(164 days)
PainFreeze II Medium Stream and Mist Spray are vapocoolants (skin refrigerants) intended for topical op skin. intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. PainFreeze II's skin refrigerant controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical (lancing boils, incisions, drainage of small abscesses, and sutures), and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).
The Subject Device consists of a chemical blend of 60% HFO-1233zd (Trans-1-chloro-3.3.3- trifluoropropene) and 40% HFO-1234ze (trans- 1.3.3.3-tetrafluoroprop-1- ene) that produces a cooling effect upon contact with the skin, intact mucous membranes, and minor open wounds. The product is delivered in the form of an aerosol in either a mist or stream spray. The device's delivery system controls the amount of chemical blend that is dispensed, the mist spray configuration produces very fine droplets that cools at the points of contact. The stream spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Upon contact with the skin, the product begins to evaporate immediately as it contacts the skin. The low evaporation rate of the product's chemical blend is what creates the coldness. The Subject Device is non- flammable and has a lower global warming potential than the predicate and provides equivalent performance.
The Subject Device is topically sprayed onto the skin. It creates a cooling effect on the surface of the application site by the immediate evaporation of the product from the skin surface.
With both product configurations, the evaporation creates the cold sensation. As the distance from the target surface is increased, the dispersion of the droplets in both the mist and stream is increased. Increasing the surface area of contact and decreasing the size of the droplets increases the evaporation rate. The increase in evaporation rate correlates to an increase in the cooling effect.
The chemical blend is incorporated in pressurized canisters, which will be offered in two (2) volumes 35 and 115 ml. The canister consists of a high-pressure canister, valve, and actuator.
The provided document is an FDA 510(k) Premarket Notification clearance letter for a medical device called "PainFreeze II," which is a vapocoolant (skin refrigerant). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced clinical effectiveness or accuracy via a traditional clinical trial or performance study typical for diagnostic/AI devices.
Therefore, the document does not contain the kind of detailed information requested about acceptance criteria, study design for proving device performance, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies that would be present for a diagnostic device or an AI/ML algorithm. The "performance" being assessed here is primarily related to safety, physical characteristics, and equivalence to a predicate, not diagnostic accuracy or clinical outcome improvement.
Based on the provided text, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical testing performed to demonstrate that the device is similar to its predicate and meets safety/performance requirements. The "criteria" are implied by the successful meeting of test requirements for each evaluation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Temperature exiting canister similar to Predicate | Evaluation demonstrated the temperature exiting from the canister is similar to the Predicate. |
| Biocompatibility per ISO 10993-1 (for compromised skin, |
N/A