RAPID PROGRAMMAR
Device Facts
| Record ID | K030118 |
|---|---|
| Device Name | RAPID PROGRAMMAR |
| Applicant | Advanced Neuromodulation Systems |
| Product Code | GZB · Neurology |
| Decision Date | Mar 11, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5880 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The ANS 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 also 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.
Device Story
Rapid Programmer is a touch-screen computer system used by clinicians to configure and optimize ANS Neurostimulation systems. It interfaces with the implanted stimulator to set waveforms and electrode configurations. The device guides clinicians through patient-specific parameter combinations, records stimulation effects, and automatically logs procedural data. By facilitating systematic parameter adjustment, it assists in identifying optimal stimulation settings for chronic pain management. Used in clinical settings, it streamlines the programming workflow and maintains a record of device settings and patient responses.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Touch-screen computer interface; software-based parameter configuration and data logging; intended for use with implanted spinal cord stimulators; Class II device (21 CFR 882.5880).
Indications for Use
Indicated for patients with chronic pain of the trunk and limbs requiring Spinal Cord Stimulation (SCS) therapy, either as a sole treatment or as an adjunct to other multidisciplinary therapies.
Regulatory Classification
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.
Related Devices
- K040609 — RAPID PROGRAMMER · Advanced Neuromodulation Systems · Mar 25, 2004
- K052374 — RAPID PROGEAMMER 3.0 · Advanced Neuromodulation Systems · Nov 22, 2005
- K091993 — RAPID PROGRAMMER, VERSION 3.3.0 · Advanced Neuromodulation Systems, Inc. (Ans Inc.) · Jul 31, 2009
- K113611 — RAPID PROGRAMMER · St Jude Medical · Apr 20, 2012
- K021518 — PAINDOC · Advanced Neuromodulation Systems · Jun 6, 2002
