(88 days)
For the over-the-counter removal of common warts and plantar warts on the bottom of the foot.
Dr. Scholl's Freeze Away Wart Remover is a cryosurgical system for the over-thecounter removal of common warts and plantar warts on the bottom of the foot. The device consists of the following:
- Pressurized canister with a cryogen mixture of liquid dimethyl ether and propane
- Reusable activator that releases the cryogen into the applicators
- Disposable applicators
- Information booklet
The Dr. Scholl's Freeze Away Wart Remover is a cryosurgical system for the over-the-counter removal of common warts and plantar warts. The device was evaluated for substantial equivalence to predicate devices, namely the Wartner Wart Removal System (K011708) and the Histofreezer Wart Removal System (K023487, K924114).
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to its predicate devices in terms of technological characteristics, safety, and effectiveness. A formal study report with detailed numerical acceptance criteria and a corresponding performance report is not provided in the given text. Instead, the submission relies on direct comparisons to the predicate devices and general statements about the device's performance.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria are not presented in the document, the table below is constructed based on the comparisons made to the predicate devices, indicating what was deemed "similar" or "sufficient."
| Feature/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Dr. Scholl's Freeze Away) |
|---|---|---|
| Applicator Temperature | Similar to predicate devices (e.g., -36°C to -42°C) | -42°C (average after saturation) |
| Applicator Effectiveness Duration | Sufficient length of time for use per instructions (e.g., 75-230 seconds) | ~170 seconds (maintains -42°C on Teflon surface), ~230 seconds for Histofreezer predicate |
| Cryogen | Same as or similar to predicate devices | Mixture of dimethyl ether and propane (same as Wartner) |
| Biocompatibility | Meet ISO 10993 for limited surface contact with breached skin | Studies conducted on applicator material (assumed to meet standard) |
| Safety Features | At least comparable to predicate devices | Cryogen released only after applicator attached and pressed; includes luer lock (additional safety) |
| Indications for Use (Common Warts) | Same as Wartner predicate device | Over-the-counter removal of common warts |
| Indications for Use (Plantar Warts) | Same as Histofreezer predicate device | Over-the-counter removal of plantar warts |
| Labeling | Adequate directions for safe use, self-diagnosis support, doctor consultation guidance | Developed to ensure adequate directions, self-diagnosis, and contact doctor if needed |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information about any clinical studies or sample sizes for a "test set" in the traditional sense (e.g., patient data). The evaluation appears to be based on laboratory testing of the device's physical characteristics (temperature, duration, cryogen composition) and comparisons to established predicate devices. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or provided in the given text. The "ground truth" for this type of submission is likely derived from established scientific principles for cryotherapy and the performance characteristics of previously cleared predicate devices, rather than expert consensus on individual cases.
4. Adjudication Method
This information is not applicable or provided as there is no mention of a human-read or human-interpreted test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as this approval is for a physical device (cryosurgical wart remover) rather than an AI-powered diagnostic or interpretive tool. There is no mention of human readers or AI assistance in this context.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a physical product, not an algorithm. Therefore, a standalone algorithm performance study was not conducted. The performance described relates to the physical properties and efficacy of the cryosurgical process itself.
7. Type of Ground Truth Used
The "ground truth" for this submission primarily relies on:
- Physical and Chemical Properties: Laboratory measurements of temperature, duration, and cryogen composition.
- Established Efficacy of Cryotherapy: The underlying principle that cryotherapy is an effective method for wart removal (as demonstrated by the predicate devices).
- Predicate Device Performance: The demonstrated safety and effectiveness of the Wartner and Histofreezer devices in removing common and plantar warts.
8. Sample Size for the Training Set
There is no mention of a training set as this device does not involve machine learning or AI models that require data for training.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this information is not applicable.
§ 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.