(133 days)
The Vapocoolshot Mist is intended for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Vapocoolshot Mist is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts, and abrasions).
The Vapocoolshot Mist is a Vapocoolant (skin refrigerant) canister with an accessory nozzle that is intended for instant topical anesthetic. The Vapocoolshot Mist allows for the ease of use for a rapid, targeted, comfortable misting action of the refrigerant (cold like ice) onto the skin surface. Vapocoolshot Mist is prescription device designed to deliver a standard mixture 245fa (1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) mist spray that will provide a transient refrigerant action. This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The Vapocoolshot's nozzle, device's delivery system, controls the amount of the vapocoolant mixture that is dispensed. The mist spray configuration produces very fine droplets that create cooling at the points of contact. The Vapocoolshot produces a mist that contacts the skin surface at a targeted location. The skin is cooled through rapid evaporation of the non-medicated propellants.
This document describes a 510(k) submission for the Vapocoolshot Mist, a topical refrigerant. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily "Gebauer's Pain Ease" (K172028) and "Ouchless" (K093951).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on comparative equivalence to predicate devices across various characteristics. The "reported device performance" is framed as demonstrating similarity or equivalence.
| Characteristic / Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials compatible for indirect contact; gas blend approved for clinical use. | Device has "Indirect Contact." Gas blend approved. Materials compatible. |
| Chemical Composition | Identical aerosol profiles as predicates (95% 245fa, 5% 134a). | Aerosol profile checked and verified upon receipt to ensure the same as primary predicate. |
| Structural and Parts Composition | Canisters, valves, caps equivalent to Gebauer; overall device equivalent to Ouchless. | Engineering measurements and visual inspections confirmed equivalence to Gebauer (canisters, valves, caps) and Ouchless (overall device). |
| Directions for Use (DFU) | Similar intended use, precautions, warnings, contraindications, and treatment regimen to predicates. | All key elements of DFU similar to Gebauer and Ouchless. No significant differences. |
| Temperature Output | Similar temperature output at application surface as Gebauer. | Comparative performance testing demonstrated equivalent results. |
| Volume Dispensed | Similar volume dispensed per actuation/total as Gebauer. | Comparative performance testing demonstrated equivalent results. |
| Stability and Shelf Life | Identity, strength, quality, and purity maintained throughout labeled dating period under controlled and accelerated conditions. | Stability protocol developed; testing confirmed all requirements met established acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for specific test sets in a numerical fashion (e.g., number of patients or devices tested). Instead, it refers to "engineering verification measurements" and "comparative performance testing."
- Sample Size: Not specified quantitatively.
- Data Provenance: The studies appear to be retrospective bench testing and engineering comparisons rather than prospective clinical trials with human subjects. The details about data origin (e.g., country) are not provided, but given the submission is to the FDA, it is implied to be relevant to U.S. regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish "ground truth" in the context of clinical outcomes or diagnostic accuracy. The testing performed is focused on comparative engineering and chemical composition, for which ground truth is established by measurement and analytical methods, not typically by expert consensus of a specific number of clinicians.
4. Adjudication Method for the Test Set
Not applicable. The reported studies are bench tests and engineering comparisons, not studies requiring adjudication of clinical or diagnostic outcomes by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the nature of this device or its reported testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The Vapocoolshot Mist is a physical device that delivers a topical refrigerant, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" in this context is based on:
- Chemical Analysis: Chromatographic or other analytical methods to determine the exact composition of the vapocoolant.
- Engineering Specifications and Measurements: Physical measurements of device components, discharge characteristics (temperature, volume), and adherence to design specifications.
- Regulatory Standards: Compliance with established safety and efficacy standards for medical devices and comparison to legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML product, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
N/A