The SHERIDAN® Endobronchial Tube is intenced for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The SHERIDAN® Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

Device Description

The Sheridan Endobronchial Tube is a sterile, single patient use PVC Double-Lumen Endobronchial Tube (also referred to as a DLT) that is inserted into the trachea via the mouth in order to selectively ventilate one lung.

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide the requested information. The text describes a 510(k) premarket notification for a medical device (Sheridan Endobronchial Tubes) and focuses on demonstrating substantial equivalence to a predicate device.

The document does not contain information about:

A table of acceptance criteria and reported device performance for a study. Instead, it lists general tests performed (e.g., 15mm machine end Connector separation strength, Cuff resting diameter, Cuff herniation, Cuff Burst Evaluation, Cuff Bond Strength, Side arm bonding strength) and their principles, but no specific acceptance criteria or quantitative performance results are provided.
Sample size used for a test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications for establishing ground truth.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm-only) performance. The device described is a physical medical device, not an AI algorithm.
Type of ground truth used.
Sample size for a training set. Once again, this is a physical device, and the concept of a "training set" for an AI algorithm does not apply.
How the ground truth for the training set was established.

The document primarily focuses on comparing the proposed device's features, intended use, technology, and materials to a predicate device to establish substantial equivalence under the FDA's 510(k) pathway. It mentions "Non-clinical Comparative Performance Testing" but only lists types of tests, not the results or acceptance criteria that would allow for the detailed answers requested.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Teleflex Medical Lori Pfohl Senior Regulatory Affairs Specialist 3015 Carrington Mills Blvd Morrisville, North Carolina 27560

Re: K180253

Trade/Device Name: Sheridan Endobronchial Tubes Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: October 3, 2018 Received: October 5, 2018

Dear Lori Pfohl:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Todd D. Courtney -S

for Tina Kiang, Ph.D. Acting 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) K180253

Device Name Sheridan Endobronchial Tubes

Indications for Use (Describe)

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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Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 3015 Carrington Mills Bvld Morrisville, NC 27560 USA Phone: 919-491-8960 Fax: 919-433-4996

Contact Person

Lori Pfohl Senior Regulatory Affairs Specialist

Device Name

Trade Name: Sheridan Endobronchial Tubes

Common Name: Bronchial Tube

Classification Name: Tube, Tracheal/Bronchial, Differential Ventilation (w/wo connector) (Class II per 21 CFR 868.5740. Product Code CBI)

Predicate Device

K141888 Rusch Endobronchial Tubes

Device Description

Intended Use

The SHERIDAN® Endobronchial Tube is intended for use in thoracic surgery. bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The SHERIDAN® Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

Contraindications

SHERIDAN® Endobronchial Tubes are contraindicated in patients with stenosis or obstruction of the main stem bronchus that will inhibit or prohibit accurate tube placement.

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Substantial Equivalence Comparison to Predicate

The proposed device is substantially equivalent to the predicate devices:

Features	Teleflex MedicalSheridan Endobronchial Tube(proposed)	Teleflex MedicalRusch Endobronchial Tube(predicate)
Classification Name	Tube, Trachael/Bronchial, Differential Ventilation(w/wo connector)	Same
Product Code	СВІ	Same
Regulation Number	868.5740	Same
Indications for Use	The SHERIDAN® Endobronchial Tube is intendedfor use in thoracic surgery, bronchospirometry,administration of Endobronchial anesthesia andother uses commonly requiring Endobronchialintubation. TheSHERIDAN® Endobronchial tube is indicated formain stem bronchus intubation and allows forselective inflation or deflation of either lung.	Rusch Endobronchial Tubes are used to isolatethe left or right lung of a patient for surgery, onelung ventilation or one lung anesthesia
Environment of Use	Hospital - OR and ICU	Same
Patient Population	Patients requiring one-lung isolation	Same
Contraindications	SHERIDAN® Endobronchial Tubes arecontraindicated in patients with stenosis orobstruction of the main stem bronchus that willinhibit or prohibit accurate tube placement.	Left sides versions are contraindicated in patientswith obstructions or stenosis in the left mainbronchus. The right sided versions arecontraindicated in patients with obstructions orstenosis in the right main bronchus. The versionswith a carina hook are contraindicated for allprocedures in the region of the carina
Design Features	Double lumen shaft, 2 cuffs, Stylet	Double lumen shaft, 2 cuffs, Stylet
Single Use	Yes	Yes
Size Range	28-41 French	26-41 French
Cuffed	Yes	Yes
Radiopaque	Yes	Yes
Connection toventilation source	15 mm connector	15 mm connector
DLT Materials	PVC	PVC

Indications for Use The indications for use are considered to be identical. ● While the Sheridan indications for use is a bit more descriptive, both include identical uses.
Technology and construction The design, fabrication, shape, size, etc. is ● equivalent to the predicate. The designs of the proposed and predicate device consists of a double lumen tube with cuffs on each lumen, and corresponding side arm assemblies to inflate the cuffs.
Environment of use Identical for the proposed and predicate devices. ●

Teleflex Medical

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K180253 510(k) SUMMARY January 25, 2018

. Patient Population - While not specifically stated, the patient population is equivalent to the predicate
. Materials -All patient contacting materials are in compliance with ISO 10993-1. Testing included cytotoxicity, sensitization, intracutaneous activity, particulate matter, inorganic matter and VOC testing.

Comparison to Predicate Device:

The proposed Endobronchial tubes are substantially equivalent to the predicate devices with respect to indications for use, technology and construction. The differences between the predicate and the proposed devices are minor and any risks have been mitigated through testing. Additionally, the proposed device is made with the similar materials as the K141888 predicate.

Non-clinical Comparative Performance Testing

A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the table below:

Test	Reference toStandard (ifapplicable)	Principle of Test
15mm machineend Connectorseparationstrength	N/A	The security of the attachment of the connector to theEndobronchial tube is tested by applying an axial separationforce to the connector
Cuff restingdiameter	ISO 5361	Verify that diameter size marked on pouch matches the diameterof the product
Cuff herniation	ISO 5361	Verify cuff is not going to distort beyond the nearest bevel
Cuff BurstEvaluation	N/A	The cuff restrained burst test is designed to ensure the cuff will notburst or rupture when inflated inside the trachea
Cuff BondStrength	N/A	To evaluate the strength needed to separate the cuff fromthe tube
Side armbonding strength	N/A	To evaluate the retention force of the inflation lineconnection to the Endobronchial tube

Substantial Equivalence Conclusion

The Sheridan Endobronchial Tubes have the same indications for use, patient population and technology of construction as the predicate device. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device can be found substantially equivalent.

Regulation Number and Section

§ 868.5740 Tracheal/bronchial differential ventilation tube.

(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).