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510(k) Data Aggregation
(102 days)
WARTNER PRO
WARTNER PRO® is intended for the treatment of common warts and plantar warts in adults and children over the age of 4. Common warts are recognized by the rough 'cauliflower-like' appearance ci the surface. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern. The product is intended as an OTC device, which will be marketed to professionals, allied professionals, and semi-professionals.
WARTNER PRO® is a cryosurgical system for the treatment of warts. It consists of
- A canister filled with 125 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life.
- 42 Foam applicators in three different sizes (6 mm, 7 mm, 8 mm) .
- An applicator stick/key for holding a foam applicator which is required to . dispense the liquid to the applicator, and is held by the person during treatment
- . Information booklet
The pressurized canister is filled with dimethyl ether and propane, which acts as a cryogen. The key is fitted with a foam applicator, which is inserted into the safety valve opening in the canister. The valve releasing the cryogen can only be actuated when the key is in place and depressed. When the key is depressed it saturates the foam applicator with the cold cryogenic gases and lowers the temperature of the applicator to approximately -50℃. The foam applicator is then placed on the wart. The freezing kills the wart and the infected skin causing the wart to fall off within a few days.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the WARTNER PRO® device:
The provided text is a 510(k) summary for a cryosurgical system called WARTNER PRO®. It focuses on demonstrating substantial equivalence to predicate devices rather than detailing independent clinical studies with specific performance metrics against pre-defined acceptance criteria. Therefore, many of the requested elements for a typical clinical study, such as specific acceptance criteria for efficacy or safety, effect sizes from MRMC studies, or detailed ground truth establishment, are not explicitly present.
However, based on the information provided, we can infer some "acceptance criteria" through the lens of performance equivalence to the predicate device and the laboratory testing described.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence and Lab Testing) | Reported Device Performance |
|---|---|
| Cryogen Composition: Identical to predicate device (dimethyl ether and propane). | WARTNER PRO® uses a cryogen composed of dimethyl ether and propane. The Wartner® Wart Removal System OTC predicate device cryogen is identical. |
| Applicator Material: Identical to predicate device (foam material). | The material used to transfer the cold to the patient in both WARTNER PRO® and Wartner® Wart Removal System OTC use is the same foam material. |
| Applicator Effectiveness Temperature: Maintains temperature of less than minus 50°C. | The average temperature of the applicator surface after saturation is -56.4°C. The WARTNER PRO® foam applicator maintains a temperature of less than minus 50°C. The Wartner® Wart Removal System OTC predicate device effectiveness is identical (implies it also maintains |
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