The Sheridan Spiral-Flex Endotracheal Tubes are spiral tracheal tubes that are inserted into the trachea via the mouth or the nose in order to establish a patent airway to allow ventilation. The subject device are sterile, single use devices. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. Each tracheal tube is supplied with an appropriately sized 15mm connector.

AI/ML Overview

This looks like a 510(k) summary for the Teleflex Sheridan Spiral-Flex Endotracheal Tubes. Based on the provided text, here's an analysis of the acceptance criteria and supporting study information:

This document does not describe a study related to AI/ML device performance, but rather summarizes the substantial equivalence of a medical device (endotracheal tubes) to previously cleared predicate devices. Therefore, many of the requested categories related to AI/ML performance studies, such as effect size of human readers with AI assistance, training set details, and specific expert qualifications for ground truth in an AI context, are not applicable in this submission.

The "study" in this context refers to bench testing to demonstrate the physical performance and safety of the endotracheal tubes.

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" with numerical targets in a table for a device performance study. Instead, it outlines the types of tests conducted and states that the device "meets its intended use" and "is substantially equivalent" to the predicate. The implication is that the device passed these tests and performed comparably to the predicate devices.

Here's a table based on the provided "Performance Data" section, interpreting the listed tests as fulfilling implicit acceptance criteria:

Acceptance Criteria (Inferred from Tests)	Reported Device Performance (Summary)
Physical Integrity & Functionality
Visual Inspection	No delamination on tip of reinforced tubes (Passed)
Cuff Inflation/Deflation	Device performed as expected (Passed; implies proper inflation, seal, and deflation)
Inflation System Leak	Device performed as expected (Passed; implies no leaks in the inflation system)
Cuff Herniation	Device performed as expected (Passed; implies cuff integrity under pressure)
Pilot Cuff Pull	Device performed as expected (Passed; implies robust attachment of pilot balloon to tube)
Simulated Use	Device performed as expected (Passed; implies proper function during simulated use scenarios)
Biocompatibility
ISO 10993-1:2009 (Biological Evaluation)	Device performed as expected (Passed; implies biocompatibility for patient contact, likely through material assessment or specific biocompatibility tests)
Material/Design Conformance
ASTM F623 Requirements	Device was tested to and met the requirements of ASTM F623 (Standard Specification for Tracheal Tubes)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify specific sample sizes for each of the bench tests listed (e.g., how many tubes were visually inspected, or how many cuffs were subjected to inflation/deflation cycles).

Sample Size: Not explicitly stated for the individual tests. This is common for bench testing where the focus is often on representative samples across different sizes/types.
Data Provenance: The tests were performed as part of Teleflex Medical, Inc.'s regulatory submission. This is prospective testing conducted specifically for this 510(k) submission, likely in a laboratory setting (manufacturer's or third-party). Country of origin is not specified but the company is based in Morrisville, NC, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as this is a physical medical device (endotracheal tube) submission, not an AI/ML diagnostic or prognostic device requiring expert interpretation for ground truth. The "ground truth" here is established by engineering and material science standards and test methods.

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

Not applicable. This type of adjudication method is used in clinical studies or expert consensus for AI/ML or diagnostic test evaluation, not for bench testing of physical device performance. The "adjudication" is inherent in the test method itself (e.g., does it leak or not, does it delaminate or not).

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this type of medical device submission.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this device's performance is established by:

Engineering specifications and design requirements: Whether the tube meets its physical dimensions, material properties, and functional characteristics.
Performance standards: Adherence to recognized standards like ASTM F623 for mechanical integrity and ISO 10993-1 for biocompatibility.
Comparison to predicate devices: The "ground truth" for substantial equivalence is that the new device performs at least as well as and poses no new safety or effectiveness concerns compared to the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm requiring a training set for this device.

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

Not applicable. There is no AI/ML algorithm or training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TeleflexMedical, Inc Lori Pfohl Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd, Suite 600 North Morrisville, North Carolina 27560

Re: K192324

Trade/Device Name: Sheridan Spiral-Flex Endotracheal Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: August 22, 2019 Received: August 27, 2019

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/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,

Todd Courtney Assistant Director DHT1C: Division of ENT, 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

510(k) Number (if known)

Device Name

Sheridan Spiral-Flex Endotracheal Tubes

Indications for Use (Describe)

Sheridan cuffed, uncuffed and reinforced tracheal tubes are designed for oral or nasal intubation and are indicated for airway management.

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

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-433-4831 Fax: 919-361-3939

B. Contact Person

Lori Pfohl Senior Regulatory Affairs Specialist

C. Date Prepared

August 23, 2019

D. Device Name

Trade Name:	Teleflex Sheridan Spiral-Flex Tracheal Tube
Common Name:	Tube, Tracheal
Product Code:	BTR
Regulation Number:	CFR 868.5730
Classification Name:	Tracheal Tube
Classification:	II
Classification Panel:	Anesthesiology

E. Predicate Device

This submission demonstrates substantial equivalence to the predicate device:

Sheridan Reinforced Tracheal Tube K844296 and Spiral-Flex Tracheal Tube K860105

F. Device Description

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G. Indications for Use

Sheridan cuffed, uncuffed and reinforced tracheal tubes are designed for oral or nasal intubation and are indicated for airway management.

H. Contraindications

None

I. Substantial Equivalence

The subject device is substantially equivalent to the predicate devices with respect to intended use, technology and construction. The differences between the predicates and the subject devices are minor and any risks have been mitigated through testing. Table 07.1 summarizes the differences between the subject and predicate device.

The subject devices are substantially equivalent to the predicate device:

Features	Teleflex Sheridan Spiral-FlexTracheal Tube (SubjectDevice)	TeleflexSheridan ReinforcedTracheal TubeK844296 (PredicateDevice 1)	Teleflex SheridanSpiral-Flex TrachealTube K860105(Predicate Device-2)
ClassificationName	Tracheal Tube	Same	Same
RegulationNumber	868.5730	Same	Same
FDA Procode	BTR	BTR	BTR
Class	II	Same	Same
Indication for Use	Sheridan cuffed, uncuffedand reinforced tracheal tubesare designed for oral or nasalintubation and are indicatedfor airway management.	Intended for airwaymanagementprocedures requiringflexing of the neck	Airway managementprocedures requiringflexing of the neck
Contraindications	None	None	None
Single Use	Yes	Yes	Same
Population	Adult and Pediatric	Adult	Adult and Pediatric
Size Range	Cuffed oral/nasal 5.0–9.0 mmUncuffed 3.0–5.0 mm	Oral 5.0 – 10.0 mmNasal 5.0 – 9.0 mm	UncuffedOral 2.0 – 7.0 mmNasal 2.0 – 7.0 mm

Table 07.1 - Comparison of Predicate vs. Subject Devices

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Sterile	Yes	Yes	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Valve System	Integral pilot balloon andvalve	Same	Same
Shaft Material	PVC. Spiral wire completelyembedded between twolayers of PVC	Same	Same
Connector	Standard 15mm	Same	Same
Cuff Design	High Volume tapered cuff	Same	Same
Murphy Eye	Yes	Same	Same
Bite Block	Yes	Same	Same
Stylet	Yes	Same	Same
Tube Tip	Beveled	Same	Same
X-Ray Marker	At extreme end	Same	Same

J. Comparison to the Predicate

Table 7.1 illustrates the similarities and differences between the subject and predicate devices. The basic technological and operating principles are the same for both devices. Although the wording is not identical, both the subject and predicate devices are for airway management. Both the subject and predicate devices are intended for similar patient populations adult and pediatric, male and female. Both the subject and predicate devices are disposable, sterile, single patient use devices. As evidenced by comparison Table 7.1. above, the subject device is substantially equivalent to the predicate device. There are no significant differences that would affect safety and efficacy.

K. Performance Data

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

Visual Inspection (No delamination on tip of reinforced tubes) ●
Cuff inflation deflation test ●
Inflation system leak test
Cuff herniation test
Pilot Cuff Pull test ●
Simulated Use Test
ISO 10993-1:2009 - Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process

The testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device.

The subject devices were tested to the requirements of ASTM F623.

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L. Conclusion

The subject device has the same intended use and technological characteristics and construction as the predicate. Test results demonstrate that the subject device meets it's intended use. It is for these reasons that the subject device can be found substantially equivalent to the predicate devices.

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).