Vis-U-All Low Temperature Sterilization Pouch/Tubing

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath. February 9, 2018 STERIS Corporation Bill Brodbeck, Ph.D. Director, Regulatory Affairs 5960 Heislev Road Mentor, Ohio 44060 Re: K172749 Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouches/Tubing Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: January 9, 2018 Received: January 10, 2018 Dear Dr. Brodbeck: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use ### 510(k) Number (if known) K172749 Device Name Vis-U-All Low Temperature Sterilization Pouches/Tubing ### Indications for Use (Describe) Lumen Cycle The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose: - o medical devices in a single or double pouch configuration - trays* containing medical devices in a single or double pouch configuration ● - small items requiring surface sterilization in a single pouch configuration within a tray* to be sterilized in the Lumen. Flexible and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches are intended to 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: | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Directly Pouched or Placed Inside of a Tray* and the Tray*<br>Pouched | | V-PRO 60<br>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 $\( \ge \)$ 0.77 mm ID and $\( \le \)$ 410 mm in length triple lumen devices $\( \ge \)$ 1.2 mm ID and $\( \le \)$ 275 mm in length $\( \ge \)$ 1.8 mm ID and $\( \le \)$ 310 mm in length or $\( \ge \)$ 2.8 mm ID and $\( \le \)$ 317 mm in length | | V-PRO 60<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. | | V-PRO 60<br>Flexible<br>Cycle | 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 $\( \ge \)$ 1 mm ID and $\( \lt \)$ 990 mm in length | | V-PRO 1, 1 | Instruments with diffusion-restricted spaces such as the hinged | | | 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 | | | ■ $\geq$ 0.77 mm ID and $\leq$ 527 mm in length | | | o 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<br>Plus & maX<br>Non Lumen<br>Cycle | Non-lumened devices including non-lumened rigid, semi-rigid<br>and flexible endoscopes and non-lumened devices with stainless<br>steel diffusion-restricted spaces such as the hinged portion of<br>forceps and scissors. | | V-PRO maX<br>Flexible<br>Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such<br>as those used in ENT, Urology and Surgical Care) and<br>bronchoscopes with a light cord (if not integral to endoscope) and<br>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<br>length | | | Load 2: Non-lumened instruments including instruments with<br>diffusion-restricted areas such as the hinged portion of forceps or<br>scissors. | | | • Instruments with diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors | | | • Non-lumened devices including non-lumened rigid and semi-<br>rigid endoscopes | | | • Medical devices, including single, dual and triple channeled<br>rigid and semi-rigid endoscopes, with the following | | V-PRO maX<br>2 Lumen<br>Cycle | configurations: | | | o single or dual lumen devices | | | ■ $\geq$ 0.77 mm ID and $\leq$ 527 mm in length | | | o 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<br>Plus & maX,<br>Non Lumen<br>Cycle | Non-lumened devices including non-lumened rigid, semi-rigid<br>and flexible endoscopes and non-lumened devices with titanium<br>diffusion-restricted spaces such as the hinged portion of forceps<br>and scissors. | | V-PRO maX<br>2 Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid<br>and flexible endoscopes and non-lumened devices with stainless<br>steel or titanium diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors. | | V-PRO maX<br>2 Flexible<br>Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such<br>as those used in ENT, Urology and Surgical Care) and | | | bronchoscopes with a light cord (if not integral to endoscope) and<br>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<br>length | | | Load 2: Non-lumened instruments including instruments with<br>diffusion-restricted areas such as the hinged portion of forceps or<br>scissors. | | V-PRO maX<br>2 Fast Non<br>Lumen | Non-lumened devices including non-lumened rigid, semi-rigid<br>and flexible endoscopes and non-lumened devices with stainless<br>steel or titanium diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors. | | | * Trays must be legally marketed for use in the V-PRO Low Temperature Sterilization Sys | | | a vent surface area to tray volume ratio $\geq$ 0.135 in-1 with the maximum number of instrument organizers | · Non-lumened devices including non-lumened rigid and semi- Vis-U-All Pouch/Tubing Claims with V-PRO Sterilization Systems {3}------------------------------------------------ {4}------------------------------------------------ Type of Use (Select one or both, as applicable) installed. _ Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - 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Below the word is an image of several horizontal wavy lines that are blue. # 510(k) Summary for K172749 Vis-U-All Low Temperature Sterilization Pouches/Tubing STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Contact: Bill Brodbeck, Ph.D. Director, Regulatory Affairs Telephone: (440) 392-7690 Fax No: (440) 357-9198 E-mail: William_Brodbeck@steris.com January 9, 2018 Date of Preparation: STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {6}------------------------------------------------ #### 1. Device Name | Trade Name: | Vis-U-All Low Temperature Sterilization<br>Pouches/Tubing | |------------------------|-----------------------------------------------------------| | Device Classification: | Class II | | Common/Usual Name: | Sterilization pouch | | Classification Name: | Sterilization wrap | | Classification Number: | 21 CFR 880.6850 | | Product Code: | FRG | #### 2. Predicate Device Vis-U-All Low Temperature Sterilization Pouches/Tubing (K160908) 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. The purpose of K172749 is to add claims for: - use in the V-PRO maX 2 Fast Non Lumen Cycle - the sterilization of titanium mated surfaces (diffusion-restricted spaces) in ● the V-PRO 1 Plus, maX, and maX 2 Sterilizers Non Lumen Cycle - addition of the V-PRO maX 2 Sterilizer to the indications for use in the Lumen, Non Lumen and Flexible Cycles of the V-PRO 1, 1 Plus and maX Sterilizers (the V-PRO maX 2 Sterilizer Lumen, Non Lumen, and Flexible Cycles are identical, with the exception of the condition phase of the Lumen Cycle, to the previously cleared cycles listed in Table 2-1). {7}------------------------------------------------ | Cycle | Most Recent<br>Premarket<br>Notification<br>Clearance | V-PRO<br>1 | V-PRO<br>1 Plus | V-PRO<br>maX | V-PRO<br>maX 2 | |----------------------|-------------------------------------------------------|------------|-----------------|--------------|----------------| | Lumen Cycle | K131120 | X | X | X | X | | Non Lumen Cycle | K160433 | * | X | X | X | | Flexible Cycle | K102330 | | | X | X | | Fast Non Lumen Cycle | Concurrent<br>Submission | | | | X | Table 2-1: V-PRO Cycles Provided in the Large Size (136 L Chamber) V-PRO Sterilizers * Shaded cell indicates that the V-PRO Sterilizer does not include the identified cycle. ### NOTE: V-PRO Sterilizer cycles are pre-set and thus the name of the cycle describes the cycle conditions. #### 4. Intended Use/ Indications for Use The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose: - . medical devices in a single or double pouch configuration - trays* containing medical devices in a single or double pouch configuration - . small items requiring surface sterilization in a single pouch configuration within a tray* to be sterilized in the Lumen, Non Lumen, Flexible and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches are intended to maintain the sterility of the enclosed devices until used. When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch. | Intended<br>Sterilization<br>Cycles | Intended Pouch Load when Medical Devices are:<br>• Directly Pouched or<br>• Placed Inside of a Tray* and the Tray* Pouched | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | V-PRO 60<br>Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors<br>• Non-lumened devices including non-lumened rigid and semi-<br>rigid endoscopes<br>• Medical devices, including single, dual and triple channeled<br>rigid and semi-rigid endoscopes, with the following<br>configurations:<br>o single or dual lumen devices<br>• ≥ 0.77 mm ID and ≤ 410 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 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 60<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. | | V-PRO 60<br>Flexible Cycle | 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>single or dual lumen device with lumens that are $\geq$ 1 mm ID and $\leq$ 990 mm in length | | V-PRO 1, 1<br>Plus & maX<br>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 $\leq$ 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 Plus<br>& max Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors. | | V-PRO maX<br>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.<br>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 | | 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 | | | Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. | | V-PRO maX 2<br>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 $\leq$ 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 Plus<br>& maX, Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | | V-PROmaX 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. | | V-PRO maX 2<br>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 $\geq$ 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 2<br>Fast Non<br>Lumen | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless | | Intended<br>Sterilization<br>Cycles | Intended Pouch Load when Medical Devices are: | | | Directly Pouched or Placed Inside of a Tray* and the Tray* Pouched | | | steel or titanium diffusion-restricted spaces such as the hinged<br>portion of forceps and scissors. | Vis-U-All Pouch/Tubing Claims with V-PRO Sterilization Systems {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ * Trays must be legally marketed for use in the V-PRO Low Temperature Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed. #### 5. Available Sizes / Configurations | Type | Size<br>(inches unless specified) | |-----------------|-----------------------------------| | Heat Seal Pouch | 3 x 7 | | | 4 x 9 | | | 4 x 12 | | | 4 x 22 | | | 6 x 10 | | | 8 x 12 | | | 10 x 15 | | | 12 x 18 | | Self Seal Pouch | 3 x 7 | | | 4 x 9 | | | 4 x 12 | | | 4 x 22 | | | 6 x 10 | | | 8 x 12 | | | 10 x 15 | | | 12 x 18 | | Tubing | 3" x 100' | | | 4" x 100' | | | 6" x 100' | | | 9" x 100' | | | 14" x 100' | #### 6. Description of Safety and Substantial Equivalence Testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing as summarized in the table below demonstrated that the proposed pouch is qualified for use in the V-PRO maX 2 Fast Non Lumen Cycle and for sterilization of titanium mated surfaces (diffusion-restricted spaces) in the V-PRO 1 Plus, maX, and maX 2 Sterilizers Non Lumen Cycle and is as safe, as effective, and performs the same as the predicate device. {11}------------------------------------------------ | Test | Acceptance Criteria | Conclusion | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Effective<br>Sterilant<br>Penetration<br>into<br>Pouches<br>(including<br>pouched<br>trays and,<br>if<br>applicable,<br>pouches<br>placed<br>within a<br>tray): | V-PRO maX 2<br>Sterilizer Fast Non<br>Lumen Cycle | Worst case test article shall be<br>reproducibly sterilized under worst<br>case abbreviated ½ cycle conditions<br>for Fast Non Lumen Cycle. | PASS | | | V-PRO 1 Plus,<br>maX, and maX 2<br>Sterilizer Non<br>Lumen Cycle,<br>diffusion restricted<br>titanium claims | Diffusion-restricted spaces<br>(composed of stainless steel and<br>titanium, as well as contact points<br>between medical devices and tray<br>accessories) shall be reproducibly<br>sterilized under worst case<br>abbreviated ½ cycle conditions for<br>Fast Non Lumen Cycle. | PASS | | | V-PRO 1 Plus,<br>maX, and maX 2<br>Sterilizer Non<br>Lumen Cycle,<br>diffusion restricted<br>titanium claims | Diffusion-restricted spaces (titanium)<br>shall be reproducibly sterilized under<br>worst case ½ cycle conditions for the<br>Non Lumen Cycle. | PASS | | Pouch<br>Integrity:<br>Physical<br>and<br>Microbial<br>Barrier<br>Properties | Tensile Strength | Pouch material tensile strength will<br>show no statistical difference between<br>processed and unprocessed samples. | PASS | | | Whole Package<br>Integrity (Burst) | Pouch burst strength will show no<br>statistical difference between<br>processed and unprocessed pouches. | PASS | | | Seal Strength | Pouch seal strength will show no<br>statistical difference between<br>processed and unprocessed pouches. | PASS | | | Microbial<br>Retention | Tyvek microbial retention will show<br>no statistical difference between<br>processed and unprocessed pouches. | PASS | | Maintenance of Package<br>Integrity | Packaged instruments shall remain<br>sterile through event related and real<br>time studies. | PASS | | | Aeration: Hydrogen Peroxide<br>Residuals | Hydrogen peroxide residuals on the<br>pouch will be reduced to acceptable<br>levels for dermal contact in Fast Non<br>Lumen Cycle with 3 minute aeration. | PASS | | | Cytotoxicity | Pouch materials shall be non-<br>cytotoxic following worst case<br>exposure in a V-PRO Sterilizer for<br>Fast Non Lumen Cycle with 3 minute<br>aeration. | PASS | | {12}------------------------------------------------ #### Comparison of Technological Characteristics 7. | Characteristic | Proposed<br>K172749 | Predicate<br>K160908 | Comparison | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Materials of<br>Construction | Tyvek and plastic | Tyvek and plastic | Same | | Types | Self Seal, Heat Seal, Tubing | Self Seal, Heat Seal, Tubing | Same | | Chemical<br>Indicator | Ethylene Oxide Process<br>Chemical Indicator Printed<br>on both sides of Tyvek | Ethylene Oxide Process<br>Chemical Indicator Printed on<br>both sides of Tyvek | Same | | Intended Use | The Vis-U-All Low<br>Temperature Sterilization<br>Pouches/Tubing are<br>sterilization containment<br>pouches for use by health<br>care providers to enclose:<br>• medical devices in a single<br>or double pouch<br>configuration<br>• trays* containing medical<br>devices in a single or double<br>pouch configuration<br>• small items requiring<br>surface sterilization in a<br>single pouch configuration<br>within a tray*<br>to be sterilized in the Lumen,<br>Non Lumen, Flexible and<br>Fast Non Lumen Cycles of<br>the V-PRO Low<br>Temperature<br>Sterilization Systems. The<br>pouches maintain the sterility<br>of the enclosed devices until<br>used.<br><br>V-PRO 1 Plus, maX, & maX<br>2 Non Lumen Cycle<br>- Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened<br>devices with stainless steel or<br>titanium diffusion-restricted<br>spaces such as the hinged<br>portion of forceps and<br>scissors. | The Vis-U-All Low<br>Temperature Sterilization<br>Pouches/Tubing are<br>sterilization containment<br>pouches for use by health care<br>providers to enclose:<br>• medical devices in a single<br>or double pouch configuration<br>• trays* containing medical<br>devices in a single or double<br>pouch configuration<br>• small items requiring<br>surface sterilization in a single<br>pouch configuration within a<br>tray*<br>to be sterilized in the Lumen,<br>Non Lumen and Flexible<br>Cycles of the V-PRO Low<br>Temperature Sterilization<br>Systems. The pouches<br>maintain the sterility of the<br>enclosed devices until used.<br><br>V-PRO 1 Plus & maX Non<br>Lumen Cycle<br>- Non-lumened devices<br>including non-lumened rigid,<br>semi-rigid and flexible<br>endoscopes and non-lumened<br>devices with stainless steel<br>diffusion-restricted spaces<br>such as the hinged portion of<br>forceps and scissors. | Similar | | | | | | | Device Features | Chevron end of pouches for ease of opening Chemical process indicator for EO | Chevron end of pouches for ease of opening Chemical process indicator for EO…