(8 days)
The Spectranetics Lead Locking Devices, LLD, are intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.
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This document is an FDA 510(k) clearance letter for a medical device (LLD EZ catheter stylet) and does not contain the information requested about acceptance criteria or a study proving the device meets acceptance criteria.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which means it has the same intended use and technological characteristics as a device already on the market, or if it has different characteristics, these do not raise new questions of safety and effectiveness.
To answer your questions, I would need to analyze a different type of document, such as a summary of safety and effectiveness data (often submitted with a 510(k)) or a clinical study report. The provided text is solely the FDA clearance letter and an "Indications for Use" statement.
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).