(119 days)
For use in injecting local anesthetics into a patient to provide regional anesthesia.
The Entellus Medical Reinforced Anesthesia Needle is a 3.5" long disposable medical device that allows the user to transnasally administer anesthetic solutions. The Reinforced Anesthesia Needle device is a 27 gauge needle with a reinforcing sleeve which supports the needle to reduce needle flex during administration of anesthetic solutions. A slight bend at the distal end of the needle is designed to improve access to nasal anatomy. The Quincke tip extends approximately 2 mm past the reinforcing sleeve creating a distal stop. The needle hub features a standard luerlock connector.
This document is a 510(k) premarket notification for a medical device called the Entellus Medical Reinforced Anesthesia Needle. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria with respect to a clinical outcome.
Therefore, much of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation (a clinical trial or a standalone performance study of an AI/diagnostic device).
However, I can provide what is present in the document about the performance data and the comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, it states that the device "meets design specifications and performed as intended" based on various engineering and biocompatibility tests. The "performance" here refers to meeting technical specifications rather than clinical efficacy metrics.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Meets ISO 10993-1 standards; included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, and pyrogen testing. |
| Sterilization Validation | Meets ISO 11137-1 standards. |
| Design Verification | Included dimensional, strength, and Human Factors Engineering & Usability Engineering (HFE/UE) testing. Meets design specifications. |
| Design Validation | Included HFE/UE testing. Performed as intended. |
| Packaging | Performance testing completed. |
| Shelf Life | Performance testing completed per ISO 594-2, ISO 9626, and ISO 7864. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The "test set" in this context refers to the samples used for the engineering, biocompatibility, and sterilization tests, not a clinical data set. The document does not specify the number of devices or units tested for each performance criterion.
- Data Provenance: Not applicable for clinical data. The tests are laboratory-based engineering and biocompatibility tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for these types of tests is typically established by laboratory standards and protocols (e.g., ISO standards), rather than expert medical consensus on patient cases.
4. Adjudication method for the test set
Not applicable. This is not a clinical study involving human judgment or adjudication of patient cases.
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 is not an AI/CAD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CAD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests conducted (biocompatibility, sterilization, dimensional accuracy, strength, HFE/UE) would be established by the relevant engineering and medical device standards (e.g., ISO, internal design specifications) rather than clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
Not applicable. This is not an AI/CAD device, and therefore no "training set" in the context of machine learning was used.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).