DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX

{0}------------------------------------------------ K070997 # 510(k) Notification DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories ### APPENDIX I: Summary ### 1. Device Name | Trade Name: | DORO® Non-Stick Bipolar Forceps<br>DORO® Bipolar Reusable Cables | |--------------|------------------------------------------------------------------| | Common Name: | Bipolar Forceps<br>Bipolar Reusable Cables | # 2. Classification The DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables of pro med instruments GmbH can be classified according following Device Names and Product Codes: | Device | Device, Electrosurgical, Cutting & Coagulation & Accessories | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device description | Electrosurgical cutting and coagulation device and accessories | | Medical Specialty | Part 878, General & Plastic Surgery | | Product Code | GEI | | Regulation Number | 878.4400 | | Device Class | 2 | | Description acc. 21 CFR 878.4400: | PART 878--GENERAL AND PLASTIC SURGERY DEVICES<br>Subpart E--Surgical Devices<br>Sec. 878.4400 Electrosurgical cutting and coagulation device and accessories.<br>(c) Identification. An electrosurgical cutting and coagulation<br>device and accessories is a device intended to remove tissue and control<br>bleeding by use of high-frequency electrical current.<br>(d) Classification: Class II. | # 3. Substantial Equivalence ### (a) DORO® Non-Stick Bipolar Forceps: The DORO® Non-Stick Bipolar Forceps are substantially equivalent to other legally marketed Bipolar Forceps from different manufacturers, Günter Bissinger Medizintechnik GmbH (product: CLARIS NON-STICK bipolar forceps, K51429), e.g. Link Technology, Inc. (product: Silverglide Surgical Technologies, K992931). The DORO® Non-Stick Bipolar Forceps are for use in general surgical procedures. These devices are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. During the coagulation of tissue, the coagulated tissue may stick to the forceps. This undesirable effect can be eliminated by the non-stick properties of the unique solid silver alloy tip forceps of the DORO line. The solid silver allov tip provides excellent thermal properties and eliminates the difficult and time-consuming of the forceps during a procedure. The non-stick properties are permanent since it is not a coating and the non-stick properties are retained through repeated and frequent sterilizations. Reusable Standard two-pin round connector cables are designed to work with all foot-switching bipolar electrosurgical generators. > pro med instruments GmbH, Bötzinger Str. 38, 79111 Freiburg / Germany Phone: 011-49-761 441545, Fax: 011-49-761 441510 MAY 16 2007 APPENDIX I, Page 2 {1}------------------------------------------------ # 510(k) Notification ### DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories Image /page/1/Picture/2 description: The image shows a logo with the letters 'rmi' stacked vertically. To the right of the letters, there is text that reads 'your used instruments' in a smaller font size and rotated 90 degrees counterclockwise. The letters 'rmi' are in a bold, sans-serif font, and there is a solid black circle above the 'r'. ### APPENDIX I: Summary ### (b) DORO® Bipolar Reusable Cables The DORO® Bipolar Reusable Cables are equivalent to the Stryker Silverglide Bipolar Forceps Reusable Cables (K061835) and nearly equivalent to CLARIS bipolar forceps (K051429) except small changes of the material. The DORO® Bipolar Reusable Cables are non-sterile, reusable bipolar cables of 3 and 5 meters. They are designed to transport electrical power from a high-frequency electrosurgical generator by a foot-activated switch. The cable fittings are compatible for use with: Erbe, Martin, Valleylab, Aesculap and other ES Generator Units with twinpin connectors (2-banana plug). The cables are comprised of silicone (outer insulation), PTFE or FEP (core insulation), and Cu-wire poreless silver plated (wire). The cable consists of a twin-pin connector (2-banana plug) that is comprised of silver plated bronze and insulated with silicone. The connector cable at the forceps end is comprised of bronze or brass - silver or nickel plated, Stainless Steel 1.4310, PP (Polypropylene or TPE). # 5. Intended Use ### (a) DORO® Non-Stick Bipolar Forceps The DORO® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch. The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterliization or tubal coagulation for sterilization procedures and should not be used for these procedures. #### (b) DORO® Bipolar Reusable Cables The DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument. # 6. Performance Standards DIN EN 60601-1: Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988 + A1:1991 + A2:1995); German version EN 60601-1:1990 + A2:1995; Version: 01-Mar-1996; DIN EN 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:1998); German version EN 60601-2-2:2000; Version: 01-Aug-2001; ANSI/AAMI HF18-2001: Electrosurgical Devices: Version: 01-May-2001. APPENDIX I, Page 3 {2}------------------------------------------------ ## 510(k) Notification ### DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories Image /page/2/Picture/2 description: The image shows a logo with the letters 'rmi' stacked vertically. To the right of the letters, there is some smaller text that is difficult to read due to the image quality. The letters are in a bold, sans-serif font, and the overall design is simple and modern. The logo appears to be for an organization or company with the initials 'rmi'. ### APPENDIX I: Summary ## 7. Sterilization by User DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables are delivered in non-sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process. #### Cleaning and Maintenance Every surgical instrument should be disinfected and thoroughly cleaned after each use. Proper cleaning, inspection and maintenance will help ensure correct function of the surgical instrument. Clean, inspect and test each instrument carefully. Sterilize all instruments before surgery. A good cleaning and maintenance procedure will extend the useful life of the instrument. Special attention must be paid to slots, stops, ends, hollow tubes and other highly inaccessible areas. Check insulation, cables and connectors for cuts, voids, cracks, tears, abrasions, etc. Do not use damaged instruments. Cleaning and rinsing must take place immediately after each use for best effect. Failure to clean promptly may result in adherent particles or dried secretions that may resist cleaning and complicate or resist future sterlization. Instruments must be completely cleaned and rinsed of all foreign matter. Use warm water and a commercially available instrument pre-soak or cleaning agent. Enzymatic cleaners (such as Enzol ") must be used to remove protein deposits. Follow the enzymatic cleaner's instructions; rinse thoroughly, Do not use corrosive cleaning agents (i.e. bleach). Cleaning solutions and rinses at or near a neutral pH (7.0) are best. Do not use abrasive cleaners. Only a soft bristle brush should be used. Immerse the entire device in detergent and clean while soaking. Rinse with sterile deionized water. Can be disinfected in the washing machine up to 203°F (95°C). Rinse thoroughly with distilled water. Prepare for storage and/or sterilization. #### Sterilization Only a validated steam-sterilization process according DIN EN 554 / ISO 11134 that uses a sterilization cycle of 137°C / 280°F, 3 bar, for min. 15 minutes should be used. (Note: Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilization times.) Caution: Autoclave temperatures should not exceed 280°F (137°C); handles, insulation or other non-metallic parts may be damaged Do not sterilize with hot air. Do not use 'Flash' autoclave procedures. # 8. Conclusion Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that DORO® Non-Stick Bipolar Forceps are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act. t {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Pro Med Instruments GmbH % Pro Med Instruments, Inc. Mr. Edgar Schuele Managing Director 5450 Lee Street, Suite 1 Lehigh Acres, Florida 33971 MAY 16 2007 Re: K070997 Trade/Device Name: DORO® Non-Stick Bipolar Forceps DORO® Bipolar Reusable Cables Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 5, 2007 Received: April 13, 2007 Dear Mr. Schuele: 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. 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 {4}------------------------------------------------ Page 2 - Mr. Edgar Schuele forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Molkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # 510(k) Notification K070997 DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories APPENDIX II: Indication Of Use Statement Image /page/5/Picture/1 description: The image shows a black and white graphic of the letter 'i'. The letter is stylized with a dot above a wavy line that forms the body of the letter. To the right of the letter, there is some text that is too blurry to read. The letter 'i' is oriented vertically in the image. pro med instruments GmbH Company: 510 (K) Number (if known): K070997 DORO® Bipolar Reusable Cables Device Name: Electrosurgical Cutting and Coagulation Device & Accessories Classification Name: GEI, Class II 21 CFR 878.4400 Product Code: ### INDICATION OF USE The DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument. (Division Sign-Off) Division of General, Restorative, (Division Sign-off) and Neurological Devices Division of General, Restorative, and Neurological Devices 510(K)Numbe510(k)997Number 1070997 PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE AN ANOHTER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X (Per 21 CFR 801 Subpart D) or Over-The Counter Use (Per 21 CFR 801 Subpart C) pro med instruments GmbH, Bötzinger Str. 38, 79111 Freiburg / Germany Phone: 011-49-761 441545, Fax.: 011-49-761 441510 APPENDIX II Page 2 {6}------------------------------------------------ ### 510(k) Notification K070997 ### DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories ### APPENDIX II: Indication Of Use Statement | Company: | pro med instruments GmbH | |----------------------------|--------------------------------------------------------------| | 510 (K) Number (if known): | K070997 | | Device Name: | DORO® Non-Stick Bipolar Forceps | | Classification Name: | Electrosurgical Cutting and Coagulation Device & Accessories | | Product Code: | GEI, Class It 21 CFR 878.4400 | #### INDICATION OF USE The DORO® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended i ne DONO Nort Online Spotar - Shopp are connected through a suitable bipolar cable with the bipolar output of an electrofor dse in generator. Bipolar probation may are used with bipolar coagulation is achieved using electrosurgical generated. Elipolar for sope mebological generator unit and activated by a footswitch. The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. #### (Division Sign-off) #### Division of General, Restorative, and Neurological Devices #### 510(K)Number K070997 PLEASE DO NOT WRITE BELOW THIS LINE --CONTINUE AN ANOHTER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) X Prescription Use (Per 21 CFR 801 Subpart D) or Over-The Counter Use (Per 21 CFR 801 Subpart C) pro med instruments GmbH, Bötzinger Str. 38, 79111 Freiburg / Germany Phone: 011-49-761 441545, Fax : 011-49-761 441510 APPENDIX II Page 1