O2 NASAL CANNULA WITH CO2 MONITORING

K140113 · Flexicare Medical, Ltd. · CCK · Mar 6, 2014 · Anesthesiology

Device Facts

• Record ID: K140113
• Device Name: O2 NASAL CANNULA WITH CO2 MONITORING
• Applicant: Flexicare Medical, Ltd.
• Product Code: CCK · Anesthesiology
• Decision Date: Mar 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

O2 Nasal cannula with CO2 monitoring is intended for use in patients who require supplemental oxygen delivery and CO2 monitoring.

Device Story

Device is a nasal cannula for simultaneous supplemental oxygen delivery and CO2 gas sampling. Input: oxygen source and patient exhaled breath. Output: delivered oxygen to patient; sampled CO2 gas to external capnograph. Used in hospital/emergency settings by clinicians. Device consists of co-extruded O2/CO2 tubing, cannula prongs, luer connectors, tube slide, Y-piece, and optional hydrophilic filter. Connects to external capnograph for CO2 monitoring. Benefits patient by enabling continuous respiratory monitoring during oxygen therapy. No software or electronic components; purely mechanical device.

Clinical Evidence

Bench testing only. Performance verified against BS EN 13544-2:2002+A1:2009 and ISO 594-1/ISO 594-2 standards. Tests included visual inspection, nipple strength, tubing flow resistance, tensile strength, kinking resistance, dimensional inspection, gauging, and leakage/separation force testing. All samples passed.

Technological Characteristics

Materials: PVC, Polypropylene, ABS. Assembly: Solvent adhesive bonding. Components: Co-extruded O2/CO2 tubing (ID 3.9mm/1.4mm), luer connectors, cannula prongs, tube slide, Y-piece, Venturi barrel, optional hydrophilic filter. Connectivity: Mechanical connection to external capnograph. Sterilization: Sterile (poly bags). No software/electronics.

Indications for Use

Indicated for adult patients requiring supplemental oxygen delivery 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

• Unomedical - Mac-Safe (was Hospita sampling/oxygen delivery cannula) (K915228)

Submission Summary (Full Text)

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# 510(k) Summary

Trade name

C.F.R Section Product Code:

## Manufacturer:

O2 Nasal cannula with CO2 monitorin

21 CFR 868.1400. Carbon Dioxide ga CCK

Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glam. CF45 4ER. United Kingdom

Christopher Watkins Quality Regulatory & Technical Direct Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glam. CF45 4ER. United Kingdom

00 44 1443 471 593

March 2014

Nasal cannula with CO2 monitoring

Class 2

Unomedical - Mac-Safe (was Hospita sampling/oxygen delivery cannula") w marketing by 510(k) No K915228.

02 Nasal cannula with CO2 monitorin that is intended to situate under the p prongs of the cannula inserted into pa oxygen is administered and CO2 mor The O2 Nasal cannula with CO2 mon administaring pronos tuto slide co-e

Telephone:

Date Summary Prepared:

Regulatory Affairs Contact:

Common Name:

Classification:

Predicate Device

Description:

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The O2 Nasal cannula with CO2 mon extruded tubes

# Part Numbers:

| | Nasal cannula with CO2 monitoring |
|--------------|----------------------------------------------------------|
| 020-10-123U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - MALE PIGT |
| 020-10-124U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - FEMALE PI |
| 020-10-125U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - MALE LUE |
| 020-10-125AU | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - MALE LUE |
| 020-10-126U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - FEMALE L |
| 020-10-126AU | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - FEMALE L |
| 020-10-127U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - MALE LUE |
| 020-10-128U | O2 NASAL CANNULA WITH CO2 MONITORING - ADULT - FEMALE L |

Intended Use:

02 Nasal cannula with CO2 monitoring is patients who require supplemental oxyge monitoring

Substantial Equivalence

02 Nasal cannula with CO2 monitorir use as predicate device:

- Unomedical Mac-Safe (was Hospita . sampling/oxygen delivery cannula") w marketing by 510(k) No K915228.
Both O2 delivering/CO2 monitoring de use devices.

Neither device is life supporting or life

Neither device uses software/ and are

Both O2 delivering/CO2 monitoring de sterile in individual poly bags.

Both O2 delivering/CO2 monitoring de came intended use in the same intent

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| | FlexicareO2 Nasal cannula with CO2<br>monitoring<br>K: Unknown | Unomedical - M<br>CO2 gas sampling<br>was c |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Conforms to: | Yes | |
| BS EN 13544-2:<br>2002 +A1:2009<br>Annex A4<br>And<br>BS EN 13544-2:<br>2002 +A1:2009<br>Annex A5 | | |
| Components | Co extruded O2/CO2 tubing<br>luer connector (male/female)<br>Cannula delivery/cannula prongs<br>O2 Connector<br>Tube slide<br>Y-piece<br>Venturi barrel<br>Hydrophilic filter (option) | Co ex<br>luer c<br>Cannula |
| Materials | PVC<br>Polypropylene<br>ABS | |
| Assembly<br>method | Bonded - Solvent adhesive | Bon |
| Target<br>population | Adult | |
| Home use | No | |
| Hospital/<br>emergency use | Yes | |
| Connectable to<br>Capnograph? | Yes | |

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Image /page/3/Picture/0 description: The image shows a logo with a stylized letter "f" that appears to be part of a word. The letters are thick and bold, with a unique design. Below the letter, there is the word "TOT" in smaller, sans-serif font.

| Colour/ size/<br>material | Devices displayed a high level of substantial equivalence. All<br>within 0.1mm of each other. ID's are classed as critical dir<br>resistance/rate through tub<br>All materials are the same, with any differences being min<br>e.g. colour/finish. | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| ID/ OD/ length | ID: 3.9mm | | |
| 02 tubing | OD: 5.0mm | | |
| | Length: 2100mm | | |
| CO2 tubing | ID: 1.4 | | |
| | OD: 2.7 | | |
| | Length: 2100mm | | |

Tests Performed:

| Test | Standard? / In-House? |
|----------------------------------------------------------------|-----------------------------------------|
| Visual inspection | In-House |
| Nipple dimensions (on venturi barrel<br>supplied with cannula) | |
| Strength of nipple(on venturi barrel<br>supplied with cannula) | BS EN13544-2: 2002 +A1:2009<br>Annex A5 |
| Tubing flow resistance | |
| O2 Connector to tubing tensile strength | |
| O2 Connector to nipple tensile strength | |
| Tube resistance to kinking | |
| Dimensional inspection of luer conical | ISO 594-1 / BS EN 20594-1:1994 |
| Dimensional inspection of luer conical | |
| Gauging tests on luer | |
| Liquid leakage from luer | |
| Air leakage from luer | |
| Luer separation force | ISO 594-2 (BS EN 1707:1997) |
| Luer unscrewing torque | |

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Image /page/4/Picture/0 description: The image shows a stylized logo, possibly for a company or brand. The logo features a bold, stylized letter 'f' with a double-line design, giving it a unique and modern appearance. Below the 'f', there is a smaller word, 'TOTAL', in capital letters, suggesting that the logo might be associated with a company named 'Total' or a product line with that name.

All Samples passed the performance testing when tested against methods House test methods and relevant BS EN standards.

The results of this testing show that the O2 Nasal cannula with CO2 monite performance tests and performs at least as well as marketed predicate dev Unomedical.

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Image /page/5/Picture/0 description: The image shows a partial view of a logo or emblem. On the left side, there is a circular seal with text around the perimeter, including the words "HUMAN SERVICES" and "USA". Inside the seal, there is a stylized design that resembles an abstract representation of a human figure or a symbol related to health and human services. On the right side of the image, the word "DEPAR" is visible, suggesting that it is part of a larger word, likely "DEPARTMENT".

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 6, 2014

Flexicare Medical Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25TH Street NW Buffalo, MN 55313

Re: K140113

Trade/Device Name: 02 Nasal Cannula with CO2 Monitoring Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: February 18, 2014 Received: February 21, 2014

#### Dear Mr. Job:

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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Please be advised that FDA's issuance of a substantial equivalence detern that FDA has made a determination that your device complies with other or any Federal statutes and regulations administered by other Federal agen comply with all the Act's requirements, including, but not limited to: regi CFR Part 807); labeling (21 CFR Part 801); medical device reporting (rep device-related adverse events) (21 CFR 803); good manufacturing practic forth in the quality systems (QS) regulation (21 CFR Part 820); and if app product radiation control provisions (Sections 531-542 of the Act); 21 CF

If you desire specific advice for your device on our labeling regulation (2 contact the Division of Small Manufacturers, International and Consumer free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.ht the regulation entitled, "Misbranding by reference to premarket notification 807.97). For questions regarding the reporting of adverse events under th CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under Division of Small Manufacturers, International and Consumer Assistance [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.h

Sincerely yours,

Image /page/6/Picture/5 description: The image shows a logo with the text "Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID". The logo is black and white and has a stylized design. The text is arranged in a way that it is easy to read. The logo is likely for a medical or clinical organization.

Erin I. Keith, M.S. Acting Director

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on lest page.

510(k) Number (if known) K 1401 13

Device Name

..

O2 Nasal Cannula with CO2 monitoring

#### Indications for Use (Describe)

O2 Nasal Cannula with CO2 monitoring is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring

Type of Use (Select one or both, as epplicable)

. . ..

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/7/Picture/14 description: The image shows a combination of text and symbols. The text includes 'Todd D', '2014.03.06', and '-05'00'. There are also some illegible symbols and characters present in the image. The text and symbols are arranged in a somewhat disorganized manner.

FORM FDA 3881 (1/14)

Page Lot 1

es (104) 445-6