Search Results
Found 1 results
510(k) Data Aggregation
(60 days)
ARTHROCARE NASASTENT CMC NASAL DRESSING
The ArthroCare NasaStent is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. NasaStent is constructed from absorbent CarboxyMethyl Cellulose (CMC) material.
NasaStent is a dissolvable polysaccharide intranasal splint made from plant-based CarboxyMethyl Cellulose (CMC). As it absorbs nasal fluids, it turns into a hydrocolloidal gel that naturally drains from the nasal cavity within several days.
The ArthroCare NasaStent™ CMC Nasal Dressing is a Class I device, and its 510(k) submission (K140992) indicates that no clinical studies were necessary to demonstrate its safety and effectiveness. Instead, the submission relies on bench testing to establish substantial equivalence to predicate devices.
Here's an analysis based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalency through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (conformance to ISO 10993-1) | Biocompatibility testing according to ISO 10993-1 was conducted. (Assumed to have met acceptance criteria, though no specific results are provided). |
| Packaging Validation | Packaging validation was conducted. (Assumed to have met acceptance criteria). |
| Equivalency in Resiliency to Predicate Devices | Equivalency testing with respect to resiliency was conducted. (Assumed to have met acceptance criteria and demonstrated equivalence). |
| Equivalency in Hygroscopic Characteristics to Predicate Devices | Equivalency testing with respect to hygroscopic characteristics was conducted. (Assumed to have met acceptance criteria and demonstrated equivalence). |
| Equivalency in Form Retention to Predicate Devices | Equivalency testing with respect to form retention was conducted. (Assumed to have met acceptance criteria and demonstrated equivalence). |
| Conformance to design specifications | Evaluated under a number of bench studies to assure safety, efficacy, and conformance to design specifications. (Implied that the device conformed to design specifications). |
| Substantial Equivalence to Predicate Devices (CogENT, NexPak, Nasopore) in terms of indications for use, device operation, technical and functional capabilities, design, principle of operation, and raising no new questions of safety or effectiveness. | "NasaStent shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices for use as a space-occupying stent/packing for nasal/sinus use. Additionally, comparative performance test data demonstrated adequate device performance." |
| "NasaStent is substantially equivalent to the predicate CogENT, NexPak, and Nasopore nasal splints in terms of design, principle of operation, and indications for use and raises no new questions of safety or effectiveness." |
2. Sample Size and Data Provenance (Test Set)
No clinical test set was used for this 510(k) submission. The evaluation was based entirely on bench testing. Therefore, there is no information regarding sample size for a test set or data provenance (country of origin, retrospective/prospective).
3. Number of Experts and Qualifications (Ground Truth for Test Set)
Not applicable as no clinical test set requiring expert ground truth was utilized.
4. Adjudication Method (Test Set)
Not applicable as no clinical test set was utilized.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. The product is a physical device (intranasal splint), not an AI algorithm, and therefore the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used (for studies that were performed)
For the bench tests that were performed, the "ground truth" would be established by validated engineering specifications, industry standards (e.g., ISO 10993-1), and comparative performance against the established characteristics of the predicate devices. The document implies that the device met these engineering and performance benchmarks.
8. Sample Size for the Training Set
Not applicable. As a physical device evaluated via bench testing, there is no "training set" in the context of an algorithm. The "training" for the device would have been its design and manufacturing processes, which are not detailed in terms of sample sizes for this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no "training set" in the algorithmic sense. The design and manufacturing would be based on established engineering principles and medical needs for intranasal splints.
Ask a specific question about this device
Page 1 of 1