(258 days)
Not Found
No
The device description details a non-dispersive infrared gas analyzer that measures CO2 concentration based on light absorption and calibrated against a known concentration. The calculation of respiration rate is based on time intervals between detected breaths. There is no mention of algorithms that learn from data or adapt their behavior, which are characteristic of AI/ML. The performance studies are bench tests against a standard, not validation of an AI/ML model.
No
The device is described as a "monitoring system" that measures carbon dioxide and respiration rate. It provides diagnostic information but does not actively treat or intervene in a therapeutic manner.
Yes
This device monitors carbon dioxide levels and provides a CO2 waveform (Capnogram) and respiration rate, which are used to assess patient airway integrity and proper endotracheal tube placement. This information helps clinicians make decisions about patient care, fitting the definition of a diagnostic device.
No
The device description explicitly details hardware components like a non-dispersive infrared gas analyzer, infrared sensor, and circuit module with pressure sensors. It describes the physical process of measuring CO2 concentration through light absorption, which is a hardware-based function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The CO2 Mainstream Module directly measures the concentration of carbon dioxide in the breathing gases of a patient. This is a measurement taken in vivo (within the living body's respiratory system), not in vitro (outside the body using a specimen).
- Intended Use: The intended use clearly states monitoring during anesthesia/recovery, emergency medicine/transport, ICU, and respiratory care. These are all clinical settings where the device is used to monitor a patient's physiological state directly.
- Device Description: The description details how the device analyzes infrared light absorption in breathing gases, which is consistent with in vivo respiratory monitoring.
Therefore, the CO2 Mainstream Module is a medical device used for physiological monitoring, not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
CCK
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.
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
anesthesia/recovery, in Emergency Medicine/Transport or Respiratory care.
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)
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.
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), and 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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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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
1
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
2
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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3
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, Xicheng |
| Dist, Beijing, P.R.C. 100053 | |
| Telephone: | +86-10-68158013 |
| Fax: | +86-10-68156857 |
| Contact Person: | Mr. Judong Gao |
| General Manager | |
| Email: | charliemack@irc-us.com |
| Date of Preparation: | May 18, 2020 |
42
4
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.
5
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.
6
Comparison to Predicate Devices
| Element of
| comparison | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| Company | Beijing Kingst Commercial & Trade | ||
| Co., 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 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 intended use of the Capnostat 5 CO2 | ||
| 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. | IFU is the same for both | ||
| devices. | |||
| The type of | |||
| protection against | |||
| electric shock | Class II | Class II | No difference in insulation |
| methodology. | |||
| The degree of | |||
| protection against | |||
| electric shock | Type BF | Type BF | No difference in |
| protection against electric | |||
| shock. | |||
| Waveform Display | No display | No display | Neither device has a |
| display. | |||
| Intended patient | |||
| population | from newborn (neonate) to adult | from newborn (neonate) to adult | Same patient population. |
7
| Element of
| comparison | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| CO2 module | CO2 Mainstream Module | CAPNOSTAT 5 EtCO2 (Main-stream) | |
| Module(K042601) | N/A | ||
| CO2 measurement | |||
| method | Infrared absorption method | Infrared absorption method | No difference in |
| the | |||
| measurement | |||
| method | |||
| CO2 measure mode | Mainstream | Mainstream | Same measure |
| mode | |||
| Performance | |||
| Standards | Complies with ISO80601-2-55 | Unknown | N/A |
| Measuring | |||
| parameters | EtCO2 and Respiration Rate | EtCO2 and Respiration Rate | Matching |
| measuring | |||
| parameters | |||
| CO2 Response Time | 80 breaths per | ||
| minute, all ranges are ±12% of actual.) | It complies with ISO80601-2- | ||
| 55 | |||
| Respiration Rate | |||
| measure range | 3 - 150 breaths/minute (RPM) | 2~150 breaths/minute (RPM) | 2 RPM of the respiration rate |
| will be abnormal. Respiration | |||
| at the minimum is not critical, | |||
| and the device complies with | |||
| ISO80601-2-55 | |||
| Respiration Rate | |||
| accuracy | ±1% of reading or ±1 breaths/min | ||
| whichever is greater | ±1 breath per minute | Both devices have the same | |
| accuracy. | |||
| Operation principles | Non-dispersive infrared gas analysis, a | ||
| multi-channel infrared detector, no moving | |||
| parts | Non-dispersive infrared (NDIR) single | ||
| beam optics, dual-wavelength, no moving | |||
| parts | The measurement technology | ||
| principle is the same. | |||
| Both devices adopt NDIR (non- | |||
| dispersive infrared gas) | |||
| technology. |
9
Biocompatibility:
The subject device is classified as an external communicating device in contact with tissue (indirect via the gas pathway) for limited contact duration (