(65 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, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
The Nuance Freeze Spray System is used in the practice of dermatology in the treatment of 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.
This 510(k) summary for the Nuance Freeze Spray System does not contain a study that proves the device meets specific acceptance criteria in the way a traditional clinical study with defined endpoints and statistical analysis would. Instead, the submission relies on the concept of substantial equivalence to previously cleared predicate devices.
Therefore, many of the requested elements regarding acceptance criteria and study design are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission does not define specific acceptance criteria (e.g., a specific percentage reduction in lesion size, a cure rate, or a predefined safety profile) nor does it report performance metrics from a dedicated study against such criteria for the Nuance Freeze Spray System itself. The device's "performance" is implicitly assumed to be equivalent to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There was no specific test set or clinical study conducted for the Nuance Freeze Spray System described in this document. The device relies on comparing its characteristics to predicate devices that have already demonstrated safety and effectiveness through their past clearances.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as no dedicated test set or ground truth establishment process is described for this specific submission. The established practices and efficacy of cryogen spray for dermatological conditions, as supported by the predicate devices, serve as the foundational "ground truth."
4. Adjudication Method for the Test Set
Not applicable, as no test set or adjudication process is described.
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 medical device (cryogen spray system), not an AI/imaging device. Therefore, MRMC studies and AI effectiveness are irrelevant to this submission.
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.
7. The Type of Ground Truth Used
The "ground truth" implicitly relied upon is the established clinical efficacy and safety of cryogen spray systems, particularly those using the specified chemical composition, for the treatment of various skin lesions, as evidenced by the predicate devices. This can be considered accepted clinical practice and outcomes data from previously cleared devices and general medical knowledge.
8. The Sample Size for the Training Set
Not applicable. The Nuance Freeze Spray System is a physical device, and its clearance is based on substantial equivalence rather than a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
Summary of the Basis for Clearance:
The Nuance Freeze Spray System gained 510(k) clearance based on Substantial Equivalence to legally marketed predicate devices:
- Primary Predicate: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K982506)
- Secondary Predicates: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K881349) and (K944221)
The "study" that proves the device meets the acceptance criteria is effectively this comparison demonstrating substantial equivalence. The core arguments for substantial equivalence are:
- Identical Indications for Use: The Nuance Freeze Spray System is intended for the treatment of the same specific skin lesions as the predicate devices.
- Identical Technical Characteristics (Cryogen Composition): The cryogen used (1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane, also known as R-404a) is stated to be the "exact same chemical composition and formulation as the predicate device."
- Similar Delivery Method: The methods for delivering the cryogen are described as "similar to the predicate."
- No New Issues of Safety or Efficacy: The statement explicitly says, "Nuance Freeze Spray System and its predicate devices do not raise any new issues of safety or efficacy."
Therefore, the "acceptance criteria" for the Nuance Freeze Spray System's clearance were met by demonstrating that it is fundamentally the same in terms of composition, intended use, and operational principles as already cleared devices, thereby inferring equivalent safety and effectiveness without requiring a new clinical performance study.
§ 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.