(123 days)
No
The device description and performance studies focus on the mechanical and material properties of a physical medical device (tracheostomy tube) and do not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device description and intended use indicate that the device provides tracheal access for airway management, acting as a conduit rather than directly treating a disease or condition. While essential for patient management, it doesn't directly provide therapy.
No
The device description states that tracheostomy tubes are "intended to provide tracheal access for airway management of tracheostomized patients." This describes a therapeutic or assistive function, not a diagnostic one.
No
The device description clearly details a physical, stainless-steel tracheostomy tube with various hardware components (outer cannula, inner cannula, pilot/obturator, neck plate, locking mechanism, etc.). It is a tangible medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pilling™ Tracheostomy Tube is a medical device used to provide a physical airway for patients with a tracheostomy. It is inserted into the trachea and facilitates breathing.
- Intended Use: The intended use clearly states "to provide tracheal access for airway management." This is a direct intervention on the patient's body, not an analysis of a specimen.
- Device Description: The description details the physical components and function of the tube for airway management. There is no mention of analyzing biological samples.
The information provided clearly indicates that this is a surgical/respiratory medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pilling™ Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
Product codes (comma separated list FDA assigned to the subject device)
BTO
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheal
Indicated Patient Age Range
Adult
Intended User / Care Setting
Home and Clinical Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
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).
1
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.
2
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
3
Indications for Use
Indications for Use
Submission Number (if known)
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
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
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 | ||
| Tubes, Silvervent | Pilling™ Tracheostomy | ||
| Tubes | Identical | ||
| 510(k) Number | K123699 | K233713 | N/A |
| Device | |||
| 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
Tubes are intended to
provide tracheal access
for airway management
of tracheostomized
patients. | Pilling™ Tracheostomy
Tubes are intended to
provide tracheal access
for airway management
of tracheostomized
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
Characteristics | Metallic, uncuffed
tracheostomy tube | Metallic, uncuffed
tracheostomy tube | Equivalent |
| Prescription Use | Yes | Yes | Identical |
| Patient
Population | Adult | Adult | Identical |
| Use
Environment | Home and Clinical Use | Home and Clinical Use | Identical |
| Single/Multiple
Use | Multiple Use, Single
Patient | Multiple Use, Single
Patient | Identical |
| Reprocessing | Reprocess per IFU
cleaning instructions. | Reprocess per IFU
cleaning instructions | Equivalent |
| Options | Available fenestrated or
non-fenestrated
Available with or
without 15mm adapter | Available fenestrated or
non-fenestrated
Available with or
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.