(88 days)
Wartie® Advanced Wart Remover is indicated for the over-the-counter treatment of common warts for patients ages 12 years and older.
The Wartie® Advanced Wart Remover is an over the counter cryosurgery product (for the treatment of warts), to be used at home.
The device consists of:
- A pressurized canister filled with 50mL of the compressed liquid gas dimethyl ether with a custom application unit used to administer the cold delivered by the cryogen to the wart.
- One 3 mL tube of conductive gel (also called gel).
- Six disposable comfort pads.
- Instructions for use in which you can read about the product how it works, how to use the product to treat warts, warnings and limitations.
The provided document is a 510(k) Premarket Notification for the "Wartie® Advanced Wart Remover". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies against predefined acceptance criteria for novel devices.
Therefore, many of the typical elements of an acceptance criteria and study section for a new medical device are not present in this document. Specifically:
- No acceptance criteria table or reported device performance for clinical effectiveness: The document does not define specific clinical effectiveness endpoints (e.g., wart clearance rate, reduction in size) with associated acceptance thresholds.
- No clinical study demonstrating device meets acceptance criteria: There is no detailed clinical study described that aims to prove the device's efficacy against such criteria. The document explicitly states "Clinical Testing: N/A" on page 5.
- No information on test set sample size, data provenance, experts for ground truth, adjudication methods, or MRMC studies: Since no clinical effectiveness study is presented, these details are not applicable or provided.
- No standalone algorithm performance or training set details: This device is a physical cryosurgical unit, not an AI/algorithm-based diagnostic or therapeutic device. Therefore, these concepts are not relevant.
- No specific ground truth type for clinical effectiveness: Again, due to the lack of clinical studies measuring effectiveness, specific ground truth methods for clinical outcomes are not described.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing. Here's what can be extracted from the document regarding the device's testing and comparison:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not present a table of clinical acceptance criteria or reported clinical device performance in the typical sense of a novel device proving its efficacy. The acceptance for a 510(k) is based on demonstrating substantial equivalence. The relevant "performance" discussed is in terms of freezing performance in a non-clinical setting, compared to predicates, and biocompatibility.
Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
---|---|
Biocompatibility per ISO 10993 | Presumed met, as "biological evaluation" is listed as a basis for substantial equivalence. (Specific results not detailed in summary.) |
Comparable Freezing Performance (Bench testing) | Demonstrated to show comparable freezing performance between subject device and predicates. (Specific metrics not detailed in summary.) |
Mechanical Safety (Pressurized canister) | Secured locking ring to assure mechanical safety. |
Thermal Safety (Aerosol activation) | Thermal safety precautions associated with activation. |
Product Design Features | Metal applicator for pen-pointed accuracy, conductive gel to optimize freezing, comfort pads for plantar warts. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No clinical test set described for demonstrating effectiveness.
- Data Provenance: Not applicable for clinical data. Bench testing data provenance is not specified beyond being "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set with human expert ground truth described.
4. Adjudication method for the test set
- Not applicable.
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 not an AI-based device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance (e.g., freezing performance), the "ground truth" would likely be measurements from standardized test setups, comparing characteristics like temperature achieved or cold transfer efficiency. Specific details are not provided in this summary.
- For biocompatibility, the ground truth is established by adherence to ISO 10993 standards and the results of tests specified by these standards.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that utilizes training data sets.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what the document does provide:
The document focuses on demonstrating substantial equivalence to predicate devices (Wartie® Wart Remover K140314 and Histofreezer® Wart Removal System K023487) by comparing:
- Intended Use: All devices are for OTC treatment of common and plantar warts.
- Target Population: While the subject device (Wartie® Advanced) is for ages 12+, the predicates are 4+. The document implies this difference does not raise new safety/effectiveness concerns.
- Energy Used: All remove thermal energy from the skin.
- Design and Cryogen/Applicator Materials: All use DME as cryogen. The primary technological differences identified are the specific applicator design (metal tip vs. sponge) and the inclusion of conductive gel and comfort pads in the subject device.
- Non-Clinical Testing: Biocompatibility per ISO 10993 and bench testing to show comparable freezing performance. The conclusion is that these differences "do not create any new risks of safety or effectiveness for the user."
This 510(k) summary is typical for a device seeking clearance based on substantial equivalence, where the emphasis is on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than establishing de novo clinical efficacy against predetermined criteria for a novel technology.
§ 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.