(58 days)
1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1- trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenic granuloma.
Cool Renewal® is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a standard cryogen composition profile to freeze common skin lesions. The main device component is the aerosol canister containing cryogen spray. The device is used with non-sterile, single-patient applicators which are disposed after use. The applicators are available in Foam Tipped Applicators, Foam Tipped Skin Tag Tweezers, and Plastic Isolation Funnels. The device is provided in a kit containing the canisters, extender tubes, assorted applicators, Instructions for Use, Patient Instruction Tear Pad, and Applicator Practice Pad.
The provided text describes a 510(k) submission for the "Cool Renewal" cryosurgical device, seeking substantial equivalence to a predicate device. This submission focuses on comparing the new device to an existing one, rather than establishing de novo performance criteria. Therefore, the information provided does not contain traditional "acceptance criteria" and "reported device performance" in the way one might expect for a novel device with specific quantitative metrics for sensitivity, specificity, etc.
Instead, the core of the submission revolves around demonstrating that the Cool Renewal device is substantially equivalent to its predicate device, the Nuance Freeze Spray (K130995), for the same Indications for Use.
Here's an attempt to extract and present the information in the requested format, interpreting "acceptance criteria" through the lens of substantial equivalence and the comparative non-clinical study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (Cool Renewal) |
|---|---|
| Cryogen Composition: Same type of cryogen gas (R404A: 1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1-trifluoroethane) as the predicate. | Uses R404A: 1,1,1,2-tetrafluoroethane (CAS 354-33-6); Pentafluoroethane (CAS 420-46-2); 1,1,1- trifluoroethane (CAS 811-97-2). Meets criterion. |
| Mechanism of Action: Same as the predicate device (application of extreme cold causing tissue destruction due to direct effects of freezing on cells and vascular stasis after thawing). | Mechanism of action is identical to the predicate device. Meets criterion. |
| Freeze Time: Capable of achieving an effective freeze time comparable to the predicate device (15-40 seconds). | Freeze time is 15-40 seconds, identical to the predicate device. Meets criterion. |
| Temperature Drop & Effectiveness: Capable of generating a degree of cold and maintaining "effective temperatures" for cryosurgery comparable to the predicate device, reaching the minimum desired temperature for the maximum treatment time of 40 seconds. Affects equal surface area and depth during application compared to the predicate. | Comparative bench testing on a "phantom skin model" showed that Cool Renewal® cryogen and applicators perform equivalently to Nuance Freeze Spray cryogen and applicators by affecting equal surface area and depth during application. Demonstrated capability of reaching the minimum desired temperature for the maximum treatment time of 40 seconds and performed comparably to the predicate device. Meets criterion. |
| Safety and Efficacy Concerns: No new questions regarding safety or effectiveness compared to the predicate device, despite minor design differences (applicators). | Minor differences (double-ended foam tipped applicators, third applicator for skin tags) do not raise any new questions about safety or effectiveness. Meets criterion. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The text mentions "comparative testing was performed on a 'phantom skin model'". It does not specify the number of tests conducted, the number of applicators, or the number of cryogen canisters used.
- Data Provenance: Not explicitly stated, but it's a non-clinical, bench testing study. The location of the testing is not mentioned, and it is a prospective comparative bench test designed to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a non-clinical bench test on a "phantom skin model" measuring physical properties (temperature drop over time, surface area, depth of effect). There was no "ground truth" to be established by human experts in the context of diagnostic or clinical evaluation for this specific non-clinical test.
4. Adjudication method for the test set
Not applicable. As this was a non-clinical bench test measuring physical parameters, there was no expert adjudication process for the test set results. The measurements likely followed a pre-defined protocol.
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 device is a cryosurgical unit, not an AI-powered diagnostic or assisted reading device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual cryosurgical unit, not an algorithm or AI system.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" was established through physical measurements of temperature and impact on a "phantom skin model" against expected performance parameters for cryotherapy, and in comparison to the predicate device. It's a technical ground truth based on physical properties and known cryosurgical principles, not expert consensus, pathology, or outcomes data in a clinical sense for this specific study.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI that would require a "training set." The submission relies on comparative bench testing and the established safety and efficacy of the predicate device and cryosurgery in general.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.