(90 days)
Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is indicated for the removal of common and plantar warts.
The product is indicated for the removal of common and plantar warts.
Wart Freeze is a private label (private label trade mark: Wart Freezer, Cryogenic Wart Remover) over the counter cryosurgery product for the treatment of common and plantar warts. The device consists of the following:
- A pressurised dispenser (canister) containing as ingredient 38ml dimethylether (DME) with a . polypropylene applicator that is permanently attached (fixed) to the dispenser. The gas does not harm the ozone layer. The applicator is used to administer the cryogen directly to the wart. The applicator is cleaned after each use.
- Disposable 70% alcohol cleansing swabs for cleaning the applicator after each use .
- Instruction for use .
The Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is a 21. cryosurgical system comprised of a dispenser containing as ingredient, dimethylether (DME), and a permanently attached (fixed) applicator to apply the cryogen directly to the wart.
The provided document is a 510(k) summary for a medical device called "Wart Freeze," which is an over-the-counter cryosurgery product for wart removal. The document focuses on establishing substantial equivalence to a predicate device (K101049) and demonstrating the safety and effectiveness of the modified device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance. Instead, it demonstrates performance through comparative laboratory testing and characterization against a predicate device and established safety standards. The primary acceptance criterion here is substantial equivalence to the predicate device, especially in terms of functionality, safety, and indications for use.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Cryogen Delivery & Application Effectiveness | |
| - Ability to deliver cryogen to wart | - Device applies cryogen directly to the wart via a permanently attached applicator. |
| - Comparable effectiveness to predicate devices | - Comparative laboratory testing using a phantom skin model indicated that the various competitor products (including the predicate) are similar in effectiveness. |
| - Consistent cold generation | - Applicator surface at the tip reaches -50 °C. The effectiveness of predicates is stated to be identical. |
| - Appropriate freeze time (dose-technique related) | - 3-short presses resulted in a freeze time of 1.31 seconds. |
- 3-long presses resulted in a freeze time of 1.99 seconds. |
| - Maximum acceptable concentration of DME administered | - Maximum acceptable concentration of DME administered was 0.37 mg/ml during both dose techniques, ensured by a safety (dose) valve. |
| Biocompatibility | |
| - Applicator material safety | - Biocompatibility testing (ISO 10993:5 Tests for in vitro cytotoxicity) performed on the polypropylene applicator in contact with cryogen. - The applicator material was found to be non-lysic. |
| Chemical Residuals/Leachables | |
| - Absence of harmful chemical residuals/leachables | - Laboratory testing concluded no chemical residuals in dimethylether/polypropylene extracts, indicating no leachable components between the applicator and cryogen. |
| Cryogen Safety (Dimethylether - DME) | |
| - Non-toxic by inhalation | - DME inhalation studies (by suppliers), including US National Toxicological Programme (NTP) acute toxicity studies (LC50) on mouse and rabbit. - Concluded DME did not produce acute toxicity in animal models or bacteria (Ames Salmonella Typhimiurium).
- Developmental toxicity studies in animal models showed no significant toxic effect on mice or rabbit pups.
- DME received a ranking of "not acutely toxic" by the NTT.
- Current exposure limits (1000 ppm or 0.1% DME for 8-hour daily life-time exposures) are significantly higher than typical consumer product exposures (~100 ppm for short periods
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.