Endoscope Sterilization Tray

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 28, 2018 Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, CA 94086 Re: K180964 Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: August 29, 2018 Received: August 30, 2018 Dear Kunal Gunjal: 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 device-related adverse events) (21 CFR 803); good {1}------------------------------------------------ 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. 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. 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, # Clarence W. Murray lii III -S For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental 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: 06/30/2020 See PRA Statement below. #### 510(k) Number (if known) Device Name Endoscope Sterilization Tray Indications for Use (Describe) The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles: - · STERRAD 100NX sterilization system using the Express cycle - · STERRAD 100S sterilization system using the Standard cycle - · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles - · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles - · Steris V-PRO 1 using the V-PRO/Lumen cycle The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 8.9 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (7/17) Image /page/2/Picture/28 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, sans-serif font, with the registered trademark symbol next to it. The logo is simple and modern. {3}------------------------------------------------ ## 510(k) Summary (K180964) | 510(k) Owner: | Intuitive Surgical, Inc. | |---------------------------------------|-----------------------------------------------------------| | | 1266 Kifer Road | | | Sunnyvale, CA 94086 | | Contact: | Kunal Gunjal | | | Regulatory Affairs Specialist | | | Phone Number: 408-523-8017<br>Fax Number: 408-523-8907 | | | Email: Kunal.Gunjal@intusurg.com | | Date Summary Prepared: | September 27, 2018 | | Trade Name: | Endoscope Sterilization Tray | | Common Name: | Sterilization Tray | | Classification: | Class II<br>21 CFR 880.6850, Sterilization Wrap | | Product Codes: | KCT | | Classification Advisory<br>Committee: | General Hospital | | Predicate Device: | Intuitive Surgical Endoscope Sterilization Tray (K170640) | Image /page/3/Picture/4 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in gray, with a yellow dot above the "U". Below "INTUITIVE" is the word "SURGICAL" in a smaller gray font with a registered trademark symbol. {4}------------------------------------------------ ### Device Description The Endoscope Sterilization Tray (P/N: 400490) is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes (Model #'s 470026, 470027) during the transport and sterilization process. The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight; it is the same tray as no changes were made to these parameters. ### Indications for Use: The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles: - STERRAD 100NX sterilization system using the Express cycle . - . STERRAD 100S sterilization system using the Standard cycle - Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles ● - Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles . - Steris V-PRO 1 using the V-PRO/Lumen cycle The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 8.9 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated. FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument. Image /page/4/Picture/13 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font in gray, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with a registered trademark symbol. {5}------------------------------------------------ | Characteristic | Subject Device<br>Endoscope Sterilization Tray<br>K180964 | Predicate Device<br>Endoscope Sterilization Tray<br>K170640 | |------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. | | Trade Name | Endoscope Sterilization Tray | SAME as subject device | | Common Name | Sterilization Tray | SAME as subject device | | Regulation No. | 21 CFR 880.6850 | SAME as subject device | | Product Code | KCT | SAME as subject device | | Device Class/<br>Regulation Name | Class II | SAME as subject device | | Classification<br>Advisory Committee | General Hospital | SAME as subject device | | Characteristic | Subject Device<br>Endoscope Sterilization Tray<br>K180964 | Predicate Device<br>Endoscope Sterilization Tray<br>K170640 | | Indications for Use | The Intuitive Surgical Endoscope<br>Sterilization Tray is intended for use to<br>encase and protect compatible da Vinci Xi<br>endoscopes for sterilization in any of the<br>following sterilization machines/cycles:<br>STERRAD 100NX sterilization<br>system using the Express cycle STERRAD 100S sterilization<br> | The Intuitive Surgical Endoscope<br>Sterilization Tray is intended for use to<br>encase and protect da Vinci Xi endoscopes<br>(Model #'s 470026 and 470027) for<br>sterilization in any of the following<br>sterilization machines/cycles:<br>STERRAD 100NX sterilization<br>system using the Express cycle STERRAD 100S sterilization<br>system using the Standard cycle Steris V-PRO maX using the Non<br>Lumen, Flexible, or Lumen<br>cycles Steris V-PRO 1 Plus using the<br>Non Lumen or Lumen cycles Steris V-PRO 1 using the V-<br>PRO/Lumen cycle The sterilization cycle parameters of the<br>sterilizers are preset by the manufacturers<br>and are not adjustable. The maximum<br>product load per tray is one da Vinci Xi<br>Endoscope. The length of the da Vinci Xi<br>Endoscope is approximately 600 mm and<br>the diameter of the shaft is 8.8 mm. The<br>maximum weight of the tray and<br>endoscope is 8.9 lbs. The Endoscope<br>Sterilization Tray is not intended to<br>maintain sterility; it is intended to be used<br>in conjunction with a legally marketed,<br>validated, FDA-cleared STERRAD and<br>Steris compatible sterilization wrap in<br>order to maintain sterility of the enclosed<br>medical instrument. | | Where used (hospital,<br>home, ambulance, etc) | Hospital | SAME as subject device | | Characteristic | Subject Device<br>Endoscope Sterilization Tray<br>K180964 | Predicate Device<br>Endoscope Sterilization Tray<br>K170640 | | Sterilization<br>machines/cycles | STERRAD 100NX sterilization system using the Express cycle STERRAD 100S sterilization system using the Standard cycle Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles Steris V-PRO 1 using the V-PRO/Lumen cycle | SAME as subject device | | Reprocessing<br>Instructions | The following changes have been made to the Reprocessing instructions for the Endoscope<br>Sterilization Tray, since the most recently cleared legally marketed device (K170640):<br><br>- The <i>da Vinci Xi</i> Endoscope model numbers (PNs: 470026 and 470027) were removed<br>from the Indications for Use Statement.<br>- The <i>da Vinci Xi</i> Endoscope model numbers (PNs: 470026 and 470027) are referenced<br>within the Reprocessing Instructions to clarify the use of the Endoscope Sterilization Tray<br>to encase and protect these specific <i>da Vinci Xi</i> Endoscopes during the sterilization<br>process. | | | Sterility / Disposable<br>or Multiple use | Multiple use | SAME as subject device | | Endoscope<br>Sterilization Tray<br>Model Number | 400490 | SAME as subject device | | Endoscopes Model<br>Numbers<br>compatible with the<br>Endoscope<br>Sterilization Tray<br>(PN 400490) | 470026 and 470027 | SAME as subject device | | Principle of<br>Operation | The subject Endoscope Sterilization Tray is<br>designed to encase and protect <i>da Vinci Xi</i><br>endoscopes during transport and<br>sterilization. The tray and lid contain<br>perforations to allow sterilization gases to<br>penetrate the tray and sterilize the<br>endoscope | SAME as subject device | | Characteristic | Subject Device<br>Endoscope Sterilization Tray<br>K180964 | Predicate Device<br>Endoscope Sterilization Tray<br>K170640 | | Features | The subject Endoscope Sterilization Tray<br>(Model# 400490) is a thermoformed plastic<br>tray with silicone inserts and a clear lid.<br>The tray and lid contain perforations to<br>allow sterilization gases to penetrate the<br>tray and sterilize the endoscope. The tray<br>has a cavity running diagonally that cradles<br>the da Vinci Endoscope. The tray lid has<br>stainless steel latches on either end to secure<br>the lid to the base. | SAME as subject device | | Materials | • Lid and Base - High Temperature,<br>Transparent, Polyetherimide Blend<br>• Base Inserts - Silicone<br>• Latches and Handles - Stainless<br>Steel | SAME as subject device | | Packaging | Non-sterile packaging, reusable | SAME as subject device | ### Technical Characteristic Table Image /page/5/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, similar font, with a registered trademark symbol next to it. The text is light gray. {6}------------------------------------------------ Image /page/6/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Above the "I" is a yellow dot. Below "INTUITIVE" is the word "SURGICAL" in a smaller font size and also in a light gray color with a registered trademark symbol. {7}------------------------------------------------ {8}------------------------------------------------ ### Technological Characteristics and Principle of Operation: The technological characteristics/principle of operation of the subject device is identical to the predicate device. ### Physical/Chemical Properties: The physical/chemical properties of the subject device are identical to the predicate device, since there are no changes to the tray features and materials. ### Performance Data: The purpose of this 510(k) is to remove the da Vinci Xi Endoscope model numbers (PNs: 470026 and 470027) from the Indications for Use Statement. These da Vinci Xi Endoscope model numbers (PNs: 470026 and 470027) are referenced within the Reprocessing Instructions to clarify the use of the Endoscope Sterilization Tray to encase and protect these specific da Vinci Xi Endoscopes during the sterilization process. The subject device Endoscope Sterilization Tray (PN 400490) is only being used with FDA Cleared da Vinci Xi Endoscope Model numbers (PNs: 470026 and 470027) and is not used with any other endoscope models/ medical instruments. {9}------------------------------------------------ Cleaning, biocompatibility and bench testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device. Additionally there are no changes to the sterilization process parameters between the subject device and the predicate device; therefore sterilization validation testing was not repeated. ### Conclusion: Based on the conclusions drawn from the intended use, technological characteristics and nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Endoscope sterilization tray cleared under K170640 under regulation 21 CFR 880.6850, product code KCT. Image /page/9/Picture/6 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in a light gray color, with the registered trademark symbol next to it. There is a yellow dot above the "I" in "INTUITIVE".