The Shiley™ Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff are intended for use in providing tracheal access for airway management.

Device Description

The subject devices are single use; single cannula tracheostomy tubes that are intended to provide an artificial airway for airway management. The new features on the subject devices include a new plasticizer, the addition of the TaperGuard cuff, and additional sizes.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device, which seeks to demonstrate that the new device is substantially equivalent to existing legally marketed predicate devices. It does not describe a study to prove the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this submission.

However, I can extract information related to product performance testing that serves a similar function to acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Test	Reported Device Performance (Conclusion)
Cuff Air Seal	Subject devices perform at least as well as the predicate and are substantially equivalent.
Cuff Fluid Seal	Subject devices perform at least as well as the predicate and are substantially equivalent.
Removal Force	Subject devices perform at least as well as the predicate and are substantially equivalent.
Cuff Pressure Mapping	Subject devices perform at least as well as the predicate and are substantially equivalent.
Biocompatibility	Met all biocompatibility requirements for its intended use (per ISO 10993-1:2009 for cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity implantation, chemical characterization, and risk assessment).

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

Test Set Sample Size: Not explicitly stated. The document mentions "product performance testing" was performed, implying a test set of devices, but the number of units or individual tests is not provided.
Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Covidien, likely in their own facilities. It is not "data" in the sense of patient data, but rather device performance data.

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

This is not applicable as the tests are for physical device performance (e.g., seal integrity, biocompatibility), not for an AI algorithm's diagnostic or predictive capabilities. The "ground truth" would be the measured physical properties of the device.

4. Adjudication method for the test set:

Not applicable. This concept is typically used in clinical or image-based studies to resolve discrepancies in expert interpretations. For physical device testing, the results are objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

No, a MRMC comparative effectiveness study was not done. This device is not an AI/algorithm and does not involve human readers for interpretation.

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

Not applicable. This device is a physical tracheostomy tube, not an algorithm.

7. The type of ground truth used:

For the performance tests (cuff air seal, fluid seal, removal force, cuff pressure mapping), the "ground truth" is based on objective physical measurements and engineering standards.
For biocompatibility, the "ground truth" is adherence to ISO 10993-1:2009 standards based on specific laboratory tests.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device; there is no "training set."

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

Not applicable. As above, there is no training set for this type of device.

Study Proving Acceptance Criteria:

The document states: "Product performance testing, including cuff air seal, cuff fluid seal, removal force, and cuff pressure mapping, were performed with the conclusion that the subject devices can be expected to perform at least as well as the predicate and can be considered substantially equivalent. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity implantation, chemical characterization, and risk assessment. The device met all biocompatibility requirements for its intended use."

This paragraph serves as the summary of the studies conducted. While the specific methodology, number of repetitions, or detailed results are not provided in this summary, it confirms that tests were performed to demonstrate that the new device's performance characteristics are comparable to the predicate devices and meet established safety standards (biocompatibility). The 510(k) process relies on demonstrating "substantial equivalence" rather than proving superiority or meeting a strict, predefined performance threshold for a novel AI device.

Summary

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

February 13, 2015

Covidien Ms. Kelsey Lee Regulatory Affairs Product Manager 6135 Gunbarrel Avenue Boulder, CO 80301

Re: K142298

Trade/Device Name: Shiley™ Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube & Tube Cuff Regulatory Class: II Product Code: JOH Dated: January 9, 2015 Received: January 14, 2015

Dear Ms. Lee:

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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Page 2 - Ms. Lee

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 Small Manufacturers, International and Consumer Assistance 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

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Indications for Use

K142298 510(k) Number (if known):

Device Name: Shiley™ Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff

Indications for Use:

The Shiley™ Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff are intended for use in providing tracheal access for airway management.

Prescription Use __ (Part 21 CFR 801 Subpart D) (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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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™ Neonatal, Pediatric Long Tracheostomy Tubes with TaperGuard Cuff.

Submitted By:	Covidien6135 Gunbarrel AvenueBoulder, CO 80301
Date:	February 12, 2015
Contact Person:	Danielle MuellerRegulatory Affairs Manager(303) 305-2603
Proprietary Name:	Shiley™ Neonatal, Pediatric & Pediatric LongTracheostomy Tubes with TaperGuard Cuff
Common Name:	Tracheostomy Tube & Tube Cuff
Device Classification Regulation:	21 CFR 868.5800 – Class II
Device Product Code & Panel:	JOH
Predicate Devices:	Shiley™ Cuffed Pediatric & Pediatric Long (K955680)Shiley™ Neonatal, Pediatric & Pediatric LongTracheostomy Tubes Cuffless (K122531)Smiths Medical Bivona Aire-Cuf Tracheostomy Tubes(K982641)

Device Description

Indications for Use/Intended Use

The subject and predicate Shiley™ devices have identical indications and similar indications to the BIVONA Aire-Cuf device. The indications for use are as follows:

The Shiley™ Neonatal, Pediatric Long Tracheostomy Tubes with TaperGuard Cuff are intended for use in providing tracheal access for airway management.

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Technological Characteristics Comparison

The subject device only differs from the predicate Shiley™ Neonatal, Pediatric Long Tracheostomy Tubes Cuffless (K122531) with the addition of the cuff. They have identical indications, basic design and sizes. The subject device has a similar cuff to the predicate Shiley Cuffed Tubes (K955680) and BIVONA Tubes (K083641). The difference between the cuff on the subject and predicate tubes is the overall shape, which is taper-shaped in the subject versus barrel shaped in the predicates.

	SUBJECT DEVICE	PREDICATE DEVICE
	Shiley™ Cuffed	Shiley™ Cuffed [K955680]	Shiley™ Cuffless [K122531]	BIVONA Aire-Cuf [K083641]
Indications	Intended for use in providing tracheal access for airway management.	Identical	Identical	Intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for a single-patient use up to 5 times for pediatric sizes.
Patient population	Neonatal & pediatric	Pediatric	Neonatal & pediatric	Neonatal & pediatric
Sterilization	EtO	EtO	EtO	EtO
Cuff shape	Taper	Barrel	N/A	Barrel
Use	Single patient use	Identical	Identical	Identical
Sizes	2.5-4.5 Neonatal2.5-5.5 Pediatric5.0-6.5 Pediatric long	4.0-5.5 Pediatric5.0-6.5 Pediatric long	2.5-4.5 Neonatal2.5-5.5 Pediatric5.0-6.5 Pediatric long	2.5-4.0 Neonatal2.5-5.5 Pediatric
Materials
Cannula	Medical grade PVC with a citrate-based non-phthalate plasticizer	Medical grade PVC with a DEHP plasticizer	Medical grade PVC with a citrate-based non-phthalate plasticizer	Silicone
Flange	Medical grade PVC with a citrate-based non-phthalate plasticizer	Medical grade PVC with a DEHP plasticizer	Medical grade PVC with a citrate-based non-phthalate plasticizer	Silicone
ISO 15mm connector	Acrylonitrile butadiene styrene (ABS)	Medical grade PVC	ABS	ABS
Cuff	Medical grade PVC with a citrate-	Medical grade PVC with a DEHP	N/A	PVC
	based non-phthalateplasticizer	plasticizer
Inflation system	Medical grade PVCwith a citrate-based non-phthalateplasticizer & PVC	Medical grade PVCwith a citrate-based non-phthalateplasticizer & PVC	N/A	Silicone & ABS
Obturator	Medical gradepolypropylene	Medical gradepolypropylene	Medical gradepolypropylene	Medical gradepolypropylene
Neck strap	Cotton	Cotton	Cotton	Cotton

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Substantial Equivalence - Non-Clinical Evidence

Product performance testing, including cuff air seal, cuff fluid seal, removal force, and cuff pressure mapping, were performed with the conclusion that the subject devices can be expected to perform at least as well as the predicate and can be considered substantially equivalent. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, irritation, acute systemic toxicity, 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.