(91 days)
CryoNize™ is indicated, for medical professional use only, in the treatment of Verruca Vulgaris, Verruca Plantaris, Condylomà Acuminata, Verruca Plana, Molluscum Contagiosum, Skin Tags, Seborrhoeic Keratosis, Actinic Keratosis, and Lentigo.
CryoNize™ is a cryosurgical system used for the treatment of Verruca Vulgaris, Verruca Plantaris, Condyloma Acuminata, Verruca Plana, Molluscum Contagiosum, Skin Tags, Seborrhoeic Keratosis, Actinic Keratosis, and Lentigo. It consists of: An aerosol canister filled with a liquid mixture of compressed gases. This mixture, or o cryogen, is composed of 95% dimethyl ether, 2% propane, and 3% isobutane (118 ml). Customized applicators ০ CryoNize™ Foam Tip Applicators-two different shapes/sizes . CryoNize™ Zone Applicators—six different sizes (3mm, 5mm, 7mm, 12mm, 15mm) . Instructions for Use Booklet O Quick Guide for Use o o Carrying Case Practice Mouse Pad o
The provided text describes the CryoNize™ device, a cryosurgical system for various dermatological lesions, and its premarket notification (K103310). However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria.
Instead, the submission focuses on establishing substantial equivalence to previously cleared predicate devices (Histofreezer® and Verruca-Freeze™ Cryosurgery Delivery System) based on technological characteristics and intended use.
Here's a breakdown of why the requested information is largely absent:
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A table of acceptance criteria and the reported device performance: This information is not provided. The document states, "To date, no performance standards have been finalized which affect this device." This indicates that the device was not evaluated against predefined performance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, clinical study, or performance data is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no ground truth establishment for a test set is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is described.
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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. The CryoNize™ is a physical cryosurgical device, not an AI-powered diagnostic or assistive tool, so an MRMC study related to AI assistance would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study or ground truth establishment is described. The approval is based on substantial equivalence to predicate devices, implying that their established safety and effectiveness implicitly serve as the "ground truth" for the new device's suitability.
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The sample size for the training set: Not applicable, as no algorithm or training set is involved.
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How the ground truth for the training set was established: Not applicable.
In summary: The K103310 submission for CryoNize™ is a substantial equivalence determination, not a performance study. It relies on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices by comparing its technological characteristics and intended use, rather than presenting new clinical or performance data against specific acceptance criteria.
§ 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.