(129 days)
For the over-the-counter removal of common and plantar warts.
The Compound W® Wart Removal System Dual Power is a cryosurgical system for the over-the-counter removal of common and plantar warts. Compound W® Wart Removal System Dual Power consists of the following:
- O Pressurized aerosol spray canister with a mixture of dimethyl ether and propane (K032271)
- o Reusable actuator/cap that releases the cryogen onto the disposable applicators
- Disposable foam applicators O
- Salicylic acid gel wart remover provided in a squeeze tube (in compliance with OTC O monograph 21 CFR 358 subpart B)
- O Comfort pads
- Instruction Leaflet o
This document is a 510(k) premarket notification for the "Compound W® Wart Removal System Dual Power." It primarily establishes substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of clinical performance.
While the document details comparisons between the new device and a predicate device (Dr Scholl's® Dual Action Freeze Away™ Wart Remover) to demonstrate substantial equivalence, it does not contain information about:
- A table of acceptance criteria and reported device performance: The document compares technical characteristics and indications for use, but there are no specific numerical acceptance criteria (e.g., success rates, cure rates) or corresponding performance data from a clinical study for the new device.
- Sample size used for the test set and data provenance: No clinical test set data is provided.
- Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical test set data is discussed.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a direct-to-consumer product, not typically requiring comparative effectiveness studies against human readers for diagnostic tasks.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm trained on data.
- How ground truth for the training set was established: Not applicable.
However, based on the provided text, we can infer the "acceptance criteria" through the lens of "substantial equivalence" to the predicate device. The primary acceptance criterion for the FDA 510(k) pathway is that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if it has different technological characteristics, it does not raise new questions of safety or effectiveness and is as safe and effective as the predicate device.
Here's an attempt to structure the answer based on the provided document, interpreting the "acceptance criteria" as meeting substantial equivalence to the predicate:
The provided document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical study with specific performance acceptance criteria. Therefore, the "acceptance criteria" are implied by the FDA's regulatory standard for 510(k) clearance, which means the device must be as safe and effective as a predicate device and not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use (Over-the-counter removal of common and plantar warts) | SAME as predicate device (Dr Scholl's® Dual Action Freeze Away™ Wart Remover). The device, Compound W® Wart Removal System Dual Power, is intended for the over-the-counter removal of common and plantar warts. |
| Principles of Operation (Cryosurgical system with adjunctive salicylic acid) | SAME as predicate device. Both devices consist of a pressurized aerosol spray canister with a mixture of dimethyl ether and propane (cryogen), applicators for cryogen, and a salicylic acid war remover. |
| Technological Characteristics | Cryogen spray application: SAME as predicate (portable cryosurgical system comprised of an aerosol pressurized canister containing cryogen and an applicator that applies the cryogen to the wart). |
| Cryogen formulation: SAME as predicate (a mixture of dimethyl ether and propane). | |
| Freeze time: Identical treatment times as predicate (dependent upon type and size of wart). | |
| Salicylic Acid Application: DIFFERENCE from predicate. The predicate uses a reusable applicator to apply acid post-cryo. The new device uses a squeezable tube for application. The manufacturer states this difference does not raise new concerns for safety or effectiveness. | |
| Salicylic Acid Formulation: DIFFERENCE from predicate. The predicate uses a 17% salicylic acid solution. The new device uses a 17% salicylic acid gel. The manufacturer states this difference does not raise new concerns for safety or effectiveness. | |
| Frequency of Use (Salicylic Acid): DIFFERENCE from predicate. Predicate: One drop of liquid 24 hours post cryo-treatment. New device: Apply 1 drop at a time, repeat once or twice a day as needed. The manufacturer states this difference does not raise new concerns for safety or effectiveness. | |
| Materials | Biocompatibility: Complies with ISO 10993 (SAME as predicate). |
| Sterility: No components are provided as sterile (SAME as predicate). | |
| Single-Use: Only disposable applicators are single-use (SAME as predicate). | |
| Target Population | SAME as predicate (Adults and children 4 or older). |
2. Sample size used for the test set and the data provenance:
The document does not describe a clinical performance study with a test set. The basis for clearance is substantial equivalence to a predicate device based on comparison of characteristics and technological features.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set data is presented.
4. Adjudication method for the test set:
Not applicable, as no clinical test set data is presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done or reported in this document. This type of study is typically conducted for diagnostic devices where human interpretation of images or signals is involved. The device is a therapeutic cryosurgical unit.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used:
Not applicable, as no clinical data with ground truth is discussed for the device's performance. The "ground truth" in the context of a 510(k) is effectively the established safety and effectiveness of the identified predicate device that the new device is compared against.
8. The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical device, not an AI 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.