CODMAN Integrated Bipolar Cord and Tubing Set

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 1, 2016 Medos International SARL Ms. Megan Palumbo Senior Regulatory Affairs Specialist Chemin-blanc 38 2400 Le Locle, Switzerland Re: K163106 Trade/Device Name: Codman Integrated Bipolar Cord and Tubing Set Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 4, 2016 Received: November 7, 2016 Dear Ms. Palumbo: 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address Sincerely, http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K163106 #### Device Name CODMAN Integrated Bipolar Cord and Tubing Set Indications for Use (Describe) The CODMAN Integrated Bipolar Cord and Tubing Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| 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}------------------------------------------------ # Section 5 – 510(k) Summary I. Submitter Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 Establishment Registration Number: 1226348 On behalf of: Medos International SARL Chemin-Blanc 38 2400 LeLocle, Switzerland Establishment Registration Number: 3008114965 Contact: Megan Palumbo Phone: (508) 828-3571 Fax: (508) 977-6979 Date of Submission: November 4, 2016 # II. Device | II. Device | Device Proprietary Name | Codman Integrated Bipolar Cord and Tubing Set | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | | Common Name | Irrigation Tubing and Bipolar Cord | | | Classification Name | Electrosurgical, Cutting & Coagulation & Accessories<br>(21 CFR 878.4400) | | | Regulatory Classification | II | | | Product Code | GEI | | III. Predicate<br>Device | The predicate device for this submission is the Codman Integrated Irrigation<br>Tubing and Bipolar Cord Set (K052449), which was cleared on October 17,<br>2005. | | | IV. Device<br>Description | The CODMAN Integrated Bipolar Cord and Tubing Set consists of an inlet<br>spike with protective cap, an on/off clamp, silicone tubing and fittings, a male<br>luer connector, two plugs, and a female socket connector. The set is packaged | | V. Indications The CODMAN Integrated Bipolar Cord and Tubing Sets are intended to for Use provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation. sterile for single use with a nonpyrogenic fluid pathway. {4}------------------------------------------------ - the same intended use, ● - use the same fundamental scientific technology, . - incorporates the same basic cord and tube set design, ● - . incorporates similar materials, - packaged and sterilized using the same packaging design, materials, . and processes. The minor differences between the predicate and subject device are: - a slight difference in device design, . - minor formulation changes to the existing materials (material types are . remaining the same), and - . change in shelf life. The table below details the comparison of the predicate and subject devices. | Comparison of the Predicate and Subject Device | | | |-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | | Predicate Device:<br>Codman Integrated Irrigation Tubing<br>and Bipolar Cord Set (K052449) | Subject Device:<br>Codman Integrated Bipolar Cord and Tubing<br>Set (This Submission) | | FDA Regulatory Information | | | | Manufacturer | Codman & Shurtleff, Inc. | Same as predicate | | FDA Product<br>Code | GEI | Same as predicate | | Classification | Class II - 21 CFR 878.4400 | Same as predicate | | Classification<br>Name | Electrosurgical, Cutting & Coagulation &<br>Accessories | Same as predicate | | Indications for Use | | | | Indications for<br>Use | The CODMAN Integrated Bipolar Cord<br>and Tubing Sets are intended to provide<br>irrigation and energy simultaneously to<br>bipolar forceps specifically designed for<br>irrigation.<br>[They are intended for use with the<br>Codman/Malis CMC-II and the<br>Codman/Malis CMC III I.E.C. Irrigation<br>Modules and the Codman/Malis Bipolar<br>Coagulators.] | Same as predicate | | Device Design | | | | Single Use | Yes | Same as predicate | | Device Design | Integrated disposable bipolar cord with an<br>irrigation tube. | Same as predicate | | | Comprised of irrigation inlet spike with<br>protective cap, male luer connector, female | Same as predicate | | Comparison of the Predicate and Subject Device | | | | | Predicate Device: | Subject Device: | | | Codman Integrated Irrigation Tubing<br>and Bipolar Cord Set (K052449) | Codman Integrated Bipolar Cord and Tubing<br>Set (This Submission) | | Devices for which<br>this Accessory is<br>to be used with | socket connector, on/off clamp, silicone<br>tubing and fittings, and two bipolar<br>generator plug components.<br>They are intended for use with the<br>Codman/Malis CMC-II and the<br>Codman/Malis CMC III I.E.C. Irrigation<br>Modules and the Codman/Malis Bipolar<br>Coagulators. | Same as predicate | | Device Color | <b>Bipolar Cord</b><br>Transparent tubing surrounding copper<br>cord with white plugs and socket<br><br><b>Irrigation Tubing</b><br>Transparent tubing and connectors with<br>white inlet spike | Same as predicate | | Device Materials | | | | Spike | ABS | ABS | | PVC Tubing | PVC | PVC | | Tubing Adaptor | PVC | Gravity Feed:<br>PVC<br><br>Rotary Pump:<br>ABS | | Silicone Tubing | Silicone | Silicone | | Extruded PVC/<br>Copper Cable | PVC and Copper | PVC and Copper | | Male Slip Luer | PVC | PVC | | Bushing | PVC | PVC | | Spike Cap | Polyethylene | Polyethylene | | Tubing Clamp | Polyethylene, Polysterene, Polypropylene | Celanese and Polyacetal | | Male Slip Luer<br>Cap | Polyethylene | Polyethylene | | Banana Plug Pin | nickel plate brass | nickel plate brass | | Banana Plug<br>Overmold | PVC | PVC | | Socket | nickel plated brass | tin plated brass | | Socket Overmold | PVC | PVC | | Other | | | | Electrical Safety<br>Testing | Testing in accordance with:<br>• ANSI/AAMI HF18:2001 | Testing in accordance with<br>• IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-2-2 | | Packaging<br>Configuration<br>(Sterile Barrier) | Peel Pouch | Same as predicate | | Comparison of the Predicate and Subject Device | | | | | Predicate Device:<br>Codman Integrated Irrigation Tubing<br>and Bipolar Cord Set (K052449) | Subject Device:<br>Codman Integrated Bipolar Cord and Tubing<br>Set (This Submission) | | Packaging<br>Materials<br>(Sterile Barrier) | Transparent bottom stock formable film-<br>thermoform and 1073B Tyvek top stock<br>thermoform | Same as predicate | | Packaging Unit | 10 units per box | Same as predicate | | Sterility<br>Assurance Level<br>(SAL) | 10-6 | Same as predicate | | Sterilization<br>Method | Ethylene oxide | Same as predicate | | Shelf Life | 5 years | 1 year | {5}------------------------------------------------ {6}------------------------------------------------ # VII. Performance Data The following performance testing has been conducted in support of the substantial equivalence determination. All testing was performed on final sterile devices unless otherwise specified. Please see the Summary of Testing table below for a summary of testing and testing results. Additional information regarding the Bench, Electrical Safety, Sterilization, Shelf Life and Biocompatibility Testing follows. | Summary of Testing | | |------------------------------------------------------------|--------| | Test | Result | | Bench Testing | | | Electrical Functionality Test - Continuity and Resistance | Pass | | Irrigation Functionality Test - Leak (Dry) | Pass | | Mating Part - Part 1: Pins | Pass | | Mating Part - Part 2: Socket | Pass | | Mating Part - Part 3: Luer | Pass | | Mating Part - Part 4: Spike | Pass | | Pull Testing | Pass | | Irrigation Simulated Use Test | Pass | | Simulated Use Pull Test | Pass | | Electrical Safety and EMC per IEC 60601 | | | High Frequency Leakage Current - 60601-1 and 60601-2-2 | Pass | | High Frequency Dielectric Strength - 60601-1 and 60601-2-2 | Pass | | Main Frequency Dielectric Strength - 60601-1 and 60601-2-2 | Pass | | Cable Flexing - 60601-1 and 60601-2-2 | Pass | | Electromagnetic Compatibility - 60601-1-2 | Pass | | Sterilization | | | Bioburden Validation | Pass | | Bioburden Test | Pass | | EO/ECH Residuals | Pass | | LAL Validation | Pass | {7}------------------------------------------------ | Shelf Life - Functionality Testing Complete after One Year Accelerated Aging | | |------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | Electrical Functionality Test - Continuity and Resistance | Pass | | Irrigation Functionality Test - Leak (Dry) | Pass | | Mating Part - Part 1: Pins | Pass | | Mating Part - Part 2: Socket | Pass | | Mating Part - Part 3: Luer | Pass | | Mating Part - Part 4: Spike | Pass | | Pull Testing | Pass | | Biocompatibility | | | Cytotoxicity - ISO MEM Elution | Pass | | Delayed Type Sensitization - ISO Maximization in Guinea<br>Pigs | Pass | | Intracutaneous Reactivity - ISO Intracutaneous Study in<br>Rabbits | Pass | | Acute Systemic Toxicity - ISO Systemic Toxicity in Mice | Pass | | Pyrogenicity Testing - USP Rabbit Pyrogen Study, Material<br>Mediated | Pass | | Hemolysis - ASTM F756 (Extract only) | Pass | | Chemical Characterization of Extractables (ISO 10993-18) | Low level of extractables | | Toxicology Risk Assessment | Extractables do not represent<br>a significant toxicological risk<br>to patients | # Bench Testing Bench testing data demonstrated that the Codman Integrated Bipolar Cord and Tubing Set performed according to its description and intended use, and established the performance characteristics of this device. The Codman Integrated Bipolar Cord and Tubing Set passed each bench test conducted, as compared to the device characteristics and performance specifications of the predicate device. Clinical testing was not required to establish substantial equivalence. Results of verification and validation testing conducted on Codman Integrated Bipolar Cord and Tubing Set demonstrated that the proposed device performed as designed, is suitable for the intended use, and is substantially equivalent to the predicate device. Performance bench testing was conducted in alignment with FDA's guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016 and internal requirements. # Electrical Safety and Electromagnetic Compatibility Testing Electrical safety testing was conducted in accordance with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-2-2:2009/C1:2014 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. Electromagnetic Compatibility Testing {8}------------------------------------------------ (EMC) was conducted in accordance with IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests. The Codman Integrated Bipolar Cord and Tubing Set passed all electrical safety and EMC testing. ### Sterilization The Codman Integrated Bipolar Cord and Tubing Sets are sterilized via ethylene oxide. The Cord and Tubing Sets have been validated to ensure a sterility assurance level (SAL) of 10t in accordance with ISO 11135:2014 Sterilization of health care products - Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices and ISO 11737-1:2006, "Sterilization of medical devices -Microbiological methods - Part 1: Determination of a population of microorganisms on products." Sterilization testing also demonstrated that ethylene oxide residuals can be reduced to an acceptable level in accordance with ISO 10993-7:2008 Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals and the proposed device can be successfully adopted into Codman's existing sterilization cycle. #### Shelf-Life Testing Shelf-life testing was conducted in accordance with FDA's guidance document Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016 and internal requirements. The Codman Integrated Bipolar Cord and Tubing Set was subjected to accelerated aging. The aging studies established that the device and packaging remain functional and maintain sterility for 1 year. # Biocompatibility Testing Biocompatibility with ISO 10993-1:2009/AC:2010, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process, and FDA's guidance documents, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued June 16, 2016 and Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016. #### Animal Studies No animal studies were performed as appropriate verification and validation of the modified device was achieved from the results of the bench testing, biocompatibility evaluation, and electrical/safety testing. #### Clinical Studies No clinical studies were performed as appropriate verification and validation of the modified device was achieved from the results of the bench testing. {9}------------------------------------------------ biocompatibility evaluation, and electrical/safety testing. VIII. Based upon the same indications for use, intended use, fundamental scientific Conclusion technology, material types, comparison to the predicate device, and testing conducted, it is concluded that the subject device, the Codman Bipolar Cord and Tubing Set, is substantially equivalent to the predicate device, the Codman Integrated Irrigation Tubing and Bipolar Cord Set (K052449), and therefore does not raise any new issues of safety and effectiveness.