PRO-LITE Sterilization Trays

{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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. February 9, 2018 Steris Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060 Re: K172755 Trade/Device Name: PRO-LITE™ Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 9, 2018 Received: January 10, 2018 ### Dear Jennifer Nalepka: 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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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, # Michael J. Ryan -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) K172755 | Device Name | PRO-LITE™ Sterilization Trays | |-------------|-------------------------------| |-------------|-------------------------------| Indications for Use (Describe) The PRO-LITE™ Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen, Flexible, and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. Prior to placing in the Sterilizer, the trays must either be: - wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization . Systems or - placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments. | Tray<br>Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load | |----------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049<br>VP0050<br>VP0051<br>VP0052 | V-PRO 60<br>Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors<br>• Non-lumened devices including non-lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single, dual and triple channeled rigid and<br>semi-rigid endoscopes, with the following configurations:<br>o single or dual lumen devices<br>• $\geq$ 0.77 mm ID and $\leq$ 410 mm in length<br>o triple lumen devices<br>• $\geq$ 1.2 mm ID and $\leq$ 275 mm in length<br>• $\geq$ 1.8 mm ID and $\leq$ 310 mm in length<br>or<br>• $\geq$ 2.8 mm ID and $\leq$ 317 mm in length | | | V-PRO 60 Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and<br>flexible endoscopes and non-lumened devices with stainless steel or<br>titanium diffusion-restricted spaces such as the hinged portion of<br>forceps and scissors. | | | V-PRO 60<br>Flexible Cycle | One flexible surgical endoscope or bronchoscope with a light cord (if<br>not integral to endoscope) and mat without any additional load. The<br>flexible endoscope may be a:<br>o single or dual lumen device with lumens that are $\geq$ 1 mm ID and $\leq$<br>990 mm in length | | Tray<br>Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load | | VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049<br>VP0050<br>VP0051<br>VP0052<br>VP0053 | V-PRO 1, 1 Plus,<br>maX & maX 2<br>Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors<br>• Non-lumened devices including non-lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single, dual and triple channeled rigid and<br>semi-rigid endoscopes, with the following configurations:<br>○ single or dual lumen devices<br>• ≥ 0.77 mm ID and ≤ 527 mm in length<br>○ triple lumen devices<br>• ≥ 1.2 mm ID and ≤ 275 mm in length<br>• ≥ 1.8 mm ID and ≤ 310 mm in length<br>or<br>• ≥ 2.8 mm ID and ≤ 317 mm in length | | | V-PRO 1 Plus,<br>maX & maX 2<br>Non Lumen<br>Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and<br>flexible endoscopes and non-lumened devices with stainless steel or<br>titanium diffusion-restricted spaces such as the hinged portion of<br>forceps and scissors. | | | V-PRO maX &<br>maX 2 Flexible<br>Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such as<br>those used in ENT, Urology and Surgical Care) and bronchoscopes<br>with a light cord (if not integral to endoscope) and mat with no<br>additional load.<br>The flexible endoscopes may contain either:<br>• a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length<br>• or two lumens with:<br>• one lumen that is ≥ 1 mm ID and ≤ 990 mm in length<br>• and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length<br>Load 2: Non-lumened instruments including instruments with<br>diffusion-restricted areas such as the hinged portion of forceps or<br>scissors. | | | V-PRO maX 2<br>Fast Non Lumen<br>Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and<br>flexible endoscopes and non-lumened devices with stainless steel or<br>titanium diffusion-restricted spaces such as the hinged portion of<br>forceps and scissors. | {3}------------------------------------------------ Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the Sterilization Trays. | Model | Description | Model | Description | |--------|---------------------|--------|---------------------| | VP0054 | Blank, Tall | VP0055 | Blank, Short | | VP0063 | 3 mm - 7 mm, Tall | VP0067 | 3 mm- 7 mm, Short | | VP0064 | 7 mm - 11 mm, Tall | VP0068 | 7 mm- 11 mm, Short | | VP0065 | 11 mm - 15 mm, Tall | VP0069 | 11 mm- 15 mm, Short | | VP0066 | 15 mm - 19 mm, Tall | VP0070 | 15 mm- 19 mm, Short | Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays. {4}------------------------------------------------ | Model | Description<br>(in) | Model | Description<br>(in) | Model | Description<br>(in) | |--------|---------------------|--------|---------------------|--------|---------------------| | VP0071 | 13 x 4.5 | VP0074 | 13 x 7.75 | VP0077 | 12 x 11.75 | | VP0072 | 19 x 4.5 | VP0075 | 19 x 7.75 | VP0078 | 25 x 11.75 | | VP0073 | 25 x 4.5 | VP0076 | 27 x 7.75 | VP0079 | 25 x 14 | Type of Use (Select one or both, as applicable) _ Prescription Use (Part 21 CFR 801 Subpart D) 2 Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) ### 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. 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FORM FDA 3881 (7/17) Page 3 of 3 {5}------------------------------------------------ ## 510(k) Summary For PRO-LITE™ Sterilization Tray ### Sponsor Facility STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198 Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist Telephone: (440) 392-7458 Fax No: (440) 357-9198 e-mail: jennifer_nalepka@steris.com Submission Date: January 24, 2018 Premarket Notification: K172755 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {6}------------------------------------------------ #### 1. Device Name | Trade Name: | PRO-LITE Sterilization Tray | |----------------------|------------------------------------------------------| | Common/usual Name: | Sterilization Trays, cassettes and other accessories | | Classification Name: | Sterilization Wrap | | Classification | 21 CFR 880.6850 | | Class | II | | Product Code | KCT | #### 2. Predicate Device Sterilization Tray K160912 #### 3. Description of Device The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60 and V-PRO maX 2 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 5-1, to accommodate the loads to be processed. The proposed trays are similar in design to the predicate Sterilization Trav (K160912) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material. | Model | Description (in) | Model | Description (in) | |--------|------------------|--------|------------------| | VP0045 | 13 x 4.5 x 2.25 | VP0050 | 27 x 7.75 x 4 | | VP0046 | 19 x 4.5 x 2.25 | VP0051 | 12 x 11.75 x 4 | | VP0047 | 25 x 4.5 x 2.25 | VP0052 | 25 x 11.75 x 4 | | VP0048 | 13 x 7.75 x 2.25 | VP0053 | 25 x 14 x 5 | | VP0049 | 19 x 7.75 x 2.25 | | | Table 5-1. External Dimensions of Tray Line Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Table 5-2 lists the organizer sizes. The organizers are either "blank" and are used to partition the tray or have a device holding portion into which the devices are inserted. At the organizer base is a flapped groove that is used to position the organizer within a PRO-LITE Sterilization Tray. {7}------------------------------------------------ | Model | Description | Model | Description | |--------|---------------------|--------|----------------------| | VP0054 | Blank, Tall | VP0055 | Blank, Short | | VP0063 | 3 mm - 7mm, Tall | VP0067 | 3 mm - 7 mm, Short | | VP0064 | 7 mm - 11mm, Tall | VP0068 | 7 mm - 11 mm, Short | | VP0065 | 11 mm - 15 mm, Tall | VP0069 | 11 mm - 15 mm, Short | | VP0066 | 15 mm - 19mm, Tall | VP0070 | 15 mm - 19 mm, Short | Table 5.2. Instrument Organizer Model Numbers Optional sterilization mats are provided as accessories to the trays. The mats, which are used to cushion and stabilize devices placed into the trays, are available in sizes as shown in Table 5-3 to fit the nine PRO-LITE Sterilization Travs. The mats are a diamond grid design with "fingers" that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the trays. Table 5-3. Silicone Mat Model Numbers | Model | Description (in) | Model | Description (in) | |--------|------------------|--------|------------------| | VP0071 | 13 x 4.5 | VP0076 | 27 x 7.75 | | VP0072 | 19 x 4.5 | VP0077 | 12 x 11.75 | | VP0073 | 25 x 4.5 | VP0078 | 25 x 11.75 | | VP0074 | 13 x 7.75 | VP0079 | 25 x 14 | | VP0075 | 19 x 7.75 | | | The purpose of this submission is to add claims and clarify the use of tray models in the V-PRO Sterilizers for: - use in the V-PRO maX 2 Fast Non Lumen Cycle ● - . the sterilization of titanium mated surfaces (diffusion-restricted spaces) in the V-PRO 1 Plus, maX, and maX 2 Sterilizers Non Lumen Cycle - addition of the V-PRO maX 2 Sterilizer to the indications for use in the . Lumen. Non Lumen and Flexible Cvcles of the V-PRO 1. 1 Plus and maX Sterilizers (the V-PRO maX 2 Sterilizer Lumen, Non Lumen, and Flexible Cycles are identical, with the exception of the condition phase of the Lumen Cycle, to the previously cleared cycles listed in Table 5-4). - Clarification of which tray models are used in which sterilizers listed in the Indications for Use. Tray model VP0053 does not fit within the V-PRO 60 Sterilizer and therefore tray model VP0053 is being removed from the Indications for Use for the V-PRO 60 Sterilizer. {8}------------------------------------------------ | Cycle | Most Recent<br>Premarket<br>Notification<br>Clearance | V-PRO 1 | V-PRO<br>1 Plus | V-PRO<br>maX | V-PRO<br>maX 2 | |----------------------|-------------------------------------------------------|---------|-----------------|--------------|----------------| | Lumen Cycle | K131120 | X | X | X | X | | Non Lumen Cycle | K160433 | * | X | X | X | | Flexible Cycle | K102330 | | | X | X | | Fast Non Lumen Cycle | K172754 | | | | X | | | Table 5-4. V-PRO Cycles Provided in the Large Size (136 L Chamber) V-PRO Sterilizers | |--|--------------------------------------------------------------------------------------| | | | * Shaded cell indicates that the V-PRO Sterilizer does not include the identified cycle. ### NOTE: V-PRO Sterilizer cycles are pre-set and thus the name of the cycle describes the cycle conditions. #### 4. Intended Use/ Indications for Use The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen, Flexible, and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. Prior to placing in the Sterilizer, the trays must either be: - wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems or - placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments. | Tray Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load | |----------------------------------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049<br>VP0050<br>VP0051<br>VP0052 | V-PRO 60<br>Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors<br>• Non-lumened devices including non-lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single, dual and triple channeled rigid<br>and semi-rigid endoscopes, with the following configurations:<br>◦ single or dual lumen devices<br>• ≥ 0.77 mm ID and ≤ 410 mm in length<br>◦ triple lumen devices<br>• ≥1.2 mm ID and ≤ 275 mm in length<br>• ≥1.8 mm ID and ≤ 310 mm in length<br>or<br>• ≥2.8 mm ID and ≤ 317 mm in length | | | V-PRO 60 Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and<br>flexible endoscopes and non-lumened devices with stainless steel or | | Tray Models | Intended<br>Sterilization<br>Cycles | Intended Tray Load | | | | titanium diffusion-restricted spaces such as the hinged portion of<br>forceps and scissors. | | | V-PRO 60<br>Flexible Cycle | One flexible surgical endoscope or bronchoscope with a light cord<br>(if not integral to endoscope) and mat without any additional load.<br>The flexible endoscope may be a:<br>○ single or dual lumen device with lumens that are ≥ 1 mm ID<br>and ≤ 990 mm in length | | VP0045<br>VP0046<br>VP0047<br>VP0048<br>VP0049<br>VP0050<br>VP0051<br>VP0052<br>VP0053 | V-PRO 1, 1<br>Plus, maX &<br>maX 2 Lumen<br>Cycle | • Instruments with diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors<br>• Non-lumened devices including non-lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single, dual and triple channeled rigid<br>and semi-rigid endoscopes, with the following configurations:<br>o single or dual lumen devices<br>≥ 0.77 mm ID and ≤ 527 mm in length<br>o triple lumen devices<br>≥ 1.2 mm ID and ≤ 275 mm in length<br>≥ 1.8 mm ID and ≤ 310 mm in length<br>or<br>≥ 2.8 mm ID and ≤ 317 mm in length | | | V-PRO 1 Plus,<br>maX & maX 2<br>Non Lumen<br>Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and<br>flexible endoscopes and non-lumened devices with stainless steel or<br>titanium diffusion-restricted spaces such as the hinged portion of<br>forceps and scissors. | | | V-PRO maX &<br>maX 2 Flexible<br>Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such as<br>those used in ENT, Urology and Surgical Care) and bronchoscopes<br>with a light cord (if not integral to endoscope) and mat with no<br>additional load.<br>The flexible endoscopes may contain either:<br>• a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length<br>• or two lumens with:<br>one lumen that is ≥ 1 mm ID and ≤ 990 mm in length<br>and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in<br>length<br>Load 2: Non-lumened instruments including instruments with<br>diffusion-restricted areas such as the hinged portion of forceps or<br>scissors. | | | V-PRO maX 2<br>Fast Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and<br>flexible endoscopes and non-lumened devices with stainless steel or<br>titanium diffusion-restricted spaces such as the hinged portion of<br>forceps and scissors. | {9}------------------------------------------------ {10}------------------------------------------------ | Model | Description | Model | Description | |--------|---------------------|--------|----------------------| | VP0054 | Blank, Tall | VP0055 | Blank, Short | | VP0063 | 3 mm - 7 mm, Tall | VP0067 | 3 mm - 7 mm, Short | | VP0064 | 7 mm - 11 mm, Tall | VP0068 | 7 mm - 11 mm, Short | | VP0065 | 11 mm - 15 mm, Tall | VP0069 | 11 mm - 15 mm, Short | | VP0066 | 15 mm - 19 mm, Tall | VP0070 | 15 mm - 19 mm, Short | Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the PRO-LITE Sterilization Trays. Sterilization mats are optional accessories intended to cushion and stabilize instruments within the PRO-LITE Sterilization Trays. | Model | Description (in) | Model | Description (in) | Model | Description (in) | |--------|------------------|--------|------------------|--------|------------------| | VP0071 | 13 x 4.5 | VP0074 | 13 x 7.75 | VP0077 | 12 x 11.75 | | VP0072 | 19 x 4.5 | VP0075 | 19 x 7.75 | VP0078 | 25 x 11.75 | | VP0073 | 25 x 4.5 | VP0076 | 27 x 7.75 | VP0079 | 25 x 14 | #### 5. Summary of Technical Characteristics The sterilization mats and instrument organizers are identical in composition to the claimed predicate devices. The proposed PRO-LITE sterilization trays are composed a material that is slightly different from the material of the predicate device. The proposed device is a mineral-filled polypropylene whereas the predicate device is a glass-filled polypropylene. The technical characteristics are summarized below in Table 5-5. ### Table 5-5. Summary of Tray Physical Description and Technological Properties | Feature | PRO-LITE Sterilization<br>Tray (proposed) | Sterilization Tray<br>(K160912) | Comparison | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The PRO-LITE Sterilization<br>Trays are used to contain<br>medical devices for<br>sterilization in the Lumen, Non<br>Lumen, Flexible and Fast Non<br>Lumen Cycles of the V-PRO<br>Low Temperature Sterilization<br>Systems. Prior to placing in the<br>Sterilizer, the trays must either<br>be:<br>• wrapped with a legally<br>marketed sterilization wrap<br>for use in the V-PRO Low | The Sterilization Trays are used<br>to contain medical devices for<br>sterilization in the Lumen, Non<br>Lumen and Flexible Cycles of<br>the V-PRO Low Temperature<br>Sterilization Systems. Prior to<br>placing in the Sterilizer, the trays<br>must either be:<br>• wrapped with a legally<br>marketed sterilization wrap for<br>use in the V-PRO Low<br>Temperature Sterilization<br>Systems or | Identical except for the<br>addition of the Fast<br>Non Lumen Cycle of<br>the V-PRO maX2<br>cycle. The Fast Non<br>Lumen Cycle is a new<br>cycle in the V-PRO<br>maX 2 Low<br>Temperature Sterilizer,<br>K172754. | | Feature | PRO-LITE Sterilization Tray (proposed) | Sterilization Tray (K160912) | Comparison | | | Temperature Sterilization Systems or<br>• placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems.<br>The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.<br>Tray models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052 | • placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems.<br>The Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.<br>Tray models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052, VP0053 | | | | V-PRO 60 Lumen Cycle<br>• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors<br>• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes<br>• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:<br>➤ single or dual lumen devices $≥ 0.77$ mm ID and less than or equal to 410 mm in length<br>➤ triple lumen devices $≥1.2$ mm ID and less than or equal to 275 mm in length<br>$≥1.8$ mm ID and less than or equal to 310 mm in | V-PRO 60 Lumen Cycle<br>• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors<br>• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes<br>• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:<br>➤ single or dual lumen devices $≥ 0.77$ mm ID and less than or equal to 410 mm in length<br>➤triple lumen devices $≥1.2$ mm ID and less than or equal to 275 mm in length<br>$≥1.8$ mm ID and less than or equal to 310 mm in length or<br>$≥2.8$ mm ID and less than or | | | Feature | PRO-LITE Sterilization<br>Tray (proposed) | Sterilization Tray<br>(K160912) | Comparison | | | or<br>$≥$ 2.8 mm ID and less than<br>or equal to 317 mm in<br>length | V-PRO 60 Non Lumen Cycle<br>- Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened<br>devices with stainless steel or<br>titanium diffusion-restricted<br>spaces such as the hinged portion<br>of forceps and scissors. | | | | V-PRO 60 Non Lumen Cycle<br>- Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened<br>devices with stainless steel or<br>titanium diffusion-restricted<br>spaces such as the hinged<br>portion of forceps and scissors. | V-PRO 60 Flexible Cycle<br>- One flexible surgical<br>endoscope or bronchoscope<br>with a light cord (if not integral<br>to endoscope) and mat without<br>any additional load. The<br>flexible endoscope may be a<br>single or dual lumen device<br>with lumens that are $≥$ 1 mm ID<br>and less than or equal 990 mm<br>in length | | | | V-PRO 60 Flexible Cycle<br>- One flexible surgical<br>endoscope or bronchoscope<br>with a light cord (if not<br>integral to endoscope) and<br>mat without any additional<br>load. The flexible endoscope<br>may be a single or dual lumen<br>device with lumens that are $≥$<br>1 mm ID and less than or<br>equal 990 mm in length | V-PRO 1, 1 Plus & maX Lumen<br>Cycle<br>• Instruments with diffusion-<br>restricted spaces such as the<br>hinged portion of forceps and<br>scissors<br>• Non-lumened devices including<br>non-lumened rigid and semi-<br>rigid endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-rigid<br>endoscopes, with the following<br>configurations:<br>$➤$ - single or dual lumen<br>devices<br>$≥$ 0.77 mm ID and less than<br>or equal to 527 mm in length<br>$➤$ triple lumen devices<br>$≥$ 1.2 mm ID and less than or<br>equal to 275 mm in length<br>$≥$ 1.8 mm ID and less than or<br>equal to 310 mm in length | | | | Tray models: VP0045,<br>VP0046, VP0047, VP0048,<br>VP0049, VP0050, VP0051,<br>VP0052 | | | | | V-PRO 1, 1 Plus, maX, &<br>maX 2 Lumen Cycle<br>• Instruments with diffusion-<br>restricted spaces such as the<br>hinged portion of forceps<br>and scissors<br>• Non-lumened devices<br>including non-lumened rigid<br>and semi-rigid endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations:<br>$➤$ - single or dual lumen<br>devices | | | | Feature | PRO-LITE Sterilization<br>Tray (proposed) | Sterilization Tray<br>(K160912) | Comparison | | | ≥ 0.77 mm ID and less<br>than or equal to 527 mm in<br>length<br>➤ triple lumen devices<br>≥1.2 mm ID and less than<br>or equal to 275 mm in<br>length<br>≥1.8 mm ID and less than<br>or equal to 310 mm in<br>length<br>or<br>≥2.8 mm ID and less than<br>or equal to 317 mm in<br>length | or<br>≥2.8 mm ID and less than or<br>equal to 317 mm in length | | | | V-PRO 1 Plus, maX, & maX 2<br>Non Lumen Cycle<br>- Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened<br>devices with stainless steel or<br>titanium diffusion-restricted<br>spaces such as the hinged<br>portion of forceps and scissors. | V-PRO 1 Plus & maX Non<br>Lumen Cycle<br>- Non-lumened devices including<br>non-lumened rigid, semi-rigid<br>and flexible endoscopes and non-<br>lumened devices with stainless<br>steel diffusion-restricted spaces<br>such as the hinged portion of<br>forceps and scissors. | | | | V-PRO maX & maX 2<br>Flexible Cycle<br>Load 1: Single or dual lumen<br>surgical flexible endoscopes<br>(such as those used in ENT,<br>Urology and Surgical Care)<br>and<br>bronchoscopes with a light<br>cord (if not integral to<br>endoscope) and mat with no<br>additional load.<br>The flexible endoscopes may<br>contain either:<br>a single lumen that is ≥ 1 mm<br>ID and less than or equal 1050<br>mm in length<br>or two lumens with:<br>one lumen that is ≥ 1 mm ID<br>and less than or equal 990 mm<br>in length | V-PRO maX Flexible Cycle<br>Load 1: Single or dual lumen<br>surgical flexible endoscopes<br>(such as those used in ENT,<br>Urology and Surgical Care) and<br>bronchoscopes with a light cord<br>(if not integral to endoscope) and<br>mat with no additional load.<br>The flexible endoscopes may<br>contain either:<br>a single lumen that is ≥ 1 mm ID<br>and less than or equal 1050 mm<br>in length<br>or two lumens with:<br>one lumen that is ≥ 1 mm ID and<br>less than or equal 990 mm in<br>length<br>and the other lumen that is ≥ 1<br>mm ID and less than or equal<br>850 mm in length<br>Load 2: Non-lumened<br>instruments including<br>instruments with diffusion-<br>restricted areas such as the<br>hinged portion of forceps or<br>scissors. | | | Feature | PRO-LITE Sterilization<br>Tray (proposed) | Sterilization Tray<br>(K160912) | Comparison | | | and the other lumen that is $\ge$ 1 mm ID and less than or equal<br>850 mm in length<br>Load 2: Non-lumened<br>instruments including<br>instruments with diffusion-<br>restricted areas such as the<br>hinged portion of forceps or<br>scissors.<br>V-PRO maX 2 Fast Non<br>Lumen<br>Non-lumened devices<br>including non-lumened rigids,<br>semi-rigids and flexible<br>endoscopes and non-lumened<br>devices with stainless steel or<br>titanium diffusion-restricted<br>spaces such as the hinged<br>portion of forceps and scissors.<br>Instrument organizers are<br>optional accessories intended<br>to stabilize cylindrical medical<br>instruments within the PRO-<br>LITE Sterilization Trays.<br>Sterilization mats are optional<br>accessories intended to cushion<br>and stabilize instruments within<br>the PRO-LITE Sterilization<br>Trays. | Instrument organizers are<br>optional accessories intended to<br>stabilize cylindrical medical<br>instruments within the<br>Sterilization Trays.<br>Sterilization mats are optional<br>accessories intended to cushion<br>and stabilize instruments within<br>the Sterilization Trays. | | | Vent to<br>Volume<br>Ratio | All trays are the same:<br>$0.135 \text{ in}^{-1}$ | All trays are the same: $0.135 \text{ in}^{-1}$ | Identical. | | Tray<br>Composition | Mineral-filled polypropylene,<br>stainless steel | Glass-filled polypropylene,<br>stainless steel | The materials of<br>construction are<br>similar. The<br>difference in<br>material has no<br>effect on<br>performance of the<br>tray. | | Organizer<br>Composition | Medical Grade Silicone, USP<br>grade VI | Medical Grade Silicone, USP<br>grade VI | Identical. | | Mat<br>Composition | Medical Grade Silicone, USP<br>grade VI | Medical Grade Silicone, USP<br>grade VI | Identical. | {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ #### Summary of Non-clinical Tests 6. Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-5 below. | | Test | Acceptance Criteria | Conclusion | |--------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Demonstration of<br>Effective Sterilant<br>Penetration | V-PRO maX 2<br>Sterilizer Fast Non<br>Lumen Cycle | Worst case test article<br>packaged in the trays shall be<br>reproducibly sterilized under<br>worst case 1/2 cycle conditions<br>for Fast Non Lumen Cycle. | PASS | | | V-PRO maX 2<br>Sterilizer Fast Non<br>Lumen Cycle | Diffusion-restricted spaces<br>(stainless steel and titanium)<br>and sterilization tray/medical<br>device contact points shall be<br>reproducibly sterilized under<br>worst case 1/2 cycle conditions<br>for Fast Non Lumen Cycle. | PASS | | | V-PRO 1 Plus, maX,<br>and maX 2 Sterilizer<br>Non Lumen Cycle,<br>titanium surface claims | Diffusion-restricted spaces<br>(titanium) shall be<br>reproducibly sterilized under<br>worst case 1/2 cycle conditions<br>for the Non Lumen Cycle. | PASS | | Package Integrity | | Not applicable. The Sterilization tray meets<br>the definition of a "tray" in ANSI/AAMI<br>ST77:2013, Containment devices for reusable<br>medical device sterilization, therefore package<br>integrity and maintenance of package integrity<br>testing are not applicable. | | | Demonstration of Effective Drying and<br>Aeration | | Residual hydrogen peroxide<br>levels shall be below<br>acceptable levels after<br>exposure to worst case<br>Sterilizer Cycle conditions. | PASS | | Demonstration of Material Compatibility | | After processing through<br>multiple worst case<br>sterilization cycles, the trays<br>and accessories shall retain<br>functionality. | PASS | | Demonstration of Biocompatibility | | Component materials shall be<br>non-cytotoxic after exposure to<br>worst case Sterilizer Cycle<br>conditions. | PASS | | Demonstration of Effective Cleaning | | Clean following automated and<br>manual cleaning. | PASS | Table 5-5. Summary of Non-clinical Testing {16}------------------------------------------------ ### 7. Conclusion Based on the intended us, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K160912), Class II (21 CFR 880.6850), product code KCT.