Laparoscopic Spray Applicator with Spinning Luers

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending downward from the bottom profile. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 11, 2016 Micromedics Inc. (d/b/a Nordson Medical) Ms. Amy Peterson Senior Regulatory Affairs Specialist 1270 Eagan Industrial Rd. Suite 120 St. Paul, Minnesota 55121 Re: K162077 Trade/Device Name: Laparoscopic Spray Applicator with Spinning Luers Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: July 22, 2016 Received: July 27, 2016 Dear Ms. Peterson: 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 {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # Christopher J. Ronk -S Fox 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K162077 ### Device Name Laparoscopic Spray Applicator with Spinning Luers Indications for Use (Describe) Intended for the application of two non-homogenous liquids. | | 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}------------------------------------------------ # K162077 – 510(K) SUMMARY Contact Person Micromedics, Inc. ### Date of Summary Preparation: August 10, 2015 #### 510(k) Applicant/Submitter Micromedics, Inc. Amy L. Peterson, M.A. d/b/a Nordson Medical Sr. Regulatory Affairs Specialist 1270 Eagan Industrial Road St. Paul, MN 55121-1385 d/b/a Nordson Medical Tel: 651-452-1977; Fax: 651-452-1787 1270 Eagan Industrial Road Establishment Registration #2183425 St. Paul, MN 55121-1385 | General Information | | | | |-------------------------------|---------------------------------------------------------------------------------------------------|--------------|---------------------------| | Device Name | Laparoscopic Spray Applicator with Spinning Luers | | | | Classification<br>Information | Endoscope and Accessories<br>per 21 CFR 876.1500 (Class II) | Product Code | GCJ | | | | Panel | General & Plastic Surgery | | Predicate<br>Device | Micromedics Inc's 360° Gas Assisted Endoscopic Applicator, K122526, cleared<br>November 16, 2012. | | | ### Device Description The Laparoscopic (Lap) Spray Applicators with Spinning Luers are sterile, single-use, disposable devices that are designed to mix two non-homogeneous liquids and to allow the resulting mixture to be applied by spraying on potentially difficult to reach treatment sites subcutaneously or within the body through a trocar. The Lap Spray Applicator with Spinning Luers consists of a lap spray applicator and a filter/tubing assembly (also called the tubing set). The Lap Spray Applicator with Spinning Luers has the following functional parts: - . Proximal hub (Y-connection) with spinning luers to connect to dual syringes (not provided) and an attachment point for the filter/tubing to the gas regulator (provided separately) - Stainless steel shaft connecting hub to Pebax ● - Flexible Pebax portion connecting stainless steel shaft to distal tip - Fixed-position distal tip. ● Lap Spray Applicator components are made from the following materials: White or Blue Polypropylene, Acrylonitrile Butadiene Styrene (ABS - regular/non-radiopaque), Acrylonitrile Butadiene Styrene (ABS) with 20% barium (radiopaque), Stainless Steel, White Nylon, Light Blue Pebax, Epoxy Adhesive. Tubing Set components are made from the following materials: Clear Medical PVC. Natural Nylon, Stainless Steel Wire Mesh, Clear Polycarbonate, Blue Nylon or Red Nylon, Clear Acrylonitrile Butadiene Styrene (ABS), Clear Acrylic, Versapor Filter Media. The device is packaged in a thermoformed tray with a tray (Tyvek) lid. Five (5) trays are then put into a shelf box and then a cardboard shipper box. Like the device from K122526, the Lap Spray Applicators with Spinning Luers are sterilized using ethylene oxide. {4}------------------------------------------------ # K162077 – 510(K) SUMMARY ### Intended Use / Indications Intended for the application of two non-homogenous liquids. ### Substantial Equivalence Comparison The Lap Spray Applicator with Spinning Luers is substantially equivalent to the predicate device in the following characteristics: - Operational mode - Basic Scientific Technology . - . Intended Use - · General physical characteristics ### Summary of Non-Clinical Performance Data The Lap Spray Applicator with Spinning Luers was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 -Biological evaluation of medical devices, Part 1 – Evaluation and tests show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use and over the labeled shelf life. Testing was conducted for the following: - Visual Inspection ● - . Particulate Matter - Dimensional Verification Test - Leak Test - . Spray Test - Pebax/Tip Bond Strength - . Pebax/Shaft Bond Strength - . Hub/Shaft Pull Strength - . Hub/Shaft Torque Strength - Spinning Luer Actuation Torque ● - Spinning Luer Side Load - Spinning Luer Pull Strength - ISO 594-1 and -2 (specifically: Luer Gauge, Luer Leak, Luer Separation, Luer Ease of Assembly, Luer Override, and Luer Stress Cracking) - Sterilization ● - Shelf life ● ### Summary of Clinical Performance Data None provided as a basis for substantial equivalence. ### Substantial Equivalence Conclusion As evidenced by the successful completion of non-clinical performance testing, the Lap Spray Applicator with Spinning Luers does not raise new questions of safety or effectiveness when compared to the predicate devices and is, therefore, substantially equivalent.