(231 days)
Temporary implant for ventilation and drainage of middle ear.
Temporary implant for ventilation or drainage of the middle ear.
The umbrella-type implant comes mounted on a tiny single-use trocar point. Its penetrating edge penetrates the tympanic membrane and simultaneously forms a passage to draw the ventilation tube into that passage at a controlled rate until the ventilation tube is implanted. The trocar is immediately withdrawn. The procedure requires the use of a specially designed trocar handle. The tubes are available with or without retention wires.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 77 ETD Trocar Ventilation Tube:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative or pass/fail format that would be typical for a device performance study. Instead, it justifies the device's safety and effectiveness through a comparison to a predicate device and by highlighting design modifications that are presented as improvements or at least not introducing new risks. Therefore, the "acceptance criteria" inferred here are based on the claims made about the device's design and its impact on the procedure and patient safety.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Safety: Device materials are safe and have a history of safe use. | Met: "The ventilation tube is provided in gilded silver or pure titanium. Both materials have a long history of safe and effective use. The trocar point and handle are manufactured of stainless surgical steel." "Testing in a 7.0 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating." |
| Effectiveness (Procedural Efficiency): Eliminates the need for prior paracentesis, leading to a shorter procedure. | Met: "Elimination of need for prior paracentesis. Simultaneous 1. incision of tympanic membrane and implant insertion. Considerably shorter procedure." (Compared to predicate device which requires "Insertion after prior paracentesis.") |
| Effectiveness (Secure Placement & Reduced Complications): Secure placement, precise cut, reduced incrustation, minimal trauma. | Met: "Secure placement due to precise cut. Reduced incrustation susceptibility due to clean and precise cut. Minimal trauma as considerably less invasive than traditional VT placement." "The precise cut and secure placement of the implant should reduce the risk of premature extrusion or dislocation. Reduced incrustation susceptibility due to clean and precise cut." "The simultaneous incision of the tympanic membrane/insertion of the tube significantly shortens the procedure while providing a controlled, precise cut for secure implant placement. This surgical technique should minimize patient trauma and reduce the risks of premature implant extrusion or dislocation." |
| No New Risks: Design modifications do not introduce new safety or effectiveness concerns. | Met: "The umbrella design of the ventilation tube comparable to many others on the market - introduces no new risks. There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants." "The results of design validation raise no new issues of safety and effectiveness." |
| Substantial Equivalence: Device is substantially equivalent to legally marketed predicate devices. | Met: The FDA's 510(k) clearance letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance
The document does not describe a specific clinical study with a test set of human subjects or data. The submission relies on a comparison to a predicate device and statements about the inherent properties of the materials and design. The only "testing" mentioned is MRI compatibility testing, which is a bench test, not a clinical study on a test set.
- Sample Size (Test Set): Not applicable, no clinical test set described.
- Data Provenance: Not applicable, no clinical data described beyond material properties and design rationale.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth for a test set is established as there is no clinical test set described. The evaluation is based on engineering design, material properties, and comparison to existing technology.
4. Adjudication method for the test set
Not applicable, as no test set or clinical study is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device, and no MRMC study or any clinical comparative effectiveness study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm, so standalone performance is not relevant in this context.
7. The type of ground truth used
The "ground truth" in this context is implicitly established by:
- Material properties and historical use: The safety of gilded silver, pure titanium, and surgical stainless steel is well-established through their long history of use in medical devices.
- Engineering design principles: Claims about precise cuts, secure placement, and reduced trauma are based on the mechanical design of the device and how it interacts with the tympanic membrane.
- Predicate device comparison: The substantial equivalence argument relies on the established safety and effectiveness of the existing K 973226 models.
- MRI compatibility testing: This bench testing provides "ground truth" for the device's behavior in an MRI environment.
8. The sample size for the training set
Not applicable, as no training set for a machine learning algorithm or clinical data for training is described.
9. How the ground truth for the training set was established
Not applicable, as no training set is described.
§ 874.3880 Tympanostomy tube.
(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.