EndoWrist Suction Irrigator

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 6, 2017 Intuitive Surgical, Inc. Ms. Melissa Gonzalez Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086 Re: K162973 Trade/Device Name: EndoWrist Suction Irrigator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: December 16, 2016 Received: December 19, 2016 Dear Ms. Gonzalez: 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 http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Jennifer R. Stevenson -S 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K162973 Device Name EndoWrist® Suction Irrigator #### Indications for Use (Describe) The EndoWrist® Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissue. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ ## 510(k) Summary ## [As Required by 21 CFR 807.92(c)] October 24, 2016 | Submitter: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 | |-------------------|---------------------------------------------------------------------------------------------------| | Official Contact: | Melissa S. Gonzalez<br>Sr. Regulatory Affairs Specialist<br>Ph: 408-523-8684<br>Fax: 408-523-1390 | | Trade Name: | Intuitive Surgical EndoWrist® Suction Irrigator | | Common Name: | System, surgical, computer controlled instrument | | Classification: | Endoscope and accessories, 21 CFR 876.1500, NAY | | Predicate Device: | Intuitive Surgical EndoWrist® One Suction/Irrigator (K110451) | Device Description: The EndoWrist® Suction Irrigator is a single-use, disposable instrument developed for use with the da Vinci Surgical System. The instrument provides the surgeon with the ability to activate suction and irrigation directly from the surgeon console or by depressing buttons on the instrument. Activation from the surgeon console will be controlled through the foot pedals on the surgeon console. The suction and irrigation sources are supplied by conventional devices (suction - canister, hospital line, etc.; and irrigation - closet, compressed air, gravity flow, etc.) that are available in an operating room setting. ## Intended Use: The EndoWrist® Suction Irrigator is intended for use in all endoscopic surgical applications where the compatible da Vinci Surgical System is indicated. ## Indications for Use: The EndoWrist Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. {4}------------------------------------------------ Technological Characteristics: The EndoWrist® Suction Irrigator is equivalent to the predicate device in terms of its indications for use, design, technology, and performance specifications. An overview of the device characteristics for the Endo Wrist® Suction Irrigator is provided in Table 1. | Subject & Predicate Device(s): | K162973 | K110451 | |--------------------------------|-------------------|---------| | General Device Characteristics | | | | Instrument Shaft OD | 0.33" | Same | | Shaft Lumen ID | 0.17" | Same | | Shaft Length | 22.2" | 17.1" | | Tubing Length | 13' | Same | | Tubing ID/OD | 0.25"/0.375" | Same | | Irrigation Flow Rate | $\geq$ 1.75 L/min | Same | | Valve Function | Sliding Cylinders | Same | | Tip Articulation | Pitch/Yaw | Same | | Provided Sterile/Single Use | Yes | Same | | Sterilization Method | EtO | Same | #### Table 1: General Device Characteristics Performance Data: The EndoWrist® Suction Irrigator was evaluated using bench testing and clinical models (animals/cadavers) to demonstrate that the design output meets the input requirements and the device performed as intended. Design Verification (bench testing): The subject device, EndoWrist" Suction Irrigator, was subjected to series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a da Vinci Xi Surgical System (Model IS4000). The design verification testing included confirmation that the device meets the: - . Physical Specifications - Mechanical Requirements ● - Electrical Requirements ● - User Interface Requirements ● - Equipment Interface Requirements . Design Validation (animal/cadaver): The safety and efficacy of the instruments was assessed in representative simulated clinical settings that utilized porcine models (in vivo) and cadavers to evaluate applicable requirements through normal and expected worst case clinical use. Representative tissue types were used, as appropriate, for evaluating applicable requirements. Design validation demonstrated that the design outputs fulfill the user needs and that the intended use has been met. {5}------------------------------------------------ Summary: Based on the intended use, technical characteristics, and performance data, the EndoWrist® Suction Irrigator is equivalent to the predicate device in terms of safety, effectiveness, and performance.