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The DermaScan C is an ultrasonic scanning system intended to be used to visualize the layers of the skin, including blood vessels, and to make approximate measurements of dimensions in the layers of the skin and blood vessels, by ultrasonic means.

The DermaScan C provides the following visualization modes: a. 2-dimensional B-scan, displayed in real time b. M-scan, displayed in real time c. A-scan, as a "frozen" image derived from a B-scan line.

The Cortex DermaScan C Ultrasonic System did not undergo a clinical study to prove it meets acceptance criteria for this 510(k) submission.

The document states:

• Acceptance Criteria & Device Performance: Not provided, as clinical tests were deemed not required.
• Sample size for the test set and data provenance: No test set was used for clinical performance evaluation.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no test set was used.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted.
• Standalone (algorithm only) performance: Not applicable, as this is an ultrasound system, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Reasoning for lack of clinical studies:
The application states, "Since the DermaScan C is identical to a previously-cleared device, clinical tests are not required." (Page A 4, Section 6b). The predicate device is identified as the "DermaScan C Ultrasonic 3D skin scanner, K894834".

The submission focuses on non-clinical tests:

• Software revalidation.
• Ultrasonic emission tests by an outside laboratory.
• Electrical safety tests.

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The CryoPro® Mini and CryoPro Maxi units are intended to be used within the fields of dermatology and plastic surgery for the treatment of cryoresponsive benign, premalignant and malignant tumors such as skin tags, verrucae, actinic keratoses and basal cell carcinoma.

The CryoPro® Mini consists of a 0.35 L stainless steel vacuum insulated, stainless steel flask equipped with a stainless steel top which holds a pressure relief valve and a dispensing valve for dispensing liquid nitrogen. The dispensing valve body is made of stainless steel with a brass valve stem and sealed with a Teflon gasket.

The dispensing valve may be mounted with spray nozzles or closed contact probes of varying sizes depending on the size and nature of the area to be treated.

The CryoPro® Maxi provides a 0.5 L stainless steel vacuum insulated flask and is otherwise identical to the CryoPro® Mini unit.

The provided text describes a 510(k) submission for the CryoPro® Mini and CryoPro® Maxi cryosurgical units. It details the device, its intended use, and its technological characteristics compared to a predicate device. However, this document does not contain information regarding detailed acceptance criteria, specific performance studies, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (CryoGun® liquid nitrogen cryosurgical system). The FDA's letter confirms this substantial equivalence based on the provided information, allowing the device to be marketed.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and study details. The information required for those points is not present in the provided text.

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