(135 days)
The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
The Primed Tracheostomy Tubes consists of various types of tracheostomy tubes, e.g., Primedistom Cannulas w/wo cuff, Silver Cannulas, Priflex Cannulas, Silicone Cannulas (Primedi Silk), and Primedi Star Cannulas. The tracheostomy tubes are made of different materials and offer a variety of inner and outer diameters and varying lengths thus making it possible to meet the individual needs of a patient.
The Primed Tracheostomy Tubes can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without one or two inner cannulas. The accessories comprise different speaking valves as well as Humid Moist Exchangers (HME) and different types of filters.
The provided 510(k) summary for the Primed Tracheostomy Tubes (K120079) indicates that the device's substantial equivalence was established through performance data related to conformity with recognized international standards, rather than a clinical study comparing device performance against specific acceptance criteria. This means the submission primarily focuses on demonstrating that the device meets established engineering and material standards applicable to tracheostomy tubes.
Here's a breakdown based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 5356-1 (Anesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets) | Conforms to ISO 5356-1 |
| ISO 5366-1 (Anesthetic and respiratory equipment — Tracheostomy tubes — Part 1: General purpose tracheostomy tubes) | Conforms to ISO 5366-1 |
Explanation: The submission states, "The Primed Tracheostomy Tubes conform to ISO 5356-1 and ISO 5366-1." These ISO standards establish requirements for the design, dimensions, materials, and sterile packaging of tracheostomy tubes and their connectors to ensure safety and performance. By conforming to these standards, the manufacturer asserts that their device meets the internationally recognized safety and performance benchmarks for this type of medical device.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. Since the submission relies on conformity to international standards (ISO), the "test set" would likely refer to engineering and material tests performed on samples of the manufactured tracheostomy tubes. The data provenance would be internal laboratory testing by the manufacturer or a certified testing facility, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. For standard conformity testing, the "ground truth" is the specifications and testing methods defined by the ISO standards themselves. The experts involved would be engineers and technicians performing the tests according to the standard's protocols, not medical experts establishing clinical ground truth.
4. Adjudication Method for the Test Set
This information is not provided. As explained above, the "test set" refers to engineering and material testing, not a clinical study with human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess the AI's impact on diagnostic accuracy. Tracheostomy tubes are mechanical devices for airway management and do not typically involve this kind of comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance assessment was not done. This concept applies to AI/software as a medical device (SaMD) where an algorithm provides a diagnosis or outcome without direct human interpretation. Tracheostomy tubes are physical medical devices, not algorithms.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by conformity to established international engineering and material standards (ISO 5356-1 and ISO 5366-1). This is not
expert consensus, pathology, or outcomes data in the clinical sense, but rather adherence to predefined technical specifications and performance characteristics.
8. The Sample Size for the Training Set
This information is not applicable and not provided. Tracheostomy tubes are physical devices, and their development does not involve "training sets" in the context of machine learning. The design and manufacturing processes are guided by engineering principles and standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reasons as #8. The "ground truth" for the design and manufacturing of the device is rooted in established engineering specifications and international standards, which are developed through expert committees and consensus over time, not through data labeling for a "training set."
In summary: K120079 is a 510(k) for a physical medical device (tracheostomy tubes). The demonstration of substantial equivalence relies on proving that the device has the same intended use, materials, and functional specifications as predicate devices, and importantly, conforms to relevant international standards (ISO 5356-1 and ISO 5366-1). This type of submission typically uses engineering and bench testing to demonstrate compliance with these standards, rather than clinical studies involving patient data or AI performance assessments.
§ 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.