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510(k) Data Aggregation
(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 < 24 hours must be safe and not cause adverse biological reactions. (Per ISO 10993-1, specific limits for cytotoxicity, sensitization, irritation/intracutaneous reactivity). | Evaluation conducted per FDA Bluebook Memorandum #G95-1 and ISO 10993-1. Cytotoxicity, Sensitization, and Irritation/Intracutaneous reactivity tests were conducted, and the device "complies with ISO 10993". |
| Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶ and Ethylene Oxide (EtO) residuals meeting ISO 10993-7 requirements. | Validated per AAMI/ANSI/ISO 11135 with an SAL of 10⁻⁶ using the overkill (half-cycle) approach. EtO residuals met ISO 10993-7 requirements. |
| Packaging & Shelf Life | Package integrity maintained throughout the shelf life; product stability and functionality maintained over time. (Specific standards: ISO 11607, ASTM 1980, ASTM D 999, ASTM D 5276). | Packaging validation per ISO 11607. Shelf life validation per ASTM 1980 & ISO 11607. Transportation Study per ASTM D 999 & ASTM D 5276. Studies were conducted to ensure package integrity throughout shelf life. |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes used for the mechanical tests, biocompatibility tests, sterilization validation, or packaging/shelf life studies. It mentions "Simulated use testing was performed" for mechanical tests, implying lab-based testing. There is no information provided regarding the provenance (country of origin, retrospective or prospective) of any data beyond what's implied by the tests being conducted by Meril Life Sciences Private Limited in India.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not provided in the document. The device is a physical surgical instrument, not an AI/ML-driven diagnostic or image analysis tool that would require expert-established ground truth for its performance evaluation. The "ground truth" here would be established by physical measurements and compliance with engineering and biological standards.
4. Adjudication method for the test set
This information is not applicable and therefore not provided in the document for the reasons stated in point 3.
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
No such study was done or reported. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided in the document, as the device is a physical surgical instrument and does not involve AI algorithms.
7. The type of ground truth used
The "ground truth" for this device's evaluation is primarily based on:
- Engineering specifications and standards: For mechanical tests (e.g., measurements, burst pressure, material properties).
- Biological standards: For biocompatibility (e.g., ISO 10993 series).
- Sterilization standards: For sterility assurance (e.g., AAMI/ANSI/ISO 11135).
- Packaging and shelf-life standards: For integrity and stability (e.g., ISO 11607).
These are established scientific and regulatory benchmarks, rather than expert consensus, pathology, or outcomes data in the context of clinical decision-making.
8. The sample size for the training set
This information is not applicable as there is no "training set" in the context of this traditional manual surgical instrument.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this device.
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