(117 days)
The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.
The ENTrigue® Sinus Dilation System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.
The ENTrigue® Sinus Dilation System consists of a disposable balloon which is mounted on a reusable delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic quidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to quide the device to the sinus ostium using endoscopic visualization.
The ENTrigue® Sinus Balloon Dilation Balloon and inflation device are individually packaged and provided sterile for single use only. The delivery instrument is a reusable instrument which must be sterilized prior to use following the recommended and validated cleaning and sterilizing procedures.
The provided text describes a 510(k) submission for the ENTrigue® Sinus Dilation System, focusing on its substantial equivalence to a predicate device. The information available pertains to the device's technical characteristics and the claim of equivalence, rather than a detailed clinical study with specific acceptance criteria and performance metrics typically found in efficacy trials.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not detail specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) for the ENTrigue® Sinus Dilation System in a typical clinical study format. Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool.
The primary "acceptance criterion" in this context is that the ENTrigue® Sinus Dilation System is "as safe and effective" as the predicate device. The performance data presented are qualitative and based on comparing technological characteristics and intended use.
Acceptance Criteria (Implicit for Substantial Equivalence):
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Intended Use | The ENTrigue® Sinus Dilation System has the same intended uses as the predicate device (access, examine, or treat nasal and paranasal tissues leading to ostia). | The ENTrigue® Sinus Dilation System's intended use is consistent with the predicate. |
| Indications for Use | The ENTrigue® Sinus Dilation System has similar indications for use as the predicate device (access and treat frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach). | The ENTrigue® Sinus Dilation System's indications for use are similar to the predicate. |
| Technological Characteristics | The ENTrigue® Sinus Dilation System has similar design, materials, and principles of operation to the predicate device. Minor technological differences do not constitute differences in fundamental scientific technology. | The ENTrigue® Sinus Dilation System consists of a disposable balloon mounted on a reusable delivery instrument for dilation, similar to the predicate's description. The document states "The ENTrigue® Sinus Dilation System has the same intended uses and similar indications, technological characteristics (design, materials), principles of operation, packaging and sterilization (EtO) as the predicate device." |
| Performance Data (Functional Equivalence) | Bench and cadaveric testing, featuring multiple users, was conducted to validate that the instrument design met user requirements and confirmed that the ENTrigue® Sinus Dilation System is substantially equivalent to the legally marketed predicate device. This implies the device functions reliably and safely for its intended purpose. | "Bench and cadaveric testing, featuring multiple users, was conducted to validate that the instrument design met user requirements and confirmed that the ENTrigue® Sinus Dilation System is substantial equivalent to the legally marketed predicate device..." "In all instances, the ENTrigue® Sinus Dilation System functioned as intended and the results observed were as expected." |
| Biocompatibility, Sterilization, Packaging, Distribution, Shelf Life | These aspects were tested to ensure the device is safe and effective in these areas, comparable to the predicate. | Biocompatibility, sterilization, packaging, distribution, and shelf life testing were submitted. "In all instances... the results observed were as expected." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "Bench and cadaveric testing, featuring multiple users." It does not specify the exact number of cadavers or the number of components tested for bench testing. It also doesn't specify the number of "users" (presumably surgeons) involved.
- Data Provenance: The provenance (e.g., country of origin, retrospective/prospective) is not specified. It is likely prospective testing specifically conducted for this 510(k) submission, given the nature of bench and cadaveric studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document refers to "multiple users" for the cadaveric testing. It does not specify the number or qualifications of these users/experts. It can be inferred that these would be medical professionals (e.g., ENT surgeons) experienced in sinus dilation procedures, as the testing was to validate "user requirements."
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method. The testing appears to be functional validation and comparison, rather than a scenario requiring multiple expert opinions for ground truth establishment. The focus is on the device's operational performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done as described in the provided text. The submission focuses on substantial equivalence through bench and cadaveric testing, not a clinical trial comparing human reader performance with and without AI assistance. This device is a surgical instrument, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable as the ENTrigue® Sinus Dilation System is a physical surgical instrument, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that it is the device itself being evaluated for its physical function, guided by a human surgeon.
7. The Type of Ground Truth Used:
- For the bench testing, the "ground truth" would be engineering specifications and expected functional performance.
- For the cadaveric testing, the "ground truth" would be the successful and safe execution of the intended surgical procedures (e.g., successful dilation of ostia as observed by the "multiple users" for meeting "user requirements"), demonstrating physical interaction with anatomical structures. This is essentially expert observation and assessment of procedural success and device functionality in a simulated environment.
8. The Sample Size for the Training Set:
- This question is not applicable. The ENTrigue® Sinus Dilation System is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI models. This type of device is developed and validated through engineering design, material science, and functional testing, not through data-driven training.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reason as point 8.
§ 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.