(112 days)
The Compound W® Freeze Off™ Plantar Wart Removal System is indicated for over-the-counter treatment of common and plantar warts.
The Compound W® Freeze Off™ Plantar Wart Removal System is a cryosurgical system for the treatment of common warts and plantar warts. It consists of:
- A canister filled with a liquid mixture of the compressed gases dimethyl O ether, propane and isobutane
- 12 Disposable Applicators O
- 1 Pumice Stone o
- o 12 Foot Comfort Pads
- 1 Reusable Activator that releases the cryogen into the applicator O
- An illustrated description of how to use the product with common and o plantar warts
This device is a portable cryosurgical system comprised of a canister containing cryogen and an applicator that is saturated with cryogen and then applied tan the wart to be treated.
The provided text is a 510(k) summary for the Compound W® Freeze Off™ Plantar Wart Removal System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo study with specific performance acceptance criteria and a detailed study report. Therefore, much of the requested information about acceptance criteria, detailed study design, and performance metrics for this specific device is not available in the provided text.
Here's an attempt to address the points based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a direct performance study for the new device (Compound W® Freeze Off™ Plantar Wart Removal System). Instead, it relies on demonstrating substantial equivalence to previously approved devices.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (Implicit from SE) |
|---|---|---|
| Intended Use | Same as predicate devices | "The Compound W® Freeze Off™ Plantar Wart Removal System is indicated for over-the-counter treatment of common warts and plantar warts. There is no change to the intended use of this device." |
| Technological Characteristics | Similar to predicate devices (Cryogen, applicator materials, method of application) | "The Compound W® Freeze Off™ Plantar Wart Removal System...is substantially equivalent to both the Compound W Freeze Off™ Wart Removal System by OraSure Technologies, Inc. and the Wartner Wart Removal System by Wartner USA b.v. The primary predicate device (Compound W® Freeze Off™) uses the same applicator constructed of the same material. There is no change to the method of application to the wart." |
| Safety and Effectiveness | Established in predicate device 510(k) (K023487) | "The safety and ease of use have been established in the 510k for this product - K023487." |
| Labeling | Adequate directions, warnings, and consistent with predicate devices for safe OTC use, especially regarding pumice stone and seeking medical advice. | "The labeling of the Compound W® Freeze Off™ Plantar Wart Removal System has been developed to ensure the consumer has adequate directions for safety... has been modified to provide adequate information for the consumer to use the pumice stone safely with plantar warts and to ensure that they contact their doctor if in any doubt, if stinging or aching persists after treatment, or if the wart does not improve after four, treatments to seek physician advice. This direction is consistent with the existing warning and cautions regarding medical advice in our instructions for use." "The safety and warning statements for the OTC predicate device... and for the labeling predicate device is essentially similar." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific "test set" for the new device. The submission relies on the established safety and effectiveness data of the predicate devices. Therefore, no information on sample size, data provenance, or study type for a test set of this specific device is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No specific test set for the new device is described, and thus no expert ground truthing process is mentioned in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No specific test set for the new device is described, and thus no adjudication method is mentioned.
5. 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
Not applicable. This is a cryosurgical device for wart removal, not an imaging or diagnostic AI device. Therefore, MRMC studies and AI assistance metrics are not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm, and its use inherently involves human interaction for application.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the predicate devices, the ground truth for establishing safety and effectiveness would have been based on clinical outcomes data (e.g., wart clearance rates, adverse events) from their original clinical studies. However, the provided document does not detail these for the predicates, only states that their safety and effectiveness were established.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device that utilizes a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm-based device.
§ 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.