(65 days)
The Cadwell TES-1 constant voltage electrical stimulator is intended for cortical stimulation. The TES-1 is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. The Cadwell TES-1 Constant Voltage Stimulator is an accessory to the Cadwell Cascade Intra-operative monitoring system only. It is not a stand-alone device nor is it compatible with other systems.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "TES-1 Constant Voltage Electrical Stimulator." It largely focuses on the regulatory approval for marketing the device based on its substantial equivalence to previously marketed devices.
Therefore, the requested information regarding acceptance criteria and performance studies for this specific device is not available within the provided text.
Here's why and what's missing:
- 510(k) Clearance: This is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It doesn't typically include detailed clinical study reports or performance acceptance criteria in the clearance letter itself. These details would be submitted by the manufacturer to the FDA as part of their 510(k) submission, but they are not disclosed in this public-facing clearance letter.
- "Substantially Equivalent": The core of a 510(k) is proving substantial equivalence. This means the device has the same intended use as a predicate and similar technological characteristics, or, if there are differences, that they do not raise different questions of safety and effectiveness. The information to support this claim would be in the manufacturer's submission, not in this letter.
To answer your questions, one would need access to the full 510(k) submission document, which is not provided here.
However, I can tell you what is present in relation to the device:
- Device Name: TES-1 Constant Voltage Electrical Stimulator
- Intended Use: For cortical stimulation; intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
- Accessory Device: It is explicitly stated as an accessory to the Cadwell Cascade Intra-operative monitoring system only, not a stand-alone device, and not compatible with other systems.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).