Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 22, 2020 Adeor Medical AG % Cassie Sopko, Regulatory Engineer JALEX Medical 30311 Clemens Rd, Suite 5D Westlake, Ohio 44145 Re: K191847 Trade/Device Name: Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use 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: April 15, 2020 Received: April 20, 2020 Dear Cassie Sopko: 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. {1}------------------------------------------------ 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 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 (QS) 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. 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K191847 #### Device Name Adeor Medical AG nxt™ Non-stick Bipolar Forceps Adeor Medical AG nxt™ Single-Use Non-stick Bipolar Forceps #### Indications for Use (Describe) The Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz; maximum generator operating voltage 600Vp. The Adeor Medical 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. The types of surgery intended include: #### - ENT - Gynecology (except for use in female sterilization) - Urology - General surgery - Neurosurgery - Laryngeal Surgery - Orthopedic Surgery - Thoracic Surgery | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;"><b> </b></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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To the right of the brain is the word "adeor" in black, with the word "MEDICAL" in smaller black letters underneath. # 510(k) Summary | Submitted By: | Adeor Medical AG<br>Biberger Str. 93<br>82008 Unterhaching<br>Germany | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | February 27, 2020 | | Contact Person: | Cassie Sopko, Regulatory Engineer | | Contact Telephone: | (440) 541-0060 | | Contact Fax: | (440) 933-7839 | | Device Trade Name: | Adeor Medical nxt ^™ Non-stick Bipolar Forceps<br>Adeor Medical nxt ^™ Single-Use Non-stick Bipolar Forceps | | Device Classification Name: | Electrosurgical, Cutting and Coagulation Accessories | | Device Classification: | II | | Reviewing Panel: | General and Plastic Surgery | | Product Code: | GEI | | Predicate Device: | K182773 Falhaber Pinzetten OHG Non-Stick Bipolar Forceps (never<br>subject to recall) | | Reference Predicates: | K101080- Faulhaber Non-Stick Bipolar Forceps<br>K162469- CODMAN VersaTru Non-Stick Bipolar Forceps<br>K130669- Olsen Medical Electrosurgical Monopolar and Bipolar<br>Forceps (subject to recall Z-1944-2018 and Z-1945-2018 for packaging<br>risks) | ## Device Description: The Adeor Medical AG Bipolar Forceps are electrosurgical instruments used to grasp, manipulate, cut or coagulate tissue. Bipolar forceps have various lengths and tip configurations, as well as irrigation and suction technologies. Both reusable and single-use forceps are available, with flat plug or two pin plug configurations. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of a high frequency generator and may be used only with bipolar coagulation current. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHz: maximum generator operating voltage 600Vn. ## Intended Use: The Adeor Medical Non-stick Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. Adeor bipolar forceps must be operated with the following parameters: Frequency range between 300 kHz and 1,000 kHZ; maximum generator operating voltage 600Vp. The Adeor Medical 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. The types of surgery intended include: {4}------------------------------------------------ Image /page/4/Picture/2 description: The image contains the logo for Adeor Medical. The logo consists of a stylized blue brain on the left, followed by the text "adeor" in black. Below "adeor" is the word "MEDICAL" in smaller, black letters. - ENT - Gynecology (except for use in female sterilization) ● - Urology ● - General Surgery - Neurosurgery - Laryngeal Surgery - Orthopedic Surgery ● - . Thoracic Surgery ## Summary of Technological Characteristics: The Adeor Medical Bipolar Forceps are identical to the predicate in that they are both intended to grasp, manipulate and coagulate soft tissue. The subject device's component materials, fundamental scientific technology, and mode of action are identical to that of the predicate device. See Table 1 for a more detailed comparison of the subject, predicate and reference devices. | Item | Adeor Medical | Faulhaber Pinzetten | CODMAN<br>VersaTru | OLSEN<br>Medical® | Comparison<br>to Predicate | |---------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------| | Classification<br>Name | Electrosurgical,<br>Cutting and<br>Coagulation<br>Accessories | Electrosurgical,<br>Cutting and<br>Coagulation<br>Accessories | Electrosurgical,<br>Cutting and<br>Coagulation<br>Accessories | Electrosurgical,<br>Cutting and<br>Coagulation<br>Accessories | Equivalent | | Regulation | 878.4400 | 878.4400 | 878.4400 | 878.4400 | Equivalent | | Common<br>Name | Single-Use and<br>Reusable Bipolar<br>Forceps | Non-stick Bipolar<br>Forceps | Disposable<br>Bipolar Forceps | Single Use<br>Bipolar and<br>Monopolar<br>Forceps<br>Multiple-Use<br>Bipolar and<br>Monopolar<br>Forceps | Equivalent | | Product Code | GEI | GEI | GEI | GEI | Equivalent | | Intended Use | The Adeor Medical | Faulhaber Single Use | Intended for use | Active | Equivalent- | | | Non-stick Bipolar | Non-Stick Bipolar | in electrosurgery | electrosurgical | Subject device | | | Forceps are | Forceps sterile/ non- | for coagulation of | devices where | includes | | | intended for use by | sterile and Single Use | tissue. | monopolar or | specific | | | a physician familiar | NonStick Irrigating | | bipolar | information | | | with electrosurgery | Forceps sterile/ non- | | electrosurgical | such as | | | in bipolar | sterile are intended for | | cutting and | operational | | | coagulation for | use by a physician | | coagulation is | frequency | | | general open | familiar with | | desired during | range | | | surgery where | electrosurgery for | | surgery and are | | | | coagulation of soft | bipolar coagulation | | intended to grasp, | | | | tissue is needed. | and irrigation of tissue | | manipulate cur or | | | | Adeor bipolar | for general surgery. | | coagulate selected | | | | forceps must be | The bipolar forceps | | soft tissue. | | | | operated with the | are used with the | | | | | | following | bipolar output for | | | | | | parameters: | standard | | | | | | Frequency range | electrosurgical | | | | | | between 300 kHz | generators. The | | | | | | and 1,000 kHZ; | products are intended | | | | | | maximum generator | for single use and are | | | | | | operating voltage | provided sterile as | | | | | | 600Vp. | well as non sterile. | | | | | | | Products supplied non | | | | | | The Adeor Medical | sterile must be | | | | | | Non-stick Bipolar | cleaned, disinfected | | | | | | Forceps have not | and sterilized prior to | | | | | | been shown to be | their use by the | | | | | | effective for tubal | validated cleaning, | | | | | | sterilization or tubal | disinfection and | | | | | | coagulation for | sterilization process. | | | | | | sterilization | The bipolar forceps | | | | | | procedures and | have not been shown | | | | | | should not be used | to be effective for | | | | | | for these | tubal sterilization or | | | | | | procedures. | tubal coagulation for | | | | | | The types of | sterilization | | | | | | surgery intended | procedures and should | | | | | | include: | not be used for these | | | | | | ENT | procedures. The types | | | | | | Gynecology | of surgery intended are | | | | | | Urology | - General surgery - | | | | | | General Surgery | Laryngeal coagulation | | | | | | Neurosurgery | - Orthopedic | | | | | | | coagulation - Thoracic | | | | | | | coagulation - | | | | | | | Neurosurgical | | | | | | | coagulation - | | | | | | | Gynecological | | | | | Item | Adeor Medical | Faulhaber Pinzetten | CODMAN<br>VersaTru | OLSEN<br>Medical® | Comparison<br>to Predicate | | | • Laryngeal<br>Surgery<br>• Orthopedic<br>Surgery<br>• Thoracic<br>Surgery | coagulation (except<br>for use in female<br>sterilization) -<br>Urological coagulation<br>- Ear-, Nose- and<br>Throat coagulation. | | | | | Sterility | Gamma Irradiation/<br>Steam | Gamma Irradiation/<br>Steam | Gamma<br>Irradiation | Irradiation | Equivalent | | Usage | Single-Use and<br>Reusable | Single use (K182773)<br>and Reusable<br>(K101080) | Single- Use | Single and<br>Reusable | Equivalent | | Tip Material | Ag 800 (80% pure<br>silver) | Sterling Silver | Plated aluminum | Stainless Steel | Equivalent | | Arm Material | Stainless Steel (ISO<br>7153) | Stainless Steel | Stainless Steel<br>and Titanium | Stainless Steel | Equivalent | | Arm Coating | Polyamide | Nylon | Polyamide | Ceramic-Metallic | Equivalent | | Size (overall<br>length) | 5-10" | 8-12" | 7-9" | 7-9" | Equivalent | | Size (distal<br>tips) | 0.2-1.5mm | 0.5-1.5mm | 0.5-1.5mm | 0.5-1.5mm | Equivalent | | Packaging | PETG Tray, Tyvek<br>Lid | Foil pouch | PETG Tray,<br>Tyvek Lid | Tyvek/film pouch | Equivalent | | Electrical<br>Safety<br>Testing | IEC 60601-2-2 | IEC 60601-2-2 | IEC 60601-1-2<br>IEC 60601-2-2 | IEC 60601-2-2 | Equivalent | #### Table 1: Subject-Predicate Comparison {5}------------------------------------------------ K191847 Image /page/5/Picture/2 description: The image shows the logo for Adeor Medical. On the left is a blue image of a brain. To the right of the brain is the word "adeor" in black, lowercase letters. Below the word "adeor" is the word "MEDICAL" in smaller, black, uppercase letters. {6}------------------------------------------------ K191847 Image /page/6/Picture/2 description: The image shows the logo for Adeor Medical. The logo consists of a stylized blue brain on the left, followed by the word "adeor" in black lowercase letters. Below "adeor" is the word "MEDICAL" in smaller black uppercase letters. The brain graphic is made up of interconnected lines, giving it a modern and technological feel. ## Non-Clinical Testing: #### Electrical Safety Electrical Safety Testing was performed on the Adeor Bipolar Forceps per IEC 60601-2-2: 2017 Medical Electrical Equipment- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. Isolation of active accessories, high-frequency leakage currents, high-frequency dielectric strength, and mains frequency dielectric strength testing was performed. Instruments did not show any signs of impairment or loss of mechanical function; therefore, testing was successfully completed. #### Non-Clinical #### Wear The device is not manufactured from a novel material and does not contain articulating components. There is no concern for wear or debris. #### Function Drop testing was performed on the bipolar forceps to ensure that dropping the device will not cause damage to the device nor loss of functionality. Forceps were dropped multiple times and inspected for grasping capabilities, frequency output, and visual damage. All test articles met the acceptance criteria. {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for Adeor Medical. The logo consists of a stylized blue brain on the left, followed by the word "adeor" in black, sans-serif font. Below "adeor" is the word "MEDICAL" in smaller, sans-serif font, also in black. ## Mechanical Strength Due to the high strength of the material and the low forces that the device may be subject to, there is no concern for mechanical strength of the forceps. Testing specific to the strength of the device is not necessary. ## System Testing The Adeor forceps are identical to the predicate in design, materials, manufacturing, manufacturer and function. No further performance testing is required. ## Conclusion: Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.