RAPID PROGRAMMER, VERSION 3.3.0

K091993 · Advanced Neuromodulation Systems, Inc. (Ans Inc.) · GZB · Jul 31, 2009 · Neurology

Device Facts

• Record ID: K091993
• Device Name: RAPID PROGRAMMER, VERSION 3.3.0
• Applicant: Advanced Neuromodulation Systems, Inc. (Ans Inc.)
• Product Code: GZB · Neurology
• Decision Date: Jul 31, 2009
• Decision: SESE
• Submission Type: Special
• 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 interface used by clinicians to configure and optimize implanted spinal cord stimulators. It functions by guiding clinicians and patients through various stimulation parameter combinations (waveforms, electrode configurations) to identify optimal settings for pain relief. The device records stimulation effects and automatically logs procedural data. Used in clinical settings, it enables physicians to manage neurostimulation therapy, facilitating personalized patient treatment through systematic parameter adjustment and data documentation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Touch-screen computer interface; software-based parameter configuration for implanted spinal cord stimulators; supports waveform and electrode configuration management; automated data logging functionality.

Indications for Use

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

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Neuromodulation Systems c/o Mia M. Ware Regulatory Affairs Specialist 6901 Preston Road Plano. TX 75024

JUL 3 1 2009

Re: K091993

Trade/Device Name: Rapid Programmer, Version 3.3.0 Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: II Product Code: GZB Dated: June 30, 2009 Received: July 2, 2009

Dear Ms. Ware:

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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Ruake Rummell
Mark D. Feldman, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):____ K091993

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 × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quỳnh Hoang

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(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K091993

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