(89 days)
To provide a means to access the frontal, sphenoid and maxillary sinuses, for diagnostic and therapeutic procedures in adults aged 18 and over.
Entellus Medical Sinus Guidewire is a 0.035" – compatible guidewire with a flexible angled radiopaque distal tip. It is constructed of nickel titanium alloys, stainless steel, and features a polymer coating.
The provided document is a 510(k) summary for the Entellus Medical Sinus Guidewire, a Class I manual surgical instrument. For such devices, the regulatory approval process often focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive, detailed clinical trials with acceptance criteria and statistical performance measures typically seen with higher-risk devices or software.
Based on the information provided, here's a breakdown of the requested data:
Acceptance Criteria and Device Performance
A formal table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy, etc.) is not explicitly provided in the 510(k) summary for clinical performance metrics. The submission focuses on demonstrating substantial equivalence through technological characteristics and design verification testing.
Instead of clinical performance metrics, the "Performance Data" section states: "Performance testing showed that the device meets design specifications and performed as intended."
The key evaluation for this device appears to be:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets design specifications. | Device meets design specifications. |
| Device performs as intended (utility in sinus spaces). | Device performed as intended. |
| Device comparable in design, function, materials, biocompatibility, packaging, and sterilization to predicate devices. | Device is comparable in these aspects to predicate devices. |
Study Details
The specific "study" that proves the device meets the (implied) acceptance criteria is described as:
- Design Verification Testing: This included simulated use and compatibility testing.
- Cadaver Study: This was conducted "to support the utility of this device in the sinus spaces."
Here's the breakdown of other requested information:
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for either the design verification testing or the cadaver study. The cadaver study would involve a sample of human cadavers, but the number is not given.
- Data Provenance: The cadaver study would be prospective in nature, as it involves active testing of the device. The geographical origin of the cadavers or the testing facility is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given the nature of a manual surgical guidewire, ground truth in a cadaver study would likely involve direct observation by surgeons or anatomical experts during the procedure, but their number and qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Clinical adjudication methods are typically used for more subjective assessments or where a definitive "answer" needs to be established from multiple reviewers, which doesn't seem to be the primary evaluation method for a simple guidewire in a cadaver study.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/radiological imaging devices, not for a manual surgical guidewire.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the cadaver study, the ground truth for "utility in the sinus spaces" would implicitly be established through direct observation and assessment by surgical or anatomical experts during the cadaver procedures. There is no mention of pathology or outcomes data in this context.
8. The sample size for the training set:
- This device is not an AI/ML device that requires a "training set." The concept of a training set is not applicable.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
In summary, the K110739 submission primarily relies on demonstrating substantial equivalence to predicate devices and verifying that the device meets its design specifications through engineering and cadaver testing, rather than extensive clinical efficacy studies with detailed performance metrics and ground truth establishment typically required for higher-risk devices or those with complex diagnostic/therapeutic functions.
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.