Endoscope Sterilization Tray

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. February 1, 2019 Intuitive Surgical, Inc. Brandon Hansen Manager, Regulatory Submissions 1266 Kifer Road Sunnyvale, California 94086 Re: K183139 Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 9, 2018 Received: November 13, 2018 #### Dear Brandon Hansen: 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. Although this letter refers to your product as a device, please be aware 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. 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 {1}------------------------------------------------ 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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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, # 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183139 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 and DUO cycles - · 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 12.2 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) | | |-------------------------------------------------|---------------------------------------------------------------------------------| | | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | | <input checked="" type="checkbox"/> 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}------------------------------------------------ ## 510(k) Summary K183139 | 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Brandon Hansen<br>Manager, Regulatory Submissions<br>Phone Number: 408-523-7485<br>Fax Number: 408-523-8907<br>Email: Brandon.Hansen@intusurg.com | | Date Summary Prepared: | January 17, 2019 | | Trade Name: | Endoscope Sterilization Tray | | Common Name: | Sterilization Tray | | Classification: | Class II<br>21 CFR 880.6850, Sterilization Wrap | | Product Codes: | KCT | | Classification Advisory Committee: | General Hospital | | Predicate Device: | Intuitive Surgical, Inc. Endoscope Sterilization Tray<br>(K180964) | Image /page/3/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. There is a yellow dot above the "I" in "INTUITIVE". Below "INTUITIVE" is the word "SURGICAL" in a smaller font and also in light gray. {4}------------------------------------------------ ### Device Description The Endoscope Sterilization Tray is a stainless steel tray with silicone inserts and a stainless steel lid. The tray and lid have a grid pattern to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S and Steris V-PRO maX V-PRO 1 Plus and V-PRO 1 sterilization systems. #### Intended Use: To encase and protect da Vinci endoscopes for sterilization. ### 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 and DUO cycles - 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 12.2 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. #### Technological Characteristics Comparison: | Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray<br>(K183139) | Predicate Device<br>Intuitive Surgical, Inc.<br>Endoscope Sterilization Tray<br>(K180964) | |---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. | | Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray<br>(K183139) | Predicate Device<br>Intuitive Surgical, Inc.<br>Endoscope Sterilization Tray<br>(K180964) | | Trade Name | Endoscope Sterilization Tray | Endoscope Sterilization Tray | | 510(k) No. | K183139 | K180964 | | Common Name | Sterilization Tray | Identical | | Regulation No. | 21 CFR 880.6850 | Identical | | Product Code | KCT | Identical | | Device Class/<br>Regulation Name | Class II/ Sterilization Wrap | Identical | | Classification<br>Advisory<br>Committee | General Hospital | Identical | | Sterilization<br>Method | H2O2 chemical sterilization | Identical | | Sterility /<br>Disposable or<br>Multiple use | Multiple use | Identical | | Intended Use | Intended to encase and protect da<br>Vinci endoscopes for sterilization<br>in the STERRAD 100NX<br>sterilization system using the<br>Express and DUO cycles settings<br>and the 100S sterilization system<br>using the Standard cycle setting<br>and in the STERIS V-PRO max,<br>V-PRO 1 Plus and V-PRO 1<br>systems. | Identical | | Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray<br>(K183139) | Predicate Device<br>Intuitive Surgical, Inc.<br>Endoscope Sterilization Tray<br>(K180964) | | Indications for<br>Use | The Intuitive Surgical Endoscope<br>Sterilization Tray is intended for use<br>to encase and protect compatible da<br>Vinci Xi endoscopes for sterilization<br>in any of the following sterilization<br>machines/cycles:<br>• STERRAD 100NX sterilization<br>system using the Express and DUO<br>cycles<br>• STERRAD 100S sterilization<br>system using the Standard cycle<br>• Steris V-PRO maX using the Non<br>Lumen, Flexible, or Lumen cycles<br>• Steris V-PRO 1 Plus using the Non<br>Lumen or Lumen cycles<br>• Steris V-PRO 1 using the V-<br>PRO/Lumen cycle<br>The sterilization cycle parameters of<br>the sterilizers are preset by the<br>manufacturers and are not adjustable.<br>The maximum product load per tray is<br>one da Vinci Xi Endoscope. The<br>length of the da Vinci Xi Endoscope<br>is approximately 600 mm and the<br>diameter of the shaft is 8.8 mm. The<br>maximum weight of the tray and<br>endoscope is 12.2 lbs. The Endoscope<br>Sterilization Tray is not intended to<br>maintain sterility; it is intended to be<br>used in conjunction with a legally<br>marketed, validated, FDA-cleared<br>STERRAD and Steris compatible<br>sterilization wrap in order to maintain<br>sterility of the enclosed medical<br>instrument. | The Intuitive Surgical Endoscope<br>Sterilization Tray is intended for use to<br>encase and protect compatible da Vinci<br>Xi endoscopes for sterilization in any of<br>the following sterilization<br>machines/cycles:<br>• STERRAD 100NX sterilization<br>system using the Express and DUO<br>cycles<br>• STERRAD 100S sterilization system<br>using the Standard cycle<br>• Steris V-PRO maX using the Non<br>Lumen, Flexible, or Lumen cycles<br>• Steris V-PRO 1 Plus using the Non<br>Lumen or Lumen cycles<br>• Steris V-PRO 1 using the V-<br>PRO/Lumen cycle<br>The sterilization cycle parameters of the<br>sterilizers are preset by the<br>manufacturers and are not adjustable.<br>The maximum product load per tray is<br>one da Vinci Xi Endoscope. The length<br>of the da Vinci Xi Endoscope is<br>approximately 600 mm and the diameter<br>of the shaft is 8.8 mm. The maximum<br>weight of the tray and endoscope is 8.9<br>lbs. The Endoscope Sterilization Tray is<br>not intended to maintain sterility; it is<br>intended to be used in conjunction with<br>a legally marketed, validated, FDA-<br>cleared STERRAD and Steris<br>compatible sterilization wrap in order to<br>maintain sterility of the enclosed<br>medical instrument. | | Where used<br>(hospital, home,<br>ambulance, etc.) | Hospital | Identical | | Materials; | stainless steel, silicone | ULTEMTM, silicone, stainless steel | | Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray<br>(K183139) | Predicate Device<br>Intuitive Surgical, Inc.<br>Endoscope Sterilization Tray<br>(K180964) | | Compatibility<br>with the<br>environment and<br>other devices | Compatible with da Vinci<br>endoscopes | Identical | | Sterilization<br>system<br>compatibility | STERRAD 100NX and 100S<br>Steris V-PRO maX, V-PRO 1 Plus<br>and V-PRO 1 | Identical | Image /page/4/Picture/16 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font above the word "SURGICAL," which is in a smaller, sans-serif font. There is a yellow dot above the word "INTUITIVE". {5}------------------------------------------------ {6}------------------------------------------------ Image /page/6/Picture/3 description: The image shows the logo for Intuitive Surgical. The logo is in gray and consists of the words "INTUITIVE" on the top line and "SURGICAL" on the bottom line. There is a registered trademark symbol after the word "SURGICAL" and a yellow dot above the word "INTUITIVE". {7}------------------------------------------------ The subject and predicate devices have the same intended use, indications for use, and materials. ## Summary of Non-Clinical Testing: Performance test data in accordance with ANSI/AAMI ST77 (bench, durability, corrosion resistance, cleaning, and sterilization tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, functional verification, biological safety assessment, cleaning and sterilization and package testing. The subject Endoscope Sterilization Tray underwent verification testing of dimensional and functional specifications. Trays were assessed for sharp edges, compatible materials, latch security, lid and base interchangeability, weight, and tray markings. The subject device successfully passed all requirements described in the protocol. These results demonstrate that the Endoscope Sterilization Tray meets the functional requirements. Based upon the toxicological assessment of the material characterization, the established biocompatibility results of the predicate device for intracutaneous injection, sensitization and hemolysis testing for the same materials and same intended clinical use, and the provisions of ISO 10993-1, the biological risk evaluation has determined that the subject Endoscope Sterilization Tray is biocompatible for its intended use as a containment device. Sterilization validation testing was conducted in the STERRAD 100NX sterilization system using the Express and DUO cycles, in the STERRAD 100S sterilization system using the Standard cycle and in the V-PRO maX using the Non Lumen cycle. The subject {8}------------------------------------------------ Endoscope Sterilization Tray, in combination with an FDA cleared sterilization wrap, passed the sterilization validations. The subject Endoscope Sterilization Tray (P/N 400490-04) was evaluated for the ability of the wrapped tray to maintain sterility during routine handling that would be encountered in the clinical setting. The sterilized wrapped tray was showered with an aerosol of spores and incubated. After incubation the tray was tested for positive growth. The tray successfully demonstrated negative growth. These results verify that, when wrapped and sterilized, the tray will maintain sterility after routine handling. The subject Endoscope Sterilization Tray underwent Limits of Reuse testing. The Iimits of reuse study consisted of repeated sterilization cycles. Each tray was inspected for damage to the cover, base and latches at the beginning of the study and again after completion of all sterilization cycles. The subject tray passed all requirements as described in the protocol. The subject Endoscope Sterilization Tray was packaged and subjected to simulated shipping testing per ASTM D4169-09 to ensure that both the product and packaging are validated for customer shipment. Packaged Endoscope Sterilization Trays were subjected to environmental conditioning, initial manual handling (drop testing), vehicle vibration, vehicle stacking (compression), etc. The packaging and the Endoscope Sterilization Tray passed all inspection criteria. #### Conclusion: The conclusions drawn from the comparison of the intended use, and technological characteristics and the results of the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K180964. Image /page/8/Picture/8 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 light gray, with the registered trademark symbol next to it. There is a yellow dot above the "I" in Intuitive.