Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". September 9, 2022 Steris Anthony Piotrkowski Director Regulatory Affairs 5960 Heisey Road Mentor, Ohio 44060 Re: K222440 Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouches / Tubing, PRO-LITE Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, KCT Dated: August 11, 2022 Received: August 12, 2022 Dear Anthony Piotrkowski: 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. {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use ### 510(k) Number (if known) K222440 ### 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. to be sterilized in the: - · Lumen. Non Lumen. Flexible. Fast Non Lumen and Fast Cvcles 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 · Non-lumened devices 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: - o single or dual lumen devices - ≥ 0.77 mm internal diameter (ID) and < 410 mm in length - ≥ 1.8 mm ID x ≤ 542 mm in length - o 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 {3}------------------------------------------------ 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 semirigid endoscopes, with the following configurations: ≥ 0.76 mm ID and ≤ 233 mm in length ≥ 1.0 mm ID and ≤ 254 mm in length ≥ 1.8 mm ID and ≤ 542 mm in length V-PRO s2 Fast Cycle · Non-lumened devices including non-lumened rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. · Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations: o single or dual lumen devices ≥ 0.77 mm ID and ≤ 410 mm in length ≥ 1.8 mm ID x ≤ 542 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 · Non-lumened devices 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 or triple channeled stainless steel lumens that are: ≥ 0.77 mm ID and ≤ 527 mm in length ≥ 0.8 mm ID and ≤ 542 mm in length ≥ 0.48 mm ID and < 100 mm in length • Medical devices with Dead end lumens that are ≥ 1.3 mm ID and ≤ 73 mm in length · Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: ≥ 3 mm ID and ≤ 298 mm in length > 4 mm ID and < 424 mm in length V-PRO 1, 1 Plus, maX & maX2 Non Lumen Cycle Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. V-PRO maX and 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 or dual channel lumen that is > 1 mm ID and < 1050 mm in length Load 2: • 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 · Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length. V-PRO maX 2 Fast Non Lumen Cycle {4}------------------------------------------------ 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. STERRAD 100S Default Cycle 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: - ≥ 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 Scope 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 sterilization only) and instruments which have diffusionrestricted 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 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) {5}------------------------------------------------ ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {6}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222440 Device Name PRO-LITE Sterilization Tray - The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles: - · 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 • Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers *STERRAD and ALLClear are trademarks of Advanced Sterilization Products Prior to placing in the Sterilizer, the trays must either be: · wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above Or · placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above. 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. Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0048, VP0048, VP0050. VP0051. VP0052 V-PRO 60 and s2 Lumen Cycle: - · Non-lumened devices 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: o Single or dual channeled devices with stainless steel lumens that are: ≥ 0.77 mm ID and ≤ 410 mm in length ≥ 1.8 mm ID x ≤ 542 mm in length o Triple channeled devices with stainless steel lumens that are: ≥ 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 and s2 Non Lumen Cycle: Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. V-PRO 60 and 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 {7}------------------------------------------------ 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 configurations: - ≥ 0.76 mm ID and ≤ 233 mm in length - ≥ 1.0 mm ID and < 254 mm in length - ≥ 1.8 mm ID and ≤ 542 mm in length Intended Sterilization Cycle and Intended Tray Load for Tray Models: VP0045, VP0047, VP0049, VP0049, VP0049 V-PRO s2 Fast Cycle: · Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes, and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps and scissors. • Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations: o Single or dual channeled devices with stainless steel lumens ≥ 0.77 mm ID and ≤ 410 mm in length ≥ 1.8 mm ID and ≤ 542 mm in length o 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 ≥ 2.8 mm ID and ≤ 317 mm in length Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052, VP0053 V-PRO 1, 1 Plus, maX, and maX 2 Lumen Cycle: · Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors · Medical devices, including single, dual or triple channeled stainless steel lumens that are: ≥ 0.77 mm ID and ≤ 527 mm in length ≥ 0.8 mm ID and < 542 mm in length ≥ 0.48 mm ID and ≤ 100 mm in length • Medical devices with dead end stainless steel lumens that are ≥ 1.3 mm ID and ≤ 73 mm in length · Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: > 3 mm ID and < 298 mm in length ≥ 4 mm ID and ≤ 424 mm in length V-PRO 1 Plus, maX, and maX 2 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 maX, and 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 or dual lumen that is > 1 mm ID and ≤ 1050 mm in length. Load 2: • 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 • Single, dual or triple channel stainless steel lumens that are > 0.48 mm ID and ≤ 100 mm in length V-PRO maX 2 Fast Non Lumen Cycle: Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0049, {8}------------------------------------------------ # VP0050, VP0051, VP0052 STERRAD 100S Default Cycle: 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 ≥ 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 Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0049 STERRAD NX and NX with ALLClear Technology Standard Cycle: Metal and non-metal 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 STERRAND NX and NX with ALLClear Technology Advanced Cycle: Metal and non-metal 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: - o a single stainless steel lumen with: ≥ 1 mm ID and ≤ 500 mm in length - o single channel polyethylene and Teflon (polytetrafluoroethylene) ≥ 1mm ID and ≤ 850 mm in length Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0048, VP0051, VP0052, VP0053 STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle: Metal and nonmetal medical devices including instruments with 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 Scope 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) ≥ 1mm ID and < 850 mm in length STERRAD 100NX and 100NX with ALLClear Technology Express Cycle: Metal and nonmetal 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 (polytetraffluoroethylene) with ≥ 1 mm ID and ≤ 875 mm in length · accessory devices that are normally connected to a flexible endoscope during use {9}------------------------------------------------ · flexible endoscopes without lumens Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) 区 Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water. # 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: Anthony Piotrkowski Director, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tony piotrkowski(@steris.com Submission Date: September 7, 2022 Premarket Notification Number: K222440 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {11}------------------------------------------------ #### 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, K183401 ### 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 or STERRAD 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 * | Type | Size* | Type | Size* | |-----------------------|---------|--------------------|---------|--------|------------| | Heat<br>Seal<br>Pouch | 3 x 7 | | 3 x 7 | Tubing | 3" x 100' | | | 4 x 9 | | 4 x 9 | | 4" x 100' | | | 4 x 12 | Self Seal<br>Pouch | 4 x 12 | | 6" x 100' | | | 4 x 22 | | 4 x 22 | | 9" x 100' | | | 6 x 10 | | 6 x 10 | | 14" x 100' | | | 8 x 12 | | 8 x 12 | | | | | 10 x 15 | | 10 x 15 | | | | | 12 x 18 | | 12 x 18 | | | | | | | 8 x 21 | | | | | | | 8 x 27 | | | | | | | 9 x 27 | | | | | | | 11 x 22 | | | | | | | 12 x 27 | | | *Sizes are in inches unless specified otherwise The purpose of this submission is to qualify use of the Vis-U-All Low Temperature Sterilization Pouches and Tubing for extended claims in the V-PRO 60, s2, maX and maX 2 Sterilizer Cycles. {12}------------------------------------------------ #### Intended Use/ Indications for Use 4. The Vis-U-All Low Temperature Sterilization Pouches/Tubing Intended use remains the same. The indications for use are being modified to expand lumen claims. A detailed comparison of the cleared and proposed indications for use are provided in Table 2. ### 5. Comparison of the Modified Device to the Predicate The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Table 2 summarizes the difference between the proposed device and predicate device cleared under K183401. | Table 2. Technical Comparison to the Predicate. | |-------------------------------------------------| |-------------------------------------------------| | Feature | Modified Vis-U-All Low Temperature<br>Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature<br>Sterilization Pouch (K183401) | Comparison | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use /<br>Indications<br>for Use | The Vis-U-All Low Temperature<br>Sterilization Pouches/Tubing are<br>sterilization containment pouches for use<br>by health care providers to enclose:<br>• medical devices in a single or double<br>pouch configuration<br>• trays* containing medical devices in a<br>single or double pouch configuration<br>• small items requiring surface<br>sterilization in a single pouch<br>configuration within a tray*<br>NOTE: Trays must be legally marketed<br>for use in the V-PRO Low Temperature<br>or STERRAD Sterilization Systems and<br>contain a vent surface area to tray<br>volume ratio ≥ $0.135 in^{-1}$ with the<br>maximum number of instrument<br>organizers installed.<br><br>to be sterilized in the:<br>• Lumen, Non Lumen, Flexible, Fast<br>Non Lumen and Fast Cycles of the V-<br>PRO® Low Temperature Sterilization<br>Systems<br>• Default Cycle of the STERRAD 100S<br>Sterilizer<br>• Standard and Advanced Cycles of the<br>STERRAD NX and NX with<br>ALLClear Technology Sterilizers<br>• Express, Standard, Flex Scope and<br>DUO Cycles of the STERRAD 100NX<br>and 100NX with ALLClear<br>Technology Sterilizers | The Vis-U-All Low Temperature<br>Sterilization Pouches/Tubing are<br>sterilization containment pouches for use<br>by health care providers to enclose:<br>• medical devices in a single or double<br>pouch configuration<br>• trays containing medical devices in a<br>single or double pouch configuration<br>• small items requiring surface<br>sterilization in a single pouch<br>configuration within a tray<br>NOTE: Trays must be legally marketed<br>for use in the V-PRO Low Temperature<br>or STERRAD Sterilization Systems and<br>contain a vent surface area to tray<br>volume ratio ≥ $0.135 in^{-1}$ with the<br>maximum number of instrument<br>organizers installed.<br><br>to be sterilized in the:<br>• Lumen, Non Lumen, Flexible, Fast<br>Non Lumen and Fast Cycles of the V-<br>PRO® Low Temperature Sterilization<br>Systems<br>• Default Cycle of the STERRAD 100S<br>Sterilizer<br>• Standard and Advanced Cycles of the<br>STERRAD NX and NX with ALLClear<br>Technology Sterilizers<br>• Express, Standard, Flex Scope and<br>DUO Cycles of the STERRAD 100NX<br>and 100NX with ALLClear<br>Technology Sterilizers | Identical except<br>for:<br>• Clarification<br>of lumen<br>claims for V-<br>PRO lumen<br>cycles<br>• Clarification<br>of endoscope<br>claims for V-<br>PRO flexible<br>cycles<br>• Removal of<br>"stainless steel<br>or titanium"<br>from V-PRO<br>Non Lumen<br>cycles. | | Feature | Modified Vis-U-All Low Temperature<br>Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature<br>Sterilization Pouch (K183401) | Comparison | | | *STERRAD and ALLClear are<br>trademarks of Advanced Sterilization<br>Products | *STERRAD and ALLClear are<br>trademarks of Advanced Sterilization<br>Products | | | | The pouches maintain the sterility of the<br>enclosed devices until used. | The pouches maintain the sterility of the<br>enclosed devices until used. | | | | When used to enclose medical devices,<br>the pouches are intended to contain the<br>devices in such a manner as to leave a<br>minimum of one inch between the<br>devices and seal on all sides. When used<br>to enclose a tray, the tray must fit loosely<br>within the pouch. | When used to enclose medical devices,<br>the pouches are intended to contain the<br>devices in such a manner as to leave a<br>minimum of one inch between the<br>devices and seal on all sides. When used<br>to enclose a tray, the tray must fit loosely<br>within the pouch. | | | | Intended Sterilization Cycles and<br>Intended Pouch Loads when Medical<br>Devices are:<br>• Directly pouched<br>• Placed inside of a tray and the tray<br>pouched | Intended Sterilization Cycles and<br>Intended Pouch Loads when Medical<br>Devices are:<br>• Directly pouched<br>• Placed inside of a tray and the tray<br>pouched | | | | V-PRO 60 & s2 Lumen Cycle<br>• Non-lumened devices with diffusion-<br>restricted spaces such as the hinged<br>portion of forceps and scissors.<br>• Non-lumened devices including non-<br>lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single, dual<br>and triple channeled rigid and semi-<br>rigid endoscopes, with the following<br>configurations:<br>o single or dual lumen devices<br>• $\ge$ 0.77 mm internal diameter<br>(ID) and $\le$ 410 mm in length<br>• $\ge$ 1.8 mm ID x $\le$ 542 mm in<br>length<br>o triple lumen devices<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 | V-PRO 60 & s2 Lumen Cycle<br>• Instruments with diffusion-restricted<br>spaces such as the hinged portion of<br>forceps and scissors<br>• Non-lumened devices including non-<br>lumened rigid and semi-rigid<br>endoscopes<br>• Medical devices, including single, dual<br>and triple channeled rigid and semi-<br>rigid endoscopes, with the following<br>configurations:<br>o single or dual lumen devices<br>• $\ge$ 0.77 mm internal diameter<br>(ID) and $\le$ 410 mm in length<br>o triple lumen devices<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 | | | Feature | Modified Vis-U-All Low Temperature<br>Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature<br>Sterilization Pouch (K183401) | Comparison | | | V-PRO 60 & s2 Non Lumen Cycle<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with diffusion-restricted spaces such as<br>the hinged portion of forceps and<br>scissors. | V-PRO 60 & s2 Non Lumen Cycle<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with diffusion-restricted spaces such as<br>the hinged portion of forceps and<br>scissors. | | | | V-PRO 60 & s2 Flexible Cycle<br>Load 1: One flexible surgical endoscope<br>or bronchoscope with a light cord (if not<br>integral to endoscope) and mat without<br>any additional load. The flexible<br>endoscope may be a:<br>• single or dual lumen device with<br>lumens that are $\ge$ 1 mm ID and $\le

lt;br>990 mm in length<br>Load 2: Non-lumened devices including<br>non-lumened rigid semi-rigid, and<br>flexible endoscopes and non-lumened<br>devices with diffusion-restricted areas<br>such as the hinged portion of forceps or<br>scissors. Medical devices, including rigid<br>and semi-rigid endoscopes, with the<br>following configurations:<br>• $\ge$ 0.76 mm ID and $\le$ 233 mm in length<br>• $\ge$ 1.0 mm ID and $\le$ 254 mm in length<br>• $\ge$ 1.8 mm ID and $\le$ 542 mm in length | V-PRO 60 & s2 Flexible Cycle<br>Load 1: One flexible surgical endoscope<br>or bronchoscope with a light cord (if not<br>integral to endoscope) and mat without<br>any additional load. The flexible<br>endoscope may be a:<br>• single or dual lumen device with<br>lumens that are $\ge$ 1 mm ID and $\le$ 990<br>mm in length<br>Load 2: Non-lumened devices including<br>non-lumened rigid, semi-rigid, and<br>flexible endoscopes and non-lumened<br>devices with diffusion-restricted areas<br>such as the hinged portion of forceps or<br>scissors. Medical devices, including rigid<br>and semi-rigid endoscopes, with the<br>following dimensions:<br>• $\ge$ 2 mm ID and $\le$ 400 mm in length<br>• $\ge$ 0.76 mm ID and $\le$ 233 mm in length<br>• $\ge$ 1.0 mm ID and $\le$ 254 mm in length | | | | V-PRO s2 Fast Cycle<br>• Non-lumened devices including non-<br>lumened rigid and semi-rigid and<br>flexible endoscopes and non-lumened<br>devices with diffusion-restricted spaces<br>such as the hinged portion of forceps<br>and scissors.<br>• Medical devices (including single, dual<br>and triple channeled rigid and semi-<br>rigid endoscopes) with the following<br>configurations:<br>• single or dual lumen devices<br>$\ge$ 0.77 mm ID and $\le$ 410 mm in<br>length<br>$\ge$ 1.8 mm ID x $\le$ 542 mm in<br>length<br>• Triple channeled devices with stainless | V-PRO s2 Fast Cycle<br>• Non-lumened devices including non-<br>lumened rigid and semi-rigid and<br>flexible endoscopes and non-lumened<br>devices with diffusion-restricted spaces<br>such as the hinged portion of forceps<br>and scissors.<br>• Medical devices (including single, dual<br>and triple channeled rigid and semi-<br>rigid endoscopes) with the following<br>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 stainless | | | | steel lumens that are either: | steel lumens that are either: | | | Feature | Modified Vis-U-All Low Temperature<br>Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature<br>Sterilization Pouch (K183401) | Comparison | | | $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length <b>Or</b><br>$\geq$ 2.8 mm ID and $\leq$ 317 mm in length V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle Non-lumened devices 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 or triple channeled stainless steel lumens that are: $\geq$ 0.77 mm ID and $\leq$ 527 mm in length $\geq$ 0.8 mm ID and $\leq$ 542 mm in length $\geq$ 0.48 mm ID and $\leq$ 100 mm in length Medical devices with Dead end lumens that are $\geq$ 1.3 mm ID and $\leq$ 73 mm in length Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: $\geq$ 3 mm ID and $\leq$ 298 mm in length $\geq$ 4 mm ID and $\leq$ 424 mm in length | $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length <b>Or</b><br>$\geq$ 2.8 mm ID and $\leq$ 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 and semi-rigid endoscopes, with the following configurations: single or dual lumen devices $\geq$ 0.77 mm ID and $\leq$ 410 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<br>$\geq$ 2.8 mm ID and $\leq$ 317 mm in length | | | | V-PRO 1, 1 Plus, maX & maX2 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 1, 1 Plus, maX & maX2 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. | | | Feature | Modified Vis-U-All Low Temperature<br>Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature<br>Sterilization Pouch (K183401) | Comparison | | | Load 1: Single or dual lumen surgical<br>flexible endoscopes (such as those used<br>in ENT, Urology and Surgical Care) and<br>bronchoscopes with a light cord (if not<br>integral to endoscope) and mat with no<br>additional load.<br>The flexible endoscopes may contain<br>either a single or dual channel lumen that<br>is $\geq$ 1 mm ID and $\leq$ 1050 mm in length<br>Load 2:<br>• Non-lumened devices including non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with diffusion-restricted spaces such<br>as the hinged portion of forceps and<br>scissors<br>• Single, dual or triple channel stainless<br>steel lumen that is $\geq$ 0.48 mm ID and<br>$\leq$ 100 mm in length. | Load 1: Single or dual lumen surgical<br>flexible endoscopes (such as those used<br>in ENT, Urology and Surgical Care) and<br>bronchoscopes with a light cord (if not<br>integral to endoscope) and mat with no<br>additional load.<br>The flexible endoscopes may contain<br>either:<br>• a single lumen that is $\geq$ 1 mm ID<br>and $\leq$ 1050 mm in length<br>• or two lumens with:<br>• one lumen that is $\geq$ 1 mm ID and<br>$\leq$ 990 mm in length<br>• and the other lumen that is $\geq$ 1<br>mm ID and $\leq$ 850 mm in 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 Cycle<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with diffusion-restricted spaces such as<br>the hinged portion of forceps and<br>scissors. | V-PRO maX 2 Fast Non Lumen Cycle<br>Non-lumened devices including non-<br>lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with stainless steel or titanium diffusion-<br>restricted spaces such as the hinged<br>portion of forceps and scissors. | | | | STERRAD 100S Default Cycle<br>Metal and nonmetal medical devices<br>including instruments which have<br>diffusion-restricted spaces, such as the<br>hinged portion of forceps and scissors.<br>Metal and nonmetal lumened instruments<br>with:<br>• $\geq$ 6 mm ID and $\leq$ 310 mm in length<br>Medical devices with a single stainless<br>steel lumen with:<br>• $\geq$ 1 mm ID and $\leq$ 125 mm in length<br>• $\geq$ 2 mm ID and $\leq$ 250 mm in length<br>• $\geq$ 3 mm ID and $\leq$ 400 mm in length…