MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS

{0}------------------------------------------------ DFC 21 2004 K043130 # 510(k) Summary of Safety and Effectiveness ### Submitter Information: PAJUNK GmbH Karl Hall Straße 1 D78187 Geisingen Germany ## USA Contact: Mr. Burk A. Brandt CE Consultancy, Inc. 5010 NW Crescent Valley Dr. Corvallis, OR 97330 - USA Phone: (541) 752-3953 Fax: (541) 752-3972 ## Device Name: Trade Name: Stimulong Plus Catheter Sets Plexalong Sets Unipolar Needles Common Name: Anesthesia Conduction Kit Anesthesia Conduction Needle (W/Wo Introducer) Classification Name: Anesthesia Conduction Kit (Reference, 21CFR, 868.5140, April 1, 2003), Anesthesia Conduction Needle (Reference, 21CFR, 868.5140, April 1, 2003) #### Predicate Devices: The Stimulong Plus Catheter sets and Plexalong sets consist of a Pajunk Unipolar needle (conduction cannula with nerve stimulus connector and tubing), and an open ended conduction catheter and a catheter adapter. The catheter in the Stimulong Plus Catheter is the same as the catheter in the Plexalong sets except for the conductive ring tip. The Stimulong Plus Catheter sets have been cleared for market by the FDA under 510(k) number K033018. The Plexalong sets have been cleared under K013041 and the Unipolar needles under 510(k) number K000722 (facet and Sprotte tip conduction cannula and tubing). Unipolar needles with a Tuohy tip were cleared for market under 510(k) number K023218. The packaging materials used to package the Stimulong Plus Catheter, Pajunk Plexolong sets, and cannula has not changed. The contract sterilizer, other than a company name change (was Griffith Micro Science, now Sterigenics) and sterilizing process is the same. {1}------------------------------------------------ ## Device Description: The Paiunk Stimulong Plus Catheter Sets and Plexalong sets are single use, sterile, non-pyrogenic and latex free conduction anesthesia sets intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. The Stimulong Plus Catheter sets and Plexalong sets consist of a single use sterile, non-pyrogenic conduction needle with tubing, a catheter and catheter adapter. The catheter in the Stimulong Plus Catheter is the same as the catheter in the Plexalong sets except for a conductive ring tip. Continuous delivery is accomplished using the catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the tip of the conduction needle and after placement of the conduction catheter (Stimulong Plus catheter) to its tip via the catheter adapter. #### Intended Use: The Pajunk Stimulong Plus Catheter Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle and after placement of the conduction catheter to its tip via the catheter adapter. # Technology Characteristics: Except for the insulating material used to coat the needles, the Pajunk conduction cannula, including the physical dimensions, connector, tubing, metal and plastics, have been cleared under 510(k) numbers K000722. K013041 and K023218. The materials used to manufacture the Pajunk catheter and catheter adapter except for the conductive catheter tip and wire are identical to the materials used to manufacture the catheter and catheter adapter of the predicate devices described earlier in this 510(k) Summary of Safety and Effectiveness. Biocompatibility testing of the conductive tip, wire and alternate plastic material is located in Section 7 of this submission. Use of a conduction catheter was cleared by FDA under 510(k) No. K030937. The Stimulong Plus Catheter Sets are supplied in polypropylene containers that are sealed to assure sterility. {2}------------------------------------------------ # Summary of Performance Testing The Pajunk Stimulong Plus Catheter Sets were designed to conform to the applicable sections of the following recognized consensus standards. The testing included verifying conformance to these standards. | Standard | Issue Date | Title | |--------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DIN 13090/ISO 594 | 08.1984 | Luer fittings w/wo locking feature | | DIN 13097 Part 1 | 01.1980 | Medical injection cannula | | DIN 13097 Part 3 | 11.1979 | Medical cannula | | DIN 17442/ISO 9626 | 10.1977 | Steel for medical instruments | | DIN EN 550 | 07.1993 | Sterilization of med. Prod.; Validation & routine controls<br>for sterilization with ETO | | DIN EN 556 | 01.1995 | Sterilization of medical products, requirements for<br>medical products that are labeled "sterile" | | DIN EN 724 | 12.1994 | Guidance on the application of EN29001 and EN46001<br>for non-active medical products | | PrEN 868-1 | 10.1996 | Packaging materials for the sterilization of packaged<br>goods. Part 1: general requirements for the validation<br>of the packaging of sterilized end-packaged products | | DIN EN 868-2 | 03.1993 | Packaging materials for the sterilization of packaged<br>goods. Part 2: sterilization packaging, requirements<br>and tests. | | DIN EN 980 | 08.1996 | Graphic symbols for marking medical products | | DIN EN 1441 | 08.1994 | Risk analysis for medical products | | EN ISO 14971 | 2000 | Risk Management | | DIN EN 1707 | 01.1997 | 6% Luer cone connections for injection cannula and<br>particular medical equipment | | DIN EN/ISO 9626 | 06.1995 | Cannula tube of non-rusting steel (SS) for the<br>manufacture of medical products | | DIN EN ISO 10993-1 | 08.2003 | Biological evaluation of medical products - instructions<br>for selection of tests | | DIN EN 46001 | 12.1993 | Particular requirements for medical products | | DIN 17440 | 09.1996 | Stainless Steels | | BS 4843 | | Single entry IV cannula | # Conclusion: The PAJUNK Stimulong Plus Catheter Sets are as safe and effective as the predicate devices when used according to the instructions in the directions for use supplied with the devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the seal is an abstract image of an eagle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 1 2004 Pajunk GmbH c/o Mr. Burk A. Brandt President CE Consultancy, Incorporated 5010 NW Crescent Valley Drive Corvallis, Oregon 97330 Re: K043130 Trade/Device Name: Pajunk Stimulong Plus Catheter Sets Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSP Dated: December 3, 2004 Received: December 6, 2004 Dear Mr. Brandt: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becater of 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 interstate connifetee prior to ria, 20, 177, 1978, 1978, 1998, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 199 Alliendinens, or to de rises and in tic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Ocommay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of an 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 If your device is classified (soch additional controls. Existing major regulations affecting (1 MA), it may of subject to back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the weat nouncements concerning your device in the Federal Register. {4}------------------------------------------------ # Page 2 - Mr. Brandt 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 modifined into may Federal statutes and regulations administered by other Federal agencies. or the Act of all, I 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 and ifsuing (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as between as 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 premained with a medicate 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), rr you contact the Office of Compliance at (240) 276-0120. 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 maj South Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address lttp://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours, Chiu Lin, Ph.D. 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known):K043130 Device Name: Pajunk Stimulong Plus Catheter Sets Indications For Use: The Pajunk Stimulong Plus Catheter Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle and after placement of the conduction cathter to its tip via the catheter adapter. 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) Sta Senille Division Sign-Off Anes ു. General Hospital. Infection Control. Jer tal Devices 510(k) Number: _ Ko 9313 Page 1 of 1