The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

Device Description

The subject devices are single patient-use dual cannula tracheostomy tubes that are intended to provide an artificial airway for airway management. The subject device represents a line extension introducing the option of a reusable inner cannula.

AI/ML Overview

This document is a 510(k) Summary for the Shiley™ Adult Flexible Tracheostomy Tube, Reusable Inner Cannula. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested elements for describing an acceptance criteria study are not directly applicable to this document.

However, I can extract information related to non-clinical testing used to support substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present explicit acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity, accuracy) typical of diagnostic or AI-driven devices. Instead, it describes non-clinical performance tests designed to confirm the new device's performance aligns with predicate devices and relevant standards.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Mechanical Performance	Insertion/Removal force	Expected to perform as well as the predicate device.
	Lock & pinch force	Expected to perform as well as the predicate device.
	ISO 5366-1:2009 (Tracheal tubes)	Compliance demonstrated.
	ISO 5361:2012 (Tracheal tubes - connectors and adapters)	Compliance demonstrated.
Biocompatibility	ISO 10993-1:2009	Met all biocompatibility requirements for intended use.
	Cytotoxicity	Performed. Outcomes supported compliance.
	Sensitization	Performed. Outcomes supported compliance.
	Acute systemic toxicity	Performed. Outcomes supported compliance.
	Genotoxicity	Performed. Outcomes supported compliance.
	Subchronic toxicity implantation	Performed. Outcomes supported compliance.
	Chemical characterization	Performed. Outcomes supported compliance.
	Risk assessment	Performed. Outcomes supported compliance.
Sterilization & Cleanliness	Cleaning methods for reusable inner cannula	Validated in accordance with AAMI TIR 30.
	Ethylene oxide residual tests (EtO-sterilized device)	Compliance to ISO 10993-7:2008 for intended use.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated as this was not a clinical study on human subjects in the traditional sense. The "test set" would refer to the physical devices subjected to the non-clinical performance and material tests. The number of devices tested for each non-clinical assessment (e.g., insertion force, biocompatibility) is not provided.
Data Provenance: The device is manufactured by Covidien, a US-based company (Boulder, CO). The non-clinical tests would have been performed in a laboratory setting, likely within the US or by a contracted lab. The document does not specify the country of origin for the test data, but it refers to international standards (ISO, AAMI). These were laboratory/bench tests, not retrospective or prospective studies involving patient data.

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

Not Applicable. This document describes non-clinical testing against engineering standards and material properties, not an evaluation of a diagnostic device requiring expert consensus for ground truth on patient data.

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

Not Applicable. As per point 3, there was no ground truth establishment by experts for a test set of patient cases. The evaluation was based on compliance with predefined standards and test protocols.

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:

No. This device is a tracheostomy tube, a physical medical device for airway management, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or AI-related effectiveness assessment is not applicable.

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

No. This device is a physical medical device, not an algorithm or AI.

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

Not Applicable in the traditional sense. The "ground truth" for the non-clinical tests was compliance with established engineering and biocompatibility standards (e.g., ISO 5366-1:2009, ISO 5361:2012, AAMI TIR 30, ISO 10993-1:2009, ISO 10993-7:2008). The ground truth is adherence to these predefined, objective criteria.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device, so there is no training set.

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

Not Applicable. No training set exists for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 14, 2015

Covidien Danielle Mueller Regulatory Affairs Manager 6135 Gunbarrel Ave Boulder, CO 80301

Re: K150844

Trade/Device Name: Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: June 10, 2015 Received: June 11, 2015

Dear Ms. Mueller:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K150844

Device Name

Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula

Indications for Use (Describe)

The Shiley™ Adult Flexible Tracheostomy Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless. Reusable Intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with Percutaneous Dilatational Tracheotomy (PDT) procedures.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a 510(k) Summary for the use of the Shiley™ Adult Flexible Tracheostomy Tube, Reusable Inner Cannula.

Submitted By:	Covidien6135 Gunbarrel AvenueBoulder, CO 80301
Date:	July 10, 2015
Contact Person:	Danielle MuellerRegulatory Affairs Manager(303) 305-2603
Proprietary Name:	Shiley™ Adult Flexible Tracheostomy Tube withTaperGuard™ Cuff, Reusable Inner CannulaShiley™ Adult Flexible Tracheostomy Tube Cuffless,Reusable Inner Cannula
Common Name:	Tracheostomy Tube & Tube Cuff
Device Classification Regulation:	21 CFR 868.5800 – Class II
Device Product Code & Panel:	JOH
Predicate Devices:	Shiley™ Adult Flexible Tracheostomy Tube, DisposableInner Cannula (K142296)Shiley™ Tracheostomy Tubes (K962173)

Device Description

Indications for Use/Intended Use

The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is intended to provide tracheal access for airway management.

The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for use with percutaneous Dilatational Tracheotomy (PDT) procedures.

The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with percutaneous Dilatational Tracheotomy (PDT) procedures.

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Technological Characteristics Comparison

The subject device is identical to the predicate Shiley™ Adult Flexible Tracheostomy Tube, Disposable Inner Cannula (K142296) with the exception of the inner cannula material and reuse status.

	SUBJECT	PREDICATE
	Shiley™ Adult Flexible Tube,Reusable Inner Cannula	Shiley™ Adult Flexible Tube,Disposable Inner Cannula[K142296]	Shiley™ Tracheostomy Tubes[K962173]
Intended Use	Intended for use in providingtracheal access for airwaymanagement. Also intended foruse with PercutaneousDilatational Tracheotomy (PDT)procedures.	Identical	Intended for use in providingtracheal access for airwaymanagement in adults.
PatientPopulation	Adults	Identical	Identical
Environment ofUse	Hospitals, long-term carefacilities, home care	Identical	Identical
Use	Single patient	Identical	Identical
Inner CannulaUse	Reusable within single patient	Disposable	Reusable & disposable optionsavailable
Cuff	Cuffless or taper-shaped cuff	Identical	Cuffless or barrel-shaped cuff
Size Range	ID: 6.5mm-10.0mmOD: 9.4mm-13.8mmLength: 62mm-79mm	Identical	ID: 5.0 - 8.9mmOD: 9.4 - 13.8mmLength: 65 - 81mm
Sterilization	Ethylene Oxide	Identical	Identical
Shelf Life	2 years	Identical	5 years
MATERIALS
Outer cannula	Medical grade PVC with citrate-based plasticizer	Identical	Medical grade PVC
Inner cannula	High density polyethylene	Low density polyethylene	Reusable: polycarbonate &polypropyleneDisposable: polypropylene & PVC
Flange	Medical grade PVC with citrate-based plasticizer	Identical	Medical grade PVC
15mmConnector	Polymethylpentene	Identical	Medical grade PVC
Cuff	Medical grade PVC with DEHT-based plasticizer	Identical	Medical grade PVC
Inflation System	Medical grade PVC with citrate-based plasticizer	Identical	Medical grade PVC
Obturator	Medical grade polypropylene	Identical	Identical
Tie Strap	Cotton	Identical	Identical

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Substantial Equivalence - Non-Clinical Evidence

Product performance testing, including insertion/removal force, lock & pinch force, and tests per ISO 5366-1:2009 and ISO 5361:2012 were performed with the conclusion that the subject devices can be expected to perform as well as the predicate and can be considered substantially equivalent. The cleaning methods for the reusable inner cannula were validated in accordance with AAMI TIR 30. The results from ethylene oxide residual tests on the EtO-sterilized device demonstrated compliance to ISO 10993-7:2008 for the device's intended use. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, subchronic toxicity implantation, chemical characterization, and risk assessment. The device met all biocompatibility requirements for its intended use.

Substantial Equivalence - Clinical Evidence

N/A - Clinical evidence was not necessary to show substantial equivalence.

Substantial Equivalence - Conclusions

No new questions of safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject devices can be considered substantially equivalent.

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.