ERBEFLO Olympus Scope Port Connector

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 6, 2018 Erbe USA, Inc. John Tartal Director of Quality and Regulatory Affairs 2225 Northwest Parkway Marietta, GA 30067 Re: K182444 > Trade/Device Name: ERBEFLO® Olympus® Scope Port Connector Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: OCX Dated: September 6, 2018 Received: September 7, 2018 Dear John Tartal: 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 mav, 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 avare 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. {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Daniel G. Walter Jr -S for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182444 Device Name ERBEFLO® Olympus® Scope Port Connector Indications for Use (Describe) The Olympus® Scope Port Connector is intended to attach the irrigation line of an ERBEFLO 2, ERBEFLO CleverCap® and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------|-----------------------------------------------------------| | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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}------------------------------------------------ September 2018 ### 510(k) SUMMARY | Submitted By: | Erbe USA, Inc.<br>2225 Northwest Parkway<br>Marietta, GA 30067<br>Tel: 770-955-4400<br>Fax: 770-955-2577 | |---------------------------------------|----------------------------------------------------------------------------------------------------------| | Contact Person: | John Tartal<br>Director of Quality and Regulatory Affairs | | Date Prepared: | September 6, 2018 | | Common Name: | Endoscopic Irrigation Tubing System Accessory/Scope Port Connector | | Trade/Proprietary Names: | ERBEFLO® Olympus® Scope Port Connector | | Classification Name: | Endoscopes and Accessories (21 CFR Part 876.1500) | | Regulatory Class: | II | | Product Code: | OCX | | Legally Marketed<br>Predicate Device: | ERBEFLO® 2 Disposable Tubing System, 510(k) Number K103235 | ### Device Description: In general; the ERBEFLO® Olympus® Scope Port Connector will be manufactured with medical grade materials or agents used in the medical device industry such as plastics, silicone, adhesive, etc. The device adjoins an irrigation line of an of an ERBEFLO 2, ERBEFLO CleverCap®, and ERBEFLO CleverCap CO2 Tubing/Cap Set designated for an Olympus Scope to an Olympus Gastrointestinal Video Endoscope for irrigation in endoscopic procedures. The Port Connector has a standard female luer lock connection that attaches to a designated Olympus ERBEFLO Tubing/Cap Set, check (backflow) valve, and housing (a scope specific connector for an Olympus Scope). The Port Connector is provided sterile, is single patient use and is disposable. ### Intended Use: The Olympus® Scope Port Connector is intended to attach the irrigation line of an ERBEFLO® 2, ERBEFLO CleverCap®, and ERBEFLO CleverCap® CO2 Tubing/Cap Set designated for an Olympus Scope to an Olympus® Gastrointestinal Video Endoscope for irrigation in endoscopic procedures. Note: The ERBEFLO® Olympus® Scope Port Connector (i.e., the proposed device) is being compared to the Endoscopy Port Connector w/Valve for Olympus® Scopes (Part Number 20325-215) [i.e., the specific substantially equivalent accessory/predicate device] in the ERBEFLO® 2 Disposable Tubing System. {4}------------------------------------------------ # Similarities and Differences of the Proposed Device to the Current Device (Predicate Comparison/Substantial Equivalence): # Similarities The proposed Olympus® Scope Port Connector has the same female connection and backflow valve as the predicate Port Connector (i.e., Endoscopy Port Connector w/Valve for Olympus® Scopes). The proposed Port Connector attaches to a designated ERBEFLO Tubing/Cap and Scope the same way (i.e., it screws on) as the predicate device. The proposed and the predicate devices will be/are packaged in the same pouch, box, and carton and labeled in the same manner. Finally, the proposed and predicate devices are sterilized via Ethylene Oxide, single use (i.e., use for a patient), and are disposable. #### Differences The proposed Olympus® Scope Port Connector has a specific intended use as a standalone accessory compared to the predicate device being a part of a Tubing System (Note: The predicate Port Connector's intended use would be the same as the proposed device if it had its own Notes On Use.). The proposed Port Connector's housing (scope specific connector) is exclusively made with one of three types of plastics and is bonded with a medical grade UV adhesive as compared to the predicate Connector which has metal and an o-ring as well as is solvent bonded. As compared to the predicate Port Connector, the proposed device's profile is less (i.e., slightly smaller in length as in weight due to the housing, scope specific connector, having a smaller shape). Evaluations and testing as described below demonstrated the safety and efficacy of the Port Connector. #### Evaluations and Testing: The following evaluations and tests were performed to demonstrate safety and efficacy. #### Biological Evaluation The evaluation was performed per the current recognized standard and demonstrated that there were no biocompatibility issues with the materials used for the proposed Port Connector. ### 2X Sterilization Functional Testing Visual inspection, connections testing, leak and flow testing, as well as back flow pressure testing demonstrated that the proposed device upon 2X sterilization met established performance specifications. #### Packaging Evaluation The evaluation demonstrated the adequacy and integrity of the packaging for the proposed product. Sterilization Evaluation The evaluation was performed using current recognized standards to demonstrate product sterility as well as the Connector meeting ethylene oxide residual requirements. #### Applied Standards AAMI / ANSI / ISO 10993-1, ISO 594-1, ISO 594-2, AAMI / ANSI / ISO 15223-1, AAMI / ANSI / ISO 11607-1, AAMI / ANSI / ISO 11607-2, AAMI / ANSI / ISO 11135(-1), AAMI / ANSI / ISO 10993-7 ### Conclusion: The intended use of the predicate Endoscopy Port Connector w/Valve for Olympus® Scopes would be the same as proposed Olympus® Scope Port Connector if the predicate had its own Notes On Use. The proposed device has the same use (i.e., single patient use), principles of operation, and technological characteristics as the predicate device. As compared to the proposed Connector is constructed with the same type of materials as well as has the same performance characteristics. In conclusion, the Olympus® Scope Port Connector is safe and efficacious.