(352 days)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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, Germany | Establishment'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 Version | Title |
---|---|
ANSI AAMI ES60601-1:2005/(R)2012 and | |
A1:2012, C1:2009/(R)2012 and | |
A2:2010/(R)2012 | Medical electrical equipment - Part 1: General |
requirements for basic safety and essential | |
performance | |
IEC 60601-1-2: 2020 | Medical electrical equipment - Part 1-2: |
General requirements for basic safety and | |
essential performance - Collateral Standard: | |
Electromagnetic disturbances - Requirements | |
and tests | |
IEC /TR 60601-4-2:2016 | Medical electrical equipment - Part 4-2: |
Guidance and interpretation - | |
Electromagnetic immunity: performance of | |
medical electrical equipment and medical | |
electrical systems | |
IEC 60601-1-12:2014 | 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 80601-2-55:2018 | Medical electrical equipment - Part 2-55: |
Particular requirements for the basic safety | |
and essential performance of respiratory gas | |
monitors | |
ANSI AAMI IEC 62304:2006/A1:2016 | Medical device software - Software life cycle |
processes [Including Amendment 1 (2016)] | |
IEC 60601-1-6:2013 | Medical electrical equipment - Part 1-6: |
General requirements for basic safety and | |
essential performance - Collateral standard: | |
Usability | |
AAMI / ANSI / IEC 62366-1:2015 | Medical devices - Part 1: Application of |
usability engineering to medical devices | |
ANSI AAMI ISO 14971:2019 | Medical devices - Applications of risk |
management to medical devices | |
ANSI AAMI ISO 10993-1:2018 | Biological evaluation of medical devices - |
Part 1: Evaluation and testing within a risk | |
management process | |
Standard Number and Version | Title |
ANSI AAMI ISO 17664:2017 | Processing 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
Specification | Proposed Device | Predicate Device | Comments |
---|---|---|---|
CO2 Mainstream Sensor | INFINITY MCABLE – MAINSTREAM | ||
CO2 | |||
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 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 | ||
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. | - | 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. | |||
Specification | Proposed Device | Predicate Device | Comments |
CO2 Mainstream Sensor | INFINITY MCABLE - MAINSTREAM | ||
CO2 | |||
Target Population / | |||
Patient Population | Adult, Pediatric | From 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 Operation | Measurement 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 mm | Similar |
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 | |||
60529 | IP64 | IP64 | Same |
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 Humidity | 5 to 95 %, non-condensing | See Instructions for Use of the parent | |
device: K103625, 5 to 95 % (no | |||
condensation) | Same | ||
Traditional 510(k) | 510(k) Summary | Section 005 | |
Specification | Proposed Device | Predicate Device | Comments |
CO2 Mainstream Sensor | INFINITY MCABLE - MAINSTREAM | ||
CO2 | |||
Operating Ambient Air | |||
Pressure | 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 Air | |||
Pressure | 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 Rate | |||
Range | 0 to 150 /min | 0 to 150 /min | Same |
Measuring range | 0 to 15.8 Vol% (at 1013 hPa), 0 to 16.0 | ||
kPa, 0 to 120 mmHg | 0 to 13.2 Vol.%, 0 to 13.3 kPa, 0 to 100 | ||
mmHg | Similar | ||
Specification for extended | |||
range 100 to 120 mmHg not | |||
published previously | |||
External Communication | |||
Communication with | |||
host device | RS 232 interface | RS 232 interface | Similar |
No effect on communication |
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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.