(69 days)
KURZ precious metal tympanostomy tubes are intended to provide a means of aerating and draining the middle ear in patients with otitis media and to reduce the likelihood of recurrent postoperative middle ear infections for the duration in which the tube remains in situ.
The MINIMAL Ventilation Tube (Benz) has been designed for
- temporary ventilation of the middle ear in secretory otitis media in adult patients for whom paracentesis alone is not sufficient, yet retention time of conventional ventilation tubes would be too long.
- It can also effectively be applied in cases of narrow meatus, atrophic drum and post-tympanoplasty tube dysfunctions. Due to its tiny size (dia. 0.6 mm), insertion after tympanoplasty considerably reduces risk of permanent tympanum perforation.
Tympanic tubes are inserted into the eardrum (myringotomy) for drainage and temporary ventilation of the middle ear subsequent to acute otitis media.
Tympanic tubes with one or two eyes are designed to increase the retention time in the eardrum.
The substantially shortened passage of the DIABOLO reduces the length of the internal hollow cylinder and the smooth surface of the gold seems to diminish the risk of luminal occlusion.
MINIMAL Tympanic Ventilation Tube (Benz):
- Temporary ventilation of the middle ear in serous otitis media in adult patients.
- In cases of narrow meatus, atrophic drum or post tympanoplasty tube dysfunction. Due to its tiny size (Diameter 0.6 mm), insertion after tympanoplasty considerably reduces the risk of permanent perforation of the tympanum.
- Typical bobbin-shaped design made of gold-platinum, gold-plated silver, and titanium; with or without a wire for secure placement and removal. Internal diameter of Size 2 is min. 0.2 mm wider than that of most predicate devices (SE: Reuter Bobbin, Collar Button).
- Bobbin shape with unilateral eye extension of inner flange; made of gold-platinum alloy (SE: Spoon Bobbin, Shah Type Tube)
- Bobbin shape with bi-lateral eye extensions of inner flange; made of gold-platinum alloy (SE: Most T-Tubes)
- External flange is cone-shaped to reduce the length of the internal hollow cylinder; made of gold-platinum alloy (SE: Beveled Bobbin; Shepard Grommets)
- Narrow tube with sharpened end for insertion without prior paracentesis. Material: gold-plated stainless steel (1.4301).
The devices are implants for single patient use. They are sold in an individual sterile package in a sealed carton.
The provided text describes a 510(k) summary for various tympanostomy tubes manufactured by Heinz Kurz GmbH Medizintechnik. This document is a pre-market notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than presenting an independent study with acceptance criteria and device performance metrics in the typical sense for a novel AI/medical device.
Therefore, much of the requested information cannot be extracted directly from this document, as it pertains to a different type of regulatory submission (i.e., proving substantial equivalence to existing devices rather than proving a device meets specific performance criteria through a new study).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't define specific quantitative "acceptance criteria" and "reported device performance" in the way a clinical trial or performance study for a novel device would. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices. The performance is implied to be equivalent to these predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial equivalence to predicate devices in: | Device designs (bobbin-shaped, with/without eye extension, cone-shaped, narrow with sharpened end) are comparable to predicate devices. |
| - Indication for Use | Intended uses are consistent with predicate devices (aerating and draining the middle ear in otitis media, reducing recurrent infections; temporary ventilation for MINIMAL tube). |
| - Material | Materials (gold-platinum, gold-plated silver, titanium, gold-plated stainless steel) are comparable to predicate devices. |
| - Design features | Specific design features are described as analogous or improved versions (e.g., internal diameter of Tübingen Size 2 is 0.2mm wider than some predicates; DIABOLO's cone-shape reduces length). |
2. Sample Size for the Test Set and Data Provenance:
Not applicable. This is a 510(k) submission based on substantial equivalence, not a new clinical study with a "test set" in the context of device performance evaluation. The data provenance would be a comparison to existing devices on the market.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. There is no mention of a "test set" requiring ground truth established by experts in this type of submission. The ground truth, in a general sense, is the performance and safety profile of the predicate devices.
4. Adjudication Method:
Not applicable. No clinical study requiring an adjudication method for a test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is not mentioned or relevant to a 510(k) submission for tympanostomy tubes.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a physical medical implant, not an algorithm or AI.
7. Type of Ground Truth Used:
The ground truth used for this 510(k) submission is the established safety and effectiveness profile of the predicate devices already on the market. The submission aims to show that the new devices do not raise different questions of safety and effectiveness.
8. Sample Size for the Training Set:
Not applicable. There is no concept of a "training set" for physical medical devices in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reasons as above. The "ground truth" for the predicate devices' performance would have been established through their own regulatory pathways (e.g., prior 510(k) submissions, pre-market approvals, or market history).
Summary of the Study (Implied by 510(k) process):
The "study" informing the FDA's decision in a 510(k) is a comparison of the new device to existing predicate devices.
- Objective: To demonstrate that the Heinz Kurz GmbH Medizintechnik tympanostomy tubes are "substantially equivalent" to legally marketed predicate devices, meaning they have the same intended use and technological characteristics, or have different technological characteristics but do not raise new questions of safety and effectiveness and are as safe and effective as the predicate device.
- Methodology: Comparative analysis of design, materials, indications for use, and performance claims against established predicate devices (XOMED, XOMED-TREACE, Smith & Nephew Richards).
- "Acceptance Criteria": The FDA's acceptance of "substantial equivalence" is the ultimate acceptance criterion. This is based on a qualitative assessment of the similarities and differences, and a determination that any differences do not negatively impact safety or effectiveness.
- "Performance": The performance is implicitly assumed to be equivalent to that of the predicate devices based on comparable design and materials. For example, the MINIMAL Ventilation Tube (Benz) is compared in terms of indication to specific Xomed-Treace tubes. The document also highlights specific features like the Tübingen's wider internal diameter or the DIABOLO's reduced length, implying these are equivalent or minor improvements, not causing new safety issues.
§ 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.