(192 days)
The Medicant Mucosal Atomizer is intended for the application of topical anesthetics to the oropharynx and upper airway region.
The proposed device delivers the solution through the nasal passages, directly to the laryngo-tracheal region via a wand-like configuration of the device is placed inside an endotracheal tube for a directed spray. The device is offered in 3 configurations, all supplied with a 3 cc syringe.
Here's an analysis of the acceptance criteria and the study details for the Medicant Mucosal Atomizer, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for Medicant Mucosal Atomizer
The 510(k) summary for the Medicant Mucosal Atomizer does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it demonstrates substantial equivalence to a predicate device (MADgic Laryngo-Tracheal Mucosal Atomization Device, K153470) by comparing key performance characteristics. The acceptance criteria can be inferred from the reported performance of the predicate device, which the new device aims to match or be similar to.
Therefore, the table below presents the performance comparisons that serve as the de facto acceptance criteria for demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate Device Performance - K153470) | Reported Device Performance (Medicant Mucosal Atomizer) |
|---|---|---|
| Total Dose Delivered (from a 3ml syringe) | 2.8 ml saline | 2.9 ml saline |
| 2.8 ml lidocaine | 2.8 ml lidocaine | |
| Particle Size MMAD (μm) | 18.7 μm saline | 18.8 μm saline |
| 18.7 μm lidocaine | 18.7 μm lidocaine | |
| Plume Geometry | Similar | Similar |
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous (passed/non-toxic for predicate) | Cytotoxicity, Sensitization, Irritation, Particulate Material, Toxicology Risk Assessment (tested, found non-cytotoxic, non-sensitizers, non-irritant) |
| Delivery form | Fine mist spray | Fine mist spray |
| Indications for Use | Application of topical anesthetics to the oropharynx and upper airway region | Application of topical anesthetics to the oropharynx and upper airway region |
| Patient Population | Individuals requiring topical anesthetics at the direction and discretion of the clinician. (Initially narrowed for predicate, but reference device K070596 used for broader comparison) | Individuals requiring topical anesthetics at the direction and discretion of the clinician. |
| Environment of Use | Hospitals and clinical settings where topical anesthetic solutions are needed. | Hospitals and clinical settings where topical anesthetic solutions are needed. |
| Rx | Yes | Yes |
| Design | Single Patient, Disposable, Non-sterile | Single Patient, Disposable, Non-sterile |
| Components | Syringe, Flexible tube (4.5" and 8.5"), Atomizer tip/nozzle, Nasal cone | Syringe, Flexible tube (4.5" and 8.5"), Atomizer tip/nozzle, Nasal cone |
| Places Inserted | Nasal, Orotracheal | Nasal, Orotracheal |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical trials or AI algorithm validation. The performance data presented (e.g., total dose, particle size, plume geometry) are likely derived from laboratory bench testing focused on the physical characteristics of the device.
- Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for particle size).
- Data Provenance: This is not a clinical study. The data provenance is from non-clinical performance testing conducted on the device itself. Given that it's a 510(k) submission, this testing would have been conducted by the manufacturer, Medica Holdings, LLC. The country of origin for the data is not specified but is implicitly where Medica Holdings conducts its R&D and testing. This is a prospective set of tests designed to evaluate the new device against established benchmarks (the predicate).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable. The device is a medical applicator, not an AI or diagnostic device that requires expert-established ground truth from images or other complex data. The "ground truth" for its performance characteristics (e.g., particle size, dose delivery) is established through established laboratory measurement techniques and instrumentation.
4. Adjudication Method for the Test Set
This question is not applicable. As there is no "test set" requiring expert judgment or interpretation (like in imaging studies), no adjudication method was used or needed. Performance is measured objectively through physical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This type of study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is compared. The Medicant Mucosal Atomizer is a physical medical device (an applicator for topical anesthetics), not a diagnostic or AI-powered system, so an MRMC study was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This question is relevant for AI algorithms. The Medicant Mucosal Atomizer is a physical device, and therefore, no "algorithm only" performance was assessed.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests is based on objective physical measurements using scientific equipment and standardized test methods (e.g., particle size analyzers, flow meters for dose delivery). For biocompatibility, the ground truth is established by adherence to recognized standards like ISO 10993 (implied by the testing types: Cytotoxicity, Sensitization, Irritation).
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this device is not an AI algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
§ 868.5170 Laryngotracheal topical anesthesia applicator.
(a)
Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.(b)
Classification. Class II (performance standards).