Who is the manufacturer of CO2 Sidestream Module?

Beijing Kingst Commercial & Trade Co., Ltd. filed the 510(k) submission for CO2 Sidestream Module (K192488).

What is the FDA product code for CO2 Sidestream Module?

CCK. It is classified under 21 CFR 868.1400 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for CO2 Sidestream Module?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CO2 Sidestream Module?

Capnograph and Oximeter (K170820); LoFlo C5 CO2 sensor (K053174).

Who can help prepare an FDA 510(k) submission like CO2 Sidestream Module?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CO2 Sidestream Module

K192488 · Beijing Kingst Commercial & Trade Co., Ltd. · CCK · May 22, 2020 · Anesthesiology

Device Facts

Record ID	K192488
Device Name	CO2 Sidestream Module
Applicant	Beijing Kingst Commercial & Trade Co., Ltd.
Product Code	CCK · Anesthesiology
Decision Date	May 22, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2

Intended Use

The CO2 Sidestream Module is designed to provide carbon dioxide monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Respiratory care. The CO2 Sidestream Module is used for adult patients.

Device Story

CO2 Sidestream Module (Capno-S, Capno-S+) is a non-dispersive infrared (NDIR) gas analyzer; measures CO2 concentration in breathing gases via infrared energy absorption. Device uses multi-channel infrared detector (Capno-S) or single-beam dual-wavelength optics (Capno-S+); includes autozero system with three-way valve and atmospheric pressure compensation. Input: gas sample from patient breathing circuit. Output: EtCO2 (mmHg, %, kPa) and respiration rate (breaths/min) transmitted to host monitoring system. Device is a component intended for integration into host monitors; operated by clinical personnel in hospital settings. Provides real-time CO2 data to support clinical decision-making regarding patient ventilation and respiratory status.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing, including performance verification (EtCO2 accuracy, respiration rate accuracy), electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1), and comprehensive biocompatibility testing (ISO 10993 and ISO 18562 series).

Technological Characteristics

NDIR gas analysis; multi-channel (Capno-S) or single-beam dual-wavelength (Capno-S+) optics; no moving parts. Materials: ABS plastic (upper/lower case). Connectivity: Module-to-host interface. Power: DC. Standards: ISO 80601-2-55, IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 18562. Non-sterile.

Indications for Use

Indicated for adult patients requiring non-invasive continuous monitoring of EtCO2, InsCO2, and respiration rate during anesthesia, recovery, ICU, or respiratory care.

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

Capnograph and Oximeter (K170820)
LoFlo C5 CO2 sensor (K053174)

Related Devices

K192446 — CO2 Mainstream Module · Beijing Kingst Commercial & Trade Co., Ltd. · May 21, 2020
K210019 — Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ · Unimed Medical Supplies, Inc. · Mar 4, 2021
K052582 — DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES · GE Healthcare · Oct 14, 2005
K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) · Nihon Kohden Corporation · Jun 10, 2025
K083750 — CAPNOSTAT / CAPNOFLEX CO2 SYSTEM · Ge Medical Systems Information Technologies · Mar 23, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Beijing Kingst Commercial & Trade Co.,Ltd. % Charlie Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249 Re: K192488 Trade/Device Name: CO2 Sidestream Module, Capno-S, Capno-S+ Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: September 3, 2019 Received: September 11, 2019 #### 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) K192488 Device Name CO2 Sidestream Module, Capno-S, Capno-S+ Indications for Use (Describe) The CO2 Sidestream Module is designed to provide carbon dioxide monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Respiratory care. The CO2 Sidestream Module is used for adult patients. 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/2 description: The image shows a logo with the word "lingst" in a stylized font. The word is in blue and is slanted upwards from left to right. Below the word "lingst" are three Chinese characters, also in blue. The logo appears to be for a company or organization. ## Beijing Kingst Commercial & Trade Co., Ltd. 510(k) Summary (21 CFR §807.92) ## 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 21, 2020 | {4}------------------------------------------------ ## Subject Devices: Trade/proprietary name: CO2 Sidestream Module Model Capno-S, Capno-S+ Common Name: CO2 Sidestream Module Regulation Number: 21CFR868.1400 Regulatory Class: Class II Classification Code: CCK ## Predicate Device: | Trade Name: | Capnograph and Oximeter | |--------------------|------------------------------------| | 510(k) Reference: | K170820 | | Common Name: | CO2 Sidestream Module and Oximeter | | Regulation Number: | 21CFR868.1400 | | Regulatory Class: | Class II | | Manufacturer: | CMI Health Inc. | | Trade Name: | LoFlo C5 CO2 sensor | | 510(k) Reference: | K053174 | | 510(k) Reference: | R053174 | | Common Name: | CO2 Sidestream Module | | Regulation Number: | 21CFR868.1400 | | Regulatory Class: | Class II | | Manufacturer: | Respironics Novametrix, LLC | ## Purpose of Submission This is a new traditional 510(K) submission of CO2 Sidestream Module. ## Device Description The CO2 Sidestream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control. The operation of the CO2 Sidestream 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 {5}------------------------------------------------ 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. As the sample gas passes through a three-way valve, with the change of temperature and time, the valve leading to the pure air will close for 3-4 seconds to adjust the zero point. The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate for 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). Respiration rate is calculated by measuring the time interval between detected breaths. ## Indication for use The CO2 Sidestream Module is designed to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery, in the intensive care unit (ICU), and in Respiratory care. The CO2 Sidestream Module is used for adult patients. ## Comparison with the predicate device: Beijing Kingst Commercial & Trade Co., Ltd. believes that the CO2 Sidestream Module is substantially equivalent to the CMI Health Inc. Capnograph and Oximeter (K170820) and the Respironics Novametrix LoFlo C5 CO2 sensor (K053174). The submitted Beijing Kingst Commercial & Trade Co., Ltd. CO2 Sidestream Module, Models Capno-S, and Capno-S+ were components within the predicate CMI Health's Capnograph and Oximeter for that device's FDA clearance. The subject device is also compared to the Respironics Novametrix LoFlo C5 sensor. Beijing Kingst Commercial & Trade Co., Ltd. is submitting the subject device for individual clearance, so that the manufacturer may market the Module separately. The submitted device will be installed in a host monitor, where the host monitor manufacturer will determine fit, form, and function. {6}------------------------------------------------ The differences noted between the submitted CO2 Sidestream Module and the predicate Capnograph and Oximeter and Respironics Novametrix LoFlo C5 are based on the use. The Capnograph and Oximeter is a complete device that measures CO2 gas and also measures oxygen saturation. The Beijing Kingst Commercial & Trade Co., Ltd. CO2 Sidestream Module only measures CO2 gas. The display, any alarms, power supply, and physical configuration differences are due to the use in the end product. The subject device is manufactured to be a component of a complete device and not intended to be a stand-alone device and relies on a host device to display information or graphics. Please refer to the following pages for specific difference details. {7}------------------------------------------------ | Element of comparison | Capno-S | Capno-S+ | Conclusion | |-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Appearance | Image: Capno-S device | Image: Capno-S+ device | different | | Indications for Use | The CO2Sidestream Module is designed for monitoring vital physiological signs of the patient. It's intended to be used for non-invasive continuous monitoring of EtCO2, InsCO2, and Respiration Rate. The Module is indicated for inpatients from newborn (neonate) to adult in a hospital environment. It is intended to be used only under the regular supervision of clinical personnel. | The CO2Sidestream Module is designed for monitoring vital physiological signs of the patient. It's intended to be used for non-invasive continuous monitoring of EtCO2, InsCO2, and Respiration Rate. The Module is indicated for inpatients from newborn (neonate) to adult in a hospital environment. It is intended to be used only under the regular supervision of clinical personnel. | same | | Intended patient type | intubated patients and non-intubated patients | intubated patients and non-intubated patients | same | | Operation principles | Non-dispersive infrared gas analysis, multi-channel infrared detector, no moving parts | Non-dispersive infrared (NDIR) single beam optics, dual-wavelength, no moving parts | same | | Units | mmHg, kPa or Vol% | mmHg, kPa or Vol% | same | | EtCO2 Measurement Range | 0-150 mmHg 0-19.7% 0-20 kPa | 0-150 mmHg 0-19.7% 0-20 kPa | same | | EtCO2 Accuracy (at 760 mmHg, ambient temperature of 25°C) | 0~40 mmHg ±2 mmHg 41~70 mmHg ±5% of reading 71~100 mmHg ±8% of reading 101~150mmHg±10% of reading | 0~40 mmHg ±2 mmHg 41~70 mmHg ±5% of reading 71~100 mmHg ±8% of reading 101~150mmHg±10% of reading | same | | Respiration Rate measure range | 3 - 150 breaths/minute (RPM) | 3 - 150 breaths/minute (RPM) | same | | Respiration Rate accuracy | ±1% of reading or ±1 breaths/min whichever is greater | ±1% of reading or ±1 breaths/min whichever is greater | same | ## Comparison Table of Capno-S and Capno-S+ {8}------------------------------------------------ # Comparison to Predicate Devices | Element of comparison | Subject Device | Predicate Device | Reference Device | Discussion | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Beijing Kingst Commercial & Trade | Respironics Novametrix, LLC | CMI Health Inc. | N/A | | | Co., Ltd. | | | | | FDA510(K) Number | N/A | K053174 | K170820 | N/A | | Device Name | CO2 Sidestream Module | LoFlo C5 CO2 sensor | Capnograph and Oximeter | N/A | | Model Number | Capno-S, Capno-S+ | LoFlo C5 | Capno-H | N/A | | CO2 Module | CapnoCore | LoFlo C5 CO2 sensor | CapnoCore | N/A | | Indications for Use | The CO2 Sidestream Module is designed to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery in the intensive care unit (ICU) and in Respiratory care. The CO2 Sidestream Module is used for adult patients. | The intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery in the intensive care unit (ICU) and Emergency Medicine/Transport or Respiratory care. | The Capnograph and Oximeter are designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), Pulse Rate, EtCO2, InsCO2, and Respiration Rate. The Capnograph and Oximeter are adaptable to adult usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel | Identical to the predicate device. The indications for the use of the subject device are the same as the predicate device, LoFlo C5 CO2 sensor, and add the limit to the adult patient population only. The subject CO2 Sidestream Module is the same as the CO2 sidestream module used in the Reference Device, and they are the same manufacturer -Beijing Kingst. The Reference device has an additional SpO2 module for additional function, but the subject device has no SpO2 module and function. | | Power Supply | DC | DC | Battery or AC | Identical All Comply with IEC requirement | | The type of protection against electric shock | Class II | Class II | Class I and internally powered per IEC 60601-1. | Identical All Comply with IEC requirement | | The degree of protection against electric shock | Type BF | Type BF | Type BF | Identical | | Display | No display | No display | LED and LCD display | Identical Module's measurement data can be displayed on the primary device. | | Element of comparison | Subject Device | Predicate Device | Reference Device | Discussion | | Intended patient population | Adult | From newborn (neonate) to adult | The whole device claim for Adult SpO2 Measurement available for Adult CO2 Measurement available for Adult and Neonatal | The target population for CO2 Measurement is smaller than the predicate device. | | CO2 measurement method | Infrared absorption method | Infrared absorption method | Infrared absorption method | Infrared absorption method | | CO2 measure mode | Sidestream | Sidestream | Sidestream | Sidestream | | Measuring parameters | EtCO2 and Respiration Rate | EtCO2 and Respiration Rate | EtCO2 and Respiration Rate | EtCO2 and Respiration Rate | | Units | mmHg, kPa or Vol% | mmHg, kPa or Vol% | mmHg, kPa or Vol% | mmHg, kPa or Vol% | | EtCO2 measure range | 0-150 mmHg 0-19.7% 0-20 kPa | 0-150 mmHg 0-19.7% 0-20 kPa | 0-150 mmHg 0-19.7% 0-20 kPa | 0-150 mmHg 0-19.7% 0-20 kPa | | CO2 Accuracy | 0~40 mmHg ±2 mmHg 41~70 mmHg ±5% of reading 71~100 mmHg ±8% of reading 101~150mmHg±10% of reading | 0~40 mmHg ±2 mmHg 41~70 mmHg ±5% of reading 71~100 mmHg ±8% of reading 101~150mmHg±10% of reading | 0~40 mmHg ±2 mmHg 41~70 mmHg ±5% of reading 71~100 mmHg ±8% of reading 101~150mmHg±10% of reading | 0~40 mmHg ±2 mmHg 41~70 mmHg ±5% of reading 71~100 mmHg ±8% of reading 101~150mmHg±10% of reading | | Respiration Rate measure range | 3 - 150 breaths/minute | 2 - 150 breaths per minute | 3 - 150 breaths/minute | 2 RPM of the respiration rate will be abnormal. So, it doesn't matter whether the minimum range is 2 or 3. It is complying with ISO80601-2-55 | | Respiration Rate accuracy | ±1% of reading or ±1 breaths/min whichever is greater | ±1 breath per minute | ±1% of reading or ±1 breaths/min whichever is greater | ±1% of reading or ±1 breaths/min whichever is greater | | Flow Rate | 50±10 mL/min | 50±10 mL/min | 50–250 mL/min | 50–250 mL/min | | NO CO2 DETECTED Alarm Delay | N/A | N/A | 15~39s off | Compare with predicate device: Identical Compare with the reference device: The Module itself has no alarm function. | | Alarm of EtCO2 | N/A | N/A | High and lower alarms. The limits are adjustable. | Compare with predicate device: Identical Compare with the reference device: The Module itself has no alarm function. | | Alarm of RR | N/A | N/A | High and lower alarms. The limits are adjustable. | Compare with predicate device: Identical Compare with the reference device: The Module itself has no alarm function. | | Operation principles | Non-dispersive infrared gas analysis, multi-channel infrared detector, no moving parts. | Non-dispersive infrared (NDIR) single beam optics, dual-wavelength, no moving parts | Non-dispersive infrared gas analysis, multi-channel infrared detector, no moving parts. | Non-dispersive infrared gas analysis, multi-channel infrared detector, no moving parts. | | Materials | the upper case: ABS the lower case: ABS | the upper case: ABS the lower case: ABS | the upper case: ABS battery cover: ABS the lower case: ABS SpO2 Module: K063641 | Identical. All comply with ISO10993-1 Biocompatibility requirement. | {9}------------------------------------------------ {10}------------------------------------------------ ## Safety and Performance Data: To establish substantial equivalence to the identified predicate devices, tests were completed as defined below to the subject devices, CO2 Sidestream Module. The results of the testing demonstrate that the device complies with the requirements of the applicable standard, and the device is substantially equivalent to the predicate device. ## Non-Clinical Study: ## 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. MODI - 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: - 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 | Test | Test Method | Test Result | Test Report No. | |-------------------------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | EtCO2 | See test report | Range: 0-150mmHg Accuracy: 0 - 40 mmHg: $\pm$ 2 mm Hg; 41- 70 mmHg: $\pm$ 5% of reading; 71 - 100 mmHg: $\pm$ 8% of reading; 101 -150 mmHg: $\pm$ 10% of reading | JJX-FDA-A/0-06-04 | | Inspired Dioxide Carbon (InsCO2) | See test report | | JJX-FDA-A/0-06-06 | | Respiration Rate | See test report | Range: 3bpm~150bpm Accuracy: $\pm$ 1% of reading or $\pm$ 1 breaths/min whichever is greater | JJX-FDA-A/0-06-07 | {11}------------------------------------------------ ## 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 10993-11: 2017 Biological evaluation of medical Devices – Part 11: Tests for systemic toxicity - 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 | Device | Category and Contact | Duration | Test Conducted | |---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Capno-S, Capno-S+ | Surface Device →Skin | A — Limited≤( 24 h) | In Vitro Cytotoxicity (ISO10993-5) Irritation (ISO10993-10) Delayed-Type Hypersensitivity (ISO10993-10) | | Accessories (nasal tubes for adult and infant, filters, L- and T-Connectors, sampling line, etc.) | external communicating devices →Tissue contact (contacting the patient's inhaled and exhaled gases) | A — Limited≤( 24 h) | In Vitro Cytotoxicity (ISO10993-5) Irritation (ISO10993-10) Delayed-Type Hypersensitivity (ISO10993-10) Acute systemic toxicity(ISO10993-11) Material mediated pyrogenicity ISO10993-11) | {12}------------------------------------------------ | Test | Test Method | Result | Test Report No. | Page 10 of | |-------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------| | In Vitro Cytotoxicity Test | ISO10993-5 MTT method extracts MEM with 10% FBS Extract | Viability%: 87.9% No toxicity. | SDWH-M201602887-1 | | | Skin Sensitization Test | ISO10993-10 Guinea Pig Maximization Test 0.9% Sodium Chloride Injection Extract | Skin sensitization rate: 0% No evidence of sensitization. | SDWH-M201602887-2 | skin | | Skin Sensitization Test | ISO10993-10 Guinea Pig Maximization Test Sesame Oil Extract | Skin sensitization rate: 0% No evidence of sensitization. | SDWH-M201602887-3 | skin | | Skin Irritation Test | ISO10993-10 0.9% Sodium Chloride Injection Extract | Primary irritation index: 0 Negligible. | SDWH-M201602887-4 | | | Skin Irritation Test | ISO10993-10 Sesame Oil Extract | Primary irritation index: 0 Negligible. | SDWH-M201602887-5 | | | Test for emissions of particulate | ISO18562-2 | Particulate Matter: $3.2 \times 10^{-3}$ µg/m3(Particle size ≤2.5 μm) $3.2 \times 10^{-3}$ µg/m3(Particle size ≤10 μm) Qualified | SDWH-M201901183-2(E) | | | Tests for emissions of volatile organic compounds (VOCs) | ISO18562-3 | Each VOC < 360 µg/d Qualified | SDWH-M201901183-1(E) | | | Tests for leachable substances in condensate | ISO18562-4 | Organic impurities(acetophenone): <0.03 µg/d Metal ions (Ba): 4.83 µg/d Metal ions(others): <0.8 µg/ d Qualified | SDWH-M201901183-3(E) | | | Acute Systemic Toxicity | ISO 10993-11 Intravenous 0.9% Sodium Chloride Extract | All animals appeared clinical normal throughout the study. Qualified | SDWH-M201901183-4(E) | | | Acute Systemic Toxicity | ISO 10993-11 Intraperitoneal Sesame Oil Extract | All animals appeared clinical normal throughout the study. Qualified | SDWH-M201901183-5(E) | | | Pyrogen Test | ISO 10993-11 0.9% Sodium Chloride Injection Extract Rabbit | No rabbit shows an individual rise in temperature of 0.5°C or more. | SDWH-M201901183-6(E) | | Clinical Study: - No clinical studies were performed. {13}------------------------------------------------ ## Sterility Information: - This device is not delivered sterile and is not sterile during operation. - ## Package and Shelf Life: - The CO2 Sidestream module (Capno-S, Capno-S+) is not subject to shelf life, as the device does not contain any sterile or degradable elements. ## Conclusion: The differences between subject device and predicate devices do not raise issues of safety and effectiveness based on the indication for use, technological characteristics, and performance testing. The subject device complies with the same applicable standards as the predicate device. 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 Sidestream Module, models Capno-S and Capno-S+ is safe and effective and substantially equivalent to predicate devices as described herein. END