(117 days)
Dr. Scholl's® Dual Action Freeze Away™ Wart Remover is indicated for the overthe-counter removal of common and plantar warts.
For the removal of common and plantar warts.
Dr. Scholl's® Dual Action Freeze Away™ Wart Remover is a cryosurgical system for the over-the-counter removal of common and plantar warts. The device consists of the following:
a. Pressurized canister with a cryogen mixture of liquid dimethyl ether and propane
b. Salicylic Acid Liquid Wart Remover
c. Reusable activator that releases the cryogen into the applicators
d. Disposable applicators
e. Cushions
f. Information booklet
Here's an analysis of the provided text regarding the Dr. Scholl's® Dual Action Freeze Away™ Wart Remover, structured according to your request.
Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance claims against specific acceptance criteria for a novel device. Therefore, some of your requested information (e.g., specific acceptance criteria for efficacy, comparative effectiveness study with human readers improving with AI, sample size for training set, how training GT was established) is not present in this type of regulatory submission and cannot be extracted from this document.
Acceptance Criteria and Reported Device Performance
The core of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices. Therefore, the "acceptance criteria" are generally aligned with the performance and safety characteristics of the predicate devices. The device's performance is reported in comparison to these benchmarks.
| Acceptance Criterion (Implied by Predicate) | Reported Device Performance |
|---|---|
| Cryogen Temperature | The average temperature of the Dr. Scholl's® Dual Action Freeze Away™ Wart Remover applicator surface after activation is -42°C. (This is identical to the primary predicate device, Dr. Scholl's® Freeze Away™ Wart Remover). |
| Cryogen Effectiveness Duration | Maintains a temperature of -42°C at the applicator tip for approximately 170 seconds when tested using a temperature probe resting on a room temperature Teflon surface. (Identical to primary predicate). |
| Cryogen Composition | A mixture of dimethyl ether and propane, in the same proportions as the cryogen used in the primary predicate device (Dr. Scholl's® Freeze Away™ Wart Remover). |
| Biocompatibility | Standard biocompatibility studies recommended under ISO 10993 for a medical device with limited surface contact duration to breached/compromised skin were conducted on the applicator material. (Implied acceptability based on predicate's material). |
| Salicylic Acid Concentration | Contains liquid wart remover, salicylic acid 17%. (Matches the predicate device, Histofreezer/17% Salicylic acid-Verruca Plantari, and is recognized as safe and effective under 21 CFR 358, Subpart B). |
| Safety Features | The cryogen unit contains the same safety features as the primary predicate device (Dr. Scholl's® Freeze Away™ Wart Remover). The safety of cryotherapy plus salicylic acid 17% is supported by the Histofreezer predicate. |
| Indications for Use | Indicated for the over-the-counter removal of common and plantar warts. (Matches the primary OTC predicate; the prescription predicate has the same indication with salicylic acid as adjunct therapy). |
| Ease of Use/Label Comprehension | Supported by an Actual Use Study to ensure adequate directions for use for OTC availability. A Label Comprehension Study was conducted before the Actual Use Study. The labeling has been developed to ensure adequate directions for safe self-use. The safety and warning statements are the same as the OTC predicate. |
Study Information
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Sample size used for the test set and the data provenance:
- Actual Use Study: 51 consumers.
- Data Provenance: The document does not explicitly state the country of origin, but given it's a US FDA submission by a US company, it's highly likely the study was conducted in the United States. The study appears to be prospective as it involved consumers actively using the device under self-treatment conditions.
- Label Comprehension Study: Sample size not specified, but this study preceded the Actual Use Study involving 51 consumers.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided in this document. The "Actual Use Study" observed consumer comprehension and safe use, not the efficacy of wart removal itself, which is generally established through clinical trials (which this document is not). The efficacy of the active ingredients (cryotherapy and salicylic acid) is supported by existing predicate devices and regulations (21 CFR 358).
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Adjudication method for the test set:
- Not applicable/Not provided. The "Actual Use Study" focused on consumer comprehension and ability to follow instructions for safe use, not on outcome adjudication by experts.
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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:
- No. This is a medical device for wart removal, not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical/chemical characteristics (temperature, composition): Direct measurement and chemical analysis.
- For biocompatibility: Results from standard ISO 10993 testing.
- For efficacy/safety of active ingredients (cryogen + salicylic acid): Referenced to the established safety and efficacy of predicate devices and FDA regulations (21 CFR 358 Subpart B, Final Rule for Wart Remover Drug Products). This could be considered "regulatory precedent" rather than a newly established ground truth for this specific device.
- For "Ease of Use/Label Comprehension": The "ground truth" was whether consumers could correctly understand and apply the instructions safely and effectively for self-treatment in a naturalistic setting. This would be observed behavioral data from the Actual Use Study.
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.