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 Description

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 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.

AI/ML Overview

The provided FDA 510(k) summary for the Flexicare Endotracheal Tube does not contain the kind of detailed information about acceptance criteria and study design that would typically be found in a submission for an AI/ML medical device. This document describes a traditional medical device (an endotracheal tube) and its substantial equivalence to a predicate device based primarily on meeting an international standard and having similar design and materials.

Therefore, for aspects related to AI/ML device evaluation, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, the answer will be that this information is not applicable or not provided in the given document because the device is not an AI/ML product.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Meet ISO 5361: Anaesthetic and respiratory equipment - Tracheal tubes and connectors	The Flexicare Medical devices and predicate meet the requirements of the ISO standard.

Study Details (for a Non-AI/ML Device)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The summary indicates testing against ISO 5361, which is a performance standard for the physical characteristics and safety of tracheal tubes, not a clinical study requiring test sets of patient data. The standard covers aspects like dimensions, strength, cuff integrity, material biocompatibility, and sterilization. Actual "sample sizes" would refer to the number of tubes tested for these physical and material properties, but this specific detail is not given.
- The manufacturer is from the United Kingdom.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable / Not provided. For a traditional physical medical device like an endotracheal tube, "ground truth" as relevant to clinical data or expert interpretation is not established in the same way as for an AI/ML diagnostic device. The "truth" for this device resides in its adherence to engineering specifications and performance standards (like ISO 5361).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This concept is for resolving disagreements among multiple experts in clinical data labeling, which is not relevant here.
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:
- Not applicable. This device is an endotracheal tube, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm for this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the typical sense for AI/ML. The "ground truth" for this device's safety and effectiveness is its compliance with the technical specifications and performance requirements outlined in the ISO 5361 standard. This involves objective measurements of physical properties, material analysis, and sterilization validation, rather than clinical outcomes or expert interpretation of patient data.
The sample size for the training set:
- Not applicable. This device is not an AI/ML product and does not have a training set.
How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML product and does not have a training set or associated ground truth.

Summary

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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: +44 (0) 1443 474647 Fax; +44 (0) 1443 474222 Customer Services: +44 (0) 1443 471580 Purchasing Fax: +44 (0)1443 476332 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:

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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 (800) 638-2041 or (240) 276-3150 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 .

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).