(59 days)
The CryoStar™ System is a cryoanalgesia device intended for use in blocking pain by temporarily ablating the peripheral nerves.
The CryoStar™ system consists of a range of cryoprobes that are used for freezing nerves to block pain by temporary ablation. A console is used to house and control the supply of gas to the cryoprobe and to provide an electrical nerve location device. A footswitch completes the system. A convenience procedure kit for probe placement is also provided as a single use disposable.
In the CryoStar™ system, compressed nitrous oxide or carbon dioxide is directed to the tip of the cryoprobe where it is allowed to expand through a fine annular space. The expansion of the gas to near atmospheric pressure causes cooling by the loule Thompson effect. The design of the cryoprobes is such that the warmer incoming gas maintains the outer stem of the cryoprobe above freezing temperatures to prevent freezing up the stem of the cryoprobe and unwanted tissue damage. A peripheral nerve stimulator in the CryoStar™ console facilitates the location of the peripheral nerve prior to freezing. Freezing of the nerve fibers creates a block which prevents the conduction of pain. The effect is usually non-permanent, and a repeat of the treatment may be necessary to deal with long term pain.
The CryoStar™ console has been designed to provide a simple user interface, together with a series of error detection and warning systems to ensure proper operation. The pedestal of the console provides a convenient small footprint mobile base for the system, and houses up to four gas tanks. A simple footswitch completes the system.
This 510(k) premarket notification for the CryoStar™ system is a substantial equivalence submission, not a de novo submission. Therefore, it does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way one might expect for a novel device undergoing a rigorous performance evaluation.
Here's why and what information can be gleaned from the provided text:
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and either the same technological characteristics or, if different technological characteristics, that those differences do not raise new questions of safety or effectiveness.
- Focus on Predicate Devices: The document primarily focuses on comparing the CryoStar™ system to existing, legally marketed predicate devices (Spembly Lloyd Neurostat, Cryomedics Neurostat, Wallach Painblocker WA5000). The argument for safety and effectiveness is built on the proven track record and characteristics of these predecessors.
- Lack of De Novo Performance Study Details: Since the device is considered substantially equivalent, there isn't a need for a new, extensive clinical or performance study to establish novel acceptance criteria or prove its efficacy from scratch. The FDA simply acknowledges that it's equivalent to devices already on the market.
Based on the provided text, the following information is either not present or not applicable in the context of a 510(k) substantial equivalence submission:
- Table of acceptance criteria and reported device performance: Not provided because this is a substantial equivalence claim, not a de novo approval requiring new performance benchmarks.
- Sample size for the test set and data provenance: No specific test set or study data is presented, as the claim is based on equivalence to existing devices.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported in this submission for the reasons stated above.
- Standalone (algorithm-only) performance: Not applicable, as this is a medical device, not a standalone algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
What the document does provide pertinent to the request (though not in the requested format):
- Intended Use: The CryoStar™ system is a cryoanalgesia device intended for use in blocking pain by temporarily ablating the peripheral nerves. This is a crucial "acceptance criterion" in the sense that the device must fulfill this purpose, and its equivalence to predicates implicitly suggests it does.
- Device Description and Principle of Operation: The document describes how the device works (Joule Thompson effect to freeze nerves, nerve stimulator for location) and its components. This implies that the device functions as intended, similar to the predicate devices.
- Safety and Effectiveness: The submission explicitly states: "There are now new issues of safety of [or] effectiveness raised by the subject device." This is the core claim of substantial equivalence, meaning no new risks or concerns are identified compared to the predicate devices.
- Predicate Devices: The specific predicate devices are listed (K781302 Spembly Lloyd Neurostat, K831963 Cryomedics Neurostat, K854334 Wallach Painblocker WA5000). The "proof" of meeting criteria relies on the regulatory approval and established performance of these devices.
In summary, this 510(k) submission successfully argued for substantial equivalence, meaning the FDA agreed it was similar enough to already-approved devices that no new, detailed performance studies or elaborate acceptance criteria (beyond those implicitly met by the predicates) were necessary.
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).