(90 days)
The Cryo-Mono Cryogenic system is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctocology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, tonsils, turbinate reduction and prostate tissues. Cryo-Mono is specifically indicated for tonsil reduction in patients with blood dyscrasias or other bleeding problems and/or patients for whom general anesthesia presents an increased risk.
The Cryo-Mono is a modified version of Cryo-Hit. They have the same technological characteristics with several exceptions: (1) Cryo-Mono can support one cryoprobe only, while its predicate, Cryo-Hit, is capable of supporting up to 8 probes; (2) the Cryo-Mono is smaller than Cryo-Hit. (3) the Cryo-Mono has 4 gas cylinders compared to the Cryo-Hit' s six; (4) Cryo-Mono software has been modified, and does not have a "Stick" option for holding the probe to the tissue during freezing; (5) Cryo-Mono can accommodate needle shaped, tonsillectomy and turbinectomy specific probes; (6) Cryo-Mono has an optional foot pedal; (7) The Cryo-Mono does not have external thermosensors, which the Cryo-Hit has; and (8) The Cryo-Mono's single-use turbinectomy and tonsillectomy cryoprobes do not have built-in thermosensors, unlike the Cryo-Hit and Cryo-Mono' s multi-use probes.
This 510(k) summary for the Cryo-Mono Cryogenic System explicitly states that no new performance data or clinical studies were conducted to establish its safety and effectiveness. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device, the Cryo-Hit Cryogenic System.
Therefore, the following information regarding acceptance criteria and a study to prove performance cannot be provided as it was not part of this 510(k) submission.
Explanation for Absence of Information:
The core of this 510(k) submission is to assert that the Cryo-Mono is "substantially equivalent" to an already approved device. Substantial equivalence means that the new device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the differences do not raise new questions of safety and effectiveness.
In this case, the submitter argues that the Cryo-Mono's differences from the Cryo-Hit (e.g., smaller size, fewer probes, no "stick" option, foot pedal, modified software, fewer gas cylinders, and acceptance of tonsillectomy and turbinectomy specific probes) do not raise any new questions of safety and effectiveness.
Instead of presenting new performance data, the submission points to:
- Biocompatibility: Based on the FDA premarket clearance of the Cryo-Hit, as the Cryo-Mono's probes are made of the same materials.
- Conformance with Standards: Influence, Inc. certified conformance with IEC 60601-1, IEC 60601-1-2, and ASTM F882-84. These are safety and quality standards, not performance evaluations related to tissue ablation efficacy.
- Literature Review: Influence, Inc. summarized representative articles in the published medical literature regarding cryotonsillectomies and cryoturbinectomies. This is a review of existing knowledge about the procedure and its effectiveness in general, not a specific study on the Cryo-Mono device's performance against acceptance criteria.
Key Takeaway: For this specific 510(k), the "study" proving the device meets acceptance criteria is the demonstration of substantial equivalence to the predicate device, thereby leveraging the predicate's prior approval and established safety/effectiveness. No new, specific performance study with defined acceptance criteria for the Cryo-Mono was performed or required for this clearance.
§ 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.