Omni Instrument Tray

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February 26, 2019 Hologic, Inc Rachelle Fitzgerald Senior Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752 Re: K182052 Trade/Device Name: Omni Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 29, 2019 Received: January 25, 2019 Dear Rachelle Fitzgerald: 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. You must comply with all the Act's {1}------------------------------------------------ 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 (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}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Food and Drug Administration | | | <b>Indications for Use</b> | | | Form Approved: OMB No. 0910-0120 | | | Expiration Date: 06/30/2020 | | | See PRA Statement below. | | | 510(k) Number (if known) | K182052 | | Device Name | Omni Instrument Tray | | Indications for Use (Describe) | | | The Omni Instrument Tray is intended to enclose, protect, and organize the Omni Hysteroscope, Sheaths, and Removable Outflow Channels during sterilization and storage. | | | The Omni Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycles. | | | The Omni Instrument Tray has been validated for the following sterilization cycles: | | | Prevacuum Steam | STERRAD ^® | |----------------------------------|----------------------------------| | 132°C (270°F) | - STERRAD 100S Short | | 4 minutes exposure | - STERRAD NX Standard | | 35 minutes dry time | - STERRAD 100NX Standard | | Contents: | Contents: | | - 1 Omni Hysteroscope | - 1 Omni Hysteroscope | | - 1 Removable Outflow Channel | - 1 Removable Outflow Channel | | - 1 XL Removable Outflow Channel | - 1 XL Removable Outflow Channel | | - 1 Omni 3.7mm Diagnostic Sheath | - 1 Omni 3.7mm Diagnostic Sheath | | - 1 Omni 5.5mm Operative Sheath | - 1 Omni 5.5mm Operative Sheath | | - 1 Omni 6mm Operative Sheath | - 1 Omni 6mm Operative Sheath | | - 3 Seal Caps | - 3 Seal Caps | | - 2 Light Guide Adapters | - 2 Light Guide Adapters | | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <label><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</label> | 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](mailto: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." | FORM FDA 3881 (7/17) | Page 1 of 1 | |----------------------|----------------------------------------| | K182052/S001 | Attachment 3M | | | PSC Publishing Services (301) 443-6740 | | | EF | | | 1 of 1 | {3}------------------------------------------------ ## 510(K) SUMMARY K182052 Date: February 20, 2019 #### 510(k) Submitter: Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Rachelle D. Fitzgerald P: 508.263.8631 F: 877.793.6434 # Establishment Reqistration Number: 1222780 Trade Name: Omni Instrument Tray Common/Usual Name: Sterilization Tray Regulation Name: Sterilization wrap Regulation Number: 21 CFR 880.6850 Product Code: KCT Classification: Class II Panel: General Hospital # PREDICATE DEVICE Tradename: MyoSure Instrument Tray Submitter/510(k) Holder: Hologic, Inc. 510(k) #: K121280 Product Code: KCT Regulation: 21CFR 880.6850 #### DEVICE DESCRIPTION The Omni Instrument Tray is intended to enclose, protect, and organize The Omni Hysteroscope, Sheaths, and Removable Outflow Channels during sterilization and storage. The Omni Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycles. The Omni Instrument Tray is made of a stainless steel, santoprene, and silicone and is supplied non-sterile and is designed for multiple use for the sterilization of the Omni Hysteroscope set prior to each use of the Hysteroscope. The Omni Instrument Tray has been validated for the following sterilization cycles: {4}------------------------------------------------ | Pre-vacuum Steam | STERRAD® | |---------------------------------|---------------------------------| | 132°C (270°F) | STERRAD NXTM Standard | | 4 minutes exposure | STERRAD 100NXTM Standard | | 35 minutes dry time | STERRAD 100S Short | | Contents: | Contents: | | - 1 Omni Hysteroscope | - 1 Omni Hysteroscope | | -1 Removable Outflow Channel | -1 Removable Outflow Channel | | -1 XL Removable Outflow Channel | -1 XL Removable Outflow Channel | | -1 Omni 3.7mm Diagnostic Sheath | -1 Omni 3.7mm Diagnostic Sheath | | -1 Omni 5.5mm Operative Sheath | -1 Omni 5.5mm Operative Sheath | | - 1 Omni 6mm Operative Sheath | - 1 Omni 6mm Operative Sheath | | - 3 Seal Caps | - 3 Seal Caps | | - 2 Light Guide Adapters | - 2 Light Guide Adapters | # INDICATIONS FOR USE: The Omni Instrument Tray is intended to enclose, protect, and organize The Omni Hysteroscope, Sheaths, and Removable Outflow Channels during sterilization and storage. The Omni Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycles. | | The Omni Instrument Tray has been validated for the following sterilization cycles: | | |--|-------------------------------------------------------------------------------------|--| |--|-------------------------------------------------------------------------------------|--| | Pre-vacuum Steam | STERRAD® | |---------------------------------|---------------------------------| | 132°C (270°F) | STERRAD NX™ Standard | | 4 minutes exposure | STERRAD 100NXT™ Standard | | 35 minutes dry time | STERRAD 100S Short | | Contents: | Contents: | | - 1 Omni Hysteroscope | - 1 Omni Hysteroscope | | -1 Removable Outflow Channel | -1 Removable Outflow Channel | | -1 XL Removable Outflow Channel | -1 XL Removable Outflow Channel | | -1 Omni 3.7mm Diagnostic Sheath | -1 Omni 3.7mm Diagnostic Sheath | | -1 Omni 5.5mm Operative Sheath | -1 Omni 5.5mm Operative Sheath | | - 1 Omni 6mm Operative Sheath | - 1 Omni 6mm Operative Sheath | | - 3 Seal Caps | - 3 Seal Caps | | - 2 Light Guide Adapters | - 2 Light Guide Adapters | {5}------------------------------------------------ #### Technological Omni Instrument Trav Predicate Device Reference Device Characteristic (K121280) (K171692) The tray is intended The tray is intended to The tray is intended Intended Use enclose, protect, and to enclose, protect, to enclose, protect, and organize and organize organize medical medical devices. medical devices. devices. Steam Autoclave Steam Autoclave; Pre-Steam Autoclave; Biocompatibility Vacuum 132°C (270°F), Pre-Vacuum 132°C Pre-Vacuum 132°C 4 min Exposure, 30 min (270°F), 3 min (270°F); 4 min Exposure; Exposure, 15-30 min dry time; 35 min dry time dry time; STERRAD® 100S Short STERRAD NX Standard STERRAD: NX cycle STERRAD 100NX Standard and Standard Hemolytic Test 10993-4 Express, 100S Short STERRAD 100S Short Biological evaluation of Cytotoxicity ISO 10993medical devices-Part: Cytotoxicity ISO 5:2009 Biological Selection of tests for 10993-5:2009 evaluation of medical interactions with blood; Biological evaluation devices-Part 5: Test for in Irritation 10993-10: Tests of medical devicesvitro cytotoxicity. for irritation and skin Part 5: Test for in vitro cytotoxicity. sensitization. Under the condition of the study, the device Under the conditions of Under the condition extract was found not to the study, device extract of the study, the be cytotoxic to the was found not to be device extract was testing assay. hemolytic to the testing found not to be assay. cytotoxic to the testing assay. Under the conditions of the study, the polar and non-polar device extracts were found not to be a sensitizer nor an irritant to the animal model. # TECHNOLOGICAL CHARACTERISTICS: {6}------------------------------------------------ | Technological<br>Characteristic | Omni Instrument Tray | Predicate Device<br>(K121280) | Reference Device<br>(K171692) | |---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Prescription Only | No | No | No | | Device Description | Stainless Steel<br>tray and lid<br>with metal lid locking<br>mechanism and handles<br>Accessories include:<br>silicone<br>grommets, and stainless<br>steel<br>posts | Fenestrated plastic tray<br>and<br>lid with metal lid locking<br>mechanism and handles<br>Accessories include:<br>silicone grommets, and<br>stainless steel posts | Rigid containment<br>device consisting of<br>a base with a lid<br>which can be<br>fastened by a<br>latching<br>mechanism. The<br>device is perforated<br>in order to enable<br>reprocessing of<br>enclosed medical<br>devices held in<br>place by silicone<br>retainers. | | Materials of<br>construction<br>Tray<br>Lid<br>Handles/<br>Latching<br>Grommets | Stainless Steel/<br>Santoprene<br>Stainless Steel<br>Stainless Steel/<br>Silicone/Santoprene<br>Silicone | Radel®R resin<br>Radel®R resin<br>Stainless Steel<br>Silicone | Stainless steel<br>Stainless steel<br>Stainless Steel<br>Silicone | | Dimensions<br>Length<br>Width<br>Height | 16.20"<br>10.11"<br>2.27" | 13.45"<br>8.41"<br>2.00" | 22.83"<br>3.03"<br>10.63" | | Sterilization cycles | Steam Autoclave:<br>Pre-Vacuum 132°C<br>(270°F);<br>4 min Exposure;<br>35 min dry time<br>STERRAD NX<br>Standard<br>STERRAD 100NX<br>Standard STERRAD<br>100S Short | Steam Autoclave<br>Pre-Vacuum 132°C<br>(270°F),<br>4 min Exposure, 30 min<br>dry time;<br>STERRAD® 100S Short<br>cycle | Steam Autoclave<br>Pre-Vacuum 132°C<br>(270°F), 3 min<br>Exposure, 15-30 min<br>dry time;<br>STERRAD: NX<br>Standard and<br>Express, 100S<br>Short | | Capacity<br>(Maximum total<br>weight) | 25 lbs | 13 lbs | 8.708 lbs | | Reusable | Yes | Yes | Yes | | Perforations<br>(Vent to Volumne<br>Ratio) | .435 in²/in³ | .020 in²/in³ | 72% | | Technological<br>Characteristic | Omni Instrument Tray | Predicate Device<br>(K121280) | Reference Device<br>(K171692) | | Patient Contacting<br>Materials | None | None | None | {7}------------------------------------------------ # PERFORMANCE TESTING ## Clinical Testing No clinical testing was performed, submitted, referenced or relied upon for the Omni Instrument Tray. ### Bench Testing Non-clinical bench testing and simulated use testing demonstrate the Omni Instrument Tray is similar to the predicate device. Design verification testing included: - . Biocompatibility testing to ISO 10993-5:2009 (Biological evaluation of medicaldevices-Part 5: Test for in vitro cytotoxicity) - Usability testing to IEC 62366-1:2015 (Medical devices-Part 1: Application of usability . engineering to medical devices) - . Packaging testing to ISTA 3A (Packaged-Products for Parcel Delivery System Shipment70 kq (150 lb or less) - Design verification testing to hold the Omni hysteroscope. Sheaths, and Removable ● Outflow Channels (ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization) - Attribute verification of component fit ● - Reliability testing including durability, drop test, and handle strength (AAMI TIR12:2010 Design, testing, and labeling reusable medical devices for reprocessing in health care facilities: A quide for medical device manufacturers) - . Latch cycle durability - Simulated table height drop test ● - Handle pull strength to sustained load # Cleaning and Sterilization The Omni Instrument Tray is supplied non-sterile and required processing through cleaning and sterilization at the health care facility by the end user. Validation testing confirmed the methods and parameters of these processes as specified in the device labeling. {8}------------------------------------------------ The following standards were used during the validation process: | Standard Reference | Standard Title | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AAMI/ANSI ST79:2017 | Comprehensive guide to steam sterilization and sterility assurance in<br>health care facilities | | ANSI/AAMI ST77:2013 | Containment devices for reusable medical device sterilization | | ISO 17664:2017 | Processing Of Health Care Products - Information To Be Provided By The<br>Medical Device Manufacturer For The Processing Of Medical Devices | | ISO 17665-1:2006 | Sterilization Of Health Care Products - Moist Heat - Part 1:<br>Requirements For The Development, Validation And Routine Control Of<br>A Sterilization<br>Process For Medical Devices | | ISO TS 17665-2:2009 | Sterilization Of Health Care Products - Moist Heat - Part 2: Guidance On<br>The Application Of ISO 17665-1 | | ANSI/AAMI/ISO<br>14937:2009/(R)<br>2013 | Sterilization of Health Care Products-General Requirements for<br>characterization of a sterilizing agent and the development, validation and<br>routine control of a sterilization process for medical devices | | AAMI TIR12:2010 | Designing, testing, and labeling reusable medical devices for reprocessing<br>in health care facilities: A guide for medical device manufacturers | | AAMI TIR30:2011 | A compendium of processes, materials, test methods, acceptance criteria<br>for cleaning reusable medical devices | The above referenced design verification testing and cleaning and sterilization validations demonstrate the subject device met the design specifications. # CONCLUSION The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device MyoSure Instrument Tray (K121280).