Vis-U-All Low Temperature Sterilization Pouch/Tubing

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January 3, 2018 STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060 Re: K183297 Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouches/Tubing Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: November 26, 2018 Received: November 27, 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. 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 (QS) 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 medical devices and radiation-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. # Elizabeth F. Claverie -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) K183297 #### Device Name Vis-U-All Low Temperature Sterilization Pouches/Tubing Indications for Use (Describe) The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose: - · medical devices in a single or double pouch configuration - · trays* containing medical devices in a single or double pouch configuration - · small items requiring surface sterilization in a single pouch configuration within a tray* to be sterilized in the Lumen, Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. The pouches maintain the sterility of the enclosed devices until used. When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch. Intended Sterilization Cycles and Intended Pouch Loads when Medical Devices are: - · Directly pouched - · Placed inside of a tray* and the tray pouched* #### V-PRO 60 & s2 Lumen Cycle - · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors - · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes - · Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: - · single or dual lumen devices - ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length - · triple lumen devices - ≥ 1.2 mm ID and ≤ 275 mm in length - ≥ 1.8 mm ID and ≤ 310 mm in length - or - ≥ 2.8 mm ID and ≤ 317 mm in length #### V-PRO 60 & s2 Non Lumen Cycle Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. #### V-PRO 60 & s2 Flexible Cycle Load 1: One flexible surgical endoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a: · single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length Load 2: Non-lumened devices including non-lumened rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes, with the following dimensions: - · > 2 mm ID and < 400 mm in length - ≥ 0.76 mm ID and ≤ 233 mm in length - ≥ 1.0 mm ID and ≤ 254 mm in length {3}------------------------------------------------ #### V-PRO s2 Fast Cycle - Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes, and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. - · Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations: - · Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 410 mm in length - · Triple channeled devices with stainless steel lumens that are either: - > 1.2 mm ID and < 275 mm in length - · ≥ 1.8 mm ID and ≤ 310 mm in length - Or - ≥ 2.8 mm ID and ≤ 317 mm in length V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle - · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors - · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes - · Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: - · single or dual lumen devices: - · ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length - · triple lumen devices: - ≥ 1.2 mm ID and ≤ 275 mm in length - ≥ 1.8 mm ID and ≤ 310 mm in length - or - · ≥ 2.8 mm ID and ≤ 317 mm in length #### V-PRO 1, 1 Plus, maX & maX 2 Non Lumen Cycle Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors #### V-PRO 1, 1 Plus, maX & maX 2 Flexible Cycle Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either: - · a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length - or two lumens with: - one lumen that is ≥ 1 mm ID and < 990 mm in length - · and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. #### V-PRO maX 2 Fast Non Lumen Cycle Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. * Trays must be legally marketed for use in the V-PRO Low Temperature Sterilization Systems and contain a vent surface area to tray volume ratio ≥0.135 in-1 with the maximum number of instrument organizers installed. 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. {4}------------------------------------------------ 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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Below the word is a graphic of three blue horizontal wavy lines. ## 510(k) Summary for Vis-U-All Low Temperature Sterilization Pouches/Tubing 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: December 30, 2018 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {6}------------------------------------------------ #### 1. Device Name | Trade Name: | Vis-U-All Low Temperature Sterilization<br>Pouches/Tubing | |------------------------|-----------------------------------------------------------| | Device Classification: | Class II | | Common/Usual Name: | Sterilization pouch | | Classification Name: | Sterilization wrap | | Classification Number: | 21 CFR 880.6850 | | Product Code: | FRG | #### Predicate Device 2. Vis-U-All Low Temperature Sterilization Pouches/Tubing (K172749) #### 3. Description of Device The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing. Available sizes and configurations are shown in Table 5-1. Table 5-1. Sizes and Configurations of Vis-U-All Low Temperature Sterilization Pouches/Tubing | Type | Size<br>(inches unless specified) | |-----------------|-----------------------------------| | Heat Seal Pouch | 3 x 7 | | | 4 x 9 | | | 4 x 12 | | | 4 x 22 | | | 6 x 10 | | | 8 x 12 | | | 10 x 15 | | | 12 x 18 | | Self Seal Pouch | 3 x 7 | | | 4 x 9 | | | 4 x 12 | | | 4 x 22 | | | 6 x 10 | | | 8 x 12 | {7}------------------------------------------------ | | 10 x 15 | |--------|------------| | | 12 x 18 | | | 8 x 21* | | | 8 x 27* | | | 9 x 27* | | | 11 x 22* | | | 12 x 27* | | | 3" x 100' | | | 4" x 100' | | Tubing | 6" x 100' | | | 9" x 100' | | | 14" x 100' | * Additional pouch sizes The purpose of this submission is to add claims for: - Use with devices having stainless steel lumens of the following . configurations: - o > 2.0 mm internal diameter (ID) and ≤ 400 mm in length - o ≥ 1.0 mm ID and ≤ 254 in length - o ≥ 0.76 mm ID and ≤ 233 mm in length in the V-PRO 60 and V-PRO s2 Sterilizer Flexible Cycle - Use with diffusion restricted spaces in addition to stainless steel and titanium when used in the V-PRO 60 and V-PRO s2 Sterilizer Non Lumen and Flexible Cycles. - Use in the V-PRO s2 Sterilizer Fast Lumen Cycle ● - . Addition of the V-PRO s2 Sterilizer to the indications for use in the Lumen Cycle of the V-PRO 60 Sterilizer. The V-PRO s2 Sterilizer Lumen Cycle is performed identically to the previously cleared cycle listed in Table 5-2. The updated claims being sought for the V-PRO 60/s2 Sterilizer Non Lumen and Flexible Cycles as well as the V-PRO s2 Sterilizer Fast Cycle are the subject of a concurrent submission (K182528). - Notify FDA of an extension of the self seal pouch line to include five additional pouch models whose sizes were optimized to contain the smaller PRO-LITE Sterilization Trays that has recently been implemented. {8}------------------------------------------------ | Cycle | Most Recent<br>Premarket<br>Notification Clearance | V-PRO 60 | V-PRO s2 | |-----------------|----------------------------------------------------|----------|----------| | Lumen Cycle | K172319 | X | X | | Non Lumen Cycle | K172319 and | X | X | | Flexible Cycle | Concurrent submission<br>(K182827) | X | X | | Fast Cycle | Concurrent Submission<br>(K182827) | | X | * 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 Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose: - medical devices in a single or double pouch configuration . - trays* containing medical devices in a single or double pouch configuration ● - . small items requiring surface sterilization in a single pouch configuration within a tray* to be sterilized in the Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. The pouches maintain the sterility of the enclosed devices until used. When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch. | Intended<br>Sterilization<br>Cycles | Intended Pouch Load when Medical Devices are:<br>• Directly Pouched or<br>• Placed Inside of a Tray* and the Tray* Pouched | | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | V-PRO 60 &<br>s2 Lumen<br>Cycle | • Instruments with diffusion-restricted spaces such as the hinged portion of<br>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-<br>rigid endoscopes, with the following configurations:<br>○ single or dual lumen devices ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length ○ triple lumen devices ≥1.2 mm ID and ≤ 275 mm in length ≥1.8 mm ID and ≤ 310 mm in length<br>or ≥2.8 mm ID and ≤ 317 mm in length | | | Intended<br>Sterilization<br>Cycles | Intended Pouch Load when Medical Devices are:<br>Directly Pouched or Placed Inside of a Tray* and the Tray* Pouched | | | V-PRO 60 &<br>s2 Non Lumen<br>Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices with diffusion-restricted spaces such as<br>the hinged portion of forceps and scissors. | | | V-PRO 60 &<br>s2 Flexible<br>Cycle | Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if<br>not integral to endoscope) and mat without any additional load. The flexible<br>endoscope may be a:<br>single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm<br>in length Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and<br>flexible endoscopes and non-lumened devices with diffusion-restricted areas<br>such as the hinged portion of forceps or scissors. Medical devices, including<br>rigid and semi-rigid endoscopes, with the following dimensions: ≥ 2 mm ID and ≤ 400 mm in length ≥ 0.76 mm ID and ≤ 233 mm in length ≥1.0 mm ID and ≤ 254 mm in length | | | V-PRO s2<br>Fast Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible<br>endoscopes, and non-lumened devices with diffusion-restricted areas such as<br>the hinged portion of forceps or scissors. Medical devices (including single, dual and triple channeled rigid and semi-<br>rigid endoscopes) with the following configurations: Single or dual channeled devices with stainless steel lumens that are ≥<br>0.77 mm ID and ≤ 410 mm in length Triple channeled devices with stainless steel lumens that are either: > 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length<br>or > 2.8 mm ID and ≤ 317 mm in length Instruments with diffusion-restricted spaces such as the hinged portion of<br>forceps and scissors | | | V-PRO 1, 1<br>Plus, maX &<br>maX 2 Lumen<br>Cycle | Non-lumened devices including non-lumened rigid and semi-rigid endoscopes Medical devices, including single, dual and triple channeled rigid and semi-<br>rigid endoscopes, with the following configurations: single or dual lumen devices ≥ 0.77 mm ID and ≤ 527 mm in length triple lumen devices > 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length<br>or ≥ 2.8 mm ID and ≤ 317 mm in length | | | V-PRO 1<br>Plus, maX &<br>maX 2 Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices with stainless steel or titanium diffusion-<br>restricted spaces such as the hinged portion of forceps and scissors. | | | V-PRO maX<br>& maX 2<br>Flexible Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such as those used<br>in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not<br>integral to endoscope) and mat with no additional load.<br>The flexible endoscopes may contain either: | | | Intended<br>Sterilization<br>Cycles | Intended Pouch Load when Medical Devices are:<br>• Directly Pouched or<br>• Placed Inside of a Tray* and the Tray* Pouched | | | | • a single lumen that is $\geq$ 1 mm ID and $\leq$ 1050 mm in length<br>• or two lumens with:<br>• one lumen that is $\geq$ 1 mm ID and $\leq$ 990 mm in length<br>• and the other lumen that is $\geq$ 1 mm ID and $\leq$ 850 mm in length<br>Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. | | | V-PRO maX 2<br>Fast Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | | {9}------------------------------------------------ ## STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing {10}------------------------------------------------ * Trays must be legally marketed for use in the V-PRO Low Temperature Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed. #### Description of Safety and Substantial Equivalence 5. The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Table 5-3 summarizes the difference between the proposed device and predicate device cleared under K172749. | Characteristic | Proposed | Predicate<br>K172749 | Comparison | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Vis-U-All Low<br>Temperature Sterilization<br>Pouches/Tubing are<br>sterilization containment<br>pouches for use by health care<br>providers to enclose:<br>• medical devices in a single<br>or double pouch<br>configuration<br>• trays* containing medical<br>devices in a single or<br>double pouch configuration<br>• small items requiring<br>surface sterilization in a<br>single pouch configuration<br>within a tray*<br>to be sterilized in the:<br>• Lumen, Non Lumen,<br>Flexible, Fast Non Lumen<br>and Fast Cycles of the V-<br>PRO® Low Temperature<br>Sterilization Systems | The Vis-U-All Low<br>Temperature Sterilization<br>Pouches/Tubing are<br>sterilization containment<br>pouches for use by health<br>care providers to enclose:<br>• medical devices in a single<br>or double pouch<br>configuration<br>• trays* containing medical<br>devices in a single or<br>double pouch configuration<br>• small items requiring<br>surface sterilization in a<br>single pouch configuration<br>within a tray*<br>to be sterilized in the Lumen,<br>Non Lumen, Flexible and<br>Fast Non Lumen Cycles of<br>the V-PRO Low Temperature<br>Sterilization Systems. | Similar<br>Data is<br>presented in<br>this submission<br>to support safe<br>and effective<br>use of the<br>pouches in the<br>additional<br>cycles and load<br>configurations.<br>Combined V-<br>PRO 1, 1 Plus<br>and maX<br>Sterilizer<br>Lumen, Non<br>Lumen and<br>Flexible Cycle<br>claims with the<br>V-PRO maX 2<br>Lumen, Non<br>Lumen and | | The pouches maintain the | The pouches maintain the | Flexible Cycle | | | sterility of the enclosed | sterility of the enclosed | claims. | | | devices until used. | devices until used. | | | | When used to enclose<br>medical devices, the pouches<br>are intended to contain the<br>devices in such a manner as<br>to leave a minimum of one<br>inch between the devices and<br>seal on all sides. When used<br>to enclose a tray, the tray<br>must fit loosely within the<br>pouch. | When used to enclose medical<br>devices, the pouches are<br>intended to contain the<br>devices in such a manner as to<br>leave a minimum of one inch<br>between the devices and seal<br>on all sides. When used to<br>enclose a tray, the tray must<br>fit loosely within the pouch. | | | | V-PRO 60 & s2 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<br>rigid and semi-rigid<br>endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen<br>devices<br>■ ≥ 0.77 mm internal<br>diameter (ID) and ≤<br>410 mm in length<br>o triple lumen devices<br>■ ≥1.2 mm ID and ≤<br>275 mm in length<br>■ ≥1.8 mm ID and ≤<br>310 mm in length<br>or<br>■ ≥ 2.8 mm ID and ≤<br>317 mm in length | V-PRO 60 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<br>rigid and semi-rigid<br>endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen<br>devices<br>■ ≥ 0.77 mm ID and ≤<br>410 mm in length<br>o triple lumen devices<br>■ ≥1.2 mm ID and ≤<br>275 mm in length<br>■ ≥1.8 mm ID and ≤<br>310 mm in length<br>or<br>■ ≥2.8 mm ID and ≤<br>317 mm in length | | | | V-PRO 60 & s2 Non Lumen<br>Cycle<br>Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened<br>devices with diffusion- | 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 | | | | restricted spaces such as the<br>hinged portion of forceps and<br>scissors. | spaces such as the hinged<br>portion of forceps and<br>scissors. | | | | V-PRO 60 & s2 Flexible<br>Cycle<br>Load 1: 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:<br>single or dual lumen device<br>with lumens that are $\ge$ 1<br>mm ID and $\le$ 990 mm in<br>length Load 2: Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid, and flexible<br>endoscopes and non-lumened<br>devices with diffusion-<br>restricted areas such as the<br>hinged portion of forceps or<br>scissors. Medical devices,<br>including rigid and semi-rigid<br>endoscopes, with the<br>following dimensions:<br>$\ge$ 2 mm ID and $\le$ 400 mm<br>in length $\ge$ 0.76 mm ID and $\le$ 233<br>mm in length $\ge$ 1.0 mm ID and $\le$ 254 mm<br>in length V-PRO s2 Fast Cycle Non-lumened devices<br>including non-lumened<br>rigid, semi-rigid and<br>flexible endoscopes, and<br>non-lumened devices with<br>diffusion-restricted areas<br>such as the hinged portion<br>of forceps or scissors. Medical devices (including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes) with the<br>following configurations: | 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<br>are $\ge$ 1 mm ID and $\le$ 990<br>mm in length | | | | | | | | | • Single or dual channeled<br>devices with stainless<br>steel lumens that are ≥<br>$0.77 mm$ ID and ≤ $410

lt;br>mm in length<br>• Triple channeled devices<br>with stainless steel<br>lumens that are either:<br>≥ $1.2 mm$ ID and ≤ $275

lt;br>mm in length<br>≥ $1.8 mm$ ID and ≤ $310

lt;br>mm in length<br>or<br>• ≥ $2.8 mm$ ID and ≤ $317

lt;br>mm in length<br><br>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<br>rigid and semi-rigid<br>endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen<br>devices<br>≥ $0.77 mm$ ID and ≤<br>$527 mm$ in length o triple lumen devices ≥ $1.2 mm$ ID and ≤<br>$275 mm$ in length ≥ $1.8 mm$ ID and ≤<br>$310 mm$ in length<br>or ≥ $2.8 mm$ ID and ≤<br>$317 mm$ in length V-PRO 1, 1 Plus, maX &<br>maX2 Non Lumen Cycle<br>Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened | V-PRO 1, 1 Plus & maX<br>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<br>rigid and semi-rigid<br>endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations:<br>o single or dual lumen<br>devices<br>≥ $0.77 mm$ ID and ≤<br>$527 mm$ in length o triple lumen devices ≥ $1.2 mm$ ID and ≤<br>$275 mm$ in length ≥ $1.8 mm$ ID and ≤<br>$310 mm$ in length<br>or ≥ $2.8 mm$ ID and ≤<br>$317 mm$ in length V-PRO 1 Plus & maX Non<br>Lumen Cycle<br>Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened | | | ## Table 5-3. Technical Comparison to the Predicate. {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ | devices with stainless steel or<br>titanium diffusion-restricted<br>spaces such as the hinged<br>portion of forceps and<br>scissors. | devices with stainless steel<br>diffusion-restricted spaces<br>such as the hinged portion of<br>forceps and scissors. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | V-PRO maX and 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 bronchoscopes with a<br>light 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<br>mm ID and ≤ 1050 mm<br>in length<br>• or two lumens with:<br>• one lumen that is ≥ 1<br>mm ID and ≤ 990<br>mm in length<br>• and the other lumen<br>that is ≥ 1 mm ID and<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. | 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)<br>and bronchoscopes with a<br>light 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<br>mm ID and ≤ 1050 mm<br>in length<br>or two lumens with:<br>• one lumen that is ≥ 1<br>mm ID and ≤ 990<br>mm in length<br>• and the other lumen<br>that is ≥ 1 mm ID and<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. | | V-PRO maX 2 Fast Non<br>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<br>scissors.<br>*Trays must be legally<br>marketed for use in the V-<br>PRO Low Temperature | V-PRO 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<br>rigid and semi-rigid<br>endoscopes<br>• Medical devices, including<br>single, dual and triple<br>channeled rigid and semi-<br>rigid endoscopes, with the<br>following configurations: | | Sterilization Systems and | | | contain a vent surface area to tray volume ratio $\ge$ 0.135 in -1 with the maximum number of instrument organizers installed. | single or dual lumen devices $\ge$ 0.77 mm ID and $\le$ 527 mm in length triple lumen devices $\ge$ 1.2 mm ID and $\le$ 275 mm in length $\ge$ 1.8 mm ID and $\le$ 310 mm in length or $\ge$ 2.8 mm ID and $\le$ 317 mm in length V-PRO maX 2 Non Lumen Cycle<br>Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.<br>V-PRO maX 2 Flexible Cycle<br>Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load.<br>The flexible endoscopes may contain either: a single lumen that is $\ge$ 1 mm ID and $\le$ 1050 mm in length or two lumens with: one lumen that is $\ge$ 1 mm ID and $\le$ 990 mm in length and the other lumen that is $\ge$ 1 mm ID and $\le$ 850 mm in length Load 2: Non-lumened instruments including instruments with diffusion- | {15}------------------------------------------------ {16}------------------------------------------------ | | | restricted areas such as the<br>hinged portion of forceps or<br>scissors.<br><br>V-PRO maX 2 Fast Non<br>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<br>scissors.<br><br>* Trays must be legally<br>marketed for use in the V-<br>PRO Low Temperature<br>Sterilization Systems and<br>contain a vent surface area to<br>tray volume ratio $≥ 0.135 in⁻¹

lt;br>with the maximum number of<br>instrument organizers<br>installed. | | |------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Device<br>Features | ■ Chevron end of pouches<br>for ease of opening<br>■ Chemical process<br>indicator for EO | ■ Chevron end of pouches for<br>ease of opening<br>■ Chemical process indicator<br>for EO | Same | | Maintenance of<br>Sterility | 1 year | 1 year…