Supra Non-Stick Bipolar Forceps

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The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. # 11/17/2022 Guenter Bissinger Medizintechnik GmbH Matthias Bissinger Managaing Director Hans-Theisen-Str. 1 Teningen, Baden-Wurttemberg 79331 Germany Re: K213042 Trade/Device Name: Supra Non-Stick Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: October 14, 2022 Received: October 20, 2022 Dear Matthias Bissinger: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Carr-S for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K213042 Device Name SUPRA Non-Stick Bipolar Forceps Indications for Use (Describe) The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected - with the appropriate cable - to the bipolar output of an HF generator. Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation. Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;"> <svg height="12" width="12"> <rect fill="none" height="10.5" stroke="black" stroke-width="1" width="10.5" x="0.75" y="0.75"></rect> </svg> </span> Remediation Use (21 CFR 201.561 Subject to) | <span style="font-family: sans-serif;"> <svg height="12" width="12"> <rect fill="none" height="10.5" stroke="black" stroke-width="1" width="10.5" x="0.75" y="0.75"></rect> </svg> </span> Over-The-Counter Use (21 CFR 201.66 Subject to) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K213042 Image /page/3/Picture/2 description: The image shows the logo for Bissinger. The logo features a stylized red letter 'b' with an eye incorporated into its design. The word 'bissinger' is written in black below the symbol. DATE OF APPLICATION: 16.09.2021 APPLICANT: Guenter Bissinger Medizintechnik GmbH Hans-Theisen-Str. 1 D-79331 Teningen Germany Tel: + 49 7641 914330 Fax: +49 7641 9143333 E-Mail: info@bissinger.com CONTACT PERSON: Matthias Bissinger Managing Director Tel.: +49 7461 914330 E-Mail: bissinger@bissinger.com {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for Bissinger. The logo features a stylized letter 'b' in red, with the upper part of the 'b' forming the outline of an eye. The pupil of the eye is black. Below the eye is the word 'bissinger' in black, lowercase letters. #### ਹ Device Name | Trade Name: | SUPRA Non-Stick Bipolar Forceps | |-----------------------------|------------------------------------------------------| | Common Name: | Bipolar Forceps | | Device Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories | #### 2 Classification / Product Code SUPRA Non-Stick Bipolar Forceps can be classified according to following device name and product code: | Device | Regulation<br>Description | Regulation<br>Medical<br>Specialty | Review Panel | Product Code | Regulation<br>Number | Device<br>Classification | |---------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------|------------------------------|--------------|----------------------|--------------------------| | Electrosurgical,<br>Cutting &<br>Coagulation &<br>Accessories | Electrosurgical<br>cutting and<br>coagulation<br>device and<br>accessories | General & Plastic<br>Surgery | General & Plastic<br>Surgery | GEI | 878.440 | 2 | #### ఆ Predicate Device / Reference Device | Device | Predicate Device | 510(k) Number | 510(k) Holder | |---------------------------------|----------------------------------|---------------|-----------------------------------------| | SUPRA Non-Stick Bipolar Forceps | Claris Non-Stick Bipolar Forceps | K051429 | Günter Bissinger<br>Medizintechnik GmbH | #### 4 Device Description SUPRA Non-Stick Bipolar Forceps are available in several working length and tip width. They are delivered with a 2pin plug to connect them to bipolar output of an HF generator. The devices are supplied in sterile state and are intended for single use only. #### 5 Intended Use The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected – with the appropriate cable to the bipolar output of an HF generator. ### Contraindication: Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation. #### б Technological Characteristics The technological characteristics of SUPRA Non-Stick Bipolar Forceps are the technological characteristics of the predicate device. #### 6.1 Device Characteristics Table | Company | Günter Bissinger Medizintechnik<br>GmbH<br>(New Device) | Günter Bissinger Medizintechnik<br>GmbH<br>(Predicate Device) | Result | |-------------------|---------------------------------------------------------|---------------------------------------------------------------|--------| | Device Name | SUPRA Non-Stick Bipolar Forceps | Claris Non-Stick Bipolar Forceps | -- | | Regulation Number | 878.440 | 878.440 | -- | {5}------------------------------------------------ K213042 Image /page/5/Picture/2 description: The image shows the logo for Bissinger. The logo features a stylized red letter "b" with an eye in the upper portion of the letter. Below the "b" is the word "bissinger" in a sans-serif font. The logo is simple and modern. | Company | Günter Bissinger Medizintechnik<br>GmbH<br>(New Device) | Günter Bissinger Medizintechnik<br>GmbH<br>(Predicate Device) | Result | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | Class | II | II | Substantially Equivalent | | Code | GEI | GEI | Substantially Equivalent | | 510(k) number | --- | K051429 | --- | | Indication for Use | The Bissinger SUPRA Non-Stick<br>Bipolar Forceps are used for<br>grasping, dissection and<br>coagulation of biological tissues.<br>The fully assembled instrument (if<br>assembly is needed) has to be<br>connected - with the appropriate<br>cable - to the bipolar output of an<br>HF generator.<br>Supra Non-Stick Bipolar Forceps<br>may not be used for tubal<br>sterilization or tubal coagulation. | The Bissinger CLARIS Non-Stick<br>bipolar forceps are designed to<br>grasp, manipulate and coagulate<br>selected tissue. It is to be<br>connected through a suitable<br>bipolar cable with the bipolar<br>output of an electro-surgical<br>generator. Bipolar For-ceps must<br>only be used with bipolar<br>coagulation current.<br>The Bissinger CLARIS Non-Stick<br>bipolar forceps has not been shown<br>to be effective<br>for tubal sterilization or tubal<br>coagulation for sterilization<br>procedures and should not be<br>used for these procedures. | Substantially Equivalent | | Prescription / OTC | Prescription | Prescription | Substantially Equivalent | | Device Design | Insulated forceps with plug | Insulated forceps with plug | Substantially Equivalent | | Tip Size [mm] | 0.5-1.5 | 0.25-2.0 | Substantially Equivalent | | Shaft Length [mm] | 101-229 | 110-240 | Substantially Equivalent | | HF Mode | Bipolar | Bipolar | Substantially Equivalent | | Maximum peak voltage [Vp] | Ref. no. 91511106: 300<br>Ref. no. 906xxxxx, 91512601: 500 | 300 | Substantially Equivalent | | Delivered condition | Sterile | Unsterile | Substantially Equivalent | | Single use | Yes | No | Substantially Equivalent | | Materials | Stainless Steel<br>Plastic Material<br>Ag800 | Stainless Steel<br>Plastic Material<br>Ag800 | Substantially Equivalent | #### Summary of Technological Characteristics 6.2 The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices are also used in the legally marketed predicate devices. #### 7 Sterilization and Shelf Life The product is delivered in sterile condition. No treatment is required prior to its shelf life is 5 years. It is intended for single-use only and as such, is not intended to be reprocessed and sterilized. Appropriate packaging, shelf-life, and sterilization validations were carried out, which prove the sterility of the products. #### 8 Biocompatibility The devices have been evaluated concerning their biological safety (according to ISO 10993-1). The material, the manufacturing process, as well as the packaging have been considered within this biological safety evaluation. Based on the evaluation of the material constituents, the devices meet the requirements of ISO 10993-1. The biological safety of the devices is therefore considered to be satisfactory demonstrated. {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows a logo for Bissinger. The logo features a stylized letter 'b' in red, with the loop of the 'b' forming an eye shape. The pupil of the eye is black. Below the eye is the word 'bissinger' in a simple, sans-serif font. Page 4 of 4 #### 9 Electrical Safety Tests according to IEC 60601-1, IEC 60601-2-2 and IEC 60601-1-2 have been performed. The device had passed all performed tests. # 10 Substantial Equivalence Summary / Conclusion Based on available 510(k) information provided herein, our SUPRA Non-Stick Bipolar Forceps are considered to be substantially equivalent to the predicate device Claris Non-Stick Bipolar Forceps in terms of indication for use, materials and technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness.