(113 days)
The CryoTouch™ is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures.
The list below shows examples of the types of lesions that may be treated:
- Verruca (warts) ●
- Plantar warts
- Seborrheic Keratoses
- Actinic Keratoses
- Achrochordon ●
- Molluscum Contagiosum ●
- Age Spots
- Dermafibroma
- Small Keloids ●
- Granuloma Annulare ●
- Porokeratosis Plantaris ●
- Angiomas
- Lentigo Maligna
- Keratoacanthoma
- Basal Cell Carcinomas ●
- Bowen's Disease
- Lentigo Discrete
- Chondrodermatitis
- Epithelial Nevus
- Leukoplakia ●
- Granuloma Pyogenicum ●
- Kaposi's Sarcoma ●
- o Pyogenic Granuloma
The CryoTouch™ device gently dispenses cryogen gas into an applicator or a uniquely designed cone. The applicator or cone is then used to apply the extreme cold to the lesion being treated to effect cryosurgical treatment.
The CryoTouch™ device is a cryosurgical unit intended for the destruction of various lesions by applying cryogenic gases at low temperatures. The submission aims to demonstrate substantial equivalence to the predicate device, Verruca Freeze K982506.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" in the traditional sense (e.g., a specific temperature range to be achieved with a defined tolerance). Instead, the performance objective is to demonstrate equivalency of temperature and cryosurgical effect compared to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalency of Temperature Attained | "Bench testing in this submission focused on demonstrating the equivalency of temperatures over their treatment times while using cone or applicators from the CryoTouch™ and Verruca Freeze." "The comparison bench testing of the CryoTouch TM to Verruca Freeze shows that the temperatures attained are sufficient for cryosurgery." The CryoTouch™ cryogen gas boiling point is -52°C, compared to -48°C for the predicate, indicating a similar or slightly colder temperature. |
| Sufficient Cryosurgical Effect (Tissue Destruction) | "When sufficient heat has been removed from the treated spot, the tissue is destroyed through cell lysis and vascular stasis." "A second bench test also used the CryoTouch™ and Verruca Freeze, comparing each device and its ability to destroy red blood cells immobilized in agar." "The data, therefore, supports the substantial equivalence between CryoTouch™ and the predicate." |
| Similar Mode of Operation and Safety Characteristics | The comparison table shows remarkably similar characteristics for intended use, materials, mode of use, mechanism of action, storage conditions, safety, treatment procedure, operation, disposal, and defined operators. The only significant difference is the specific cryogen mixture and its boiling point, which are handled in the temperature equivalency testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The study involved "bench testing" and "a second bench test." The quantity of devices, cones/applicators, or agar samples used is not detailed.
- Data Provenance: The data is generated from bench testing, meaning it was conducted in a laboratory setting. There is no information about country of origin of the data as it's a technical bench study. It is inherently prospective as the tests were designed and executed to compare the devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the bench testing described. The "ground truth" here is objective physical measurements (temperature, red blood cell destruction) rather than expert interpretation of medical images or clinical outcomes. There is no mention of experts being used in this capacity for the bench tests.
4. Adjudication Method for the Test Set
Not applicable. The bench tests involved objective measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images. This submission describes a cryosurgical device, and its performance evaluation focused on its physical characteristics and direct effect on biological material in a lab setting. It does not involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI/algorithm-driven device. Its performance is assessed physically.
7. Type of Ground Truth Used
The ground truth used in the bench testing was:
- Physical Measurements: Primarily temperature profiles attained by the device.
- Direct Biological Effect: The device's ability to destroy red blood cells immobilized in agar, serving as a simplified model for tissue destruction.
8. Sample Size for the Training Set
Not applicable. This is a medical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.