(261 days)
The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.
The MADgic™ Laryngo-Tracheal Mucosal Atomization Device is a disposable nonsterile device that converts a solution of topical anesthetic into a fine particle spray for application to mucosal surfaces. The device consists of an atomizer tip, a semirigid tubular extension, a standard luer lock adapter and a syringe. The clinician draws up the desired volume of topical anesthetic into the syringe, attaches it to the luer lock fitting of the atomizer, and manipulates the tubing extensions into the desired position. As the syringe plunger is compressed, the anesthetic is forced into the tubular extension and out of the atomizer tip. The tip takes the pressurized fluid column and begins spinning it, allowing the fluid to exit the small hole at the end in a cone shaped spray. The anesthetic mist is gently distributed onto the mucosal surface in front of this tip. Topical anesthesia application can begin in the mouth and pharynx, and then proceed to the hypopharynx, epiglottis and vocal cords, larynx and trachea via direct visualization using a laryngoscope.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MADgic™ Laryngo-Tracheal Mucosal Atomization Device:
Device: MADgic™ Laryngo-Tracheal Mucosal Atomization Device
FDA 510(k) Number: K153470
Predicate Device: MADgic™ Laryngo-Tracheal Mucosal Atomization Device (K002255)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity - L929 MEM Elution Assay | Grade of 0, 1, or 2 (not more than 50% of cells are round, devoid of intracytoplasmic granules, and no extensive cell lysis) | Acceptable |
| Sensitization - Kligman Maximization Assay | Difference between test article mean score and vehicle control mean score is 1.0 or less (non-irritant). | Acceptable |
| Irritation - Intracutaneous Injection Assay | Grade of 1, 0 or less using the Kligman scoring system. | Acceptable |
| Performance Data (Non-Clinical) | ||
| Visual Inspection | Proper assembly, presence of all components, no cracks in tip and luer, no short shots in molded components, solvent presence around bonding surface covering minimum one third total area, no gaps between insert post and tubing. | Pass |
| Flow Test | Flow rate ≥ 225 sccm and ≤ 700 sccm. | Pass |
| Leak Test | Leak value ≤ 0.05 psi. | Pass |
| Hydrostatic Test | Device must remain assembled after being subjected to a minimum 300 psi hydrostatic pressure. | Pass |
| Atomization Test Post Hydrostatic | No streaming, no excessive dripping, or occlusions upon atomization. | Pass |
| Tensile | Tensile strength ≥ 6.0 lb. | Pass |
| Specification Verification (Not direct performance, but conformance) | ||
| Typical Particle Size | 30-100 microns | N/A. Specification Study. |
| System Dead Space | MAD600/600OS = 0.24mL; MAD700-730/730OS = 0.18mL; MAD720 = 0.12mL | N/A. Specification Study. |
| Tip Diameter | 0.19 inches (4.8 mm) | N/A. Specification Study. |
| Applicator Length | MAD600/6000S/700 = 8.9 inches; MAD720/730/730OS = 4.9 inches | N/A. Specification Study. |
| Conical Fittings with 6% Taper | Clauses 4.1-4.1 of ISO 540-2:1998 | Certificate of Conformance from the Supplier |
| Sterile Hypodermic Syringes of Single Use | ISO 7886-1:1993 | Certificate of Conformance from the Supplier |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the biocompatibility or performance tests. The data provenance is not explicitly mentioned, but these are all non-clinical, bench-top tests conducted to verify product specifications and safety, likely performed internally by the manufacturer (Teleflex Medical). No human or animal data is described for these tests; they are related to material properties and device functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the described tests are non-clinical and do not involve expert interpretation or human ground truth. They are objective measurements against defined chemical, physical, and engineering criteria.
4. Adjudication method for the test set
This section is not applicable as the described tests are objective measurements against defined criteria, not subjective assessments requiring adjudication.
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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component to this device. This device is a manual, single-use medical device for topical anesthetic application.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is not an algorithm or AI-based system. It is a physical medical device.
7. The type of ground truth used
The "ground truth" for the biocompatibility tests is established by recognized international standards (ISO 10993-1) and specific grading scales (e.g., Kligman scoring system). For performance tests, the "ground truth" is the predefined quantitative and qualitative acceptance criteria based on engineering specifications and functional requirements. For specification verification, it's conformance to established international standards (e.g., ISO 540-2, ISO 7886-1) or internal product specifications.
8. The sample size for the training set
This section is not applicable as there is no training set mentioned for this type of device.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set described.
§ 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).