Vis-U-All Low Temperature Sterilization Pouch/Tubing

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Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-000 July 22, 2016 STERIS Corporation Mr. Anthony Piotrkowski Sr. Manager, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060 Re: K160908 > Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouch/Tubing Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: June 22, 2016 Received: June 23, 2016 Dear Mr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/1/Picture/5 description: The image shows a signature that appears to say "Tina Kiang". The signature is written in black ink on a white background. There is a large looping design to the left of the name. for Erin I. Keith, M.S. 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) K160908 Device Name Vis-U-All Low Temperature Sterilization Pouches/Tubing ### Indications for Use (Describe) The Vis-U-All Low Temperature Sterilization Pouches Tubing are sterilization containment pouches for use by health care providers to enclose: - medical devices in a single or double pouch configuration . - . trays* containing medical devices in a single or double pouch configuration - . small items requiring surface sterilization in a single pouch configuration within a tray* to be sterilized in the Lumen Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches maintain the sterility of the enclosed devices until used. When used to enclose medical devices, the ntended 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. Vis-U-All Pouch/Tubing Claims with V-PRO Sterilization Systems | Intended<br>Sterilization<br>Cycles | Intended Pouch Load when Medical Devices are: | | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | • Directly Pouched or | | | | • Placed Inside of a Tray* and the Tray* Pouched | | | V-PRO 60<br>Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged portion of forceps<br>and scissors<br>• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes<br>• Medical devices, including single, dual and triple channeled rigid and semi-rigid<br>endoscopes, with the following configurations:<br>o single or dual lumen devices<br>≥ 0.77 mm ID and ≤ 410 mm in length<br>o triple lumen devices<br>≥1.2 mm ID and ≤ 275 mm in length<br>≥1.8 mm ID and ≤ 310 mm in length<br>or<br>≥2.8 mm ID and ≤ 317 mm in length | | | V-PRO 60 Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices with stainless steel or titanium diffusion-<br>restricted spaces such as the hinged portion of forceps and scissors. | | | V-PRO 60<br>Flexible Cycle | One flexible surgical endoscope or bronchoscope with a light cord (if not integral to<br>endoscope) and mat without any additional load. The flexible endoscope may be a<br>single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 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<br>and scissors<br>• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes<br>• Medical devices, including single, dual and triple channeled rigid and semi-rigid<br>endoscopes, with the following configurations:<br>o single or dual lumen devices<br>≥ 0.77 mm ID and ≤ 527 mm in length<br>o triple lumen devices<br>≥ 1.2 mm ID and ≤ 275 mm in length<br>≥ 1.8 mm ID and ≤ 310 mm in length<br>or<br>>> 2.8 mm ID and ≤ 317 mm in length | | {3}------------------------------------------------ | V-PRO 1 Plus<br>& maX Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible<br>endoscopes and non-lumened devices with stainless steel diffusion-restricted spaces<br>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<br>ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral<br>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

lt;$ 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<br>areas such as the hinged portion of forceps or scissors. | area to tray volume ratio ≥ 0.135 in" with the maximum number of instrument organizers installed. Type of Use (Select one or both, as applicable) _ Prescription Use (Part 21 CFR 801 Subpart D) > Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font. Below the word "STERIS" is an image of several horizontal, wavy lines in a light blue color. The lines are arranged in a stacked formation, creating a visual representation of water or waves. # 510(k) Summary for Vis-U-All Low Temperature Sterilization Pouch/Tubing STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459 Contact: Anthony Piotrkowski Sr. Manager, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 E-mail: tpiotrko@steris.com > Submission Date: July 22, 2016 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {5}------------------------------------------------ #### 1. Device Name | Trade Name: | Vis-U-All Low Temperature Sterilization<br>Pouch/Tubing | |----------------------|------------------------------------------------------------| | Common/Usual Name: | Sterilization Pouch | | Classification Name: | Sterilization wrap<br>(21 CFR 880.6850, Product Code FRG). | #### 2. Predicate Device Vis-U-All Low Temperature Sterilization Pouch/Tubing (K140487) Reference Device - Vis-U-All Low Temperature Sterilization Pouch/Tubing (K092745) #### 3. Description of Device The proposed Vis-U-All Low Temperature Sterilization Pouch/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, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing. The purpose of this submission is to add claims for: use in the V-PRO maX Flexible cycle; pouching of sterilization trays and for sterilization of pouched items within a sterilization tray. #### 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 and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches maintain the sterility of the enclosed devices until used. When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch. {6}------------------------------------------------ | Intended<br>Sterilization<br>Cycles | Intended Pouch Load when Medical Devices are: | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | V-PRO 60<br>Lumen Cycle | Directly Pouched or Placed Inside of a Tray* and the Tray* Pouched Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors Non-lumened devices including non-lumened rigid and semi-rigid endoscopes Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: single or dual lumen devices $\geq$ 0.77 mm ID and $\leq$ 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 $\geq$ 2.8 mm ID and $\leq$ 317 mm in length | | V-PRO 60 Non<br>Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion- restricted spaces such as the hinged portion of forceps and scissors. | | 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 single or dual lumen device with lumens that are $\geq$ 1 mm ID and

lt;$ 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

lt;$ 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. | ## Vis-U-All Pouch/Tubing Claims with V-PRO Sterilization Systems *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. {7}------------------------------------------------ #### 5. Available Sizes / Configurations | Type | Size<br>(inches unless specified) | Part Number | |-----------------|-----------------------------------|-------------| | Heat Seal Pouch | 3 x 7 | 875037 | | | 4 x 9 | 875049 | | | 4 x 12 | 875412 | | | 4 x 22 | 875422 | | | 6 x 10 | 875610 | | | 8 x 12 | 875812 | | | 10 x 15 | 875115 | | | 12 x 18 | 875118 | | Self Seal Pouch | 3 x 7 | 876037 | | | 4 x 9 | 876049 | | | 4 x 12 | 876412 | | | 4 x 22 | 876422 | | | 6 x 10 | 876610 | | | 8 x 12 | 876812 | | | 10 x 15 | 876115 | | | 12 x 18 | 876118 | | Tubing | 3" x 100' | 872031 | | | 4" x 100' | 872041 | | | 6" x 100' | 872061 | | | 9" x 100' | 872091 | | | 14" x 100' | 872141 | #### Description of Safety and Substantial Equivalence 6. The device models are identical to the cleared predicate K140487. Testing of the Vis-U-All Low Temperature Sterilization Pouch/Tubing as summarized in the table below demonstrated that the proposed pouch is qualified for use in the V-PRO 60 Sterilizer and is as safe, as effective, and performs the same as the predicate device. | Test | Acceptance Criteria | Conclusion | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------| | Effective Sterilant<br>Penetration | Worst case test article shall be<br>reproducibly sterilized under worst<br>case ½ cycle conditions. | PASS | | Package Integrity: Event<br>Related Package Integrity<br>Pouching a Qualified Tray | No visual damage to pouch<br>material (no holes or tears).<br>Seals remain intact. | PASS | {8}------------------------------------------------ | Characteristic | Proposed | Predicate | 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 Chemical<br>Indicator Printed on both sides of<br>Tyvek | Ethylene Oxide Process<br>Chemical Indicator Printed on<br>both sides of Tyvek | Same | | Intended Use | The Vis-U-All Low Temperature<br>Sterilization Pouches/Tubing are<br>sterilization containment pouches<br>for use by health care providers to<br>enclose:<br>medical devices in a single<br>or double pouch<br>configurationtrays* containing medical<br>devices in a single or double<br>pouch configurationsmall items requiring<br>surface sterilization in a<br>single pouch configuration<br>within a tray*to be sterilized in the Lumen,<br>Non Lumen and Flexible Cycles<br>of the V-PRO Low<br>Temperature Sterilization<br>Systems. The pouches maintain<br>the sterility of the enclosed<br>devices until used. | 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 medical<br>devices to be sterilized in<br>Lumen and Non Lumen<br>Cycles in the V-PRO 60 Low<br>Temperature Sterilization<br>System. The pouches<br>maintain the sterility of the<br>enclosed devices until used. | Similar (bolded<br>text illustrates<br>differences).<br>Data is presented<br>in this<br>submission to<br>support<br>substantial<br>equivalent use of<br>the pouches in<br>the additional<br>cycles and load<br>configurations. | | Device Features | Chevron end of pouches for<br>ease of openingChemical process indicator<br>for EO | ■ Chevron end of pouches for<br>ease of opening<br>■ Chemical process indicator<br>for EO | Same | | Maintenance of<br>Sterility | 1 year | 1 year | Same | #### 7. Comparison of Technological Characteristics #### 8. Conclusion In conclusion, the subject device the Vis-U-All Low Temperature Sterilization Pouches/Tubing is substantially equivalent to predicate device K140487 the Vis-U-All Low Temperature Sterilization Pouches/Tubing. Based on the intended use, technological characteristics, and performance data, the subject The Vis-U-All Low Temperature Sterilization Pouches/Tubing is substantially equivalent and is as safe and as effective as the legally marketed predicate device.