(110 days)
The Relieva Solo Elite Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic 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 Relieva Solo Elite Sinus Balloon Catheter 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 Solo Elite 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 a 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. The subject device also has the capability to irrigate the sinus through the distal tip and three side holes on the distal end.
This is a 510(k) premarket notification for a medical device (Relieva Solo Elite Sinus Balloon Catheter), which typically demonstrates substantial equivalence to predicate devices rather than proving clinical efficacy or diagnostic accuracy with extensive human studies. Therefore, many of the requested elements for AI/device performance studies (like MRMC, expert consensus, training set details) are not applicable to this type of submission.
However, I can extract the relevant performance data and acceptance criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the Relieva Solo Elite Sinus Balloon Catheter met various performance acceptance criteria. While the specific numerical acceptance criteria values are not given, the categories of criteria and the confirmation that they were met are provided.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Specifications | Met all criteria |
| Balloon Burst Pressure | Met all criteria |
| Joint Separation Force | Met all criteria |
| Deflation Time | Met all criteria |
| Irrigation Flow Rate | Met all criteria |
| Balloon Cycle Fatigue | Met all criteria |
| Sterility (SAL 10^-6) | Met criteria (validated per AAMI/ANSI/ISO 11135-1: 2007) |
| Ethylene Oxide Residuals | Met ISO 10993-7:2008 requirements |
| Shelf Life | Established per ASTM F1980-07, ASTM F88/F88M-09, ISTA 2A-11, and ASTM F2096-04 requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). These are typically detailed in the test reports themselves, which are referenced but not included in this summary document. The tests conducted are primarily engineering performance tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device submission focuses on engineering performance and substantial equivalence, not diagnostic accuracy requiring expert panel review for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This device submission focuses on engineering performance tests, not clinical performance requiring adjudication.
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
Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic device, and no MRMC study is mentioned or relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be the established engineering standards and material specifications. For example:
- Dimensional Specifications: Engineering drawings and measurement standards.
- Balloon Burst Pressure: Material failure limits and design specifications.
- Sterility: Microbiological validation guidelines (e.g., AAMI/ANSI/ISO 11135-1).
- Ethylene Oxide Residuals: Toxicology standards (e.g., ISO 10993-7).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
§ 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.