PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5

K083119 · Smiths Medical Asd, Inc. · BTR · Jun 26, 2009 · Anesthesiology

Device Facts

• Record ID: K083119
• Device Name: PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
• Applicant: Smiths Medical Asd, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Jun 26, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric excluding neonatal and infant use.

Device Story

Sterile, single-use tracheal tube for oral/nasal airway management; used by clinicians in clinical settings. Device features thermosensitive PVC material, initially rigid for insertion, softening at body temperature to conform to patient anatomy; includes radio-opaque Blue Line for X-ray visualization; 15mm connector (ISO 5356); depth markings for tip positioning; smooth Murphy eye. Cuffed versions include high-volume, low-pressure cuff with pilot balloon and one-way luer valve. Device provides patent airway for ventilation; assists in preventing trauma via material properties; enables verification of placement via imaging. Maximum duration of use is 29 days.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and compliance with ISO 5361:1999 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors).

Technological Characteristics

Materials: Clear polyvinyl chloride (PVC). Features: Thermosensitive material, radio-opaque Blue Line, 15mm connector (ISO 5356), Murphy eye, depth markings. Cuffed models: high-volume tapered low-pressure cuff, pilot balloon, one-way luer valve. Sterilization: Sterile. Standards: ISO 5361:1999.

Indications for Use

Indicated for oral and/or nasal intubation for airway management in adult and pediatric patients, excluding neonates and infants.

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

• Well Lead Aircare™ Endotracheal tube (K042683)

Submission Summary (Full Text)

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K083119

# SECTION 5: SUMMARY

JUN 26 2009

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| Trade Name: | Portex® Tracheal Tube |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Tracheal Tube |
| Classification Name: | Tube, Tracheal (21 CFR 888.5730, Product Code BTR) |
| Contact Person: | Brian Farias, RAC<br>Regulatory Affairs Manager<br>Smiths Medical North America<br>10 Bowman Drive<br>Keene, NH 03431<br>Tel: [phone], ext 2493<br>Fax: [phone]<br>www.smiths-medical.com<br>E-Mail: [e-mail] |
| Date: | 07, October 2008 |
| Equivalent to: | Well Lead Aircare™ Endotracheal tube (K.042683) |
| Device Description: | A range of sterile, single use tracheal tubes for oral and/or nasal intubation<br>intended for airway management. Manufactured from clear polyvinyl<br>chloride (PVC) incorporating the following features:<br>• Thermosensitive materials with sufficient initial rigidity for intubation<br>which then conforms to the individuals respiratory tract at body<br>temperature ensuring minimum trauma.<br>• Radio-opaque Blue Line ^® to confirm correct tube placement by X-ray<br>• All Portex® tracheal tubes are packed with a 15mm connector<br>conforming to ISO5356<br>• Sterile unless the unit pack is opened or damaged<br>• Cuffed tracheal tubes are designed with a high volume tapered low<br>pressure cuff and all have an attached pilot balloon with a one way luer<br>valve<br>• Smooth Murphy eye<br>• As a reference during intubation, the tracheal tubes have depth marks in<br>centimetres which indicates the distance to distal tip. |
| Intended Use: | Portex® tracheal tubes are intended for oral and/or nasal intubation for<br>airway management. Expert clinical judgement should be exercised<br>in the selection of the appropriate tracheal tube size and style for an<br>individual patient. For adult, Paediatric excluding neonatal and infant<br>use. |

.

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## SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Portex® Tracheal Tube

Indications for Use:

Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric, excluding neonatal and infant use.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/ OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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### SECTION 11: EXECUTIVE SUMMARY

#### Description of the Device A.

A range of sterile, single use tracheal tubes for oral and/or nasal intubation intended for airway management. Manufactured from clear polyvinyl chloride (PVC) incorporating the following features:

- · Thermosensitive materials with sufficient initial rigidity for intubation which then conforms to the individuals respiratory tract at body temperature ensuring minimum trauma.
- · Radio-opaque Blue Line® to confirm correct tube placement by X-ray
- · All Portex® tracheal tubes are packed with a 15mm connector conforming to ISO5356
- · Sterile unless the unit pack is opened or damaged
- Cuffed tracheal tubes are designed with a high volume tapered low pressure cuff and all . have an attached pilot balloon with a one way luer valve
- · Smooth Murphy eve
- · As a reference during intubation, the tracheal tubes have depth marks in centimetres which indicates the distance to distal tip.

#### B. Indications for Use

Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric excluding neonatal and infant use.

#### C. Compliance with relevant standards

The products conform to the relevant requirements of the ISO 5361:1999 Anaesthetic and respiratory equipment - Tracheal tubes and connectors. Evidence of this compliance is supplied in Exhibit F

#### D. Comparison with Predicate Devices

A comparison of Portex® Tracheal Tube with the predicate device is presented in Table 2. This comparison supports a claim of substantial equivalence by virtue of the similarity between the Portex® Tracheal Tube and the identified predicate in terms of indications for use, design characteristics, presentation, method of sterilization, materials of composition, packaging and performance characteristics.

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### SECTION 13: SUBSTANTIAL EQUIVALENCE

#### A. Predicate Devices

The Portex® Tracheal Tube is substantially equivalent to the existing marketed Class II device identified in Table 3. The predicate device has been cleared by FDA for commercial distribution in USA via pre-amendment route.

| C<br>able 3 | | 3 - Predicate device for Portex® Tracheal Tube<br>CALIFORNIA A LA MILLIAM ME R E E LE LI R E B E E E E E E E E E E E E E E E LE E LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LEA E |
|-------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |

| Device Trade Name | Product Codes | 510(k) Submitter | 510(k) Number(s) |
|-----------------------------------------|-----------------|-------------------|------------------|
| Well Lead Aircare™<br>Endotracheal tube | 100/100/050-095 | Well Lead Medical | K042683 |

#### B. Substantial Equivalence Rationale

#### 1. Indications for Use

The indications for use of the Portex® Tracheal Tube are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric excluding neonatal and infant use.

Tracheal tube maximum period of use 29 days.

The above indications for use are substantially equivalent to that of the predicate device, Well Lead AircareTM Endotracheal tube (K042683),

#### 2. Substantial Equivalence

#### i) Device Design and Material Composition

The device design and material composition equivalence data between the Portex Tracheal Tube and the predicate device is provided in table 4.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and a circular seal around the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the seal.

Public Health Service

JUN 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smiths Medical ASD, Incorporated C/O Mr. Ian Stace Principal Project Engineer Smiths Medical International Limited Boundary Road Hythe, Kent UNITED KINGDOM CT216JN

Re: K083119

Trade/Device Name: Portex® Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: June 11, 2009 Received: June 16, 2009

Dear Mr. Stace:

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. Stace

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 (OS) 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 Punones

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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## SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number: K083119

Device Name:

Portex® Tracheal Tube

Indications for Use:

Portex® tracheal tubes are intended for oral and/or nasal intubation for airway management. Expert clinical judgement should be exercised in the selection of the appropriate tracheal tube size and style for an individual patient. For adult, Paediatric, excluding neonatal and infant use.

Prescription Use_ X (Per 21 CFR 801 Subpart D)

···

AND/ OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Schutten

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

510(k) Number: K083119

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