RAPID PROGEAMMER 3.0

K052374 · Advanced Neuromodulation Systems · GZB · Nov 22, 2005 · Neurology

Device Facts

• Record ID: K052374
• Device Name: RAPID PROGEAMMER 3.0
• Applicant: Advanced Neuromodulation Systems
• Product Code: GZB · Neurology
• Decision Date: Nov 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2

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 (Models 3830, 3831) is a touch-screen computer system used by clinicians to program ANS Neurostimulation systems. Device facilitates optimization of stimulation parameters by guiding patients through various electrode configurations and waveforms while recording stimulation effects. System automatically logs procedure data. Clinicians use output to determine optimal performance settings for chronic pain management. Device serves as an interface between clinician and implanted stimulator to refine therapy delivery.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Touch-screen computer interface; software-based parameter programming; automated data logging; intended for clinical use with implanted spinal cord stimulators.

Indications for Use

Indicated for patients with chronic pain of the trunk and limbs requiring spinal cord stimulation (SCS) as a primary or adjunct therapy.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2005

Katryna Warren Manager, Regulatory Affairs Advanced Neuromodulation Systems 6901 Preston Road Plano, Texas 75024

Re: K052374

Trade/Device Name: Rapid Programmer, Models 3830 and 3831 Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: August 26, 2005 Received: August 30, 2005

Dear Ms. Warren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Not of countines (1) ); good manufacturing practice requirements as set CITY at 807), ademig (21 CFR Part 820), good if applicable, the electronic forth in the quality by some (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation offices po begin marketing your device as described in your Section 510(k) I ms leter will and w yours of substantial equivalence of your device of your device to a legally prematics notification "Tresults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please it you acon office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionmation on your Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Mikkelson

Sor Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: Rapid™ Programmer

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_Ko52374