StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit

K142432 · Bioness, Inc. · GZF · Feb 20, 2015 · Neurology

Device Facts

• Record ID: K142432
• Device Name: StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
• Applicant: Bioness, Inc.
• Product Code: GZF · Neurology
• Decision Date: Feb 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

Device Story

StimRouter Neuromodulation System provides electrical stimulation to peripheral nerves for chronic pain management. System consists of an implanted lead/receiver and an external pulse transmitter (EPT) worn over the implant site. EPT transmits stimulation signals transcutaneously to the implanted lead via radiofrequency (RF) coupling. Physician programs stimulation parameters; patient controls stimulation intensity/on-off status via external controller. Device serves as adjunct to other therapies (e.g., medications). Benefits include non-pharmacological pain management for patients with intractable peripheral nerve pain.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

Implantable peripheral nerve stimulator; RF-coupled external pulse transmitter; transcutaneous energy/signal delivery. System includes implanted lead/receiver and external controller. Materials and sterilization methods consistent with Class II implantable nerve stimulators.

Indications for Use

Indicated for adults with severe intractable chronic pain of peripheral nerve origin as adjunct therapy. Contraindicated for pain in the craniofacial region.

Regulatory Classification

Identification

An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Predicate Devices

• Bioness NESS L300 (K061336)
• Medtronic InterStim System (K970356)

Submission Summary (Full Text)

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

February 20, 2015

Bioness Inc. Robert Schulz, RAC Global Director, Regulatory Affairs and Quality Assurance, 25103 Rye Canyon Loop Valencia, CA 91355

Re: K142432

Trade/Device Name: StimRouter Neuromodulation System Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZF Dated: Jan 16th 2015 Received: Jan 20th 2015

Dear Mr. Schulz,

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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Felipe Aquel -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): __ K142432 _________________________________________________________________________________________________________________________________________

Device Name:

StimRouter Neuromodulation System

## Indications for Use:

The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

Image /page/2/Picture/8 description: The image contains a single Chinese character. The character is "风", which means wind. The character is inside of a square.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH)