Search Results
Found 1 results
510(k) Data Aggregation
(102 days)
RELIEVA SPIN SINUS DILATION SYSTEM
The Relieva Spin Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the Relieva Spin Sinus Dilation System is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
The Relieva Spins Sinus Dilation System is comprised of three components: Handle System, Sinus Guide Catheter Tip, and Sinus Balloon Catheter. The Handle System unites the various components into one device. A suction line is embedded in the Handle System which can be actuated by the user covering the suction port. The Sinu Guide Catheter Tip is a sinus guide catheter that is available in three shapes and attaches to the Handle System on the distal end. The Sinus Balloon Catheter is a flexible catheter with a balloon on the distal tip; one lumen is used for inflation of the sinus balloon and the second permits passage of a sinus guidewire. A hypotube is incorporated on the proximal end of the device to provide rigidity as the Sinus Balloon Catheter is advanced and retracted in the Handle System. There are several markers placed along the Sinus Balloon Catheter to aid in positioning under direct endoscopic visualization. A sinus guidewire is packaged with the Relieva Spin Sinus Dilation System.
This document describes the Relieva Spin Sinus Dilation System, a medical device, and its acceptance criteria as presented in a 510(k) summary. The information provided is for a device submission, not an AI or algorithm-based product. Therefore, several of the requested categories related to AI performance, such as MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for AI, are not applicable.
Here's an analysis based on the provided text for the medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|---|
| Dimensional | Met established specifications for dimensions. | Bench testing met all acceptance criteria. |
| Cycle Fatigue | Met established specifications for durability under simulated use. | Bench testing met all acceptance criteria. |
| Balloon Burst | Withstood specified inflation pressures without bursting. (e.g., > 12 ATM for maximum inflation pressure) | Bench testing met all acceptance criteria (implicitly > 12 ATM). |
| Joint Separation | Maintained integrity of device components during use. | Bench testing met all acceptance criteria. |
| Biocompatibility | Met biocompatibility standards for medical devices. | Testing showed that Spin is biocompatible. |
| Sterilization | Achieved a Sterility Assurance Level (SAL) of 10⁻⁶. | Sterilization process is validated per AAMI/ANSI/ISO 11135-1:2007 and demonstrated a sterility assurance level of 10⁻⁶. |
| Ethylene Oxide (EtO) Residuals | Met ISO 10993-7:2008 requirements. | EtO residuals were tested and meet ISO 10993-7:2008 requirements. |
| Packaging Shelf Life | Met relevant ASTM and ISTA standards for packaging integrity and shelf life. | Packaging shelf life was 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 describes bench testing, meaning the "test set" refers to the manufactured device units subjected to various physical and chemical tests. The sample sizes for these specific bench tests are not explicitly stated in the provided text.
- Data Provenance: The tests are conducted on manufactured devices in a laboratory setting, not patient data. The country of origin of the data is implicitly where Acclarent, Inc. conducts its testing, which is likely the USA given their address. All data is prospective as it's generated through controlled testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the "ground truth" for a physical medical device in bench testing is defined by engineering specifications, material science standards, and established regulatory guidelines (e.g., ISO, ASTM standards). It does not involve expert clinicians establishing ground truth on medical images or patient outcomes. The "experts" would be the engineers and scientists conducting and interpreting the tests, ensuring compliance with the defined standards.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for resolving discrepancies in expert interpretations of clinical data, especially in AI studies. For bench testing of a physical device, results are objectively measured against predefined pass/fail criteria.
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
This question is not applicable. This device is a physical medical instrument (sinus dilation system), not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. This device is a physical medical instrument; there is no algorithm for standalone performance.
7. The Type of Ground Truth Used
For this physical medical device, the "ground truth" is based on:
- Engineering Specifications: Pre-defined design parameters for dimensions, material properties, and performance limits.
- International and National Standards: Adherence to established standards like AAMI/ANSI/ISO 11135-1:2007 for sterilization, ISO 10993-7:2008 for EtO residuals, and ASTM/ISTA standards for packaging.
- Bench Testing Results: Objective measurements from physical tests (e.g., burst pressure, fatigue cycles, dimensional measurements).
8. The Sample Size for the Training Set
This question is not applicable. This device is not an AI system that requires a "training set" of data. Its performance is verified through physical bench testing on manufactured units.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1