Vis-U-All Low Temperature Sterilization Pouch/Tubing

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue. March 25, 2019 STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060 Re: K183401 Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouch/Tubing Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: FRG Dated: December 6, 2018 Received: December 7, 2018 Dear Jennifer Nalepka: This letter corrects our substantially equivalent letter of March 1, 2019. 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 {1}------------------------------------------------ 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) 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 (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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Clarence W. Murray lii III -S For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K183401 #### 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 - NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed. and to be sterilized in the: - · Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems - · Default Cycle of the STERRAD 100S Sterilizer - Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers - · Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers *STERRAD and ALLClear are trademarks of Advanced Sterilization Products 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 {3}------------------------------------------------ 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, 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 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 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 ≤ 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 - or - · ≥ 2.8 mm ID and ≤ 317 mm in length # V-PRO 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 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-luments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. {4}------------------------------------------------ # 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. # STERRAD 100S Default Cycle - · Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. - · Metal and non metal lumened instruments with: - · ≥ 6 mm ID and ≤ 310 mm in length - · Medical devices with a single stainless steel lumen with: - ≥ 1 mm ID and ≤ 125 mm in length - ≥ 2 mm ID and ≤ 250 mm in length - · ≥ 3 mm ID and ≤ 400 mm in length # STERRAD NX and NX with ALLClear Technology Standard Cycle - · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. - · Medical devices with a single stainless steel lumen with: - ≥ 1 mm ID and < 150 mm in length - ≥ 2 mm ID and ≤ 400 mm in length # STERRAD NX and NX with ALLClear Technology Advanced Cycle - · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. - · Medical Devices, including most flexible endoscopes, with: - a single stainless steel lumen with: - ≥ 1 mm ID and ≤ 500 mm in length - · single channel polyethylene and Teflon (polytetrafluoroethylene): - · ≥ 1 mm ID and < 850 mm in length ### STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle - · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. - · Medical devices with a single stainless steel lumen with: - · ≥ 0.7 mm ID and ≤ 500 mm in length ### STERRAD 100NX and 100NX with ALLClear Technology Flex Cycle - · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. - · Medical Devices, including most flexible endoscopes, with: - · Single channel polyethylene and Teflon (polytetrafluoroethylene) - ≥ 1 mm ID and ≤ 850 mm in length ### STERRAD 100NX and 100NX with ALLClear Technology Express Cycle Metal and nonmetal medical devices surfaces and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle - · Medical devices including: - · most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with ≥ 1 mm ID and ≤ 875 mm in length - · accessory devices that are normally connected to a flexible endoscope during use - · flexible endoscopes without lumens {5}------------------------------------------------ Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the word "STERIS" is an image of several horizontal, wavy lines in blue. # K183401 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 6, 2018 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {7}------------------------------------------------ #### 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 | #### 2. Predicate Device Vis-U-All Low Temperature Sterilization Pouches/Tubing, K172749 Reference Device: Vis-U-All Low Temperature Sterilization Pouch/Tubing K183297 Reference Device: Vis-U-All Low Temperature Sterilization Pouch/Tubing K092745 #### 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 1. Table 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 | {8}------------------------------------------------ | | 4 x 9 | |--------|------------| | | 4 x 12 | | | 4 x 22 | | | 6 x 10 | | | 8 x 12 | | | 10 x 15 | | | 12 x 18 | | | 8 x 21 | | | 8 x 27 | | | 9 x 27 | | | 11 x 22 | | | 12 x 27 | | Tubing | 3" x 100' | | | 4" x 100' | | | 6" x 100' | | | 9" x 100' | | | 14" x 100' | The purpose of this submission is to allow for use of the products in the following sterilizer cycles: - STERRAD® 100S Sterilizer Default Cycle ● - STERRAD NX® with and without ALLClear™ Technology Sterilizer ● Standard and Advanced Cycles - STERRAD 100NX® with and without ALLClear Technology Sterilizer ● Standard, Flex Scope, Express and Duo Cycles #### 4. 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 trav NOTE: Trays must be legally marketed for use in the V-PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in - with the maximum number of instrument organizers installed. and to be sterilized in the: - Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-● PRO® Low Temperature Sterilization Systems - Default Cycle of the STERRAD® 100S Sterilizer - Standard and Advanced Cycles of the STERRAD NX and NX with . ALLClear™ Technology Sterilizers - Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX . and 100NX with ALLClear Technology Sterilizers {9}------------------------------------------------ *STERRAD and ALLClear are trademarks of Advanced Sterilization Products 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 & s2<br>Lumen Cycle | • 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>o single or dual lumen devices<br>≥ 0.77 mm internal diameter (ID) and ≤ 410 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 60 & s2<br>Non Lumen<br>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<br>Flexible Cycle | Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:<br>o single or dual lumen device with lumens that are ≥ 1 mm ID and < 990 mm in length<br>Load 2: 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 rigid and semi-rigid endoscopes, with the following dimensions:<br>o ≥ 2.0 mm ID and ≤ 400 mm in length<br>o ≥ 1.0 mm ID and ≤ 254 mm in length<br>o ≥0.76 mm ID and ≤ 233 mm in length | | V-PRO s2 Fast<br>Cycle | • 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 channeled devices:<br>o ≥ 0.77 mm ID and ≤ 410 mm in length<br>• triple channeled devices:<br>o ≥ 1.2 mm ID and ≤ 275 mm in length<br>o ≥ 1.8 mm ID and ≤ 310 mm in length<br>or<br>o ≥ 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 | | | 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 and semi-rigid endoscopes, with the following configurations: single or dual lumen devices $\geq$ 0.77 mm ID and $\leq$ 527 mm in length triple lumen devices $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length or $\geq$ 2.8 mm ID and $\leq$ 317 mm in length | | V-PRO 1, 1<br>Plus, maX &<br>maX 2 Lumen<br>Cycle | | | V-PRO 1 Plus,<br>max & maX 2<br>Non Lumen<br>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. | | | 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 $\geq$ 1 mm ID and $\leq$ 1050 mm in length or two lumens with: one lumen that is $\geq$ 1 mm ID and $\leq$ 990 mm in length and the other lumen that is $\geq$ 1 mm ID and $\leq$ 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 &<br>maX 2 Flexible<br>Cycle | | | 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. | | | Metal and nonmetal medical devices including instruments which have diffusion- restricted spaces, such as the hinged portion of forceps and scissors. Metal and nonmetal lumened instruments with: $\geq$ 6 mm ID and $\leq$ 310 mm in length Medical devices with a single stainless steel lumen with: $\geq$ 1 mm ID and $\leq$ 125 mm in length $\geq$ 2 mm ID and $\leq$ 250 mm in length $\geq$ 3 mm ID and $\leq$ 400 mm in length | | STERRAD<br>100S (Default<br>Cycle) | | | STERRAD NX<br>and NX with<br>ALLClear<br>Technology<br>Standard Cycle | Metal and nonmetal medical devices including instruments which have diffusion- restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with a single stainless steel lumen with: $\geq$ 1 mm ID and $\leq$ 150 mm in length $\geq$ 2 mm ID and $\leq$ 400 mm in length | | STERRAD NX<br>and NX with<br>ALLClear<br>Technology<br>Advanced<br>Cycle | Metal and nonmetal medical devices including instruments which have diffusion- restricted spaces, such as the hinged portion of forceps and scissors. Medical Devices, including most flexible endoscopes, with: a single stainless steel lumen with: $\geq$ 1 mm ID and $\leq$ 500 mm in length Single channel polyethylene and Teflon (polytetrafluoroethylene) $\geq$ 1 mm ID and $\leq$ 850 mm in length | | STERRAD<br>100NX and | Metal and nonmetal medical devices including instruments which have diffusion- restricted spaces, such as the hinged portion of forceps and scissors. | | 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 | | 100NX with<br>ALLClear<br>Technology<br>Standard Cycle | Medical devices with a single stainless steel lumen with:<br>• $\ge$ 0.7 mm ID and $\le$ 500 mm in length | | STERRAD<br>100NX and<br>100NX with<br>ALLClear<br>Technology<br>Flex Scope<br>Cycle | Metal and nonmetal medical devices including instruments which have diffusion-<br>restricted spaces, such as the hinged portion of forceps and scissors.<br>Medical Devices, including most flexible endoscopes, with:<br>• Single channel polyethylene and Teflon (polytetrafluoroethylene)<br>o $\ge$ 1 mm ID and $\le$ 850 mm in length | | STERRAD<br>100NX and<br>100NX with<br>ALLClear<br>Technology<br>Express Cycle | Metal and nonmetal medical devices (surfaces sterilization only) and instruments which<br>have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. | | STERRAD<br>100NX and<br>100NX with<br>ALLClear<br>Technology<br>Duo Cycle | Medical devices including:<br>• most flexible endoscopes with a single channel of polyethylene and Teflon<br>(polytetrafluoroethylene) with $\ge$ 1 mm ID and $\le$ 875 mm in length<br>• accessory devices that are normally connected to a flexible endoscope during<br>use<br>• flexible endoscopes without lumens | {10}------------------------------------------------ {11}------------------------------------------------ ### STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing #### 5. Technological Characteristics The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Table 3 summarizes the difference between the proposed device and predicate device cleared under K172749. | Characteristic | K183401 | Predicate | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | K172749 | | Indications for Use | The Vis-U-All Low Temperature<br>Sterilization Pouches/Tubing are<br>sterilization containment pouches for<br>use by health care providers to<br>enclose:<br>• medical devices in a single or<br>double pouch configuration<br>• trays containing medical devices in<br>a single or double pouch<br>configuration<br>• small items requiring surface<br>sterilization in a single pouch<br>configuration within a tray<br>NOTE: Trays must be legally | The Vis-U-All Low Temperature<br>Sterilization Pouches/Tubing are<br>sterilization containment pouches for<br>use by health care providers to<br>enclose:<br>• medical devices in a single or<br>double pouch configuration<br>• trays* containing medical devices<br>in a single or double pouch<br>configuration<br>• small items requiring surface<br>sterilization in a single pouch<br>configuration within a tray*<br>to be sterilized in the Lumen, Non<br>Lumen, Flexible and Fast Non | | marketed for use in the V-PRO Low<br>Temperature or STERRAD<br>Sterilization Systems and contain a<br>vent surface area to tray volume ratio<br>$\geq$ 0.135 in-1 with the maximum<br>number of instrument organizers<br>installed.<br><br>and to be sterilized in the:<br>Lumen, Non Lumen, Flexible,<br>Fast Non Lumen and Fast Cycles<br>of the V-PRO® Low Temperature<br>Sterilization Systems Default Cycle of the STERRAD®<br>100S Sterilizer Standard and Advanced Cycles of<br>the STERRAD NX and NX with<br>ALLClearTM Technology<br>Sterilizers Express, Standard, Flex Scope,<br>and DUO Cycles of the<br>STERRAD 100NX and 100NX<br>with ALLClear Technology<br>Sterilizers *STERRAD and ALLClear are<br>trademarks of Advanced Sterilization<br>Products | Lumen Cycles of the V-PRO Low<br>Temperature Sterilization Systems.<br><br>The pouches maintain the sterility of<br>the enclosed devices until used.<br><br>When used to enclose medical<br>devices, the pouches are intended to<br>contain the devices in such a manner<br>as to leave a minimum of one inch<br>between the devices and seal on all<br>sides. When used to enclose a tray,<br>the tray must fit loosely within the<br>pouch. | | | The pouches maintain the sterility of<br>the enclosed devices until used.<br><br>When used to enclose medical<br>devices, the pouches are intended to<br>contain the devices in such a manner<br>as to leave a minimum of one inch<br>between the devices and seal on all<br>sides. When used to enclose a tray,<br>the tray must fit loosely within the<br>pouch. | | | | V-PRO 60 & s2 Lumen Cycle Instruments with diffusion-<br>restricted spaces such as the hinged<br>portion of forceps and scissors Non-lumened devices including<br>non-lumened rigid and semi-rigid<br>endoscopes Medical devices, including single,<br>dual and triple channeled rigid and | V-PRO 60 Lumen Cycle Instruments with diffusion-<br>restricted spaces such as the hinged<br>portion of forceps and scissors Non-lumened devices including<br>non-lumened rigid and semi-rigid<br>endoscopes Medical devices, including single,<br>dual and triple channeled rigid and | | | semi-rigid endoscopes, with the<br>following configurations: | semi-rigid endoscopes, with the<br>following configurations: | | | ○ single or dual lumen devices ≥ 0.77 mm internal diameter<br>(ID) and ≤ 410 mm in length ○ triple lumen devices ≥1.2 mm ID and ≤ 275 mm<br>in length ≥1.8 mm ID and ≤ 310 mm<br>in length<br>or ≥ 2.8 mm ID and ≤ 317 mm<br>in length | ○ single or dual lumen devices ≥ 0.77 mm ID and ≤ 410 mm<br>in length ○ triple lumen devices ≥1.2 mm ID and ≤ 275 mm<br>in length ≥1.8 mm ID and ≤ 310 mm<br>in length<br>or ≥2.8 mm ID and ≤ 317 mm<br>in length | | | V-PRO 60 & s2 Non Lumen Cycle<br>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 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. | | | V-PRO 60 & s2 Flexible Cycle<br>Load 1: One flexible surgical endoscope or bronchoscope 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, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors.<br>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 | V-PRO 60 Flexible Cycle<br>One flexible surgical endoscope or bronchoscope 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 | | Table 3. Technical Characteristic Comparison Table {12}------------------------------------------------ # STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing {13}------------------------------------------------ {14}------------------------------------------------ | V-PRO s2 Fast Cycle | V-PRO 1, 1 Plus & maX Lumen Cycle | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Non-lumened devices including<br>non-lumened rigid, semi-rigid and<br>flexible endoscopes, and non-<br>lumened devices with diffusion-<br>restricted areas such as the hinged<br>portion of forceps or scissors.<br>• Medical devices (including single,<br>dual and triple channeled rigid and<br>semi-rigid endoscopes) with the<br>following configurations:<br>• Single or dual channeled devices<br>with stainless steel lumens that<br>are $\ge$ 0.77 mm ID and $\le$ 410 mm<br>in length<br>• Triple channeled devices with<br>stainless steel lumens that are<br>either:<br>$\ge$ 1.2 mm ID and $\le$ 275 mm in<br>length<br>$\ge$ 1.8 mm ID and $\le$ 310 mm in<br>length<br>or<br>• $\ge$ 2.8 mm ID and $\le$ 317 mm in<br>length | • Instruments with diffusion-<br>restricted spaces such as the hinged<br>portion of forceps and scissors<br>• Non-lumened devices including<br>non-lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single,<br>dual and triple channeled rigid and<br>semi-rigid endoscopes, with the<br>following configurations:<br>○ single or dual lumen devices<br>$\ge$ 0.77 mm ID and $\le$ 527 mm<br>in length<br>• triple lumen devices<br>$\ge$ 1.2 mm ID and $\le$ 275 mm<br>in length<br>$\ge$ 1.8 mm ID and $\le$ 310 mm<br>in length<br>or<br>• $\ge$ 2.8 mm ID and $\le$ 317 mm<br>in length | | V-PRO 1, 1 Plus, maX & maX2 Non<br>Lumen Cycle<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and<br>flexible endoscopes and non-<br>lumened devices with stainless steel<br>or titanium diffusion-restricted<br>spaces such as the hinged portion of<br>forceps and scissors. | V-PRO 1 Plus & maX Non Lumen<br>Cycle<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and<br>flexible endoscopes and non-<br>lumened devices with stainless steel<br>diffusion-restricted spaces such as<br>the hinged portion of forceps and<br>scissors. | | V-PRO maX and maX 2 Flexible<br>Cycle<br>Load 1: Single or dual lumen<br>surgical flexible endoscopes (such as<br>those used in ENT, Urology and<br>Surgical Care) and bronchoscopes<br>with a 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 mm<br>ID and ≤ 1050 mm in length<br>• or two lumens with:<br>• one lumen that is ≥ 1 mm ID<br>and ≤ 990 mm in length<br>• and the other lumen that is ><br>1 mm ID and ≤ 850 mm in<br>length<br>Load 2: Non-lumened instruments<br>including instruments with diffusion-<br>restricted areas such as the hinged<br>portion of forceps or scissors. | V-PRO maX Flexible Cycle<br>Load 1: Single or dual lumen<br>surgical flexible endoscopes (such as<br>those used in ENT, Urology and<br>Surgical Care) and bronchoscopes<br>with a 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 mm<br>ID and ≤ 1050 mm in length<br>• or two lumens with:<br>• one lumen that is ≥ 1 mm ID<br>and ≤ 990 mm in length<br>• and the other lumen that is ><br>1 mm ID and ≤ 850 mm in<br>length<br>Load 2: Non-lumened instruments<br>including instruments with diffusion-<br>restricted areas such as the hinged<br>portion of forceps or scissors. | | V-PRO maX 2 Fast Non Lumen<br>Cycle<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and<br>flexible endoscopes and non-<br>lumened devices with stainless steel<br>or titanium diffusion-restricted<br>spaces such as the hinged portion of<br>forceps and scissors. | V-PRO maX 2 Lumen Cycle<br>• Instruments with diffusion-<br>restricted spaces such as the hinged<br>portion of forceps and scissors<br>• Non-lumened devices including<br>non-lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single,<br>dual and triple channeled rigid and<br>semi-rigid endoscopes, with the<br>following configurations:<br>○ single or dual lumen devices<br>■ ≥ 0.77 mm ID and ≤ 527 mm<br>in length<br>○ triple lumen devices | | STERRAD 100S Default Cycle<br>Metal and nonmetal medical devices<br>including instruments which have<br>diffusion-restricted spaces, such as<br>the hinged portion of forceps and<br>scissors. | | | Metal and nonmetal lumened instruments with: ≥ 6 mm ID and ≤ 310 mm in length Medical devices with a single stainless steel lumen with: ≥ 1 mm ID and ≤ 125 mm in length ≥ 2 mm ID and ≤ 250 mm in length ≥ 3 mm ID and ≤ 400 mm in length | ≥ 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 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. | | STERRAD NX and NX with ALLClear Technology Standard Cycle<br>Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.<br>Medical devices with a single stainless steel lumen with: ≥ 1 mm ID and ≤ 150 mm in length ≥ 2 mm ID and ≤ 400 mm in length | 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 ≥ 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. | | STERRAD NX and NX with ALLClear Technology Advanced Cycle<br>Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.<br>Medical Devices, including most flexible endoscopes, with: a single stainless steel lumen with: ≥ 1 mm ID and ≤ 500 mm in length Single channel polyethylene and Teflon (polytetrafluoroethylene) ≥1 mm ID and ≤ 850 mm in length | V-PRO maX 2 Fast 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. | | STERRAD 100NX and 100NX with<br>ALLClear Technology Standard<br>Cycle<br>Metal and nonmetal medical devices<br>including instruments which have<br>diffusion-restricted spaces, such as<br>the hinged portion of forceps and<br>scissors.<br>Medical devices with a single<br>stainless steel lumen with:<br>• ≥ 0.7 mm ID and ≤ 500 mm in<br>length | * Trays must be legally marketed for<br>use in the V-PRO Low Temperature<br>Sterilization Systems and contain a<br>vent surface area to tray volume ratio<br>≥ 0.135 in⁻¹ with the maximum<br>number of instrument organizers<br>installed. | | STERRAD 100NX and 100NX with<br>ALLClear Technology Flex Scope<br>Cycle<br>Metal and nonmetal medical devices<br>including instruments which have<br>diffusion-restricted spaces, such as<br>the hinged portion of forceps and<br>scissors.<br>Medical Devices, including most<br>flexible endoscopes, with:<br>• Single channel polyethylene<br>and Teflon<br>(polytetrafluoroethylene)<br>o ≥ 1 mm ID and ≤ 850 mm in<br>length | | | STERRAD 100NX and 100NX with<br>ALLClear Technology Express<br>Cycle<br>Metal and nonmetal medical devices<br>(surfaces sterilization only) and<br>instruments which have diffusion-<br>restricted spaces, such as the hinged<br>portion of forceps and scissors. | | | STERRAD 100NX and 100NX with<br>ALLClear Technology Duo Cycle<br>Medical devices including:<br>• most flexible endoscopes with a<br>single channel of polyethylene<br>and Teflon<br>(polytetrafluoroethylene) with ≥<br>1 mm ID and ≤ 875 mm in<br>length<br>• accessory devices that are<br>normally connected to a flexible<br>endoscope during use | | {15}------------------------------------------------ {16}------------------------------------------------ # STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing {17}------------------------------------------------ {18}------------------------------------------------ # STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing | | • flexible endoscopes without<br>lumens | | |------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Device<br>Features | ■ Chevron end of pouches for ease<br>of opening<br>■ Chemical process indicator for<br>EO | ■ Chevron end of pouches for ease of<br>opening<br>■ Chemical process indicator for<br>EO | | Maintenance of<br>Sterility | 1 year | 1 year | | Materials of<br>Construction | Tyvek and plastic | Tyvek and plastic | | Types | Self Seal, Heat Seal, Tubing | Self Seal, Heat Seal, Tubing | | Chemical<br>Indicator | Ethylene Oxide Process<br>Chemical Indicator Printed on<br>both sides of Tyvek | Ethylene Oxide Process Chemical<br>Indicator Printed on both sides of<br>Tyvek | # 6. Summary of Non-Clinical Testing Table 4 summarizes the testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing to demonstrate that the proposed pouch is qualified for use in STERRAD 100S Sterilizer Default Cycle, STERRAD NX and NX with ALLClear Technology Sterilizer Standard and Advanced Cycles, and the STERRAD 100NX with and without ALLClear Technology Sterilizer Standard, Flex Scope, Express and Duo Cycles. Table 4. Performance Test Summary | Test | Acceptance Criteria…