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.

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Dead space volume	Meets established performance requirements
Flow resistance	Meets established performance requirements
Color change	Meets established performance requirements
Conical fitting measurements/tolerances	Meets established performance requirements
Fitting tightness	Meets established performance requirements
Packaging integrity	Meets established performance requirements

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "In vitro performance tests were performed," but does not specify the sample size for these tests. The provenance of the data is not explicitly stated, but it's implied to be from the manufacturer (Seebreath AB) as part of their verification testing. The tests are described as "in vitro," meaning they were conducted in a controlled laboratory environment rather than on live subjects (retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the in vitro performance tests. The tests performed are objective, physical measurements (e.g., dead space volume, flow resistance, color change) and would likely be assessed against predetermined engineering specifications rather than expert consensus.

4. Adjudication Method for the Test Set

Since experts were not involved in establishing ground truth for the performance tests, no adjudication method such as 2+1 or 3+1 was used or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document describes in vitro performance tests of the device itself and mentions material equivalence to predicate products. There is no indication of a multi-reader multi-case comparative effectiveness study involving human readers with or without AI assistance. The device is a colorimetric CO2 detector, not an AI-powered diagnostic tool requiring human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, in essence. The performance tests described (dead space volume, flow resistance, color change, etc.) are evaluating the standalone physical and functional aspects of the device without human intervention or interpretation beyond observing the color change. The device's primary function is to chemically react to CO2 and display a color change, which is an inherent property being tested.

7. The Type of Ground Truth Used

The ground truth used for the performance tests appears to be engineering specifications and predetermined performance requirements for physical and functional parameters (e.g., specific dead space volume limits, specific flow resistance limits, expected color changes at certain CO2 concentrations, ISO standard dimensions for fittings).

8. The Sample Size for the Training Set

Not applicable. The device is a physical, colorimetric CO2 detector. It does not employ an algorithm or AI that requires a "training set" in the computational sense. The device's function is based on chemical reactions and physical design, not machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. As stated above, there is no training set for this type of device.

Summary

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510K(k) SUMMARY

SUBMITTER:	Seebreath ABKontoret NybrovikenBirger Jarlsgatan 2, 5trSE-114 34 StockholmSwedenPhone: +46(0)8 50565100	JUL 13 2012
DATE PREPARED:	September 25th 2011
DEVICE NAME:	CapnoDura Combi & CapnoDura Pedi CO2Detectors
CLASSIFICATION NAMES:	Carbon Dioxide Gas Analyzer

Device Description:

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Device	510(k) DocumentNumber	Date Cleared	Indications
Mercury MedicalMini Stat CO2 DetectorModel 10-55371	K031411	7/30/2003	Carbon DioxideGas Analyzer
Mercury Medical StatCO2 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.

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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.

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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

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SECTION XIII.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: CapnoDura Combi & CapnoDura Pedi CO2 Detectors

Indications for Use:

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: < 10(k)

112840

Appendix 1; Mercury Medical IFU

Regulation Number and 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).