Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

Q: Who is the manufacturer of Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)?

Covidien, LLC filed the 510(k) submission for Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) (K233341).

Q: What is the FDA product code for Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)?

BTR. It is classified under 21 CFR 868.5730 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K233341 · Covidien, LLC · BTR · May 20, 2024 · Anesthesiology

Device Facts

Record ID	K233341
Device Name	Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
Applicant	Covidien, LLC
Product Code	BTR · Anesthesiology
Decision Date	May 20, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5730
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Indications for Use

The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is intended for use in oral or nasal intubation of the trachea for anesthesia and is indicated for airway management.

Device Story

Shiley™ Oral/Nasal Endotracheal Tube is a single-patient-use device for airway management; facilitates tracheal access via oral or nasal intubation. Device consists of a translucent PVC tube with a Magill curve, radiopaque line, and a high-pressure, low-volume cuff. Inflation system includes an inflation line, pilot balloon, and valve for cuff management. Manufactured without latex or DEHP. Used in clinical settings (e.g., anesthesia) by healthcare professionals. Provides an air and fluid seal within the trachea. Bench testing confirms performance per ISO 5361, ISO 5356, and ISO 18190 standards.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing per ISO 5361:2016, including connector pull, cuff performance, inflation line pull, fluid seal, kink resistance, and print adherence tests. Biocompatibility testing performed per ISO 10993-1:2018 (cytotoxicity, implantation, sensitization, irritation, material-mediated pyrogenicity). Usability evaluated per EN 62366-1:2015 + A1:2020.

Technological Characteristics

Materials: Non-DEHP, latex-free PVC. Design: Magill curve, radiopaque line, 15mm connector per ISO 5356. Cuff: High-pressure, low-volume. Dimensions: 3.0-10.0 mm ID. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None. MRI Compatibility: MRI Conditional.

Indications for Use

Indicated for oral or nasal intubation of the trachea for airway management in pediatric and adult patient populations.

Regulatory Classification

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.

Predicate Devices

Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non-DEHP (K223130)

Reference Devices

Shiley™ Hi-Lo Oral/Nasal Tracheal Tube Cuffed, Intermediate, Murphy Eye (K965132)
Cuffed Tracheal Tube (K871204)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. May 20, 2024 Covidien LLC Stephanie Reneau Principal Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301 Re: K233341 Trade/Device Name: Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490. 87495. 87410) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: April 12, 2024 Received: April 12, 2024 Dear Stephanie Reneau: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 -S Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and {2}------------------------------------------------ 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 {3}------------------------------------------------ #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) K233341 Device Name Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) Indications for Use (Describe) Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is intended for 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 510(K) SUMMARY ## Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP This summary of 510(k) safety and effectiveness information for the Shiley™ Oral/Nasal Endotracheal Tube Intermediate 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 Bv: Covidien, llc 6135 Gunbarrel Avenue Boulder, CO 80301 Establishment Registration Number: 2936999 Date Prepared: 05/14/2024 #### Contact Person: Stephanie Reneau Principal Regulatory Affairs Specialist Phone: 303-305-2713 Email : stephanie.reneau@medtronic.com #### DEVICE Trade Name: Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP Common Name: Endotracheal Tube with Cuff Classification Regulation: 21 CFR § 868.5730 Classification Name: Tube, Tracheal (w/wo connector) Regulatory Class: Class II Product Code: BTR Review Panel: Anesthesiology #### PREDICATE DEVICE Predicate Manufacturer: Covidien llc Predicate Trade Name: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non-DEHP Predicate 510(k): K223130 {5}------------------------------------------------ ### DEVICE DESCRIPTION The subject device is an oral/nasal endotracheal tube intermediate cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) high pressure, low volume cuff with two different cuff shapes. 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. #### INTENDED USE The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is intended for use in oral or nasal intubation of the trachea for anesthesia and is indicated for airway management. #### TECHNOLOGICAL CHARACTERISTICS The subject device is substantially equivalent to the predicate device in terms of technological characteristics. Both devices are designed in accordance with ISO 5361 and have the following features in common: standard 15mm connector, Magill curve, similar material composition, and similar size range. The following technological characteristics were compared between the subject device, predicate devices, and reference device to demonstrate substantial equivalence in Table 1 below: {6}------------------------------------------------ | Characteristics | Subject Device: Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non- DEHP | Predicate Device: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, non-DEHP (K223130) | Reference Device Shiley™ Hi-Lo Oral/Nasal Tracheal Tube Cuffed, Intermediate, Murphy Eye (K965132) | Reference Device Cuffed Tracheal Tube (Multiple) (K871204) | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | Indications for Use | Oral or nasal intubation of the trachea for airway management. | Oral or nasal intubation of the trachea for airway management. | Intubation of trachea for airway management | Intubation of trachea for airway management | | Patient Population | Pediatric and Adults | Pediatric | Pediatric and Adults | Pediatric and Adults | | Use | Single Patient Use | Single Patient Use | Single Patient Use | Single Patient Use | | Product Size Range (nominal inside diameter) | 3.0-10.0 mm | 2.5-6.0 mm | 3.0 to 10.0 mm | 5.0 to 10.0 mm | | Shelf Life | 5 years | 5 years | 5 years | 5 years | | Sterilization | Ethylene Oxide (SAL) of 10-6 | Ethylene Oxide (SAL) of 10-6 | Ethylene Oxide (SAL) of 10-6 | Ethylene Oxide (SAL) of 10-6 | | MRI Compatibility | MRI Conditional | MRI Conditional | MRI Conditional | MRI Conditional | Table 1. Comparison of Technological Characteristics {7}------------------------------------------------ ## SUBSTANTIAL EQUIVALENCE DISCUSSION #### Indications for Use The subject device and predicate device share the same intended use, both devices provide tracheal access for airway management. The subject and predicate devices are indicated for facilitating oral or nasal intubation of the trachea. The Shiley™ Oral/Nasal Endotracheal Intermediate Cuff, Non DEHP is designed with a high volume, low pressure cuff which comes in two cuff shapes based on tube size to provide air and fluid seal. Additionally, the subject device uses the same materials used in the predicate device. #### Technical Characteristics Comparison The subject and predicate devices have the same technological characteristics (Magill curve, 15 mm connector, inflation system, similar size range and material composition). The subject device was tested to comply with FDA recognized standards related to airway devices, ISO 5361, ISO 5356 and ISO 18190 (see Declaration of Conformity section). The subject device can be considered substantially equivalent to the predicate device as they both have the same intended use, designed in accordance with ISO 5361 and ISO 5356 requirements. ## PERFORMANCE DATA Performance bench testing has been conducted to verify the performance of the subject device the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP will perform as intended and is substantially equivalent to the predicate device. Bench top testing has been conducted on the subject device per ISO 5361:2016 (FDA 1-118) and all testing requirements were met. The following tests were performed on terminally sterilized samples which met all defined acceptance criteria: - Connector Pull Test ● - Cuff Performance ● - Inflation Line Pull Test ● - Fluid Seal Test - Kink Resistance ● - Print Adherence ● The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff. Non DEHP met the standard supporting a 5-year shelf life. The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP has been tested in accordance with the standard ISO 5361:2016 for dimensions, bevel angle, radius of curvature, cuff diameter, connectors and met the standard. The subject device was compared to the predicate device and considered substantially equivalent as the device met the same acceptance criteria as the predicate device. {8}------------------------------------------------ ## BIOCOMPATIBILITY TESTING - The following biocompatibility testing was performed in accordance with ISO 10993-1:2018 (FDA 2-258). The subject device has two different resins, one for sizes 3.0 to 8.0 mm and second for sizes 8.5 to 10.0 mm. Testing from predicate device was leveraged for sizes 3.0-8.0 mm and for sizes 8.5 mm to 10.0 mm, testing was performed on final finished subject device. - Cytotoxicity ● - Implantation ● - Sensitization - Irritation/Intracutaneous reactivity ● - Material Mediated Pyrogenicity . # HUMAN FACTORS The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP was evaluated for human factors/usability study and found to be in conformance with EN 62366-1:2015 + A1:2020 Medical devices- Application of usability engineering medical devices standard. ## STERILIZATION Sterilization by ethylene oxide has been validated for Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP. ## ANIMAL PERFORMANCE TESTING Not applicable. Non animal performance testing was required to demonstrate the device's safety and effectiveness. # CLINICAL PERFORMANCE TESTING Not applicable. Non animal performance testing was required to demonstrate the device's safety and effectiveness. # CONCLUSION Based on the information included in this premarket notification submission, the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP met all predetermined acceptance criteria as specified in the applicable standards, test protocols and FDA guidance documents. Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is considered substantially equivalent to ShileyTM Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, non-DEHP, predicate device and reference devices Shiley™ Hi-Lo Oral/Nasal Tracheal Tube Cuffed, Intermediate, Murphy Eye (K965132) and Cuffed Tracheal Tube, Multiple (K871204) currently marketed for the same intended use.

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

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Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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