(136 days)
The SJM Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
This document is a 510(k) clearance letter from the FDA for the "Rapid Programmer" device. It does not contain any information about acceptance criteria, device performance tables, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter primarily:
- Confirms that the device is substantially equivalent to legally marketed predicate devices.
- States the regulation number, name, and class for the device (21 CFR 882.5880, Implanted Spinal Cord Stimulator for Pain Relief, Class II).
- Details general control provisions and additional controls that may apply.
- Provides contact information for compliance and adverse event reporting.
- Includes an "Indications for Use Statement" describing the intended use of the Rapid Programmer in conjunction with the SJM Neurostimulation system for Spinal Cord Stimulation (SCS) in treating chronic trunk and limb pain.
Therefore, I cannot fulfill your request for detailed study information based on the provided text. The document is a regulatory clearance letter, not a study report or technical specification 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).