(142 days)
The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. Including but not limited to tonsillectorny and blepharoplasty. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The Colorado MicroDissection Needle is not intended for use in the central nervous system or in the central circulatory system.
The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Stryker Leibinger Colorado MicroDissection Needle®), which primarily focuses on establishing substantial equivalence to previously cleared devices. It details the device's intended use and regulatory classification but does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size, data provenance, or ground truth for a test set.
- Information on experts, adjudication methods, or MRMC studies.
- Details on standalone algorithm performance.
- Information about the training set, its size, or how its ground truth was established.
The document's purpose is to demonstrate that the device is substantially equivalent to existing, legally marketed devices, not to present a de novo study against specific performance criteria.
§ 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.