(288 days)
Not Found
No
The device is a simple colorimetric CO2 detector that changes color based on CO2 concentration. There is no indication of computational analysis or learning algorithms.
No.
The device is used for diagnostic purposes (visualizing CO2 in the patient airway, verifying tracheal tube placement, observing respiration) as an adjunct in patient assessment, not for direct treatment or therapy.
Yes
Explanation: The device provides "semi quantitative visualization of the CO2 in the patient airway" and is "an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms." It also "assist[s] verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes." These functions indicate that it is used to gather information about a patient's medical condition for diagnostic purposes.
No
The device description clearly states it is a "non-sterile, single use, colorimetric CO2 detector" with a physical indicator area that changes color. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens derived from the human body. The CapnoDura devices analyze the CO2 content of exhaled breath directly from the patient's airway. They do not process or analyze a biological specimen (like blood, urine, or tissue) that has been removed from the body.
- The intended use is for monitoring and verifying tracheal tube placement and observing respiration. While this provides information about the patient's physiological state, it's a direct measurement of a gas in the airway, not an analysis of a biological sample.
- The device description focuses on the physical connection to the breathing circuit and tracheal tube, and the colorimetric indicator. This aligns with a device used for direct monitoring in the airway, not for laboratory analysis of a specimen.
Therefore, the CapnoDura Pedi and CapnoDura Combi CO2 Detectors are considered in vivo devices, used for monitoring within the patient's body (specifically, the airway).
N/A
Intended Use / Indications for Use
To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes.
CapnoDura Pedi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighting 1 kg - 15 kg.
CapnoDura Combi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighting 10 kg or above.
Both the CapnoDura Pedi and the CapnoDura Combi are adjuncts in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
CapnoDura Pedi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighing 1 kg - 15 kg. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes.
CapnoDura Combi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighing 10 kg or above. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
The CapnoDura Combi & CapnoDura Pedi CO2 Detectors are non-sterile, single use, colorimetric CO2 detectors to be connected between a breathing circuit and a tracheal tube. The colorimetric indicator area in the center of the device indicates the presence of carbon dioxide during the breathing to assist verification of tracheal tube placement in trachea following intubation and to observe respiration by the detector's color changes The indicator panel is blue when no CO2 is present, green at intermediate concentrations and yellow when approximately 5% CO2 is present. A permanent blue or blue-green color indicates absence of exhaled CO2. A damaged indicator will exhibit a permanent yellow or white color.
The unit has a printed reference scale against which the actual indicator color may be compared to obtain an approximate CO2 concentration. There are two sizes of the detector, Combi and Pedi, and these will fit with the breathing circuit and tracheal tube connections for both adults and children, respectively. The connections are ISO standard dimensions
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
CapnoDura Pedi: patient weighting 1 kg - 15 kg.
CapnoDura Combi: patient weighting 10 kg or above.
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)
Results of verification testing indicates that the product meets the established performance requirements. In vitro performance tests were performed for dead space volume, flow resistance, color change, conical fitting measurements/tolerances, fitting tightness and packaging integrity.
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.
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).
0
510K(k) SUMMARY
| SUBMITTER: | Seebreath AB
Kontoret Nybroviken
Birger Jarlsgatan 2, 5tr
SE-114 34 Stockholm
Sweden
Phone: +46(0)8 50565100 | JUL 13 2012 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------|
| DATE PREPARED: | September 25th 2011 | |
| DEVICE NAME: | CapnoDura Combi & CapnoDura Pedi CO2
Detectors | |
| CLASSIFICATION NAMES: | Carbon Dioxide Gas Analyzer | |
Device Description:
The CapnoDura Combi & CapnoDura Pedi CO2 Detectors are non-sterile, single use, colorimetric CO2 detectors to be connected between a breathing circuit and a tracheal tube. The colorimetric indicator area in the center of the device indicates the presence of carbon dioxide during the breathing to assist verification of tracheal tube placement in trachea following intubation and to observe respiration by the detector's color changes The indicator panel is blue when no CO2 is present, green at intermediate concentrations and yellow when approximately 5% CO2 is present. A permanent blue or blue-green color indicates absence of exhaled CO2. A damaged indicator will exhibit a permanent yellow or white color.
The unit has a printed reference scale against which the actual indicator color may be compared to obtain an approximate CO2 concentration. There are two sizes of the detector, Combi and Pedi, and these will fit with the breathing circuit and tracheal tube connections for both adults and children, respectively. The connections are ISO standard dimensions
- 1
1
| Device | 510(k) Document
Number | Date Cleared | Indications |
|-------------------------------------------------------------|---------------------------|--------------|--------------------------------|
| Mercury Medical
Mini Stat CO2 Detector
Model 10-55371 | K031411 | 7/30/2003 | Carbon Dioxide
Gas Analyzer |
| Mercury Medical Stat
CO2 Detector Model 10-
55370 | K021576 | 11/4/2002 | Carbon Dioxide |
Indications for Use:
To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes.
CapnoDura Pedi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighting 1 kg - 15 kg.
CapnoDura Combi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighting 10 kg or above.
Both the CapnoDura Pedi and the CapnoDura Combi are adjuncts in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.
Technological Characteristics:
Technologically, both the new device and the predicate device are substantially equivalent, partially identical. The form, fit, function and method of operation are similar Any differences between the two devices do not raise new questions of safety and effectiveness
Performance Data and pre clinical testing:
Results of verification testing indicates that the product meets the established performance requirements. In vitro performance tests were performed for dead space volume, flow resistance, color change, conical fitting measurements/ tolerances, fitting tightness and packaging integrity.
The material used are the same as in predicate products and no new biocompatibility testing was needed.
Conclusions:
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the proposed device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle symbol. The logo is simple, using only black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Anette Sjögren QA/RA Manager Seebreath AB Morkullevägen 31 Bjärred SWEDEN 23736
JUL 13 2012
Re: K112840
Trade/Device Name: CapnoDura Combi & CapnoDura Pedi CO2 Detectors Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: June 23, 2012 Received: July 2, 2012
Dear Ms. Sjögren:
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. 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.
3
Page 2 - Ms. Sjögren
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
ph tor
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION XIII.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: CapnoDura Combi & CapnoDura Pedi CO2 Detectors
Indications for Use:
CapnoDura Pedi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighing 1 kg - 15 kg. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes.
CapnoDura Combi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighing 10 kg or above. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR -
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
$\mathcal{L}$ Schulthe Page _ of _
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
Page 100 of 103
510(k) Number: