample size for the training set:
- Not applicable. This device is a hardware sensor, not a machine learning or AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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Beijing Kingst Commercial & Trade Co.,Ltd. % Charlie Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K192446
Trade/Device Name: CO2 Mainstream Module Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: March 21, 2020 Received: April 14, 2020
Dear Charlie Mack:
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 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) 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,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192446
Device Name
CO2 Mainstream Module, Capno-M, Capno-M+
Indications for Use (Describe)
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery, in Emergency Medicine/Transport or Respiratory care.
| 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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Image /page/3/Picture/2 description: The image shows a logo for a company called "Jingst". The logo is blue and features a stylized letter "J" on the left side. Below the company name are three Chinese characters.
Beijing Kingst Commercial & Trade Co., Ltd.
510(k) Summary (21 CFR §807.92)
K192446
Submitter Information:
| Submitter Name: | Beijing Kingst Commercial & Trade Co., Ltd. |
|---|---|
| Address: | 6th Floor of No.2-7, Beibinhe Road, Xibianmen, XichengDist, Beijing, P.R.C. 100053 |
| Telephone: | +86-10-68158013 |
| Fax: | +86-10-68156857 |
| Contact Person: | Mr. Judong GaoGeneral Manager |
| Email: | charliemack@irc-us.com |
| Date of Preparation: | May 18, 2020 |
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K192446
Subject Devices :
Trade/proprietary name : CO2 Mainstream Module Model Capno-M, Capno-M+ Carbon Common Name: Dioxide Gas Analyzer Classification: CCK
Regulatory Class: Class II
Regulation Number: 21CFR868.1400
Predicate Device :
| Trade Name: | CAPNOSTAT 5 |
|---|---|
| 510(k) Reference: | K042601 |
| Common Name: | Carbon Dioxide Gas Analyzer |
| Regulation Number: | 21CFR868.1400 |
| Regulatory Class: | Class II |
| Manufacturer: | Respironics Novametrix, Inc. |
Purpose of Submission
This is a new traditional 510(K) submission of a Carbon Dioxide Gas Analyzer.
Device Description
The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control.
The operation of the CO2 Mainstream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the module'smemory.
The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate the calculation for the concentrations of carbon dioxide, which improves the design accuracy.
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The module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). In addition, a CO2 waveform (Capnogram) may be displayed, which is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time interval between detected breaths.
The differences between the Capno M and M+ are only with the intended patient type. The Capno M is intended for use on intubated patients, where the Capno M+ is intended for use with intubated and non-intubated patients. The operating principles, unit of measurement, ETCO2 measurement range, accuracy, respiration rate range, and respiration rate accuracy are the same for both devices.
Indication for use
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a monitoring system during anesthesia/recovery in host Emergencv Medicine/Transport or Respiratory care.
Comparison with the predicate device:
Beijing Kingst Commercial & Trade Co., Ltd. believes that the Beijing Kingst Commercial & Trade Co., Ltd. CO2 Mainstream Module is substantially equivalent to the Respironics Novametrix. Inc. CAPNOSTAT 5 Carbon Dioxide Gas Analyzer (K042601).
There are differences in the CO2 response time and the respiration rate measurement range. The response time difference is 10 ms. This does not affect the accuracy or usage. The measurement range difference is at the lowest part of the scale. The predicate devices' range is 2-150 breaths per minute, where the submitted device range is 3-150 breaths per minute. The difference at the lower end of the range does not pose any risks or hazards to patients. They have the same intended use. The minor differences in technological characteristics do not raise issues of safety and effectiveness. The subject device is identical to the predicate device. Please refer to the following pages for specific difference details.
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Comparison to Predicate Devices
| Element ofcomparison | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| Company | Beijing Kingst Commercial & TradeCo., Ltd. | RESPIRONICS NOVAMETRIX, INC. | N/A |
| FDA510(K) Number | Pending | K042601 | N/A |
| Device Name | CO2 Mainstream Module | CAPNOSTAT 5 EtCO2 SENSOR (Mainstream) | N/A |
| Model Number | Capno-M, Capno-M+ | CAPNOSTAT 5 | N/A |
| Indications for Use | The CO2 Mainstream Module isintended to provide carbon dioxidemonitoring to a host monitoring systemduring anesthesia/recovery, in theintensive care unit (ICU), and inEmergency Medicine/Transport orRespiratory care. | The intended use of the Capnostat 5 CO2sensor is to provide carbon dioxide monitoringto a host monitoring system duringanesthesia/recovery, in the intensive care unit(ICU), and in Emergency Medicine/Transport orRespiratory care. | IFU is the same for bothdevices. |
| The type ofprotection againstelectric shock | Class II | Class II | No difference in insulationmethodology. |
| The degree ofprotection againstelectric shock | Type BF | Type BF | No difference inprotection against electricshock. |
| Waveform Display | No display | No display | Neither device has adisplay. |
| Intended patientpopulation | from newborn (neonate) to adult | from newborn (neonate) to adult | Same patient population. |
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| Element ofcomparison | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| CO2 module | CO2 Mainstream Module | CAPNOSTAT 5 EtCO2 (Main-stream)Module(K042601) | N/A |
| CO2 measurementmethod | Infrared absorption method | Infrared absorption method | No difference inthemeasurementmethod |
| CO2 measure mode | Mainstream | Mainstream | Same measuremode |
| PerformanceStandards | Complies with ISO80601-2-55 | Unknown | N/A |
| Measuringparameters | EtCO2 and Respiration Rate | EtCO2 and Respiration Rate | Matchingmeasuringparameters |
| CO2 Response Time | <70 ms | Mainstream: < 60 ms (rise time) | The 10 msdifference inresponse time willnot influence theusage effect.It complies withISO80601-2-55 |
| Units | mmHg, kPa or Vol% | mmHg, kPa or Vol% | The sameunit ofmeasurement |
| EtCO2 MeasurementRange | 0-150 mmHg0-19.7%0-20 kPa | 0 - 150 mmHg0 - 20%0 - 20 kPa | It complies withISO80601-2-55 |
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| Element ofcomparison | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| EtCO2 Accuracy(at 760 mmHg,ambienttemperature of25°C) | 0 | 0 | It complies with ISO80601-2-55 |
| Respiration Ratemeasure range | 3 - 150 breaths/minute (RPM) | 2~150 breaths/minute (RPM) | 2 RPM of the respiration ratewill be abnormal. Respirationat the minimum is not critical,and the device complies withISO80601-2-55 |
| Respiration Rateaccuracy | ±1% of reading or ±1 breaths/minwhichever is greater | ±1 breath per minute | Both devices have the sameaccuracy. |
| Operation principles | Non-dispersive infrared gas analysis, amulti-channel infrared detector, no movingparts | Non-dispersive infrared (NDIR) singlebeam optics, dual-wavelength, no movingparts | The measurement technologyprinciple is the same.Both devices adopt NDIR (non-dispersive infrared gas)technology. |
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Biocompatibility:
The subject device is classified as an external communicating device in contact with tissue (indirect via the gas pathway) for limited contact duration (<24 h).
Safety and Performance Data :
To establish substantial equivalence to the identified predicate devices, tests were completed as defined below to the subject devices, Carbon Dioxide Gas Analyzer. The results of the testing demonstrate that the device complies with the requirements of the applicable standards, and the device is substantially equivalent to the predicate device.
Non-Clinical Study:
Electrical Safety and EMC
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601 - 1:2005, MOD)
- -IEC 60601-1-2: 2014 Medical devices part 1-2: General requirements for basic safety and essential performance - Collateral standards: electromagnetic compatibility - Test and requirements
Performance Data:
- Bench testing for Inspired CO2 range and accuracy, and Respiration rate range and accuracy in accordance to ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Biocompatibility
- ISO 10993-5: 2009 Biological evaluation of medical devices Part 5 Tests for In Vitro -Cytotoxicity
- ISO 10993-10: 2010 Biological evaluation of medical Devices Part 10: Tests for -Irritation and Delayed-Type Hypersensitivity
- ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
- ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
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Clinical Study:
- No clinical studies were performed. -
Sterility Information:
- This device is not delivered sterile and is not sterile during operation. -
Package and Shelf Life:
- -The CO2 Mainstream module (Capno-M, Capno-M+) is not subject to shelf life, as the device does not contain any sterile or degradable elements.
Conclusion:
The subject device has the same intended use as the predicate device, and the technological differences are addressed by performance testing, and do not raise different questions of safety and effectiveness.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, the subject device, CO2 Mainstream Module, models Capno-M and Capno-M+ is substantially equivalent to predicate device
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END
.
50
§ 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).