PORTEX PERCUTANEOUS TRACHEOSTOMY KIT

K060945 · Smiths Medical International · BTO · Jun 19, 2006 · Anesthesiology

Device Facts

• Record ID: K060945
• Device Name: PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
• Applicant: Smiths Medical International
• Product Code: BTO · Anesthesiology
• Decision Date: Jun 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To create a percutaneous dilational tracheostomy using guidewire, pre-dilator, forceps and components of this product, which allows for tracheal access for airway management.

Device Story

The Portex Percutaneous Tracheostomy Kit is a procedural set used to establish a percutaneous dilational tracheostomy. The kit includes a guidewire, pre-dilator, and forceps. The device is used by clinicians in a hospital setting to facilitate tracheal access for airway management. The procedure involves using the provided components to dilate the trachea percutaneously, allowing for the insertion of a tracheostomy tube. This provides a secure airway for patients requiring long-term ventilation or airway maintenance. The device is a mechanical toolset; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Mechanical procedural kit consisting of a guidewire, pre-dilator, and forceps. No electronic components, software, or energy sources. Sterilization method not specified.

Indications for Use

Indicated for patients requiring tracheal access for airway management via percutaneous dilational tracheostomy.

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 19 2006

Mr. Stewart Lee Regulatory Affairs Director Smiths Medical International Limited 1, Saint Crispin Way Haslingden, Rossendale Lancashire, BB4 4PW. United Kingdom

Re: K060945

Trade/Device Name: Portex Percutaneous Tracheostomy Kit Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: May 22, 2006 Received: May 25, 2006

Dear Mr. Lee:

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 such 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. Lee

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Saytie y. Michael Dons.

Chiú Lin, Ph.D. 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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## Indications for Use Statement

510(k) Number (if known):

Device Name: Portex Percutaneous Tracheostomy Kit

Indications for Use:

To create a percutaneous dilational tracheostomy using guidewire, pre-dilator, forceps and components of this product, which allows for tracheal access for airway management.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/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)

2. Mail for AAb

Sign-Off)
ion of Anesthesiology, General Hospital,
ution Control, Dental Devices

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