(28 days)
FinESS is indicated to access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
The access sheath component of the FinESS Sinus Treatment System is comprised of a polycarbonate flange that is over-molded on a stainless steel fluted tube which, when mated with the trocar provided in the kit, gains access to the maxillary sinus. Once the trocar is removed, the access sheath allows delivery of the FinESS cannula, endoscope and balloon catheter.
The FinESS™ Sinus Treatment Access Sheath (K091681) did not have specific acceptance criteria for performance defined by clinical studies. Instead, its acceptance was based on a demonstration of substantial equivalence to a predicate device through non-clinical testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Properties | Biocompatibility of new material (grey polycarbonate) | Biocompatibility of the new material (grey polycarbonate) was "completed." (This implies it met the necessary standards, though specific values are not provided). |
| Mechanical Properties | Outer profile of the modified access sheath | Assessed. (Implies satisfactory, though details are not provided). |
| Fit of the trocar to the sheath | Assessed. (Implies satisfactory, though details are not provided). | |
| Tensile strength of the overmolded component | Assessed. (Implies satisfactory, though details are not provided). | |
| Torque strength of the overmolded component | Assessed. (Implies satisfactory, though details are not provided). | |
| Clinical Performance | No clinical performance acceptance criteria were established or met as "No clinical evaluations were conducted." | No clinical evaluations were conducted. The device was deemed substantially equivalent based on non-clinical testing and comparison of indications for use and device technology with the predicate. |
| Substantial Equivalence | Equivalence to the existing access sheath in the FinESS Sinus Treatment System based on indications for use and technology. | The modified access sheath is shown to be substantially equivalent to the existing access sheath included in the FinESS Sinus Treatment System based on a comparison of indications for use and device technology. This was the overarching "acceptance criterion" for market clearance. |
2. Sample Size for Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. No clinical test set was used for performance evaluation. Non-clinical testing was performed on device components, but the sample sizes for these tests are not specified in the summary.
- Data Provenance: Not applicable for a clinical test set. The non-clinical test data provenance is not detailed (e.g., in-house lab, third-party lab).
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. No clinical evaluations were conducted, thus no expert-established ground truth for a test set was required.
4. Adjudication Method for Test Set:
- Not applicable. No clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states, "No clinical evaluations were conducted." Therefore, no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a manual surgical instrument, not an algorithm or AI-driven system. Therefore, a standalone algorithm performance study was not conducted.
7. Type of Ground Truth Used:
- Not applicable for clinical performance. For the non-clinical tests, the "ground truth" would be established by engineering specifications, material standards, and validated test methods to ensure the device met its design requirements.
8. Sample Size for Training Set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How Ground Truth for Training Set Was Established:
- Not applicable.
Summary of Study that Proves Device Meets Acceptance Criteria:
The study that "proves" the device meets its acceptance criteria is a summary of non-clinical testing. This testing focused on:
- Assessments of the outer profile
- Fit of the trocar to the sheath
- Tensile strength of the overmolded component
- Torque strength of the overmolded component
- Biocompatibility of the new material (grey polycarbonate)
The conclusion of this non-clinical testing, in conjunction with a comparison of the device's indications for use and technology to the predicate device (FinESS Sinus Treatment (K073202)), led to the Statement of Equivalence. This statement asserts that "The modified access sheath is shown to be substantially equivalent to the existing access sheath included in the FinESS Sinus Treatment System based on a comparison of indications for use and device technology."
Therefore, the device was deemed acceptable and received 510(k) clearance based on its substantial equivalence to a legally marketed predicate device, supported by non-clinical device characteristic testing rather than clinical performance data.
§ 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.