(254 days)
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.
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 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.
The provided text describes the acceptance criteria and a study demonstrating the device's compliance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| EtCO2 Measurement Range | 0-150 mmHg, 0-19.7%, 0-20 kPa |
| EtCO2 Accuracy | 0-40 mmHg: ±2 mmHg41-70 mmHg: ±5% of reading71-100 mmHg: ±8% of reading101-150 mmHg: ±10% of reading |
| Respiration Rate Measurement Range | 3 - 150 breaths/minute (RPM) |
| Respiration Rate Accuracy | ±1% of reading or ±1 breaths/min, whichever is greater |
| In Vitro Cytotoxicity | Viability%: 87.9% (No toxicity) |
| Skin Sensitization | 0% skin sensitization rate (No evidence of sensitization) |
| Skin Irritation | Primary irritation index: 0 (Negligible) |
| Emissions of Particulate Matter | 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) |
| Emissions of Volatile Organic Compounds | Each VOC < 360 µg/d (Qualified) |
| Leachable Substances in Condensate | Organic impurities (acetophenone): <0.03 µg/dMetal ions (Ba): 4.83 µg/dMetal ions (others): <0.8 µg/d (Qualified) |
| Acute Systemic Toxicity | All animals appeared clinically normal throughout the study (Qualified) |
| Pyrogen Test | No rabbit shows an individual rise in temperature of 0.5°C or more |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the performance tests (EtCO2, Respiration Rate). It mentions "See test report" for the test method, implying the full details are in separate reports (e.g., JJX-FDA-A/0-06-04, JJX-FDA-A/0-06-06, JJX-FDA-A/0-06-07) which are not provided.
For the biocompatibility tests:
- In Vitro Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity, Pyrogen Test: These tests were conducted on animal models (Guinea Pig, Rabbit) and in vitro (cell culture). Specific numbers of animals or cell cultures are not explicitly stated in this summary but are implied by the nature of these standardized tests.
- Emissions and Leachables: These tests analyze the device materials themselves rather than patient samples.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of performance validation tests (e.g., accuracy, stability, electromagnetic compatibility) using standard methods and controlled environments, these are generally prospective and performed in a laboratory setting. Biocompatibility tests are also typically conducted in labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported performance relates to the device's adherence to specified technical standards for measurement accuracy and safety, rather than interpretations by medical experts to establish a "ground truth" for diagnostic or clinical purposes. The ground truth for EtCO2 and Respiration Rate accuracy is established against highly accurate reference measurement systems in a laboratory setting. For biocompatibility, ground truth is established by standardized biological assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is a CO2 Sidestream Module measuring physiological parameters. The testing described is performance verification against technical standards, not involving human interpretation or adjudication of clinical outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a measurement module, not an AI-assisted diagnostic tool where human readers would interpret results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (EtCO2, Respiration Rate accuracy, biocompatibility, EMC, etc.) are for the device (CO2 Sidestream Module models Capno-S, Capno-S+) operating standalone in controlled test environments. The device itself is designed to be a component of a host monitoring system, meaning its internal function and measurements are "standalone" in the sense of not requiring human-in-the-loop for its basic operation and data generation. It outputs data which the host monitor then displays.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the technical performance data (EtCO2 and Respiration Rate accuracy) would be based on highly accurate reference measurement devices in a controlled laboratory setting (e.g., calibrated gas mixtures for CO2 concentration, precise timing mechanisms for respiration rate). For biocompatibility, the ground truth is determined by the results of standardized biological and chemical tests as defined in the ISO 10993 and ISO 18562 series.
8. The sample size for the training set
Not applicable. This device is a measurement instrument, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) 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)
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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 |
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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
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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.
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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.
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| Element ofcomparison | Capno-S | Capno-S+ | Conclusion |
|---|---|---|---|
| Appearance | Image: Capno-S device | Image: Capno-S+ device | different |
| Indications forUse | The CO2Sidestream Module is designed formonitoring vital physiological signs of the patient.It's intended to be used for non-invasivecontinuous monitoring of EtCO2, InsCO2, andRespiration Rate. The Module is indicated forinpatients from newborn (neonate) to adult in ahospital environment. It is intended to be used onlyunder the regular supervision of clinical personnel. | The CO2Sidestream Module is designed formonitoring vital physiological signs of the patient.It's intended to be used for non-invasive continuousmonitoring of EtCO2, InsCO2, and Respiration Rate.The Module is indicated for inpatients from newborn(neonate) to adult in a hospital environment. It isintended to be used only under the regularsupervision of clinical personnel. | same |
| Intendedpatient type | intubated patients and non-intubated patients | intubated patients and non-intubated patients | same |
| Operationprinciples | Non-dispersive infrared gas analysis, multi-channelinfrared 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 |
| EtCO2MeasurementRange | 0-150 mmHg0-19.7%0-20 kPa | 0-150 mmHg0-19.7%0-20 kPa | same |
| EtCO2Accuracy(at 760mmHg,ambienttemperatureof 25°C) | 0 | 0 | same |
| RespirationRatemeasurerange | 3 - 150 breaths/minute (RPM) | 3 - 150 breaths/minute (RPM) | same |
| RespirationRateaccuracy | ±1% of reading or ±1 breaths/min whichever isgreater | ±1% of reading or ±1 breaths/min whichever isgreater | same |
Comparison Table of Capno-S and Capno-S+
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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 isdesigned to provide carbon dioxidemonitoring to a host monitoringsystem during anesthesia/recoveryin the intensive care unit (ICU) and inRespiratory care.The CO2 Sidestream Module is usedfor adult patients. | The intended use of the LoFlo C5 CO2sensor is to provide carbon dioxidemonitoring to a host monitoring systemduring anesthesia/recovery in theintensive care unit (ICU) andEmergency Medicine/Transport orRespiratory care. | The Capnograph and Oximeter aredesigned for monitoring the vitalphysiological signs of the patient. It isused for non-invasive continuousmonitoring of oxygen saturation (SpO2),Pulse Rate, EtCO2, InsCO2, andRespiration Rate.The Capnograph and Oximeter areadaptable to adult usage in a hospitalenvironment. It is intended to be usedonly under regular supervision ofclinical personnel | Identical to the predicate device.The indications for the use of the subjectdevice are the same as the predicatedevice, LoFlo C5 CO2 sensor, and addthe limit to the adult patient populationonly.The subject CO2 Sidestream Module isthe same as the CO2 sidestream moduleused in the Reference Device, and theyare the same manufacturer -BeijingKingst.The Reference device has an additionalSpO2 module for additional function, butthe subject device has no SpO2 moduleand function. |
| Power Supply | DC | DC | Battery or AC | IdenticalAll Comply with IEC requirement |
| The type of protectionagainst electric shock | Class II | Class II | Class I and internally powered per IEC60601-1. | IdenticalAll Comply with IEC requirement |
| The degree of protectionagainst electric shock | Type BF | Type BF | Type BF | Identical |
| Display | No display | No display | LED and LCD display | IdenticalModule's measurement data can bedisplayed on the primary device. |
| Element of comparison | Subject Device | Predicate Device | Reference Device | Discussion |
| Intended patientpopulation | Adult | From newborn (neonate) to adult | The whole device claim for AdultSpO2 Measurement available for AdultCO2 Measurement available for Adultand Neonatal | The target population for CO2Measurement is smaller than thepredicate device. |
| CO2 measurementmethod | 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 mmHg0-19.7%0-20 kPa | 0-150 mmHg0-19.7%0-20 kPa | 0-150 mmHg0-19.7%0-20 kPa | 0-150 mmHg0-19.7%0-20 kPa |
| CO2 Accuracy | 0 | 0 | 0 | 0 |
| Respiration Ratemeasure range | 3 - 150 breaths/minute | 2 - 150 breaths per minute | 3 - 150 breaths/minute | 2 RPM of the respiration rate will beabnormal. So, it doesn't matter whetherthe minimum range is 2 or 3.It is complying with ISO80601-2-55 |
| Respiration Rateaccuracy | ±1% of reading or ±1 breaths/minwhichever is greater | ±1 breath per minute | ±1% of reading or ±1 breaths/minwhichever is greater | ±1% of reading or ±1 breaths/minwhichever is greater |
| Flow Rate | 50±10 mL/min | 50±10 mL/min | 50–250 mL/min | 50–250 mL/min |
| NO CO2 DETECTEDAlarm Delay | N/A | N/A | 15~39s off | Compare with predicate device: IdenticalCompare with the reference device: TheModule itself has no alarm function. |
| Alarm of EtCO2 | N/A | N/A | High and lower alarms.The limits are adjustable. | Compare with predicate device: IdenticalCompare with the reference device: TheModule itself has no alarm function. |
| Alarm of RR | N/A | N/A | High and lower alarms.The limits are adjustable. | Compare with predicate device: IdenticalCompare with the reference device: TheModule itself has no alarm function. |
| Operation principles | Non-dispersive infrared gas analysis,multi-channel infrared detector, nomoving parts. | Non-dispersive infrared (NDIR) singlebeam optics, dual-wavelength, nomoving parts | Non-dispersive infrared gas analysis,multi-channel infrared detector, nomoving parts. | Non-dispersive infrared gas analysis,multi-channel infrared detector, nomoving parts. |
| Materials | the upper case: ABSthe lower case: ABS | the upper case: ABSthe lower case: ABS | the upper case: ABSbattery cover: ABSthe lower case: ABSSpO2 Module: K063641 | Identical.All comply with ISO10993-1Biocompatibility requirement. |
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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: 0-150mmHgAccuracy: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~150bpmAccuracy: $\pm$ 1% of reading or $\pm$ 1breaths/min whichever is greater | JJX-FDA-A/0-06-07 |
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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≤( 24h) | In Vitro Cytotoxicity (ISO10993-5)Irritation (ISO10993-10)Delayed-Type Hypersensitivity (ISO10993-10) |
| Accessories(nasal tubes foradult and infant,filters, L- andT-Connectors,sampling line,etc.) | externalcommunicatingdevices →Tissuecontact(contactingthepatient'sinhaledand exhaled gases) | A — Limited≤( 24h) | In Vitro Cytotoxicity (ISO10993-5)Irritation (ISO10993-10)Delayed-Type Hypersensitivity (ISO10993-10)Acute systemic toxicity(ISO10993-11) Materialmediated pyrogenicity ISO10993-11) |
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| Test | Test Method | Result | Test Report No. | Page 10 of |
|---|---|---|---|---|
| In VitroCytotoxicity Test | ISO10993-5 MTT methodextracts MEM with 10%FBS Extract | Viability%: 87.9%No toxicity. | SDWH-M201602887-1 | |
| Skin SensitizationTest | ISO10993-10Guinea PigMaximization Test0.9% Sodium ChlorideInjection Extract | Skin sensitization rate:0% No evidence ofsensitization. | SDWH-M201602887-2 | skin |
| Skin SensitizationTest | ISO10993-10Guinea PigMaximization TestSesame Oil Extract | Skin sensitization rate:0% No evidenceof sensitization. | SDWH-M201602887-3 | skin |
| Skin Irritation Test | ISO10993-100.9% Sodium ChlorideInjection Extract | Primary irritation index:0 Negligible. | SDWH-M201602887-4 | |
| Skin Irritation Test | ISO10993-10Sesame Oil Extract | Primary irritation index:0 Negligible. | SDWH-M201602887-5 | |
| Test for emissionsof 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 emissionsof volatileorganiccompounds (VOCs) | ISO18562-3 | Each VOC < 360 µg/dQualified | SDWH-M201901183-1(E) | |
| Tests forleachablesubstancesin condensate | ISO18562-4 | Organicimpurities(acetophenone):<0.03 µg/dMetal ions (Ba): 4.83 µg/dMetal ions(others): <0.8 µg/d Qualified | SDWH-M201901183-3(E) | |
| Acute SystemicToxicity | ISO 10993-11Intravenous 0.9%Sodium Chloride Extract | All animals appeared clinicalnormal throughout the study.Qualified | SDWH-M201901183-4(E) | |
| Acute SystemicToxicity | ISO 10993-11Intraperitoneal SesameOil Extract | All animals appeared clinicalnormal throughout the study.Qualified | SDWH-M201901183-5(E) | |
| Pyrogen Test | ISO 10993-110.9% Sodium ChlorideInjection Extract Rabbit | No rabbit shows an individualrise in temperature of 0.5°C ormore. | SDWH-M201901183-6(E) |
Clinical Study:
- No clinical studies were performed.
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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
§ 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).