(284 days)
Intended Use: Cryosurgical unit used for ablative type surgical technique
Indications for use: Multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.
The CryoPen system provides a means of freezing tissue without the use of cryogenic liquids or gases. The system consists of three hand-held freezing modules, a refrigeration unit, and disposable tips. When used properly, the system will deliver effective temperature for tissue ablation. The refrigeration component is the largest unit, and is used to lower the temperature of the CryoPen units to temperature of -100 C. It operates on 115 VAC obtained from conventional convenience outlets. The supporting housed in the refrigerator cabinet include a DC power source to indicate the temperature of the CryoPen units during cool down, and all other necessary control and electrical safety features. There are currently three different sizes of the hand-held modules: a 0.4 inch diameter unit, a 0.25 inch diameter unit, and a 0.19 inch diameter unit.
The provided text is a 510(k) summary for the CryoPen device. However, it does not contain information regarding acceptance criteria, device performance studies, or details of ground truth establishment.
The document primarily focuses on:
- General Information: Submitter, contact details, date prepared, registration number.
- Device Description: Name, trade name, common name, classification, product code, description of the CryoPen system components (hand-held modules, refrigeration unit, disposable tips).
- Intended Use Statement: Cryosurgical unit for ablative surgical techniques on multiple organ systems for various diseases (viral, benign, pre-malignant, malignant tissue).
- Components: List of parts and part numbers.
- Substantial Equivalence: Comparison to a predicate device (Wallach LL100) and rationale for substantial equivalence (both use cryogenic temperatures for tissue destruction, with a note on different contact materials).
- FDA Letter: A letter from the FDA confirming the substantial equivalence determination for K012214, allowing the device to be marketed.
Therefore, I cannot provide the requested information such as acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment, as these essential data points are missing from the provided text.
§ 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.