The Capnomask is intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide. Environment of use - hospital and sub-acute settings. Patient population - Non-intubated patients who are breathing spontaneously.

Device Description

The proposed Capnomask design is like a standard oxygeu mask with a port for connecting a gas sampling line which is then to be comected to a gas monitor to measure exhaled carbon dioxide. The mask has a connector which incorporates ports for connecting standard oxygen tubing and a luer fitting to counect a standard gas sampling line. In addition, it has air entrainment holes to supply room air if needed. It is available in sizes ranging from large to snuall, similar to the predicate device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Capnomask, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document defines substantial equivalence primarily by comparing the proposed device (Capnomask) to a predicate device (Capnoxygen LLC Capnoxygen mask K971229) across various attributes. The acceptance criteria are implicitly defined by the predicate's characteristics and performance, with the Capnomask demonstrating equivalence.

Here's a table summarizing the comparison, with performance essentially being "determined to be substantially equivalent" or "identical" to the predicate.

Acceptance Criteria (Predicate)	Reported Device Performance (Capnomask)
Indications for Use: Deliver supplemental oxygen and monitor breathing by sampling exhaled CO2.	Identical: Intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide. (Discussion: Each device is indicated for use delivering supplemental oxygen and sampling expired gases.)
Environment of use: Hospitals and sub-acute setting.	Identical: Hospitals and sub-acute setting. (Discussion: The environments of use are identical to the predicate.)
Patient population: Non-intubated patients who are breathing spontaneously.	Identical: Non-intubated patients who are breathing spontaneously. (Discussion: The patient populations are identical to the predicate.)
Technology and construction (Design, fabrication, shape, size, etc.): Equivalent to predicate.	Equivalent: Demonstrated by dimensional verification, internal volume, entrainment port size, and configuration of the sampling connector. Minor dimension/volume differences not clinically significant due to non-airtight seal and entrainment holes. (Discussion: The design incorporates a standard face mask shape, connector for oxygen tubing and luer fitting for connecting a gas sampling line.)
Performance Testing (End-tidal CO2 results and waveform at various settings): Comparative results against predicate.	Substantially Equivalent: Comparative CO2-sampling and waveform performance at various breathing rates, tidal volumes, and oxygen flow rates. Noted dilution of EtCO2 at higher flow/breath rates, which is expected. (Device is a tool for qualitative detection of breathing and supplemental O2 delivery.)
Performance Testing (Real-time aging): Evaluation for performance to specifications (pressure drop and resistance).	Substantially Equivalent: Real-time aging performed and device evaluated for performance to specifications including pressure drop and resistance.
Performance Testing (Environmental and Mechanical testing): Successful completion.	Substantially Equivalent: Environmental and mechanical testing completed.
Materials (Biocompatibility): Compliance with ISO 10993 for surface (direct) and externally communicating (indirect) contact.	Compliant: ISO 10993 testing performed for Cytotoxicity, Sensitization, Intracutaneous Irritation, and Total VOC.

Study Details

The document describes non-clinical testing performed to establish substantial equivalence.

Sample size used for the test set and the data provenance:
- The document does not explicitly state a specific numerical sample size for the "test set" in terms of how many devices were tested or how many breathing cycles/scenarios were performed. The testing described is "at various breathing rates, tidal volumes, and oxygen flow rates."
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission seeking clearance in the US, these tests would typically be performed internally or by a contracted lab as pre-market validation studies. There's no mention of external clinical data or specific geographic origin for the test data itself (e.g., country of origin for the data). It is a retrospective evaluation of the device's technical and performance characteristics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for the performance testing (CO2 sampling, pressure drop, etc.) would be established by validated test equipment and scientific measurements, not by expert human interpretation of medical images or observations. The comparison is against the predicate device's established performance, implicitly considered the benchmark.
Adjudication method for the test set:
- Not applicable. This type of performance testing involves objective measurements rather than subjective human assessment requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device (oxygen mask with CO2 sampling), not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies and AI-assisted improvements for human readers are irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm. It is a passive device (mask) with a port for sampling gas for an external monitor. Its performance is inherent in its design and ability to deliver oxygen and allow for accurate gas sampling, not in an independent algorithm.
The type of ground truth used:
- For performance testing (CO2 sampling and waveform, pressure drop, resistance): The ground truth would be established by objective physical measurements using calibrated laboratory equipment and gas analyzers. The "truth" is what is measured by these instruments under controlled conditions. The comparison is then made against the predicate device's measured performance under similar conditions.
- For material biocompatibility: Standardized ISO 10993 biological evaluation tests (Cytotoxicity, Sensitization, Intracutaneous Irritation, Total VOC) serve as the ground truth for safety.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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NOV 2 5 2013

510(k) Summary Page 1 of 4 20-Nov-2013

Date Prepared:

Mediplus Ltd. Unit 7. The Gateway Centre Coronation Road, Cressex Business Park High Wycombe, Bucks, HP12 3SU UK

Tel - +44 (0) 1494 551299 Fax - +44 (0) 1494 536333

Official Contact:	Tim Ward
	Operations Manager
Proprietary or Trade Name:	Capnomask
Common/Usual Name:	Oxygen mask with gas sampling
Classification Name:	analyzer, gas, carbon-dioxide, gaseous phase (accessories)
	CCK - CFR 868.1400
	Class II
Predicate Devices:	K971229 - Capnoxygen LLC, Capnoxygen mask

Device Description:

The proposed Capnomask design is like a standard oxygeu mask with a port for connecting a gas sampling line which is then to be comected to a gas monitor to measure exhaled carbon dioxide.

The mask has a connector which incorporates ports for connecting standard oxygen tubing and a luer fitting to counect a standard gas sampling line.

In addition, it has air entrainment holes to supply room air if needed.

It is available in sizes ranging from large to snuall, similar to the predicate device.

Indications for Use:

The Capnomask is intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide.

Environment of use - hospital and sub-acute settings.

Patient population - Non-intubated patients who are breathing spontaneously.

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510(k) Summary

510(k) Summary

20-Nov-2013

20-Nov-2013
Attribute	PredicateCapnoxygen LLCCapnoxygen Mask K971229	ProposedCapnomask
Indications for Use	The Capnoxygen mask is a mediumconcentration single -use mask intended tobe used for the delivery of supplementaloxygen and monitoring breathing bysampling exhaled carbon dioxide. Standardconnectors for the oxygen tubing and astandard female luer connector for the gassample line are provided.	The Capnomask is intended to deliversupplemental oxygen to patients and monitorbreathing by sampling exhaled carbondioxide.
Environments of use	Hospitals and sub-acute setting	Hospitals and sub-acute setting
Prescriptive	Yes	Yes
Patient population	Non-intubated patients who are breathingspontaneously	Non-intubated patients who are breathingspontaneously
Single patient use,disposable	Yes	Yes
Basic components	Face maskElastic head strapConnector for oxygen tubing and gassampling lineEntrainment ports	Face maskElastic head strapConnector for oxygen tubing and gassampling lineEntrainment ports
Sizes	Large and Small	Large and Small
Overall dimensions	Large -Length - 140 mmWidth - 89 mm (at widest point)Height - 67 mmSmall -Length - 95 mmWidth - 76 mm (at widest point)Height - 59 mm	Large -Length - 121 mmWidth - 85 mm (at widest point)Height - 72 mmSmall -Length - 94 mmWidth - 74 mm (at widest point)Height - 59 mm
Internal Volume	Large - 155 ccSmall - 65 cc	Large - 160 ccSmall - 72 cc
Entrainment holes	Yes	Yes
Typical Flow RateRange	< 10 lpm however this is set by the clinician	< 10 lpm however this is set by the clinician
Method of oxygendelivery and Gassampling	Split connector with barbed oxygen tubingfitting on top of Luer fitting for attaching agas sampling line.The gas sampling port extends into the mask	Split connector with barbed oxygen tubingfitting on top of Luer fitting for attaching agas sampling line.The gas sampling port extends into the mask
Method of holdingmask on patient	Elastic band	Elastic band
PerformanceTesting	Comparative End-tidal CO₂ results andwaveform at various settings of oxygen flowrate, tidal volume and breathes per minute	Comparative End-tidal CO₂ results andwaveform at various settings of oxygen flowrate, tidal volume and breathes per minuteEnvironmental and Mechanical testingReal-time agingInternal Volune

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510(k) Summary Page 3 of 4 20-Nov-2013

Substantial Equivalence Discussion

The above table compares the key features of the vroposed Capnomask with the identified predicate and how the proposed device can be found to be substantially equivalent.

In summary one can conclude that substantial equivalence is met based upon the following:

Indications for Use -

The indications for use are identical for the proposed device when commared to the predicate -K971229 - Capnoxygen LLC Capnoxygen mask.

Discussion - Each device is indicated for use delivering supplemental oxygen and sampling expired gases.

Technology and construction -

The design, fabrication, shape, size, etc. are equivalent to the predicate - K971229 - Capnoxygen LLC Capnoxygen mask. This has been confirmed by dimensional verification, internal volume, entrainment port size, and configuration of the sampling connector.

Discussion - The design incorporates a standard face mask shape, connector for oxygen tubing and luer fitting for connecting a gas sampling line. The minor diffreences in dimenrsions and internal volume are not clinical significant as this mask does not provide an air tight seal and air will leak around the surface as well as through the entrainment holes.

Environment of Use -

The environments of use are identical to predicate - K971229 - Capnoxygen LLC Capnoxygen mask

Discussion - The environments of use are identical to the predicate K971229 - Capnoxygen LLC Capnoxygen mask

Patient Population -

The patient population is Non-intubated patients who are breathing spontaneously which is identical to the predicate - K971229 - Capnoxygen LLC Capnoxygen mask Discussion - The patient populations are identical to the predicate K971229 - Capnoxygen LLC Capnoxygen mask.

Non-Clinical Testing Summary -

We have performed a number of performance tests which include:

Courative CO-sampling and waveform performance at various breathing rates, tidal . volumes and oxygen flow rates. The testing was performed at oxygen flow rates of 1 Ipm, 5 lpm, and 10 lpm and CO2% of 1% and 5%.
Real-time aging was performed and the device evaluated for performance to ● specifications which included pressure drop and resistance.
Environmental and mechanical testing �
. Total VOC

All testing demonstrated that the proposed device is substantially equivalent to the predicate device. It was noted that with higher oxygen flow rates and breath rates that the measured EtCO2 would be diluted which is as expected. As the proposed devices are a tool to detect the qualitative presence of breathing and delivery supplemental oxygen.

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510(k) Summary Page 4 of 4 20-Nov-2013

Materials -

We have performed ISO 10993 testing on the component materials of the Capnomask which has parts which are considered as Surface (direct) contact and Externally Communicating (Indirect) mucosal contact with the patient which means the following tests are required if a material certification cannot be provided.

Cytotoxicity .
Sensitization .
Intracutaneous Irritation .
Total VOC �

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2013

Mediplus, Limited C/O Mr. Paul Dryden President, Regulatory Consultant ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, FL 34134

Re: K131339

Trade/Device Name: Capnomask Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon dioxide gas analyzer Regulatory Class: II Product Code: CCK Dated: October 21, 2013 Received: October 24, 2013

Dear Mr. Dryden:

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 - Mr. Dryden

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default,htm.

Sincerely vours.

Image /page/5/Picture/8 description: The image shows the text "ErinFDith" in a bold, sans-serif font. The letters are closely spaced together, and the word appears to be a combination of two names, "Erin" and "Edith". The letters "FDA" are in the middle of the word and are stylized with a decorative border.

Erin Keith M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number: K131339 .

Indications for Use:

The Capnomask is intended to deliver supplemental oxygen to patients and monitor breathing by sampling exhaled carbon dioxide.

Environment of use - hospital and sub-acute settings.

Patient population - Non-intubated patients who are breathing spontaneously.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Navar 2013 05.00,

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).