K Number
K210019
Device Name
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
Date Cleared
2021-03-04

(59 days)

Product Code
Regulation Number
868.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery in Emergency Medicine/Transport or Respiratory care.
Device Description
The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an auto-zero adjustment systemand 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 theenergy 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's memory. 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.
More Information

Not Found

No
The description details a standard non-dispersive infrared gas analyzer and its operation based on physical principles of light absorption. There is no mention of AI or ML algorithms for data processing, interpretation, or decision-making. The calculations are based on direct measurements and calibration against known values.

No
The device is a monitoring system that measures carbon dioxide in breathing gases and displays CO2 concentration and respiration rate. It does not provide any therapeutic intervention.

Yes

This device monitors carbon dioxide levels in breathing gases and displays a CO2 waveform (capnogram), which is used by medical professionals to assess patient airway integrity and endotracheal tube placement. These measurements provide information that aids in diagnosing or assessing patient conditions related to respiratory function.

No

The device description clearly outlines hardware components like an infrared gas analyzer, infrared sensor, and pressure sensors, indicating it is not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The CO2 Mainstream Module analyzes the concentration of carbon dioxide in the breathing gases of a patient. This is a measurement of a physiological process (respiration) occurring in vivo (within the living body), not a test performed on a sample in vitro (outside the living body).
  • Intended Use: The intended use clearly states monitoring during anesthesia/recovery, Emergency Medicine/Transport, or Respiratory care, all of which involve monitoring the patient directly.
  • Device Description: The description details the analysis of gases in the breathing pathway, not analysis of bodily fluids or tissues.

Therefore, the CO2 Mainstream Module is a physiological monitoring device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery in Emergency Medicine/Transport or Respiratory care.

Product codes

CCK

Device Description

The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an auto-zero adjustment systemand 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 theenergy 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's memory.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

From newborn (neonate) to adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical test data:
Electrical Safety and EMC:

  • V ANSI AAMIES60601-1:2005/(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 es sential performance - Collateral standards : electromagnetic compatibility - Test and requirements

Performance Data:

  • V 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 -Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

Biocompatibility:
The subject device is classified as an external communicating device in contact with tissue (indirect via the gas pathway) for limited contact duration ( ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests forleachables in condensate

Clinical test data:
Not applicable, the determination of substantial equivalence is not based on Clinical Performance data.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K192446

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

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March 4, 2021

Unimed Medical Supplies, Inc. Linbin Ye RA Manager Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan Shenzhen, Guangdong 518108 China

Re: K210019

Trade/Device Name: Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: December 25, 2020 Received: January 4, 2021

Dear Linbin Ye:

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, 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

1

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 (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) K210019

Device Name Unimed CO2 Mainstream Module

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/1 description: The image shows the logo for Unimed medical supplies. The logo consists of the text "A brand of Xinwell" in blue, followed by the word "unimed" in gray. Below "unimed" is the text "medical supplies" also in gray. To the right of the text is a red oval with a white design inside.

510(k) Summary

K210019

Submitter:Name: Unimed Medical Supplies, Inc.
Address: Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan,
518108, Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Contact Person:Name: Mr. Linbin Ye
Title: RA Manager
Phone Number: +86 755 2669 5137
Email Address:yelb@unimed.cn
Date Prepared:December 25, 2020
Device Trade Name:Unimed CO2 Mainstream Module
Device Common Name:CO2 Mainstream Module
Classification Names :Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation Number:21 CFR 868.1400
Product Code:CCK
Predicate Device :
510(k) Number:K192446
Device Name:CO2 Mainstream Module
Manufacturer:Beijing Kingst Commercial & Trade Co.,Ltd.

Description of Devices:

The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an auto-zero adjustment systemand 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 theenergy 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's memory.

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

4

Image /page/4/Picture/1 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" in a smaller font above the word "Unimed" in a larger, bold font. Below "Unimed" is the text "medical supplies" in a smaller font. To the right of the text is a red oval with a white design inside.

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.

Intended Use:

The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a host monitoring systemduring anesthesia/recovery in Emergency Medicine/Transport or Respiratory care.

Comparison to predicate device:

The subject and predicate devices are exactly the same, and there is no any difference between them.

DescriptionSubject DevicePredicate Device (K192446)
Indications for useThe CO2 Mainstream Module is
intended to provide carbon dioxide
monitoring to a host monitoring
systemduring anesthesia/recovery
in Emergency Medicine/Transport
or Respiratory care.The CO2 Mainstream Module is
intended to provide carbon dioxide
monitoring to a host monitoring
systemduring anesthesia/recovery
in Emergency Medicine/Transport
or Respiratory care.
Prescription/over
-the-counterusePrescriptionPrescription
The type of
protection
against
electric shockClass IIClass II
The degree of
protection
against electric
shockType BFType BF
Waveform
DisplayNo displayNo display
Intended patient
populationFrom newborn (neonate) to adultFrom newborn (neonate) to adult
CO2
measurement
methodInfrared absorption methodInfrared absorption method
CO2 measure
modeMainstreamMainstream
MeasuringEtCO2 and Respiration RateEtCO2 and Respiration Rate

Table 1 Substantial Equivalence Table

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Image /page/5/Picture/1 description: The image shows the Unimed medical supplies logo. The logo consists of the text "A brand of Xinwell" in blue, followed by the word "unimed" in gray. Below the word "unimed" is the text "medical supplies" in gray. To the right of the text is a red circle with a white design inside.

parameters
CO2 Response
TimeISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests forleachables in condensate

Clinical test data:

Not applicable, the determination of substantial equivalence is not based on Clinical Performance data.

Conclusions :

Based on the comparison, analysis, and the submitted performance data, we believe that the Unimed CO2 Mainstream Module are as safe, as effective, and performs as well as the predicate device. The subject device and the predicate device are identical with the same intended use and technological characteristics, and are substantially equivalent.