Single Use Irrigation bipolar cable

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. October 19, 2021 Modern Medical Equipment Manufacturing, LTD. Philip Hung Management Representative Flat A, 11/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street, Kwai Chung, N.T. Hong Kong, China Re: K211170 Trade/Device Name: Single Use Irrigation bipolar cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 14, 2021 Received: September 20, 2021 Dear Philip Hung: 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 ffor 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/cfpm/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 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 (0S) 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) K211170 Device Name Sterile Single Use Irrigation Bipolar Cable #### Indications for Use (Describe) The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or The Malis irrigation module 1000. Type of Use (Select one or both, as applicable) | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |------------------------------------------------------------------|-----------------------------------------------------------------| |------------------------------------------------------------------|-----------------------------------------------------------------| ### 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}------------------------------------------------ | 1. 510(k) Owner<br>Name: | Modern Medical Equipment Manufacturing Limited | | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--| | Address: | Modern Medical Equipment Mfg., Ltd.<br>Flat A, 11/F., Mai Wah Ind. Bldg.,<br>1-7 Wah Sing Street,<br>Kwai Chung, N.T., Hong Kong, China. | | | Telephone: | (852) 2420 9068 | | | Fax: | (852) 2481 1234 | | | Contact person: | Philip Hung | | | Date of preparation: | 16 October 2021 | | | 2. Device<br>Name of Device: | Sterile Single Use Irrigation Bipolar Cable | | | Trade or proprietary name: | Sterile Single Use Irrigation Bipolar Cable | | | Common or usual name: | Sterile Single Use Irrigation Bipolar Cord | | | Classification name: | Electrosurgical Cutting & Coagulation<br>Device & Accessories | | | Classification number: | 21 CFR 878.4400 | | | Classification Panel: | General & Plastic Surgery | | | Product Code: | GEI | | | Class: | II | | ## 3. Predicate device Codman Integrated Irrigation Tubing and Bipolar Cord Set with 510(k) number K052449. ## 4. Device description The device is single use and is used to connect an irrigation bipolar forceps to electrosurgical generator and irrigation module for coagulation and delivering saline to the tip of forceps simultaneously. The socket connector of the cable is to fit Codman irrigating bipolar forceps. The fixed 2-pin plug is connected to any compatible generators or the flying lead connectors are connected to Malis bipolar coagulators or any compatible generators. The tubing set of the cable can be used with the Malis CMC-II irrigation module or the Malis {4}------------------------------------------------ irrigation module 1000. # 5. Indication for use The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or the Malis irrigation module 1000. ## 6. Substantial Equivalence The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. The following table shows the comparisons in more detail information among the subject devices and the predicate device. | Compared<br>Items | Proposed Device<br>(K211170)<br>Single Use<br>Irrigation bipolar<br>cable (CD933) | Predicate Device<br>(K052449)<br>Coeman Integrated<br>Irrigation Tubing and<br>Bipolar Cord Set | Comments on<br>difference | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Indication for<br>use | The device is<br>intended to provide<br>irrigation and<br>energy<br>simultaneously to<br>standard bipolar<br>forceps specifically<br>designed for<br>irrigation. The<br>device is used with<br>Malis bipolar<br>coagulators or the<br>compatible<br>generators and the<br>Malis CMC-II<br>Irrigation Module<br>or the Malis<br>irrigation module<br>1000. | The device is intended to<br>provide irrigation and<br>energy simultaneously to<br>bipolar forceps specifically<br>designed for irrigation.<br>They are intended for use<br>with Codman/Malis CMC-II<br>and the Codman/Malis<br>CMC III I.E.C. Irrigation<br>Modules and the<br>Codman/Malis Bipolar<br>Coagulators. | Same | | Regulation<br>number | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | | Product code | GEI | GEI | Same | | OTC or<br>prescription | For prescription<br>use | For prescription use | Same | | Energy<br>delivery | High frequency<br>electrical<br>current/energy | High frequency electrical<br>current/energy | Same | | Technology | For monopolar<br>electrosurgery | For monopolar<br>electrosurgery | Same | | Design | Combined of<br>Irrigation tubing<br>with bipolar cable | Combined of Irrigation<br>tubing with bipolar cable | Same | | Material of the<br>components | | | | | -<br>Cable wire<br>with plug | Copper wire and<br>PVC insulation | Copper wire and PVC<br>insulation | Same | | -<br>Tubing | PVC | PVC | Same | | -<br>Luer lock | PC | PC | Same | | -<br>Puncture<br>utensil | ABS | ABS | Same | | -<br>Protector<br>for luer and<br>puncture<br>utensil | ABS | LDPE/PP | Similar,<br>provide the<br>same function | | -<br>Pinch<br>clamp | PP | PP | Same | | Rated<br>accessory<br>voltage | 500Vp | 500Vp-p | Both meets<br>IEC safety<br>requirements | | Sterile | EO sterile | EO sterile | Same | | Shelf life | 3 years | 3 years | Same | | Electrical<br>safety and<br>EMC | Comply with<br>dielectric strength<br>in with accordance<br>IEC60601-1,<br>IEC60601-1-2 &<br>IEC60601-2-2 | Comply with dielectric<br>strength in with accordance<br>AAMI HF-18 | Same | | Biocompatibility | Comply with<br>ISO10993 | Comply with ISO10993 | Meet<br>biocompatibility<br>requirements so<br>it does not raise<br>any safety issue<br>for | {5}------------------------------------------------ {6}------------------------------------------------ # 7. Non-clinical Performance Testing Data Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014. The safety performance of the subject device passed all the testing according to internal requirements and international standards shown below to support the substantial equivalence of the subject device - IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment Part 1: -General requirements for basic safety and essential performance - -IEC60601-2-2: 2017 (Fifth Ed), Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surqical equipment and high frequency surqical accessories. - IEC60601-1-2:2014, Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance - Collateral Standard. Electromagnetic Disturbances - Requirements and Tests - -ISO10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - -ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices - ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life. ## 8. Conclusion The non-clinical testing demonstrates that the subject device, the Single Use Irrigation Bipolar Cable, is substantially equivalent as the predicate device (K052449).