(92 days)
When inserted through a myringotomy, a ventilation tube provides a passageway for movement of air between the auditory canal and the middle ear. The unobstructed passageway may also allow a means of drainage of fluids resulting from acute or chronic otitis media from the middle ear into the auditory canal. In addition, surgical placement of ventilation tubes also provides a means of equalizing air pressures between the outer ear and the middle ear and continued ventilation to prevent fluid accumulation within the middle ear.
The surgeon must use medical judgment and consider the patient's medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but not limited to:
- Chronic otitis media with effusion characterized as serous, mucoid, or purulent
- Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies
- A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus
- Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction
Medtronic® Xomed® Ventilation (tympanostomy) Tubes are small tubular implants available in a variety of biocompatible materials including silicone elastomer, fluoroplastic. C-FLEX® TPE. stainless steel and titanium. Numerous designs and sizes are available with single or multiple flanges to satisfy various surgical techniques for insertion and to facilitate short or long-term communication of the auditory canal with the middle ear. Some tubes are fitted with semi-permeable membranes intended to allow free passage of air while preventing movement of fluids into the middle ear.
The provided text describes a 510(k) premarket notification for "Ventilation (Tympanostomy) Tubes" by Medtronic Xomed, Inc. This submission is for consolidating previously cleared and preamendment ventilation tubes and claims substantial equivalence to predicate devices. As such, it does not contain information about a study to prove acceptance criteria for a new device or algorithm performance.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this document. This submission relies on the existing clearance and established performance of the predicate devices.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for devices that have already been cleared or were preamendment devices, meaning their performance and safety were established previously. No new performance acceptance criteria or study results are presented in this document. The document asserts "same" for all comparative characteristics with existing predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No new test set or data provenance is mentioned as no new performance testing was conducted for this 510(k). The document states, "The Ventilation (Tympanostomy) Tubes did not undergo any design changes as a result of this submission. Therefore no additional bench, animal or clinical testing is required."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No test set or ground truth establishment relevant to the performance of a new device is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or related adjudication method is mentioned.
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 device, and no MRMC study was conducted or referenced for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No new ground truth for performance evaluation is mentioned. The clearance is based on substantial equivalence to predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/algorithm device and thus has no training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/algorithm device and thus has no training set or associated ground truth establishment.
Summary of Relevant Information from the Document:
The document focuses on demonstrating substantial equivalence to existing predicate devices. The key argument is that the proposed Ventilation (Tympanostomy) Tubes are identical in intended use, indications for use, technological characteristics, and principle of operation to 12 previously cleared predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
Based on the document, the "acceptance criteria" appear to be meeting the characteristics of the predicate devices, thereby establishing substantial equivalence. The reported "performance" is implicitly that these devices function identically to the legally marketed predicates.
| Feature / Criterion | Subject Device (Medtronic Xomed Ventilation (Tympanostomy) Tubes) | Predicate Devices | Comparison / Outcome |
|---|---|---|---|
| Intended Use | Provides a passageway for air movement between the auditory canal and middle ear; allows drainage of fluids from otitis media; equalizes air pressures and prevents fluid accumulation. | Same as Subject Device | Same (Substantially Equivalent) |
| Indications for Use | Chronic otitis media with effusion (serous, mucoid, purulent); Recurrent acute otitis media failing alternative therapies; Persistent high negative middle ear pressure (with conductive hearing loss, otalgia, vertigo, tinnitus); Atelectasis from tympanic membrane retraction pocket or eustachian tube dysfunction. The surgeon must use medical judgment. | Same as Subject Device | Same (Substantially Equivalent) |
| Technological Characteristics (Materials) | Silicone elastomer, fluoroplastic, C-FLEX® TPE, stainless steel, titanium. Some fitted with semi-permeable membranes. | Various Materials: Silicone, Teflon, Titanium Stainless Steel, C-Flex, Silicone/Microgel, FEP, Fluoroplastic, Hydroxylapatite Coating from 12 listed predicate devices. | Same (Substantially Equivalent, encompassing the full range of materials already on market) |
| Technological Characteristics (Design/Sizes) | Small tubular implants, numerous designs and sizes available with single or multiple flanges. (ID: 0.76-1.65 mm; IFD: 1.09-9.80 mm; L: 1.06-13.40 mm) | Various Sizes (ID: 0.76-1.65; IFD: 1.09-9.80 L: 1.06-13.40 mm) | Same (Substantially Equivalent, covering the range of previously cleared sizes) |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same (Substantially Equivalent) |
| Principle of Operation | Surgically inserted in the tympanic membrane following myringotomy to provide a passageway for air movement between the auditory canal and the middle ear. | Surgically inserted in the tympanic membrane following myringotomy to provide a passageway for the movement of air between the auditory canal and the middle ear. | Same (Substantially Equivalent) |
| Performance Testing (Clinical, Bench, Animal) | "The Ventilation (Tympanostomy) Tubes did not undergo any design changes as a result of this submission. Therefore no additional bench, animal or clinical testing is required. A Literature Review is provided with post market surveillance data for these Ventilation Tubes." (Details of literature review not provided in the excerpt.) | Previously established performance and safety based on prior 510(k) clearances (listed in Section X) and preamendment status of predicate devices. Implied long-term successful use and safety profiles of the predicate devices. | The device meets the acceptance criteria by demonstrating substantial equivalence in all key characteristics to legally marketed predicate devices, negating the need for new performance studies. The prior clearances and post-market surveillance data of predicates serve as evidence of acceptable performance. |
§ 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.