Pilling Tracheostomy Tubes

K233713 · Teleflex Medical · BTO · Mar 22, 2024 · Anesthesiology

Device Facts

• Record ID: K233713
• Device Name: Pilling Tracheostomy Tubes
• Applicant: Teleflex Medical
• Product Code: BTO · Anesthesiology
• Decision Date: Mar 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Pilling™ Tracheostomy Tubes are stainless-steel, reusable, single-patient devices providing tracheal access for airway management. The device consists of an outer cannula, inner cannula, and pilot/obturator. Available in various diameters, curvatures, and neck plate configurations (Jackson, Jackson Improved, Mayo styles). Some models are fenestrated to facilitate speech; others include 15mm adapters. Used in home and clinical settings by healthcare providers or patients. The device is inserted into the trachea to maintain an open airway. The inner and outer tubes fit closely to allow for complete cleaning. The device is provided non-sterile and must be cleaned prior to initial use and reprocessed per instructions for use.

Clinical Evidence

Bench testing only. Testing included biocompatibility per ISO 10993-1:2018, locking mechanism tests, fitted connector checks, pilot/obturator tests, and neckplate/adapter separation tests per ISO 5366:2016.

Technological Characteristics

Metallic (stainless steel), uncuffed, reusable tracheostomy tube. Available with/without 15mm adapter and fenestration. Sizes 00 to 12. Compliant with ISO 10993-1:2018 for biocompatibility and ISO 5366:2016 for mechanical security of attachments.

Indications for Use

Indicated for adult tracheostomized patients requiring tracheal access for airway management.

Regulatory Classification

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.

Predicate Devices

• Fahl Tracheostomy Tube (K123699)

Reference Devices

• Shikani-French Speaking Valve (K982128)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

# 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: [phone] Fax:

### B. Contact Person

Hannah Boning, RAC-Devices, Requlatory Affairs Specialist RA Product Management Surgical Business Unit Tel – [phone] Fax – [phone] Email - [e-mail]

#### 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

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

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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.

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.

# 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) | Clearance<br>Date |
|-------------------------|---------------------|---------|-------------------|
| 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 Tracheostomy<br>Tubes, Silvervent | Pilling™ Tracheostomy<br>Tubes | Identical |
| 510(k) Number | K123699 | K233713 | N/A |
| Device<br>Classification | 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 Tracheostomy<br>Tubes are intended to<br>provide tracheal access<br>for airway management<br>of tracheostomized<br>patients. | Pilling™ Tracheostomy<br>Tubes are intended to<br>provide tracheal access<br>for airway management<br>of tracheostomized<br>patients. | 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 |
| Technological<br>Characteristics | Metallic, uncuffed<br>tracheostomy tube | Metallic, uncuffed<br>tracheostomy tube | Equivalent |
| Prescription Use | Yes | Yes | Identical |
| Patient<br>Population | Adult | Adult | Identical |
| Use<br>Environment | Home and Clinical Use | Home and Clinical Use | Identical |
| Single/Multiple<br>Use | Multiple Use, Single<br>Patient | Multiple Use, Single<br>Patient | Identical |
| Reprocessing | Reprocess per IFU<br>cleaning instructions. | Reprocess per IFU<br>cleaning instructions | Equivalent |
| Options | Available fenestrated or<br>non-fenestrated<br>Available with or<br>without 15mm adapter | Available fenestrated or<br>non-fenestrated<br>Available with or<br>without 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.