Vis-U-All Low Temperature Sterilization Pouches

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". August 7, 2023 STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060 Re: K231500 Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouches Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: May 22, 2023 Received: May 24, 2023 ## 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/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). Sincerelv. # Christopher K. Dugard - S for Clarence W. Murray, III, Ph.D. 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) K231500 #### Device Name Vis-U-All Low Temperature Sterilization Pouches 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 *3-D printed items should not be double pouched. to be sterilized in the: · Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty 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 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. 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. #### V-PRO 60 & s2 Lumen Cycle · Non-lumened instruments and 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: 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 ``` {3}------------------------------------------------ ## 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: o single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length •Load 2: Non-lumened instruments 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 configurations: ○ ≥ 0.76 mm ID and ≤ 233 mm in length o ≥ 1.0 mm ID and ≤ 254 mm in length o ≥ 1.8 mm ID and ≤ 542 mm in length #### V-PRO s2 Fast Cycle o 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 o 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 and ≤ 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 1, 1 Plus, maX & maX 2 Lumen Cycle • Non-lumened instruments and 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 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 · Instruments with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps) 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 instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors · Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes. V-PRO maX and maX 2 Flexible Cycle FORM FDA 3881 (6/20) {4}------------------------------------------------ · Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors · Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two load configurations: o Load 1: Two flexible endoscopes with single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length with a light cord (if not integral to endoscope) and mat with no additional load o Load 2: One flexible endoscope with single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length with a light cord (if not integral to endoscope accessories, mat, and additional instruments that may include nonlumened or lumened medical devices with the following configurations: o 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 · Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors · Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. V-PRO maX 2 Specialty Cycle: Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures .* or Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes. ** * The validation studies were conducted using a validation load consisting of pouched guide(s) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material. ** The validation studies were conducted using a validation load consisting of one pouched instrument tray or one pouched instrument tray or one pouch with guide(s) (with or without tray) for a total weight of 11 lbs (5 kg). | Material | Manufacturer | Specialty Cycle | Lumens | |--------------------------------|--------------|-----------------|---------------------| | Surgical Guide Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L | | BioMed Amber Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L | | Dental LT Clear V2 Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L | | BioMed Clear Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L | | Biocompatible Clear MED610 | Stratasys | E | ≥3 mm ID x ≤20 mm L | | Biocompatible Opaque MED615RGD | Stratasys | E | ≥3 mm ID x ≤20 mm L | | VeroGlaze™ MED620 | Stratasys | E | ≥3 mm ID x ≤20 mm L | ## 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: {5}------------------------------------------------ ≥ 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 diffusion-restricted spaces, such as the hinged portion of forceps and scissors. STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle Medical devices including: o most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with ≥ 1 mm ID and ≤ 875 mm in length o accessory devices that are normally connected to a flexible endoscope during use o flexible endoscopes without lumens * 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. Ethylene Oxide Sterilization The Vis-U-All Low Temperature Sterilization Pouch has been qualified by STERIS as suitable for use by health care providers to enclose and seal other medical devices to be sterilized by ethylene oxide (ETO). The Vis-U-All Low Temperature Sterilization Pouch for ethylene oxide is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use. The following are the validated test conditions: - · 1 hour exposure, at 130(±5) °F, * >30% RH using 100% ETO (750-790 mg/L) - · 4.5 hour exposure at 100(±5) °F, * >30% RH using 100% ETO (750-790 mg/L) - *±5 °F is used during sterilization phase following an equilibrium period of 10% of exposure time. The ethylene oxide process indicator is intended to be used by health care providers with the Vis- U-All Low Temperature FORM FDA 3881 (6/20) Page 4 of 5 {6}------------------------------------------------ Sterilization Pouches to distinguish between processed and unprocessed units. 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. 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.qov "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." {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, serif font, with a registered trademark symbol to the right of the "S". Below the word is an image of several horizontal, wavy lines in a light blue color. # 510(k) Summary for K231500 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 Manager, Regulatory Affairs Telephone: (440) 392-7458 e-mail: jennifer_nalepka@steris.com Submission Date: July 28, 2023 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {8}------------------------------------------------ #### Device Name 1. | 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, K222400 (Vaporized Hydrogen Peroxide claims) Vis-U-All Low Temperature Sterilization Pouches/Tubing, K092745 (Ethylene Oxide claims) #### 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 5-1. | 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 | Table 5-1. Sizes and Configurations of Vis-U-All Low Temperature Sterilization Pouches/Tubing {9}------------------------------------------------ | Type | Size<br>(inches unless specified) | |--------|-----------------------------------| | | 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' | | Tubing | 4" x 100' | | Tubing | 6" x 100' | | Tubing | 9" x 100' | | Tubing | 14" x 100' | 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 maX 2 Specialty Cycle. No changes have been made to the device for this claim other than labeling. #### Intended Use/ Indications for Use 4. 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* *3-D printed items should not be double-pouched. to be sterilized in the: - Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty 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 **STERRAD and ALLClear are trademarks of Advanced Sterilization Products The pouches maintain the sterility of the enclosed devices until used. 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. {10}------------------------------------------------ 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 trav, the tray must fit loosely within the pouch. #### V-PRO 60 & s2 Lumen Cycle - · Non-lumened instruments and 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: - 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 diffusion-restricted spaces such as the hinged portion of forceps and scissors #### V-PRO 60 & s2 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: - o single or dual lumen device with lumens that are > 1 mm ID and < 990 mm in length - · Load 2: Non-lumened instruments 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 configurations: - . > 1.8 mm ID and < 542 mm in length - ≥ 1.0 mm ID and ≤ 254 mm in length - I ≥ 0.76 mm ID and ≤ 233 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 spaces such as the hinged portion of forceps and scissors - · Medical devices (including single, dual and triple channeled rigid and semi-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 and ≤ 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 - {11}------------------------------------------------ Or - ≥2.8 mm ID and ≤ 317 mm in length #### V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle - · Non-lumened instruments and 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 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 - · Instruments 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 endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors #### V-PRO maX and maX 2 Flexible Cycle - · Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors - · Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two load configurations: - o Load 1: Two flexible endoscopes with single or dual channel lumens that are ≥ 1 mm ID and < 1050 mm in length with a light cord (if not integral to endoscope) and mat with no additional load - o Load 2: One flexible endoscope with single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length with a light cord (if not integral to endoscope), endoscope accessories, mat, and additional instruments that may include non-lumened medical devices with the following configurations: - . 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 - · 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 2 Specialty 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. Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures {12}------------------------------------------------ * The validation studies were conducted using a validation load consisting of pouched guide(s) ) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material. ** The validation studies were conducted using a validation load consisting of one pouched instrument trav or one pouched instrument tray or one pouch with) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material. | Material | Manufacturer | Specialty Cycle | Lumens | |--------------------------------|--------------|-----------------|---------------------| | Surgical Guide Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L | | BioMed Amber Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L | | Dental LT Clear V2 Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L | | BioMed Clear Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L | | Biocompatible Clear MED610 | Stratasys | E | ≥3 mm ID x ≤20 mm L | | Biocompatible Opaque MED615RGD | Stratasys | E | ≥3 mm ID x ≤20 mm L | | VeroGlaze™ MED620 | Stratasys | E | ≥3 mm ID x ≤20 mm L | #### 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 I - . > 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: - o a single stainless steel lumen with: - . > 1 mm ID and < 500 mm in length - o 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. {13}------------------------------------------------ - · Medical Devices, including most flexible endoscopes, with: - O 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 diffusion-restricted spaces, such as the hinged portion of forceps and scissors. #### STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle #### · Medical devices including: - o most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with ≥ 1 mm ID and ≤ 875 mm in length - o accessory devices that are normally connected to a flexible endoscope during use - o flexible endoscopes without lumens *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. #### Ethylene Oxide Sterilization The Vis-U-All Low Temperature Sterilization Pouch has been qualified by STERIS as suitable for use by health care providers to enclose and seal other medical devices to be sterilized by ethylene oxide (ETO). The Vis-U-All Low Temperature Sterilization Pouch for ethylene oxide is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use. The following are the validated test conditions: - . 1 hour exposure, at 130(±5) °F, * >30% RH using 100% ETO (750-790 mg/L) 4.5 hour exposure at 100(±5) °F, * >30% RH using 100% ETO (750-790 mg/L) . *±5 °F is used during sterilization phase following an equilibrium period of 10% of exposure time. The ethylene oxide process indicator is intended to be used by health care providers with the Vis-U-All Low Temperature Sterilization Pouches to distinguish between processed and unprocessed units. #### 5. Description of Safety and Substantial Equivalence The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Tables 5-2 and 5-3 summarizes the difference between the proposed device and predicate device cleared under K222440 and K092745. Table 5-2. Technical Comparison to the K222440 Predicate Device (Vaporized Hydrogen Peroxide claims) | Feature | Vis-U-All Low Temperature Sterilization<br>Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization<br>Pouch (K222440) | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended<br>Use / | The Vis-U-All Low Temperature<br>Sterilization Pouches/Tubing are<br>sterilization containment pouches for use by | The Vis-U-All Low Temperature<br>Sterilization Pouches/Tubing are<br>sterilization containment pouches for use by | | Feature | Vis-U-All Low Temperature Sterilization<br>Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization<br>Pouch (K222440) | | Indications<br>for Use | 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 sterilization<br>in a single pouch configuration within a<br>tray<br>*3-D printed items should not be double-<br> | 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 sterilization<br>in a single pouch configuration within a<br>tray | | | pouched<br>to be sterilized in the:<br>• Lumen , Non Lumen, Flexible , Fast Non<br>Lumen and Fast Cycles of the V-PRO ®<br>Low Temperature Sterilization 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 Technology<br>Sterilizers<br>**STERRAD and ALLClear are trademarks<br>of Advanced Sterilization Products<br>NOTE: Trays must be legally marketed for<br>use in the V PRO Low Temperature or<br>STERRAD Sterilization Systems and<br>contain a vent surface area to tray volume<br>ratio ≥ 0.135 in-1 with the maximum<br>number of instrument organizers installed. | NOTE: Trays must be legally marketed for<br>use in the V PRO Low Temperature or<br>STERRAD Sterilization Systems and<br>contain a vent surface area to tray volume<br>ratio ≥ 0.135 in-1 with the maximum<br>number of instrument organizers installed.<br>to be sterilized in the:<br>• Lumen , Non Lumen , Flexible , Fast Non<br>Lumen and Fast Cycles of the V-PRO ®<br>Low Temperature Sterilization 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 Technology<br>Sterilizers<br>*STERRAD and ALLClear are trademarks<br>of Advanced Sterilization Products | | | The pouches maintain the sterility of the<br>enclosed devices until used.<br>When used to enclose medical devices, the<br>pouches are intended to contain the devices<br>in such a manner as to leave a minimum of<br>one inch between the devices and seal on all<br>sides. When used to enclose a tray, the tray<br>must fit loosely within the pouch.<br>Intended Sterilization Cycles and Intended<br>Pouch Loads when Medical Devices are: | The pouches maintain the sterility of the<br>enclosed devices until used.<br>When used to enclose medical devices, the<br>pouches are intended to contain the devices<br>in such a manner as to leave a minimum of<br>one inch between the devices and seal on all<br>sides. When used to enclose a tray, the tray<br>must fit loosely within the pouch.<br>Intended Sterilization Cycles and Intended<br>Pouch Loads when Medical Devices are: | | | • Directly pouched<br>• Placed inside of a tray and the tray<br>pouched<br>V-PRO 60 & s2 Lumen Cycle<br>• Non-lumened devices with diffusion-<br>restricted spaces such as the hinged | • Directly pouched<br>• Placed inside of a tray and the tray<br>pouched<br>V-PRO 60 & s2 Lumen Cycle<br>• Non-lumened devices with diffusion-<br>restricted spaces such as the hinged | | | portion of forceps and scissors.<br>• Non-lumened devices including non- | portion of forceps and scissors.<br>• Non-lumened devices including non- | | Feature | Vis-U-All Low Temperature Sterilization<br>Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization<br>Pouch (K222440) | | | lumened rigid and semi-rigid endoscopes<br>• Medical devices, including single, dual<br>and triple channeled rigid and semi-rigid<br>endoscopes, with the following<br>configurations:<br>single or dual lumen devices<br>$\ge$ 0.77 mm internal diameter (ID) and $\le$ 410<br>mm in length<br>$\ge$ 1.8 mm ID x $\le$ 542 mm in length<br>triple lumen devices<br>$\ge$ 1.2 mm ID and $\le$ 275 mm in length<br>$\ge$ 1.8 mm ID and $\le$ 310 mm in length<br>Or<br>$\ge$ 2.8 mm ID and $\le$ 317 mm in length | lumened rigid and semi-rigid endoscopes<br>• Medical devices, including single, dual<br>and triple channeled rigid and semi-rigid<br>endoscopes, with the following<br>configurations:<br>single or dual lumen devices<br>$\ge$ 0.77 mm internal diameter (ID) and $\le$ 410<br>mm in length<br>$\ge$ 1.8 mm ID x $\le$ 542 mm in length<br>triple lumen devices<br>$\ge$ 1.2 mm ID and $\le$ 275 mm in length<br>$\ge$ 1.8 mm ID and $\le$ 310 mm in length<br>Or<br>$\ge$ 2.8 mm ID and $\le$ 317 mm in length | | | 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 with<br>diffusion-restricted spaces such as the<br>hinged portion of forceps and 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 with<br>diffusion-restricted spaces such as the<br>hinged portion of forceps and 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 lumens<br>that are $\ge$ 1 mm ID and $\le$ 990 mm in<br>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 lumens<br>that are $\ge$ 1 mm ID and $\le$ 990 mm in<br>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 s2 Fast Cycle<br>Non-lumened devices including non-<br>lumened rigid and semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with diffusion-restricted spaces such as<br>the hinged portion of forceps and scissors.<br>• Medical devices (including single, dual<br>and triple channeled rigid and semi-rigid<br>endoscopes) with the following<br>configurations:<br>single or dual lumen devices | V-PRO s2 Fast Cycle<br>Non-lumened devices including non-<br>lumened rigid and semi-rigid and flexible<br>endoscopes and non-lumened devices<br>with diffusion-restricted spaces such as<br>the hinged portion of forceps and scissors.<br>• Medical devices (including single, dual<br>and triple channeled rigid and semi-rigid<br>endoscopes) with the following<br>configurations:<br>single or dual lumen devices | | Feature | Vis-U-All Low Temperature Sterilization<br>Pouch (proposed, K231500) | Vis-U-All Low Temperature Sterilization<br>Pouch (K222440) | | | $\ge$ 1.8 mm ID x $\le$ 542 mm in length | $\ge$ 1.8 mm ID x $\le$ 542 mm in length | | | • Triple channeled devices with stainless<br>steel lumens that are either: | • Triple channeled devices with stainless<br>steel lumens that are either: | | | $\ge$ 1.2 mm ID and $\le$ 275 mm in length | $\ge$ 1.2 mm ID and $\le$ 275 mm in length | | | 1.8mm ID and 310mm in length | 1.8mm ID and 310mm in length | | | Or | Or | | | $\ge$ 2.8 mm ID and $\le$ 317 mm in length | $\ge$ 2.8 mm ID and $\le$ 317 mm in length | | | V-PRO 1, 1 Plus, maX & maX 2<br>Lumen Cycle | V-PRO 1, 1 Plus, maX & maX 2<br>Lumen Cycle | | | • Non-lumened devices with diffusion-<br>restricted spaces such as the hinged<br>portion of forceps and scissors. | • Non-lumened devices with diffusion-<br>restricted spaces such as the hinged<br>portion of forceps and scissors. | | | • Non-lumened devices including non-<br>lumened rigid and semi-rigid<br>endoscopes | • Non-lumened devices including non-<br>lumened rigid and semi-rigid<br>endoscopes | | | • Medical devices , including single,<br>dual or triple channeled stainless steel<br>lumens that are:<br>$\ge$ 0.77 mm ID and $\le$ 527 mm in length | • Medical devices , including single,<br>dual or triple channeled stainless steel<br>lumens that are:<br>$\ge$ 0.77 mm ID and $\le$ 527 mm in length | | | $\ge$ 0.8 mm ID and $\le$ 542 mm in length | $\ge$ 0.8 mm ID and $\le$ 542 mm in length | | | $\ge$ 0.48 mm ID and $\le$ 100 mm in length | $\ge$ 0.48 mm ID and $\le$ 100 mm in length | | | • Medical devices with Dead end lumens<br>that are $\ge$ 1.3 mm ID and $\le$ 73 mm in<br>length | • Medical devices with Dead end lumens<br>that are $\ge$ 1.3 mm ID and $\le$ 73 mm in<br>length | | | • Devices with rigid non-metallic<br>lumens (such as those used in<br>endoscope sheaths, take-apart<br>forceps and trocars) that are: | • Devices with rigid non-metallic<br>lumens (such as those used in<br>endoscope sheaths, take-apart<br>forceps and trocars) that are: | | | $\ge$ 3 mm ID and $\le$ 298 mm in length…