The Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula are intended to be placed into a surgical opening of the trachea to provide tracheal access for airway management. The device is intended to be a component of a life-sustaining device to be used with adult patients.

Device Description

The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula includes an extended length outer cannula, extended length disposable inner cannula, tracheostomy tube holder, neck strap, and obturator. The device is used to provide an artificial airway, in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by means of the swivel neck plate/flange that is connected to a tracheostomy tube holder or neck strap. When appropriately connected to a tracheostomy tube holder or neck strap, the device provides a secure artificial airway for spontaneous or mechanical ventilation.

AI/ML Overview

This 510(k) summary describes a Special 510(k) submission for the Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula. A Special 510(k) can be submitted when modifications to a legally marketed device do not require a new clinical study to demonstrate substantial equivalence. Instead, the submission relies on design control activities and verification testing to show that the modified device remains safe and effective for its intended use, similar to the predicate device.

Given that this is a Special 510(k) and the provided text focuses on the substantial equivalence to a predicate device based on design, materials, and technical characteristics, it does not contain the detailed study information typically found for devices requiring performance testing against acceptance criteria in a standalone study or a comparative clinical effectiveness study. The submission essentially states that the new device meets the same performance as the predicate due to similar design and materials, and that verification testing confirmed these aspects.

Therefore, the requested information elements related to specific performance studies, expert involvement, and ground truth establishment, as typically applied to novel devices or those undergoing significant functional changes, are not explicitly provided in this document.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics for the Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula. Instead, it states that:

"Product design and development, (including verification testing, test and quality procedures) were conducted using internal company requirements, referencing external standards."
"Information provided in this Special 510(k) submission provides comparative, predicate device information and describes development procedures that support the determination of substantial equivalence and assertion that the modified device is safe and effective for its intended use."

This implies that the device's performance was evaluated against internal design specifications and relevant standards, and found to be comparable to the predicate device. However, the specific quantitative acceptance criteria and results are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not mention a specific "test set" in the context of clinical data or a formal study with statistical sample sizes. The evaluation relies on "verification testing," which typically involves engineering and bench testing, rather than human subject testing in the sense of a clinical trial. Therefore, information about data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The submission focuses on device modifications and verification testing, not on a diagnostic or interpretive task that would require expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done. This type of study is typically performed for imaging or diagnostic AI devices to assess the impact of AI assistance on human reader performance. This device is a medical accessory, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No standalone performance study of an algorithm was done. This device does not inherently contain an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this type of device is established through engineering principles, material science, and conformance to recognized standards for medical devices of this class. It would involve demonstrating physical properties, biocompatibility, and functional integrity through various tests (e.g., tensile strength, flexibility, dimensions, leakage) to ensure it performs as intended and is safe. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.

8. Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or a "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable due to the absence of a training set for an AI algorithm.

Summary

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tyco Healthcare

Nellcor

JUN 16 2005

K 0514/16

4280 Hacienda Drive Pleasanton, CA 94588

Tele: 925 463-4000 Fax: 925 463-4020

510(k) Summary

Submitted by:	Nellcor Puritan Bennett, Inc.4280 Hacienda DrivePleasanton, CA 94588
Company Contact:	James Patrick Garvey II, RRT, RACRegulatory Affairs Manager(925) 463-4479 - Phone(925) 463-4020 - FAX
Date Summary Prepared:	April 11, 2005
Product Name:	Shiley TracheoSoft XLT Extended LengthTracheostomy Tube and Disposable Inner Cannula
Common Name:	Tracheostomy Tube
Classification:	Class II; Tracheostomy tube and cuff 21 CFR§868.5800
Legally Marketed(Unmodified) Device:	• Mallinckrodt, Inc, K003315,Shiley TracheoSoft XLT Extended LengthTracheostomy Tube and Disposable Inner Cannula

DEVICE DESCRIPTION

INTENDED USE

Purpose of The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and . Disposable Inner Cannula is to provide tracheal access for airway management.
. The device is intended for use on adult patients.

INTENDED ENVIRONMENT OF USE:

. The device is intended for use in hospitals and hospital-type facilities, surgery centers, and home care environments.

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. The device is contraindicated in procedures which will involve the use of LASER or an electrosurgical active electrode in the immediate area of the device. Contact of the beam or electrode with tracheostomy tube and inner cannula, especially in the present of oxygenenriched or nitrous oxide containing mixtures could result in the rapid combustion of the tube with harmful thermal effects and with emission of corrosive and toxic combustion products including hydrochloric acid (HCl).
. The device is intended for sale by or on the order of a physician only.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The intended use of the modified Shiley TracheoSoft Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula is the same as that for previously marketed Shiley TracheoSoft Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula. The materials and design of this device are similar to those of the predicate device. The technical characteristics of the device modification do not introduce new questions regarding safety or effectiveness of critical care ventilators. Furthermore, the labeling associated with The Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula provides similar information as the predicate devices.

Information provided in this Special 510(k) submission provides comparative, predicate device information and describes development procedures that support the determination of substantial equivalence and assertion that the modified device is safe and effective for its intended use. Product design and development, (including verification testing, test and quality procedures) were conducted using internal company requirements, referencing external standards.

In summary, Nellcor Puritan Bennett has provided information that indicates the Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula to be safe and effective. This device is considered to be substantially equivalent to currently marketed devices, incorporating designs that have been previously cleared by FDA.

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo features the department's seal, which includes an emblem of an eagle with three stylized lines representing its wings. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

JUN 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mallinckrodt Medical C/O Mr. Patrick Garvey Nellcor Puritan Bennett Incorporated 4280 Hacienda Drive Pleasanton, California 94588

Re: K051416

Trade/Device Name: Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: May 31, 2005 Received: June 1, 2005

Dear Mr. Garvey:

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 vour 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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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) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Senyite G. Michael Ond.

Chiu 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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510(k) Number (if known):
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Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and Device Name: Disposable Inner Cannula

Indications For Use:

The Mallinckrodt Inc. Shiley TracheoSoft XLT Extended Length Tracheostomy Tube and The Mallinektodt inc. Shiley Tractico son Aced into a surgical opening of the traches to Disposable Inner Cannula are michued to be placed into a search of eachers of a between the trachean wall and the tracheostomy tube. This device is intended to be a component of a life-sustaining device to be used with adult patients.

(per 21 CFR 801.109) Yes Prescription Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Senette Michie Dm.D.

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

510(k) Number: K051416

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

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