(92 days)
MESIRE™ - Balloon Sinus Dilatation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
The MESIRE™ - Balloon Sinus Dilatation System consists of following components. It is available as an integrated system or individual components.
- MESIRE™ Sinus Balloon Catheter
- MESIRE™ Guide - Sinus Guide Catheter
- MESIRE™ Illuminus Sinus Light Wire
- MESIRE™ Latch Catheter Holding System
The MESIRE™ - Balloon Sinus Dilatation System is a Class I device and the provided documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with specific performance metrics against acceptance criteria that are typically seen for higher-risk devices or software.
Based on the provided text, the acceptance criteria and the study demonstrating the device meets them can be summarized as follows:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or reported device performance in a comparative table format. Instead, it states that "The following testing demonstrated that Mesire™ Balloon Sinus dilatation System effectively dilated the sinus." It then lists various mechanical tests, biocompatibility tests, sterilization validation, and packaging/shelf life studies. The results are generally described as "demonstrated" or "complies with/meets requirements", implying successful achievement of pre-defined criteria for each test.
| Category | Acceptance Criteria (Implicit from testing) | Reported Device Performance |
|---|---|---|
| Mechanical Tests | The device should effectively dilate the sinus and maintain structural integrity and functionality under simulated use conditions. Specific criteria for each test (e.g., maximum pressure, inflation/deflation times, bond strength, flexibility, kink resistance, absence of leakage, visual inspection standards, dimensional tolerances, burst pressure, fatigue resistance, refoldability). | "The following testing demonstrated that Mesire™ Balloon Sinus dilatation System effectively dilated the sinus." All listed mechanical tests were performed, and the device presumably met the internal specifications. |
| Biocompatibility | The device materials in contact with mucous membrane for |
§ 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.