(60 days)
The RELIEVA ULTIRRA® Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic 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. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.
The RELIEVA ULTIRRA® Sinus Balloon Catheter may be utilized in conjunction with TruDi™ NAV Wire and TruDi™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. It is NOT intended to irrigate from within a target sinus for therapeutic procedures nor to facilitate diagnostic procedures with TruDi™ NAV Wire.
The RELIEVA ULTIRRA® Sinus Balloon Catheter is a flexible catheter that is intended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon and permits the passage of an electromagnetic navigable sinus guidewire or sinus illumination system to facilitate access to the target sinus ostia. A hypotube is incorporated on the proximal end to provide rigidity during insertion through a sinus guide catheter.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Simulated Use Testing | Met all performance acceptance criteria |
| Dimensional Specifications | Met all performance acceptance criteria |
| Balloon Burst Pressure | Met all performance acceptance criteria |
| Joint Separation Force | Met all performance acceptance criteria |
| Deflation Time | Met all performance acceptance criteria |
| Balloon Cycle Fatigue | Met all performance acceptance criteria |
| Shelf Life | Established per ASTM F1980-07, ASTM F88/F88M-09, ISTA 2A, and ASTM F2096-11 requirements. |
| Biocompatibility | Biocompatible per ISO 10993-1. |
| Sterilization Assurance Level (SAL) | 10^-6, validated per AAMI/ANSI/ISO 11135:2014 (overkill/half-cycle approach in a fixed chamber). |
| Ethylene Oxide Residuals | Met ISO 10993-7:2008 requirements. |
| Packaging Shelf Life | Established per ASTM F1980-07. |
2. Sample Size for Test Set and Data Provenance
The document states, "Clinical data was not necessary for the RELIEVA ULTIRRA® Sinus Balloon Catheter." This indicates that no clinical test set was used, and therefore no sample size or data provenance for a clinical test set is applicable. The evaluation was based on non-clinical performance testing.
3. Number of Experts and Qualifications for Ground Truth
Since no clinical data or human-in-the-loop performance was performed for this 510(k) submission, the concept of "experts used to establish ground truth" is not applicable in the context of evaluating diagnostic accuracy or clinical decision-making. The ground truth for the non-clinical performance tests would be the established engineering and materials standards and specifications. Engineers and technicians with expertise in medical device testing would have established and verified these.
4. Adjudication Method for Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The submission explicitly states "Clinical data was not necessary."
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a manual surgical instrument (catheter), not an algorithm or AI system. The performance studies conducted were non-clinical, evaluating the physical and mechanical properties of the device.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance data was based on established engineering standards, material specifications, and regulatory requirements (e.g., ISO, ASTM standards) for medical device performance (e.g., burst pressure, fatigue, biocompatibility, sterilization).
8. Sample Size for Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The device's design and manufacturing processes are developed and refined through engineering principles and iterative testing, not through data-driven training sets as understood in AI systems.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set in this context. The "ground truth" for the device's development and manufacturing would be its intended function, design specifications, and relevant industry standards.
§ 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.