(113 days)
The Epiducer system is an accessory to the leads component of St. Jude Medical Neuromodulation Division neurostimulation systems, which are indicated for spinal cord stimulation (SCS) in the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent or as an adjunct to other modes of therapy used in a multi-disciplinary approach.
The Epiducer™ lead delivery system is intended to introduce Lamitrode S-Series paddle leads and/or St. Jude Medical Neuromodulation Division percutaneous leads into the epidural space at or below the L1 vertebra.
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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Epiducer™ Lead Delivery System," indicating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and includes an "Indication For Use Statement."
Therefore, I cannot fulfill your request to describe acceptance criteria and a study from this document.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).