(78 days)
The CryoGen Cardiac Cryosurgical System is indicated for use in minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The cardiac cryoprobes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response, or cryonecrosis.
The CryoGen Cardiac Cryosurgery System consists of three components: the Console, which contains the compressors and the dewar. The CryoGen Cardiac Cryosurgery System is a cryosurgical unit incorporating a gas cooled cryoprobe. Operation of the cryosurgical System is based on the Joule-Thomson principle in which pressurized coolants are expanded through a small orifice to produce cooling. The device is intended to produce extreme cold. Temperatures of -100 to -120 °C are developed at the tip of the cryoprobe.
The provided text (K974320) does not contain information about studies conducted to prove device performance against acceptance criteria. It primarily focuses on the device description, intended use, technological characteristics, and its substantial equivalence to predicate devices for regulatory clearance.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone performance (algorithm only) study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This 510(k) summary is a premarket notification for a Class II medical device, and substantial equivalence to existing devices is typically the primary focus for clearance, rather than extensive clinical efficacy studies with predefined acceptance criteria as might be required for a Class III device or a novel technology. The "studies" mentioned refer to comparisons with predicate devices regarding design, materials, and principle of operation, rather than performance studies against specific clinical endpoints.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.