K Number
K221118
Device Name
CO2 Mainstream Sensor
Date Cleared
2023-04-05

(352 days)

Product Code
Regulation Number
868.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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).
More Information

Not Found

No
The description details standard signal processing and calculation of respiratory rate using an infrared absorption technique and a microcontroller, with no mention of AI or ML algorithms.

No
The device is for diagnosis and monitoring patients by measuring CO2, not for treating any condition.

Yes

The "Indications for Use" section explicitly states that the CO2 mainstream sensor "enables the diagnosis and monitoring of patients by measuring CO2."

No

The device description explicitly states it is a "CO2 Mainstream Sensor" that uses an "infrared absorption technique" and includes a "microcontroller." It also mentions being adapted to the breathing system by "airway adapters (CO2 measuring cuvettes)." These are all hardware components. The performance studies also include hardware-related testing like sterilization, biocompatibility, electrical safety, and EMC.

Based on the provided information, the Dräger CO2 Mainstream Sensor is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is to measure CO2 concentration in breathing gas for diagnosis and monitoring of patients. This is a measurement of a physiological parameter directly from the patient's breath, not from a sample of bodily fluid or tissue that is tested in vitro (outside the body).
  • Device Description: The device uses an infrared absorption technique to measure CO2 in the breathing system. This is a non-invasive, direct measurement from the patient's airway.
  • Lack of IVD Characteristics: The description does not mention any testing of samples (blood, urine, tissue, etc.) or any reagents used for analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures a gas directly from the patient's respiratory system.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

CCK

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).

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

Adult, Pediatric

Intended User / Care Setting

Not Found

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)

The CO2 Mainstream Sensor is a new device and has undergone extensive testing to qualify it with e.g. 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
    • Technical data
    • Essential safety and performance
  • Accessories compatibility

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.

INFINITY MCABLE - MAINSTREAM CO2, K100941

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).

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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

1

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

2

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. KGaA
Moislinger Allee 53-55
23542 Lübeck, GermanyEstablishment's registration number: 9611500
Contact Person:Dr. Bettina Moebius
Head of Regulatory Affairs Central
E-Mail: bettina.moebius@draeger.com
Telephone: +49 451 882 3247
Applicant's US Contact Person:Tom Hirte
Head of Regulatory Affairs
E-Mail: tom.hirte@draeger.com
Telephone: (978) 3796461
Date prepared:April 08, 2022
Device Name:Trade Name: CO2 Mainstream Sensor
Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number: 21 CFR §868.1400
Product Code: CCK
Class: 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 VersionTitle
ANSI AAMI ES60601-1:2005/(R)2012 and
A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-2: 2020Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and tests
IEC /TR 60601-4-2:2016Medical electrical equipment - Part 4-2:
Guidance and interpretation -
Electromagnetic immunity: performance of
medical electrical equipment and medical
electrical systems
IEC 60601-1-12:2014Medical 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 80601-2-55:2018Medical electrical equipment - Part 2-55:
Particular requirements for the basic safety
and essential performance of respiratory gas
monitors
ANSI AAMI IEC 62304:2006/A1:2016Medical device software - Software life cycle
processes [Including Amendment 1 (2016)]
IEC 60601-1-6:2013Medical electrical equipment - Part 1-6:
General requirements for basic safety and
essential performance - Collateral standard:
Usability
AAMI / ANSI / IEC 62366-1:2015Medical devices - Part 1: Application of
usability engineering to medical devices
ANSI AAMI ISO 14971:2019Medical devices - Applications of risk
management to medical devices
ANSI AAMI ISO 10993-1:2018Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk
management process
Standard Number and VersionTitle
ANSI AAMI ISO 17664:2017Processing of health care products -
Information to be provided by the medical
device manufacturer for the processing of
medical devices

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510(k) Summary

Section 005

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510(k) Summary

Section 005

Comparison to Predicate

SpecificationProposed DevicePredicate DeviceComments
CO2 Mainstream SensorINFINITY MCABLE – MAINSTREAM
CO2
ManufacturerDrägerwerk AG & Co. KGaADraeger Medical AG & Co. KGSame
510(k) Number--K100941--
Regulation Number868.1400 -868.1400 -Same
Product CodeCCKCCKSame
ClassificationAnalyzer, Gas, Carbon-Dioxide,
Gaseous-PhaseAnalyzer, Gas, Carbon-Dioxide,
Gaseous-PhaseSame
Regulatory ClassIIIISame
Intended UseThe Dräger CO2 Mainstream Sensor is a
sensor for measuring the CO2
concentration in breathing gas (CO2
mainstream sensor).Dräger Infinity MCable.Mainstream CO2
is a sensor for measuring the CO2
concentration in breathing gas (CO2
mainstream sensor).Same
IndicationsThe 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.-Different
Detailed information
establishes better
understanding for the user
while function, use and patient
population of the sensor in the
clinical setting remain
identical. The safety and
effectiveness of the current
design is supported by
biocompatibility, software,
electromagnetic compatibility,
electrical safety and bench
testing and is finally not
affected and the Intended Use
not altered.
SpecificationProposed DevicePredicate DeviceComments
CO2 Mainstream SensorINFINITY MCABLE - MAINSTREAM
CO2
Target Population /
Patient PopulationAdult, PediatricFrom neonates to adults.Same
The patient population has not
been changed from predicate.
The terms "neonate" and
"pediatric” have been defined
more specifically in recent
years.
Technological Characteristics
Principle of OperationMeasurement based on the principle that
CO2 molecules absorb light at a specific
wavelength. Dual wavelength infrared
absorption.Measurement based on the principle that
CO2 molecules absorb light at a specific
wavelength. Dual wavelength infrared
absorption.Same
Physical Attributes
Sensor head
dimensions~45 x 30 x 20 mm~50 x 30 x 20 mmSimilar
The new sensor head could
be designed smaller thanks to
a new photo detector.
No effect on function
Protection against
penetrating liquids in
accordance with IEC
60529IP64IP64Same
Environmental
Operating Temperature-20 to +50 °C (-4 to 122 °F)See Instructions for Use of the parent
device: K103625, -20 to +50 °C (-4 to
122 °F)Same
Operating Humidity5 to 95 %, non-condensingSee Instructions for Use of the parent
device: K103625, 5 to 95 % (no
condensation)Same
Traditional 510(k)510(k) SummarySection 005
SpecificationProposed DevicePredicate DeviceComments
CO2 Mainstream SensorINFINITY MCABLE - MAINSTREAM
CO2
Operating Ambient Air
Pressure570 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 Humidity5 to 95 %, non-condensing5 to 95 % (no condensation)Same
Storage Ambient Air
Pressure115 to 1100 hPa (86 to 825 mmHg)115 to 1100 hPa (1.67 to 15.95 psi)Same
General Performance
Measuring PrincipleInfrared absorption spectroscopyInfrared absorption spectroscopySame
Respiratory Rate
Range0 to 150 /min0 to 150 /minSame
Measuring range0 to 15.8 Vol% (at 1013 hPa), 0 to 16.0
kPa, 0 to 120 mmHg0 to 13.2 Vol.%, 0 to 13.3 kPa, 0 to 100
mmHgSimilar
Specification for extended
range 100 to 120 mmHg not
published previously
External Communication
Communication with
host deviceRS 232 interfaceRS 232 interfaceSimilar
No 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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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.