(123 days)
Pilling™ Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
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.
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.
§ 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.