RAPID PROGRAMMER

K113611 · St Jude Medical · GZB · Apr 20, 2012 · Neurology

Device Facts

• Record ID: K113611
• Device Name: RAPID PROGRAMMER
• Applicant: St Jude Medical
• Product Code: GZB · Neurology
• Decision Date: Apr 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

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.

Device Story

Rapid Programmer is a touch-screen computer system used by clinicians to program St. Jude Medical neurostimulation devices. It guides clinicians through patient-specific stimulation parameter combinations (waveforms, electrode configurations) to optimize therapeutic performance. The device automatically logs procedure data and stimulation effects during the programming session. It functions as a clinical tool to facilitate efficient device setup and data management in a clinical setting, ultimately assisting in the delivery of spinal cord stimulation for chronic pain management.

Clinical Evidence

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

Technological Characteristics

Touch-screen computer interface; software-based parameter programming and data logging; communicates with implanted neurostimulators to adjust waveforms and electrode configurations.

Indications for Use

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

Predicate Devices

• St. Jude Medical Eon/Eon C/Eon Mini/Eon IPG (K042619, K061336, K081535, K102656)

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002

St. Jude Medical c/o Ms. Teri Gilio Sr. Regulatory Affairs Specialist 6901 Preston Road Plano, TX 75024

Re: K113611

Trade/Device Name: Rapid Programmer Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: March 22, 2012 Received: March 23, 2012

Dear Ms. Gilio:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

AAR 2 0 2012

{1}------------------------------------------------

Page 2 - Ms. Teri Gilio

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.

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/MedicalDevices/Safety/ReportalProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ra. Stimm/b

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

Enclosure

{2}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known): K 11361)

Device Name(s): Rapid Programmer

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.

Prescription Use _X (Per 21 CFR 801.109) or

Over-The-Counter Use _

Concurrence of CDRH, Office of Device Evaluation (ODE)

KRISTEN BOWSHER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_K 113 611