FLEXICARE MEDICAL ENDOTRACHEAL TUBES

K091591 · Flexicare Medical, Ltd. · BTR · Jun 17, 2009 · Anesthesiology

Device Facts

• Record ID: K091591
• Device Name: FLEXICARE MEDICAL ENDOTRACHEAL TUBES
• Applicant: Flexicare Medical, Ltd.
• Product Code: BTR · Anesthesiology
• Decision Date: Jun 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The Endotracheal Tubes are intended for airway management by nasal or oral intubation of the trachea. They are intended for use on Adult and Pediatric patients.

Device Story

Single lumen endotracheal tube; available in cuffed or uncuffed variants. Used for airway management and gas transport; connects to ventilators or resuscitation devices. Cuffed variants include inflation lumen, pilot balloon, and valve for cuff inflation/deflation via syringe. Features include Murphy eye and radio-opaque axial marker for X-ray identification. Sterile, single-use, disposable device. Intended for clinical use by healthcare professionals for tracheal intubation.

Clinical Evidence

Bench testing only. Device evaluated against international standard ISO 5361 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors).

Technological Characteristics

Constructed primarily from polyvinyl chloride. Single lumen tube design; includes Murphy eye and radio-opaque marker. Cuffed variants feature inflation lumen, pilot balloon, and valve. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for airway management via nasal or oral intubation of the trachea in adult and pediatric patients.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Predicate Devices

• Unomedical Sdn BHD (K951696)

Submission Summary (Full Text)

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K091341

# JUN 17 2009

#### 510(k) Summary

Image /page/0/Picture/3 description: The image shows the logo for "Flexicare". The logo is black and white and features a stylized "F" followed by the word "lexicare" in a sans-serif font. Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.

Cynon Valley Business Park, Mountain Ash, Mid Glamorgan. CF45 4ER UK. Tel: [phone] Fax; [phone] Customer Services: [phone] Purchasing Fax: [phone] Email: enquiries(@flexicare.com www.flexicare.com

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Flexicare Breathing Filters Bacterial

Manufacturer:

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

Regulatory Affairs Contact: David Moynham Regulatory Affairs Manager Flexicare Medical Limited, Cynon Valley Business Park Mountain Ash, Mid Glamorgan, CF45 4ER. United Kingdom

Telephone:

Date Summary Prepared:

Common Name;

Classification:

Predicative Devices:

Description:

00 44 1443 471593

30 April 2009

Endotracheal Tube

Class II, Tube, Tracheal (W/WO Connector) 21 CFR 868.5730, BTK

Unomedical Sdn BHD K951696 05/22/1995

Flexicare Medical Endotracheal tubes are available in a number of sizes / variants. The Flexicare Endotracheal tube is a single lumen tube with or without a cuff. The device is used for airway management / gas transport and is connected to a ventilator or resuscitation devices via a connector and breathing tubing. Cuffed variants have an inflatable Cuff, a narrow

Revised pages 10 Jun 09

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inflation lumen and pilot balloon with valve permitting inflation and deflation using a suitable syringe fitted with a tapered luer connector. All variants (less reinforced) have a radio opaque marker consisting of an axial line embedded into the tube which enables identification the device when patient is x-ray viewed. All variants have a Murphy eye. All variants are supplied sterile and are single use/disposable.

The Endotracheal Tubes are intended for airway management by nasal or oral intubation of the trachea. They are intended for use on Adult and Pediatric patients.

The Flexicare Medical Endotracheal Tubes are primarily constructed from polyvinyl chloride. It has the same intended use and design and is manufactured from the similar biocompatible materials as the predicate device.

Flexicare Medical Endotracheal tubes have been evaluated by testing against international standard ISO 5361 Anaesthetic and respiratory equipment - Tracheal tubes and connectors. Both the Flexicare Medical devices and predicate meet the requirements of the ISO standard.

#### Intended Use:

Substantial Equivalence

Summary of Testing:

3

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## Device Description

The Flexicare Endotracheal Tube is a single lumen tube with or without a cuff. It is intended to be inserted orally or nasally (depending on variant) into the trachea. The device is used for airway management / gas transport and is connected to a ventilator or resuscitation devices via a connector and breathing tubing.

Cuffed variants have a Cuff which is intended to be inflated in the trachea in order to seal the device to prevent loss of inspiratory gases from by-passing the tube and the inhalation of vomit. Cuffed variants have an inflatable Cuff, a narrow inflation lumen and pilot balloon with valve permitting inflation and deflation using a suitable syringe fitted with a tapered luer connector.

Image /page/2/Picture/3 description: The image shows a black and white photograph of what appears to be a radar screen. The screen displays a curved line, possibly indicating the path of an object or a boundary. The upper portion of the image is darker, suggesting the background or the area beyond the radar's range.

All variants (less reinforced) have a radio opaque marker consisting of an axial line imbedded into the tube which enables identification the device when patient is x-ray viewed.

All variants have a Murphy eye.

All variants are supplied sterile and are single use/disposable.

The device is intended for single patient use only.

Intended use:

The Endotracheal Tubes are intended for airway management by nasal or oral intubation of the trachea. They are intended for use on Adult and Pediatric patients.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.

Public Health Service

JUN 17 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K091591

Trade/Device Name: Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: May 29, 2009 Received: June 2, 2009

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.

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. Job

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runoes

Susan Runner, D.D.S., M.A. Acting Division 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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Flexicare Medical Ltd

Endotracheal Tube 510(k)

# Indications for Use

510(k) Number (if known): K091591

Page 1 of 1

Device Name: Endotracheal Tube

Indications for Use:

The Endotracheal Tubes are intended for airway management by nasal or oral intubation of the trachea. They are intended for use on Adult and Pediatric patients.

Prescription Use V (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)

L. Schutter

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091591

Revised pages 10 Jun 09 .