STIMUPLEX PEN

{0}------------------------------------------------ Annex II K061983 12 2 2 Image /page/0/Picture/3 description: The image shows the logo for Stockert GmbH. The logo features a black and white crest on the left side, with a helmet and feathers on top. To the right of the crest is the text "Stockert GmbH" in a simple, sans-serif font, with a line underneath the text. ## 510(k) Summary November 9, 2006 Bötzinger Straße 72 79111 Freiburg phone: ++49-761-20716-0 Fax: ++49-761-20716-20 eMail: info@stockert.de http://www.stockert.de This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. Contact: Dominika Schuler, Management Representative Trade Name: Stimuplex® Pen Common Name: Device for cutaneous electrical nerve stimulation Classification Name: Neurological Devices, Class II, GXY Cutaneous electrode 21 CFR 882.1320 Predicate Device: Nerve Mapping Probe (accessory only) for NeuroTrace III Nerve Stimulator K023342 Superficial nerves can be stimulated electrically through the skin by means of a weak current. Cutaneous electrical nerve stimulation (CENS) represents a decisive advance in the location of superficial nerve structures: it enables the cutaneous projection of any superficial nerve to be determined and the point of needle entry to be optimized in order to more easily perform peripheral nerve block in adults and children. The Stimuplex® Pen is an electrode for cutaneous stimulation which, when connected to the Stimuplex® HNS 11 or HNS 12 nerve stimulator and placed on the skin, it conducts electrical impulses which initiates muscular contractions and/or synchronous electrical paresthesia whitin the distribution area of a nerve. The nerve passes perpendicularly to the place where a response is observed at the lowest level of current. This designated point of needle entry is situated directly perpendicular with the nerve. {1}------------------------------------------------ Stimuplex® Pen is intended to be used only with B.Braun's nerve stimulators: Stimuplex® HNS 11 (510k no. K003983) and/or Stimuplex® HNS 12 (510k no. K052313). The configuration of the electrode connection is realized with a 1 pin plug safety connection system, which ensures correct polarity of the electrode to the Stimuplex® HNS 11 or HNS 12 nerve stimulator. The nerve stimulator generates neqative, current-stabilized square pulses with selectable frequency, selectable pulse width and fine adjustable stimulation current. It displays the actual stimulation current so that the proper current flow can be checked. The intended use is a cutaneous stimulation electrode for locating superficial peripheral nerves through the skin in local/regional anaesthesia, local/regional analgesia and neurology. Stimuplex® Pen is a prescription use only device, the patient is not the operator. It can be used on adult, pediatric, and/or infant population The general technological characteristics of the Stimuplex® Pen are generally equivalent in materials, form and intended use to the Nerve Mapping Probe (accessory only) for the NeuroTrace III peripheral nerve stimulator. Differences between the Stimuplex® HNS 12 and the predicate device consist only in the nerve stimulation parameters of the nerve stimulators and the diameter of the tip, The small power density difference doesn't affect safety and effectiveness for the intended use. All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release includes, but is not limited to: physical testing, visual examination (in process and finished product). The physical testing is defined by quality control test procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's. sianed: Dominika Schuler, Management Representative Stockert GmbH te: 2006-11-09 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three curved lines forming its body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Dominika Schuler Management Representative Stockert GmbH Boetzinger Strasse 72 Freiburg, B-W, GERMANY, D-79111 NOV 2 1 2006 Re: K061983 Trade/Device Name: Stimuplex Pen Regulation Number: 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: BXN Dated: November 9, 2006 Received: November 13, 2006 Dear Ms. Schuler: 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. {3}------------------------------------------------ Page 2 – Ms. Mr. Schuler 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Ovei Sullom for Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K061983 Device Name: Stimuplex Pen Indications for Use: Stimuplex® Pen is a cutaneous stimulation electrode for locating superficial peripheral nerves through the skin in local/regional anaesthesia, lor looding openhold peripieral hervey. Ban invesive device non invasive device. Intended patient population: for adult, pediatric and/or infant use. Stimuplex® Pen is intended to be used only with B.Braun's nerve stimulators: Stimuplex® HNS 11 (510k no. K003983) and/or Stimuplex® HNS 12 (510k no. K05213). It can be used wherever peripheral anesthesia is normally applied (i.e. physician's office on hospital). 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) Cuns Sulion