Pilling™ Tracheostomy Tubes are stainless-steel tracheostomy tubes that are intended to provide tracheal access for airway management of tracheostomized patients. The tracheostomy tubes are reusable, single-patient devices that are provided non-sterile, and intended to be cleaned prior to initial use. Each tube consists of an outer cannula, inner cannula, and pilot/obturator. The inner and outer tubes fit closely to provide maximum airway. The distal edge of the inner tube is flush with, and fits very closely to, that of the outer tube to allow for complete cleaning. Variations in diameter, shape of the inner and outer tubes (radius of curvature), locking mechanism, and neck plate configurations are the basis of the various styles available.

The tubes are available in sizes ranging from 00 (4.5mm outside diameter, 2.4mm inside diameter) to 12 (16.3mm outside diameter. 12.7mm inside diameter) based on individual style. Insertable lengths range from 33mm (size 00) to 85mm (size 9 Extra Long) based on individual style. Shape of the device and specific design of the neck plate and locking feature is based on style (Jackson, Jackson Improved, and Mayo).

Some Pilling™ Tracheostomy Tubes are fenestrated to facilitate speech and all tubes can be fenestrated upon request. Certain inner tubes are compatible with the Shikani-French Speaking Valve (Product Code JOH, 510(k) K982128). Pilling™ Tracheostomy Tubes are available in models with or without permanently attached 15mm adapters.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Pilling™ Tracheostomy Tubes, based on the provided FDA 510(k) summary:

It's important to note that this document is a 510(k) summary for a medical device, not an AI or software device. Therefore, many of the typical questions related to AI acceptance criteria, ground truth, and reader studies are not applicable. The focus here is on demonstrating equivalence to a predicate conventional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Requirement/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1:2018; materials must be equivalent to the predicate device with respect to safety and biocompatibility.	"Biocompatibility testing to ISO 10993-1:2018 demonstrated that Pilling™ Tracheostomy Tubes are equivalent to the predicate device with respect to material safety and biocompatibility."
Functional & Performance	Device must meet specified functional and performance requirements (e.g., proper operation of locking mechanism, secure fit of connectors, correct function of obturator/pilot).	"Bench testing was conducted to demonstrate that functional and performance requirements were met, including a Locking Mechanism Test, Fitted Connector Check, and Pilot/Obturator Test."
Security of Attachment	Compliance with ISO 5366:2016 for the security of attachment of the neckplate and 15mm adapter to the tracheostomy tube. (Implicitly, this means the components should not detach unexpectedly, meeting the standard's specifications).	"Additionally, a Separation Test was completed on the neckplate and 15mm Adapter to demonstrate compliance to the requirements of ISO 5366:2016 for security of attachment of neckplate and fitted connector to a tracheostomy tube."
Overall Equivalence	The device must demonstrate substantial equivalence in performance, safety, and effectiveness to the predicate device (Fahl Tracheostomy Tubes, K123699). This is the overarching "acceptance criteria" for a 510(k) submission, meaning the new device poses no new questions of safety or effectiveness and is as safe and effective as a legally marketed device.	"Based upon the biocompatibility study, comparison of characteristics, and functional test results, the proposed Pilling™ Tracheostomy Tubes are substantially equivalent in performance, safety, and effectiveness to the predicate device cleared to market via 510(k) K123699."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for each test (e.g., number of tubes tested for biocompatibility, locking mechanism, or separation). This is common for traditional medical device bench testing where the focus is on design verification against established standards and predicate characteristics, rather than statistical significance across a large patient dataset as seen in AI/Clinical studies.
Data Provenance: Not applicable in the context of clinical data. The tests described are non-clinical performance testing (bench testing and biocompatibility analysis) of the manufactured device. These tests are inherently prospective, conducted by the manufacturer. There is no mention of country of origin for "data" in a patient/clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable for this type of medical device submission. Ground truth, in the AI/clinical sense, typically refers to expert annotations or diagnoses on medical images/data. For a physical device like a tracheostomy tube, "ground truth" is established by adherence to engineering specifications, recognized international standards (like ISO 10993 and ISO 5366), and direct physical measurements or functional tests of the device itself. Experts involved would be engineers, materials scientists, and quality control professionals, ensuring the device meets its design requirements and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, particularly for AI, to resolve discrepancies in expert opinions on ground truth. For the described non-clinical bench testing, results are typically objective (e.g., does it lock, does it separate at a certain force, are materials biocompatible). Any discrepancies would be handled through standard engineering and quality control procedures (e.g., re-testing, root cause analysis), not through expert adjudication in the medical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is designed to evaluate the performance of human readers (e.g., radiologists) with and without the assistance of an AI tool on a set of cases. This submission is for a physical medical device (tracheostomy tube), not an AI system. Therefore, no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No. This question is specific to AI algorithms. The Pilling™ Tracheostomy Tube is a physical medical device. There is no algorithm involved to perform a standalone study.

7. The Type of Ground Truth Used

Engineering Specifications and International Standards: For this device, the "ground truth" is primarily based on:
- Biocompatibility: Confirmation by laboratory testing that materials meet the requirements of ISO 10993-1:2018.
- Functional Performance: Verification through bench tests that the device components (locking mechanism, connector fit, obturator) operate as designed according to internal engineering specifications.
- Security of Attachment: Demonstration of compliance with ISO 5366:2016 related to the physical integrity and attachment strength of specific components.
- Comparison to Predicate: The ultimate "ground truth" for a 510(k) is demonstrating that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness, based on its characteristics and performance.

8. The Sample Size for the Training Set

Not applicable. This question refers to the training data for an AI algorithm. As established, this is a physical medical device, not an AI product.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This question pertains to AI algorithm development.

Summary

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March 22, 2024

Teleflex Medical Hannah Boning Regulatory Affairs Specialist 3015 Carrington Mill Blvd. Morrisville, North Carolina 27560

Re: K233713

Trade/Device Name: Pilling Tracheostomy Tubes Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube And Tube Cuff Regulatory Class: Class II Product Code: BTO Dated: February 26, 2024 Received: February 27, 2024

Dear Hannah Boning:

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.

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).

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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 OS 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.

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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 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)

K233713

Device Name

Pilling Tracheostomy Tubes

Indications for Use (Describe)

Tracheostomy tubes are intended to provide tracheal access for airway management of tracheostomized patients.

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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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a bold, dark blue font. The word is slightly stylized, with the "T" having a unique shape. A small, circled "R" symbol is located to the right of the "x" in "Teleflex", indicating that the name is a registered trademark.

Teleflex Medical, Inc

3015 Carrington Mill Blvd Morrisville NC 27509 USA 919-544-8000 Phone: Fax· 866-804-9881

eleflex.com

510(k) SUMMARY

Pilling™ Tracheostomy Tube

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

Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 Phone: 919-544-8000 919-433-3914 Fax:

B. Contact Person

Hannah Boning, RAC-Devices, Requlatory Affairs Specialist RA Product Management Surgical Business Unit Tel – (919) 228-2437 Fax – (919) 433-4996 Email - hannah.boning@teleflex.com

C. Date Prepared

22 March 2024

D. Device Name

Trade Name:	Pilling™ Tracheostomy Tube
Common Name:	Tracheostomy Tube
Product Code:	BTO
Regulation:	21 CFR 868.5800
Classification Name:	Tube, Tracheostomy (w/wo connector)

E. Predicate Device

K123699 – Fahl Tracheostomy Tube, BTO and JOH

F. Device Description

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Image /page/5/Picture/0 description: The image shows the word "Teleflex" in a bold, blue font. The word is written in all lowercase letters, except for the first letter, which is capitalized. To the right of the word is a small, circled "R" symbol, indicating that the word is a registered trademark. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.

inner and outer tubes (radius of curvature), locking mechanism, and neck plate configurations are the basis of the various styles available.

G. Intended Use

Pilling™ Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

H. Substantial Equivalence

Pilling™ Tracheostomy Tubes are substantially equivalent to Fahl Tracheostomy Tubes (K123699), specifically the Silvervent tracheostomy tubes.

Predicate Device	Manufacturer	510(k)	ClearanceDate
Fahl Tracheostomy Tubes	Fahl Medizintechnik	K123699	12 August 2013

. Comparison To Predicate Devices

Pilling™ Tracheostomy Tubes are substantially equivalent to the predicate device with respect to technology, intended use, indications, and functional characteristics.

Feature	Predicate Device	Subject Device	Equivalence
Device Name	Fahl TracheostomyTubes, Silvervent	Pilling™ TracheostomyTubes	Identical
510(k) Number	K123699	K233713	N/A
DeviceClassification	Class II	Class II	Identical
Product Code	BTO and JOH	BTO	Equivalent
Regulation	21 CR 868.5800	21 CR 868.5800	Identical

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Image /page/6/Picture/0 description: The image shows the word "Teleflex" in a bold, sans-serif font. The word is a dark blue color. There is a registered trademark symbol to the right of the word "Teleflex."

Intended Use	The Fahl TracheostomyTubes are intended toprovide tracheal accessfor airway managementof tracheostomizedpatients.	Pilling™ TracheostomyTubes are intended toprovide tracheal accessfor airway managementof tracheostomizedpatients.	Identical
Size Range	0 to 14	00 to 12	Equivalent
w/wo cuff	w/o cuff	w/o cuff	Identical
Provided Sterile	No	No	Identical
Material	Sterling Silver	Stainless Steel	Equivalent
TechnologicalCharacteristics	Metallic, uncuffedtracheostomy tube	Metallic, uncuffedtracheostomy tube	Equivalent
Prescription Use	Yes	Yes	Identical
PatientPopulation	Adult	Adult	Identical
UseEnvironment	Home and Clinical Use	Home and Clinical Use	Identical
Single/MultipleUse	Multiple Use, SinglePatient	Multiple Use, SinglePatient	Identical
Reprocessing	Reprocess per IFUcleaning instructions.	Reprocess per IFUcleaning instructions	Equivalent
Options	Available fenestrated ornon-fenestratedAvailable with orwithout 15mm adapter	Available fenestrated ornon-fenestratedAvailable with orwithout 15mm adapter	Identical

J. Materials

All patient contacting materials are compliant with ISO 10993-1:2018 according to their nature and duration of contact. Pilling™ Tracheostomy Tube patient contacting materials are equivalent to the predicate device with respect to safety and biocompatibility.

K. Technological Characteristics

A comparison of the technological characteristics of the Pilling™ Tracheostomy Tubes and the predicate has been performed. Both subject and predicate device are metallic, uncuffed, reusable tracheostomy tubes for single-patient multiple-use. Both predicate and subject devices are available in variations with or without permanently attached 15mm adapter and with or without fenestration. Pilling™ Tracheostomy Tubes additionally include an obturator/pilot for use in inserting the tracheostomy tube. This is used for tube placement only and does not constitute a technological difference from the predicate device as the obturator does not affect the performance or use of the tracheostomy tube. The results of this comparison demonstrate that the Pilling™ Tracheostomy Tubes are equivalent to the marketed predicate device in performance characteristics.

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Image /page/7/Picture/0 description: The image shows the word "Teleflex" in a bold, sans-serif font. The word is in blue, and there is a registered trademark symbol to the right of the "x". The logo is simple and modern.

L. Performance Data

Non-clinical performance testing has been conducted in order to ensure the device performed equivalently to the predicate. Biocompatibility testing to ISO 10993-1:2018 demonstrated that Pilling™ Tracheostomy Tubes are equivalent to the predicate device with respect to material safety and biocompatibility. Bench testing was conducted to demonstrate that functional and performance requirements were met, including a Locking Mechanism Test, Fitted Connector Check, and Pilot/Obturator Test. Additionally, a Separation Test was completed on the neckplate and 15mm Adapter to demonstrate compliance to the requirements of ISO 5366:2016 for security of attachment of neckplate and fitted connector to a tracheostomy tube.

M. Conclusion

Based upon the biocompatibility study, comparison of characteristics, and functional test results, the proposed Pilling™ Tracheostomy Tubes are substantially equivalent in performance, safety, and effectiveness to the predicate device cleared to market via 510(k) K123699.

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.