The Shiley™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.

Device Description

The subject device is pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) low pressure taper-shaped cuff (TaperGuard™) to provide air and fluid seal. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.

AI/ML Overview

The provided document describes the Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP, and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, a direct response to your request, which focuses on acceptance criteria and studies for AI/ML devices, cannot be fully generated from the provided text.

The document does not contain information on:

Sample sizes for test sets (training or test data)
Data provenance (country of origin, retrospective/prospective)
Number of experts, their qualifications, or adjudication methods for ground truth
Multi-reader multi-case comparative effectiveness studies
Standalone algorithm performance
How ground truth was established for "training sets" (as this is not an ML device)

However, I can extract the acceptance criteria and the performance results for the physical device based on the information provided in the "PERFORMANCE DATA" section.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Compliance with ISO 5361:2016 for dimensions (bevel angle, curvature, cuff diameter, connectors)	The subject device met the standard.
Print Adherence Test	All testing requirements were met on terminally sterilized unaged and aged samples.
Cuff herniation	All testing requirements were met on terminally sterilized unaged and aged samples.
Cuff performance	All testing requirements were met on terminally sterilized unaged and aged samples.
Inflation line pull test	All testing requirements were met on terminally sterilized unaged and aged samples.
Connector pull force	All testing requirements were met on terminally sterilized unaged and aged samples.
Kink test	All testing requirements were met on terminally sterilized unaged and aged samples.
Tube collapse	All testing requirements were met on terminally sterilized unaged and aged samples.
Fluid Seal test	All testing requirements were met on terminally sterilized unaged and aged samples.
Radius Curvature test	All testing requirements were met on terminally sterilized unaged and aged samples.
MRI Safety and compatibility tests	All testing requirements were met on terminally sterilized unaged and aged samples.
Biocompatibility (ISO 10993-1:2009 & FDA guidance)	Testing was performed and listed tests (Cytotoxicity, Implantation, Sensitization, Irritation/Intracutaneous reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Subacute/sub chronic toxicity, Genotoxicity, Particulate matter and VOC) were concluded. The implication is that the device met these criteria.
Human Factors / Usability Study (IEC 62366-1:2015)	The device was found to be in conformance with the standard.
Sterilization (Ethylene Oxide)	Validation was performed, supporting a 5-year shelf life.
Functional and Mechanical tests (compared to predicate)	Met the same acceptance criteria as the predicate device, demonstrating substantial equivalence.
Shelf life	5 years (supported by unaged and aged sample testing).

Study Information (Based on available document sections):

This document describes a medical device clearance for an endotracheal tube, not an AI/ML powered device. Therefore, the specific questions related to AI/ML device studies (such as sample sizes for AI training/test sets, data provenance for AI, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to the provided content.

The studies conducted were bench-top performance testing, biocompatibility testing, and a human factors/usability study to demonstrate substantial equivalence to predicate devices and compliance with relevant ISO standards.

Type of Ground Truth Used: For the physical device, the "ground truth" is defined by compliance with established engineering and medical device standards (e.g., ISO 5361:2016, ISO 10993-1:2009, IEC 62366-1:2015) and comparison to the performance of predicate devices. There is no "ground truth" of the kind used for AI/ML validation (e.g., expert consensus on medical images or pathology results).
Sample Size for Training Set & Ground Truth for Training Set: These concepts are not applicable as this is not an AI/ML device. The "training" for this device would be its design and manufacturing process, optimized to meet design specifications and regulatory standards.

Summary

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August 30, 2023

Covidien Anila Tarte Principal Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301

Re: K223130

Trade/Device Name: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: Class II Product Code: BTR Dated: June 27, 2023 Received: June 27, 2023

Dear Anila Tarte:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -5

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K223130

Device Name

Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)

ndications for Use (Describe)

The Shiley™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.

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

Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP

This summary of 510(k) safety and effectiveness information for the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP is submitted in accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with the requirements of 21 CFR §807.92.

SUBMITTER INFORMATION

Submitted By:

Covidien, llc 6135 Gunbarrel Avenue Boulder, CO 80301

Establishment Registration Number: 2936999

Date Prepared: June 25, 2023

Contact Person:

Anila Tarte Principal Regulatory Affairs Specialist Phone: 978-496-6694 Email: anila.k.tarte(@medtronic.com

DEVICE

Trade Name:	Shiley™ Pediatric Oral/Nasal Endotracheal Tube withTaperGuard™ Cuff, Non-DEHP (86125, 86130, 86135, 86140,86145, 86150, 86155, 86160)
Common Name:	Endotracheal Tube with cuff
Classification Regulation:	21 CFR 868.5730
Classification Name:	Tracheal tube – Class II

Class II Regulatory Class:

BTR Product Code:

Anesthesiology Review Panel:

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PREDICATE DEVICE

Predicate Manufacturer:	Covidien llc
Predicate Trade Name:	Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless, Non-DEHP,Murphy Eye
Predicate 510(k):	K151381
PREDICATE DEVICE
Predicate Manufacturer:	Covidien llc
Predicate Trade Name:	Hi-Lo Evac and Evac II Endotracheal Tubes
Predicate 510(k):	K965132
REFERENCE DEVICE
Predicate Manufacturer:	Covidien llc

Predicate Manufacturer:	Covidien llc
Predicate Trade Name:	Shiley™ Neonatal/Pediatric Tracheostomy Tube
Predicate 510(k):	K182861

DEVICE DESCRIPTION

INTENDED USE

The Shiley™ pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non DEHP is intended for use in facilitating oral or nasal intubation of the trachea.

TECHNOLOGICAL CHARACTERISTICS

The subject device is substantially equivalent to the predicate devices in terms of technological characteristics. Both devices are designed in accordance with ISO 5361 and have the following features in common: Cuff, standard 15mm connector, Magill curve, similar material composition, and similar size range. The following technological characteristics were compared between the subject device and predicate devices to demonstrate substantial equivalence in Table 5.1 below:

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Characteristic	Subject Device ShileyTMPediatric oral/nasalendotracheal tube withTaperGuardTM Cuff, non-DEHP	Primary Predicate DeviceMallinckrodtTM Oral/NasalTracheal Tube Cuffless,Non- DEHP-, Murphy Eye[K151381]	SecondaryPredicatedeviceHi-Lo Evac and EvacII EndotrachealTubes(K965132)
Indications for Use	Oral or nasal intubationof the trachea for airwaymanagement.	Oral or nasal intubationof the trachea for airwaymanagement.	The Hi-Lo- EvacTMendotracheal tube isindicated for airwaymanagement byoral/nasal intubationof the tracheaparticularly in caseswhere duration ofintubation is expectedto be more than 24hours or maynot bepredictable.
PatientPopulation	Pediatrics	Pediatrics	Pediatrics,Adults
Use	Single patient	Single patient	Single patient
Device Design	Per ISO 5361:2016,ISO 5356-1	Per ISO 5361:2012,ISO 5356-1	Per ISO 5361:1999,ISO5356-1
Product Sizerange (nominal insidediameter)	2.5-6.0mm	2.0 - 7.0mm	3.0 - 10.0mm
Shelf life	5 years	5 years	5 years
Sterilization	SAL: 1X10-6 ETOSterilization	SAL: 1X10-6 ETOSterilization	SAL: 1X10-6 ETOSterilization

Table 5.1: Comparison of Technological Characteristics

Substantial Equivalence Discussion

Indications for Use

The subject device and predicate devices share intended use. The subject device as well as predicate devices provide tracheal access for airway management. Subject device and predicate devices are indicated for facilitating oral or nasal intubation of the trachea.

The Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP is designed with a low-pressure taper-shaped cuff (TaperGuard™) to provide air and fluid seal.

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Additionally, the subject device tube and cuff uses identical materials used in the primary device and reference device respectively.

Technological Characteristics Comparison

The subject and predicate devices have the same technological characteristics (Magill curve, similar size range, similar material composition, cuff, inflation line, 15 mm connector). The subject device was tested to comply with FDA recognized standards related to Airway devices, ISO 18190, ISO 5361 and ISO 5356 (see Section Declaration of Conformity). As the subject and predicate devices have the same intended use, designed in accordance with ISO 5361, and performance in compliance with ISO 5361 requirements, the subject device can be considered substantially equivalent to the predicate device.

PERFORMANCE DATA

Performance Bench Testing has been conducted to verify that the performance of the subject device the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP is substantially equivalent to the predicate devices and that the subject device will perform as intended. Bench-top testing have been conducted on subject device in accordance with ISO 5361:2016 and all testing requirements were met. The following tests were performed on terminally sterilized unaged and aged samples which met all defined acceptance criteria:

. Print Adherence Test
Cuff herniation ●
. Cuff performance
Inflation line pull test ●
Connector pull force
Kink test
Tube collapse
Fluid Seal test .
Radius Curvature test ●
. MRI Safety and compatibility tests

The Shiley™ Pediatric oral/nasal endotracheal tube with Cuff, non-DEHP unaged and aged met the standard, supporting the 5-year shelf life.

The Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP has been tested in accordance with the standard ISO 5361:2016 for dimensions, including bevel angle, curvature, cuff diameter, connectors. The subject device met the standard. The Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP was

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compared to the predicate device for the functional and mechanical tests and met the same acceptance criteria as the predicate device, demonstrating substantial equivalence.

Biocompatibility Testing

The following Biocompatibility testing was performed in accordance with ISO 10993-

1:2009 and FDA guidance on Use of International Standard ISO 10993-1

. Cytotoxicity
Implantation .
Sensitization ●
Irritation / Intracutaneous reactivity ●
Material Mediated Pyrogenicity
Acute Systemic Toxicity ●
Subacute/sub chronic toxicity ●
Genotoxicity ●
. Particulate matter and VOC (ISO 18562-2:2017 & ISO 18562-3:2017)

Human Factors

A Human Factors / Usability Study was conducted and the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP was found to be in conformance with the IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices standard.

Sterilization

Sterilization by ethylene oxide has been validated for Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP.

Animal Performance Testing

Not applicable. No animal performance testing was required to demonstrate device safety and effectiveness.

Clinical Performance Testing

No clinical performance testing was required to demonstrate device safety and effectiveness.

CONCLUSION

Based on the information included in this premarket notification submission, the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP met all predetermined

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acceptance criteria as specified by the applicable standards, FDA guidance documents and test protocols. Therefore, the Shiley™ Pediatric oral/nasal endotracheal tube with TaperGuard™ Cuff, non-DEHP is considered substantially equivalent to the predicate devices currently marketed for the same intended use.

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).