(352 days)
Intended use The Dräger CO2 Mainstream Sensor for measuring the CO2 concentration in breathing gas (CO2 mainstream sensor).
Indications The CO2 mainstream sensor enables the diagnosis and monitoring of patients by measuring CO2. The use of the medical device is limited to one patient at a time.
The CO2 Mainstream Sensor is designed for continuous, non-invasive mainstream measurement of Carbon Dioxide. The sensor is able to monitor CO2 using an infrared absorption technique and measures end tidal CO2 and inspired CO2 and calculates the respiratory rate. The data are processed by a microcontroller and provided to the parent device via a serial interface.
The sensor is adapted to the breathing system by airway adapters (CO2 measuring cuvettes).
Here's a summary of the acceptance criteria and study information for the CO2 Mainstream Sensor, based on the provided FDA 510(k) premarket notification:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics of the CO2 Mainstream Sensor with corresponding reported values in a consolidated format. However, it mentions extensive testing against various standards, which imply certain performance criteria. The key performance-related mention is the "Measuring range," which has been slightly extended compared to the predicate device.
| Performance Metric | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance |
|---|---|---|
| Measuring range | 0 to 13.2 Vol.%, 0 to 13.3 kPa, 0 to 100 mmHg | 0 to 15.8 Vol% (at 1013 hPa), 0 to 16.0 kPa, 0 to 120 mmHg |
| Respiratory Rate Range | 0 to 150 /min | 0 to 150 /min |
| Operating Temperature | -20 to +50 °C (-4 to 122 °F) | -20 to +50 °C (-4 to 122 °F) |
| Operating Humidity | 5 to 95 %, non-condensing | 5 to 95 %, non-condensing |
| Operating Ambient Air Pressure | 57 - 110 kPa (K100941) / 570 to 1100 hPa (428 to 825 mmHg) | 570 to 1100 hPa (428 to 825 mmHg) |
| Protection against penetrating liquids | IP64 | IP64 |
| Electrical Safety | Conformance to IEC 60601-1-6, IEC 60601-1-12 | Tested and Conforms |
| EMC | Conformance to IEC 60601-1-2, IEC/TR 60601-4-2 | Tested and Conforms |
| Biocompatibility | Conformance to ANSI AAMI ISO 10993-1 | Tested and Conforms |
| Software | Conformance to ANSI AAMI IEC 62304 | Tested and Conforms |
| Usability | Conformance to IEC 60601-1-6, AAMI / ANSI / IEC 62366-1 | Tested and Conforms |
| Risk Management | Conformance to ANSI AAMI ISO 14971 | Tested and Conforms |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for specific performance tests or studies like clinical trials in terms of the number of patients or specific data points. The testing mentioned is primarily bench testing and in vitro evaluations against technical standards and requirements.
The data provenance is not specified beyond indicating "extensive testing" and "well-established methods." It's reasonable to infer these tests were conducted by the manufacturer (Drägerwerk AG & Co. KGaA) in Germany, given the submitter's location. The studies appear to be retrospective in nature, drawing from the predicate device's established performance and applying new testing to demonstrate equivalence or improvement.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for testing in the context you describe (e.g., radiologists for image interpretation). The testing conducted is primarily objective, technical verification and validation against pre-defined standards and specifications for a CO2 sensor. Therefore, the "ground truth" for the test set would be derived from:
- Reference gases with known concentrations for CO2 measurements.
- Calibrated instruments for temperature, humidity, pressure, and electrical measurements.
- Standardized test procedures and benchmarks for software, EMC, and safety.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned, as this type of human expert consensus is not typically applicable to the kind of technical and bench testing described for this device. Test results would be compared directly to the specified standards and requirements.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. The CO2 Mainstream Sensor is a measurement device where its output is directly read rather than interpreted by multiple human readers in a comparative setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described appears to be primarily standalone performance testing, focusing on the algorithm (implicitly, the sensor's measurement principle and data processing) and hardware of the device itself. The "Discussion of Non-clinical Testing" section lists various technical evaluations, including software, electrical safety, EMC, and specific performance requirements from ISO 80601-2-55 for respiratory gas monitors. These are conducted on the device's inherent capabilities without human intervention for interpretation as part of the performance evaluation.
7. The Type of Ground Truth Used
The ground truth used for the technical testing would be:
- Reference Standards: Such as known concentrations of CO2 for accuracy testing, established environmental conditions (temperature, humidity, pressure), and defined electrical safety limits.
- Calibration Standards: High-precision instruments used to calibrate and verify the accuracy of the sensor's measurements.
- Compliance to Standards: The device's performance is measured against predefined thresholds and specifications outlined in the various IEC and ISO standards listed (e.g., ISO 80601-2-55 specific requirements for respiratory gas monitors).
8. The Sample Size for the Training Set
This device appears to be based on an established measurement principle (infrared absorption), and the submission focuses on demonstrating substantial equivalence through non-clinical testing rather than development of a novel algorithm that would require a "training set" in the machine learning sense. Therefore, there is no mention of a training set sample size as it's not applicable to the development verification of this type of device.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" mentioned in the context of machine learning, this question is not applicable to the information provided. The principles the device operates on are well-understood physics, and the validation relies on meeting established technical specifications and standards rather than learning from a dataset.
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April 5, 2023
Draegerwerk AG & Co. KGaA Lyubov Lange Regulatory Affairs Manager 53/55 Moislinger Allee Luebeck, Schleswig-Holstein 23542 Germany
Re: K221118
Trade/Device Name: CO2 Mainstream Sensor Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: March 2, 2023 Received: March 6, 2023
Dear Lyubov Lange:
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 and Part 809); 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 mediation-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,
James J. Lee -S
James J. Lee, Ph.D. Director DHT1C: Division of 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) K221118
Device Name CO2 Mainstream Sensor
Indications for Use (Describe) Intended use The Dräger CO2 Mainstream Sensor for measuring the CO2 concentration in breathing gas (CO2 mainstream sensor).
Indications
The CO2 mainstream sensor enables the diagnosis and monitoring of patients by measuring CO2. The use of the medical device is limited to one patient at a time.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Premarket Notification Summary | ||
|---|---|---|
| Submitter: | Drägerwerk AG & Co. KGaAMoislinger Allee 53-5523542 Lübeck, Germany | Establishment's registration number: 9611500 |
| Contact Person: | Dr. Bettina MoebiusHead of Regulatory Affairs CentralE-Mail: bettina.moebius@draeger.comTelephone: +49 451 882 3247 | |
| Applicant's US Contact Person: | Tom HirteHead of Regulatory AffairsE-Mail: tom.hirte@draeger.comTelephone: (978) 3796461 | |
| Date prepared: | April 08, 2022 | |
| Device Name: | Trade Name: CO2 Mainstream SensorClassification Name: analyzer, gas, carbon-dioxide, gaseous-phaseRegulation Number: 21 CFR §868.1400Product Code: CCKClass: II | |
| Predicate Device: | INFINITY MCABLE - MAINSTREAM CO2, K100941 |
Drägerwerk AG & Co. KGaA is submitting a traditional 510(k) premarket notification for a new device, the CO2 Mainstream Sensor.
Device Description
The CO2 Mainstream Sensor is designed for continuous, non-invasive mainstream measurement of Carbon Dioxide. The sensor is able to monitor CO2 using an infrared absorption technique and measures end tidal CO2 and inspired CO2 and calculates the respiratory rate. The data are processed by a microcontroller and provided to the parent device via a serial interface.
The sensor is adapted to the breathing system by airway adapters (CO2 measuring cuvettes).
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Intended Use
The Dräger CO2 Mainstream Sensor for measuring the CO2 concentration in breathing gas (CO2 mainstream sensor).
Indications
The CO2 mainstream sensor enables the diagnosis and monitoring of patients by measuring CO2. The use of the medical device is limited to one patient at a time.
List of Consensus Standards
| Standard Number and Version | Title |
|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance |
| IEC 60601-1-2: 2020 | Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral Standard:Electromagnetic disturbances - Requirementsand tests |
| IEC /TR 60601-4-2:2016 | Medical electrical equipment - Part 4-2:Guidance and interpretation -Electromagnetic immunity: performance ofmedical electrical equipment and medicalelectrical systems |
| IEC 60601-1-12:2014 | Medical electrical equipment - Part 1-12:General requirements for basic safety andessential performance - Collateral Standard:Requirements for medical electricalequipment and medical electrical systemsintended for use in the emergency medicalservices environment |
| ISO 80601-2-55:2018 | Medical electrical equipment - Part 2-55:Particular requirements for the basic safetyand essential performance of respiratory gasmonitors |
| ANSI AAMI IEC 62304:2006/A1:2016 | Medical device software - Software life cycleprocesses [Including Amendment 1 (2016)] |
| IEC 60601-1-6:2013 | Medical electrical equipment - Part 1-6:General requirements for basic safety andessential performance - Collateral standard:Usability |
| AAMI / ANSI / IEC 62366-1:2015 | Medical devices - Part 1: Application ofusability engineering to medical devices |
| ANSI AAMI ISO 14971:2019 | Medical devices - Applications of riskmanagement to medical devices |
| ANSI AAMI ISO 10993-1:2018 | Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process |
| Standard Number and Version | Title |
| ANSI AAMI ISO 17664:2017 | Processing of health care products -Information to be provided by the medicaldevice manufacturer for the processing ofmedical devices |
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510(k) Summary
Section 005
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510(k) Summary
Section 005
Comparison to Predicate
| Specification | Proposed Device | Predicate Device | Comments |
|---|---|---|---|
| CO2 Mainstream Sensor | INFINITY MCABLE – MAINSTREAMCO2 | ||
| Manufacturer | Drägerwerk AG & Co. KGaA | Draeger Medical AG & Co. KG | Same |
| 510(k) Number | -- | K100941 | -- |
| Regulation Number | 868.1400 - | 868.1400 - | Same |
| Product Code | CCK | CCK | Same |
| Classification | Analyzer, Gas, Carbon-Dioxide,Gaseous-Phase | Analyzer, Gas, Carbon-Dioxide,Gaseous-Phase | Same |
| Regulatory Class | II | II | Same |
| Intended Use | The Dräger CO2 Mainstream Sensor is asensor for measuring the CO2concentration in breathing gas (CO2mainstream sensor). | Dräger Infinity MCable.Mainstream CO2is a sensor for measuring the CO2concentration in breathing gas (CO2mainstream sensor). | Same |
| Indications | The CO2 mainstream sensor enables thediagnosis and monitoring of patients bymeasuring CO2. The use of the medicaldevice is limited to one patient at a time. | - | DifferentDetailed informationestablishes betterunderstanding for the userwhile function, use and patientpopulation of the sensor in theclinical setting remainidentical. The safety andeffectiveness of the currentdesign is supported bybiocompatibility, software,electromagnetic compatibility,electrical safety and benchtesting and is finally notaffected and the Intended Usenot altered. |
| Specification | Proposed Device | Predicate Device | Comments |
| CO2 Mainstream Sensor | INFINITY MCABLE - MAINSTREAMCO2 | ||
| Target Population /Patient Population | Adult, Pediatric | From neonates to adults. | SameThe patient population has notbeen changed from predicate.The terms "neonate" and"pediatric” have been definedmore specifically in recentyears. |
| Technological Characteristics | |||
| Principle of Operation | Measurement based on the principle thatCO2 molecules absorb light at a specificwavelength. Dual wavelength infraredabsorption. | Measurement based on the principle thatCO2 molecules absorb light at a specificwavelength. Dual wavelength infraredabsorption. | Same |
| Physical Attributes | |||
| Sensor headdimensions | ~45 x 30 x 20 mm | ~50 x 30 x 20 mm | SimilarThe new sensor head couldbe designed smaller thanks toa new photo detector.No effect on function |
| Protection againstpenetrating liquids inaccordance with IEC60529 | IP64 | IP64 | Same |
| Environmental | |||
| Operating Temperature | -20 to +50 °C (-4 to 122 °F) | See Instructions for Use of the parentdevice: K103625, -20 to +50 °C (-4 to122 °F) | Same |
| Operating Humidity | 5 to 95 %, non-condensing | See Instructions for Use of the parentdevice: K103625, 5 to 95 % (nocondensation) | Same |
| Traditional 510(k) | 510(k) Summary | Section 005 | |
| Specification | Proposed Device | Predicate Device | Comments |
| CO2 Mainstream Sensor | INFINITY MCABLE - MAINSTREAMCO2 | ||
| Operating Ambient AirPressure | 570 to 1100 hPa (428 to 825 mmHg) | 57 - 110 kPa (K100941) | Same |
| Storage Temperature | -40 to 75 °C (-40 to 167 °F) | -40 to 75 °C (-40 to 167 °F) | Same |
| Storage Humidity | 5 to 95 %, non-condensing | 5 to 95 % (no condensation) | Same |
| Storage Ambient AirPressure | 115 to 1100 hPa (86 to 825 mmHg) | 115 to 1100 hPa (1.67 to 15.95 psi) | Same |
| General Performance | |||
| Measuring Principle | Infrared absorption spectroscopy | Infrared absorption spectroscopy | Same |
| Respiratory RateRange | 0 to 150 /min | 0 to 150 /min | Same |
| Measuring range | 0 to 15.8 Vol% (at 1013 hPa), 0 to 16.0kPa, 0 to 120 mmHg | 0 to 13.2 Vol.%, 0 to 13.3 kPa, 0 to 100mmHg | SimilarSpecification for extendedrange 100 to 120 mmHg notpublished previously |
| External Communication | |||
| Communication withhost device | RS 232 interface | RS 232 interface | SimilarNo effect on communication |
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Image /page/7/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The two dots above the "a" are also blue. The word is the logo for the Dräger company, which is a German company that makes medical and safety technology.
Traditional 510(k) 510(k) Summary Section 005
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Image /page/8/Picture/1 description: The image shows the word "Dräger" in a stylized, bold, blue font. The "ä" in "Dräger" is represented by two dots above the letter. The font appears to be sans-serif and has a modern, clean look. The logo is likely for the Dräger company, which specializes in medical and safety technology.
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510(k) Summary
Discussion of Non-clinical Testing
The CO2 Mainstream Sensor is a new device and has underqone extensive testing to qualify it with e.q. national and international consensus standards, technical system requirements and other requirements. The following identified verification and validation activities necessary to establish substantial equivalence to the predicate device were carried out under well-established methods, their results summarized in Test Summary tables and the evidence included in this submission.
- Sterilization
- . Biocompatibility
- Software, including cybersecurity ●
- IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for . basic safety and essential performance – Collateral standard: Usability
- IEC 62366-1 Medical devices Part 1: Application of usability engineering to . medical devices
- Human Factors engineering
- Electrical safety
- . Electromagnetic compatibility (EMC)
- . IEC 60601-1-12 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
- ISO 80601-2-55 Medical electrical equipment Part 2-55: Particular requirements . for the basic safety and essential performance of respiratory gas monitors
- Technical System Requirements, covering:
- Risk control measures
- o Technical data
- Essential safety and performance
- Accessories compatibility ●
Conclusion
The conclusions drawn from the non-clinical tests and the comparison of intended use and technological characteristics with its predicate demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device INFINITY MCABLE – MAINSTREAM CO2 (K100941) identified in this section.
§ 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).