CAPNOMASK

K131339 · Mediplus , Ltd. · CCK · Nov 25, 2013 · Anesthesiology

Device Facts

• Record ID: K131339
• Device Name: CAPNOMASK
• Applicant: Mediplus , Ltd.
• Product Code: CCK · Anesthesiology
• Decision Date: Nov 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Capnomask is a single-use, disposable oxygen mask with integrated gas sampling capabilities. Device features a face mask, elastic head strap, air entrainment holes, and a split connector with ports for standard oxygen tubing and a luer fitting for a gas sampling line. The sampling port extends into the mask to collect exhaled gases. Used in hospital and sub-acute settings by clinicians to deliver supplemental oxygen while simultaneously monitoring breathing via an external gas monitor. The device provides a qualitative assessment of breathing presence and supplemental oxygen delivery. It does not provide an airtight seal; air leakage occurs around the mask and through entrainment ports. Benefits include simultaneous oxygen therapy and respiratory monitoring for non-intubated patients.

Clinical Evidence

Bench testing only. Performance testing evaluated CO2 sampling and waveform performance at various breathing rates, tidal volumes, and oxygen flow rates (1, 5, and 10 lpm) with CO2 concentrations of 1% and 5%. Additional testing included real-time aging, pressure drop, resistance, environmental/mechanical testing, and ISO 10993 biocompatibility (cytotoxicity, sensitization, intracutaneous irritation, total VOC).

Technological Characteristics

Single-use face mask with elastic head strap. Materials meet ISO 10993 standards for surface and externally communicating mucosal contact. Features air entrainment ports and a split connector for oxygen tubing and luer-lock gas sampling. Dimensions: Large (121x85x72mm, 160cc) and Small (94x74x59mm, 72cc). Passive device; no energy source or software.

Indications for Use

Indicated for non-intubated, spontaneously breathing patients in hospital or sub-acute settings requiring supplemental oxygen and CO2 monitoring.

Regulatory Classification

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.

Predicate Devices

• Capnoxygen LLC, Capnoxygen mask (K971229)

Submission Summary (Full Text)

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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 - [phone] Fax - [phone]

| 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 | Predicate<br>Capnoxygen LLC<br>Capnoxygen Mask K971229 | Proposed<br>Capnomask |
| Indications for Use | The Capnoxygen mask is a medium<br>concentration single -use mask intended to<br>be used for the delivery of supplemental<br>oxygen and monitoring breathing by<br>sampling exhaled carbon dioxide. Standard<br>connectors for the oxygen tubing and a<br>standard female luer connector for the gas<br>sample line are provided. | The Capnomask is intended to deliver<br>supplemental oxygen to patients and monitor<br>breathing by sampling exhaled carbon<br>dioxide. |
| Environments of use | Hospitals and sub-acute setting | Hospitals and sub-acute setting |
| Prescriptive | Yes | Yes |
| Patient population | Non-intubated patients who are breathing<br>spontaneously | Non-intubated patients who are breathing<br>spontaneously |
| Single patient use,<br>disposable | Yes | Yes |
| Basic components | Face mask<br>Elastic head strap<br>Connector for oxygen tubing and gas<br>sampling line<br>Entrainment ports | Face mask<br>Elastic head strap<br>Connector for oxygen tubing and gas<br>sampling line<br>Entrainment ports |
| Sizes | Large and Small | Large and Small |
| Overall dimensions | Large -<br>Length - 140 mm<br>Width - 89 mm (at widest point)<br>Height - 67 mm<br>Small -<br>Length - 95 mm<br>Width - 76 mm (at widest point)<br>Height - 59 mm | Large -<br>Length - 121 mm<br>Width - 85 mm (at widest point)<br>Height - 72 mm<br>Small -<br>Length - 94 mm<br>Width - 74 mm (at widest point)<br>Height - 59 mm |
| Internal Volume | Large - 155 cc<br>Small - 65 cc | Large - 160 cc<br>Small - 72 cc |
| Entrainment holes | Yes | Yes |
| Typical Flow Rate<br>Range | < 10 lpm however this is set by the clinician | < 10 lpm however this is set by the clinician |
| Method of oxygen<br>delivery and Gas<br>sampling | Split connector with barbed oxygen tubing<br>fitting on top of Luer fitting for attaching a<br>gas sampling line.<br>The gas sampling port extends into the mask | Split connector with barbed oxygen tubing<br>fitting on top of Luer fitting for attaching a<br>gas sampling line.<br>The gas sampling port extends into the mask |
| Method of holding<br>mask on patient | Elastic band | Elastic band |
| Performance<br>Testing | Comparative End-tidal CO₂ results and<br>waveform at various settings of oxygen flow<br>rate, tidal volume and breathes per minute | Comparative End-tidal CO₂ results and<br>waveform at various settings of oxygen flow<br>rate, tidal volume and breathes per minute<br>Environmental and Mechanical testing<br>Real-time aging<br>Internal 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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another figure, composed of three curved lines.

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 [phone] or [phone] 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 [phone] or [phone] 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,