Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
Device Facts
| Record ID | K210019 |
|---|---|
| Device Name | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ |
| Applicant | Unimed Medical Supplies, Inc. |
| Product Code | CCK · Anesthesiology |
| Decision Date | Mar 4, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1400 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery in Emergency Medicine/Transport or Respiratory care.
Device Story
Non-dispersive infrared (NDIR) gas analyzer; measures CO2 concentration in breathing gases via infrared energy absorption. Input: gas sample from patient airway; infrared light beam passed through sample. Processing: compares remaining light energy against IR source; uses atmospheric pressure sensor for compensation; auto-zero adjustment; gain control. Output: EtCO2 numerical value (mmHg, %, or kPa); capnogram waveform; respiration rate (calculated from breath intervals). Used in clinical settings (anesthesia, recovery, emergency, transport, respiratory care) as a module integrated into a host monitoring system. Operated by clinicians. Benefits: provides real-time airway integrity assessment and endotracheal tube placement verification.
Clinical Evidence
No clinical data. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), performance testing per ISO 80601-2-55 (CO2 range/accuracy, respiration rate range/accuracy), and biocompatibility testing (ISO 10993-5, ISO 10993-10, and ISO 18562 series).
Technological Characteristics
Non-dispersive infrared (NDIR) gas analyzer; multi-channel infrared detector; no moving parts. Includes atmospheric pressure sensors for compensation. Dimensions/form factor: module. Connectivity: integrates with host monitoring system. Sterilization: not specified. Standards: ISO 80601-2-55, IEC 60601-1, IEC 60601-1-2, ISO 10993, ISO 18562.
Indications for Use
Indicated for carbon dioxide monitoring in neonates to adults during anesthesia, recovery, emergency medicine, transport, or respiratory care. Capno-M is for intubated patients; Capno-M+ is for intubated and non-intubated patients.
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
- CO2 Mainstream Module (K192446)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo features a stylized depiction of a human figure embracing a sphere. The FDA part of the logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
{2}------------------------------------------------
# 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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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.
| Description | Subject Device | Predicate Device (K192446) |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The CO2 Mainstream Module is<br>intended to provide carbon dioxide<br>monitoring to a host monitoring<br>systemduring anesthesia/recovery<br>in Emergency Medicine/Transport<br>or Respiratory care. | The CO2 Mainstream Module is<br>intended to provide carbon dioxide<br>monitoring to a host monitoring<br>systemduring anesthesia/recovery<br>in Emergency Medicine/Transport<br>or Respiratory care. |
| Prescription/over<br>-the-counteruse | Prescription | Prescription |
| The type of<br>protection<br>against<br>electric shock | Class II | Class II |
| The degree of<br>protection<br>against electric<br>shock | Type BF | Type BF |
| Waveform<br>Display | No display | No display |
| Intended patient<br>population | From newborn (neonate) to adult | From newborn (neonate) to adult |
| CO2<br>measurement<br>method | Infrared absorption method | Infrared absorption method |
| CO2 measure<br>mode | Mainstream | Mainstream |
| Measuring | EtCO2 and Respiration Rate | EtCO2 and Respiration Rate |
Table 1 Substantial Equivalence Table
{5}------------------------------------------------
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<br>Time | <70 ms | <70 ms |
| Units | mmHg, kPa or Vol% | mmHg, kPa or Vol% |
| EtCO2<br>Measurement<br>Range | 0-150 mmHg<br>0-19.7%<br>0-20 kPa | 0-150 mmHg<br>0-19.7%<br>0-20 kPa |
| EtCO2 Accuracy<br>(at 760 mmHg,<br>ambient<br>temperature of<br>25°C) | 0~40 mmHg ±2 mmHg<br>41~70 mmHg ±5% of reading<br>71~100 mmHg ±8% of reading<br>101~150mmHg ±10% of reading | 0~40 mmHg ±2 mmHg<br>41~70 mmHg ±5% of reading<br>71~100 mmHg ±8% of reading<br>101~150mmHg ±10% of reading |
| Respiration Rate<br>measure range | 3 - 150 breaths/minute (RPM) | 3 - 150 breaths/minute (RPM) |
| Respiration Rate<br>accuracy | ±1% of reading or ±1 breaths/min<br>whichever is greater | ±1% of reading or ±1 breaths/min<br>whichever is greater |
| Operation<br>principles | Non-dispersive infrared gas<br>analysis, a multi-channel infrared<br>detector, no moving parts | Non-dispersive infrared gas<br>analysis, a multi-channel infrared<br>detector, no moving parts |
| Performance<br>Standards | Complies with ISO 80601-2-55 | Complies with ISO 80601-2-55 |
#### Non-clinical test data:
## Flectrical 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 (<24 h).
- V 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
- V 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
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for Unimed medical supplies. The logo includes the text "A brand of Xinwell" at the top, followed by the word "UNIMED" in a bold, sans-serif font. Below the word "UNIMED" is the text "medical supplies". To the right of the text is a red oval containing a white stylized "UM".
- √ ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- V ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests foremissions of volatile organic compounds
- > 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.
#### 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.
