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 Description

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 eye
• As a reference during intubation, the tracheal tubes have depth marks in centimetres which indicates the distance to distal tip.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Portex® Tracheal Tube. This document establishes substantial equivalence to a predicate device rather than presenting a study proving performance against defined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. The submission is for substantial equivalence, meaning the device's performance is demonstrated by its similarity to an already legally marketed device, not by meeting specific, quantitative acceptance criteria through a dedicated performance study.

2. Sample sized used for the test set and the data provenance

This information is not applicable as no specific "test set" and associated study data were provided in the context of acceptance criteria and proven device performance. The submission relies on a comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as no specific "test set" and ground truth establishment by experts were performed for this substantial equivalence submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no specific "test set" with expert adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission is for a medical device (tracheal tube), not an AI-powered diagnostic or assistive tool where MRMC studies would typically be conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This submission is for a physical medical device (tracheal tube), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable. The submission establishes equivalence based on design characteristics, materials, intended use, and conformance to standards, rather than proving performance against a specific ground truth.

8. The sample size for the training set

This information is not applicable as there is no mention of a training set or machine learning algorithm in the context of this traditional medical device submission.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary of Relevant Information from the Document:

The submission focuses on demonstrating substantial equivalence of the Portex® Tracheal Tube to a predicate device, the Well Lead Aircare™ Endotracheal tube (K042683). The basis for equivalence is primarily by comparison of:

Indications for Use: Both devices are intended for oral and/or nasal intubation for airway management, for adult and pediatric excluding neonatal and infant use.
Device Design and Material Composition: The document states that equivalence data between the Portex Tracheal Tube and the predicate device is provided in Table 4 (which is not included in the provided snippets, but implied to detail similarities).
Performance Characteristics: The general description mentions features like thermosensitive materials, radio-opaque blue line for X-ray confirmation, 15mm connector conforming to ISO5356, sterile packaging, high volume tapered low-pressure cuff, smooth Murphy eye, and depth marks in centimeters. These features are standard for tracheal tubes and are presumably consistent with the predicate device.
Compliance with Standards: The Portex® Tracheal Tube conforms to ISO 5361:1999 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors). This standard conformance acts as a performance benchmark.

In essence, the "proof" that the device meets "acceptance criteria" is that it is sufficiently similar to a device already deemed safe and effective by the FDA. There are no explicit quantitative acceptance criteria or a dedicated performance study described in the provided text.

Summary

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K083119

SECTION 5: SUMMARY

JUN 26 2009

Trade Name:	Portex® Tracheal Tube
Common Name:	Tracheal Tube
Classification Name:	Tube, Tracheal (21 CFR 888.5730, Product Code BTR)
Contact Person:	Brian Farias, RACRegulatory Affairs ManagerSmiths Medical North America10 Bowman DriveKeene, NH 03431Tel: +1 603-352-3812, ext 2493Fax: +1 603-355-8157www.smiths-medical.comE-Mail: brian.farias@smiths-medical.com
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 intubationintended for airway management. Manufactured from clear polyvinylchloride (PVC) incorporating the following features:• Thermosensitive materials with sufficient initial rigidity for intubationwhich then conforms to the individuals respiratory tract at bodytemperature ensuring minimum trauma.• Radio-opaque Blue Line ® to confirm correct tube placement by X-ray• All Portex® tracheal tubes are packed with a 15mm connectorconforming to ISO5356• Sterile unless the unit pack is opened or damaged• Cuffed tracheal tubes are designed with a high volume tapered lowpressure cuff and all have an attached pilot balloon with a one way luervalve• Smooth Murphy eye• As a reference during intubation, the tracheal tubes have depth marks incentimetres which indicates the distance to distal tip.
Intended Use:	Portex® tracheal tubes are intended for oral and/or nasal intubation forairway management. Expert clinical judgement should be exercisedin the selection of the appropriate tracheal tube size and style for anindividual patient. For adult, Paediatric excluding neonatal and infantuse.

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SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Portex® Tracheal Tube

Indications for 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

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.

Cable 3		3 - Predicate device for Portex® Tracheal TubeCALIFORNIA 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™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 (800) 638-2041 or (240) 276-3150 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:

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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Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
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.(b)
Classification. Class II (performance standards).