Tyvek Sterilization Pouches with Chevron Seal

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 12, 2020 Andersen Sterilizers, Inc. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258 Re: K200336 Trade/Device Name: Tyvek Sterilization Pouches with Chevron Seal Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: October 8, 2020 Received: October 13, 2020 #### Dear William Andersen: 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. 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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, CAPT Elizabeth Claverie, MS 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) K200336 Device Name Tyvek Sterilization Pouches with Chevron Seal #### Indications for Use (Describe) Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in 3-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1. Table 1. Critical sterilization cycle parameters in the EOGas 4 Ethylene Oxide Gas Sterilizer | Ethylene Oxide | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time | |----------------|-------------|-------------------|------------------|------------------| | 17.6 g ± 5% | 50°C ± 3°C | 35-70% | 3 hours | 3.5 hours | | | | | 6 hours | 7 hours | The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes working length shorter than 1100 mm as specified in the sterilizer labeling. The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the sterilizer labeling. {3}------------------------------------------------ | Device Type | Maximum Load | Device Examples | Required Aeration | |-------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Metal | 24 lbs (11 kg) | Surgical instruments,<br>delicate sharps,<br>including those with<br>hinges and mated<br>surfaces | No additional aeration<br>required;<br>Follow pouch or wrap<br>manufacturer's<br>instructions (Example: Tyve<br>pouches require ≥ 6 hours<br>at 50°C) | | Plastic | 7.0 lbs (3.2 kg) | Reusable power cords,<br>trocars, and similar<br>devices | 24 hours at 50°C;<br>Follow manufacturer's<br>instructions | | Fabric | 6.1 lbs (2.8 kg) | Reusable cloth gowns,<br>towels, and similar devices | | | ≤ 1100 mm<br>Working<br>Lumen<br>Length<br>Endoscopes | One (1)<br>≥ 2.0 mm ID biopsy channel<br>≤ 1100 mm working length | Gastrovideoscopes,<br>gastrointestinal videoscopes,<br>and similar devices | 8 hours at 50°C;<br>Follow manufacturer's<br>instructions | | | Four (4)<br>> 1.2 mm ID biopsy channel<br>≤700 mm working length | Bronchoscopes,<br>bronchovideoscopes, cystoscopes,<br>ureteroscopes, choledocoscopes, | | 6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe) | | Two (2) Duodenoscopes* | Olympus TJF-Q180V, | | |------------|------------------------------------------------------------|----------------------------------------|--------------------------| | | ≥ 2.0 mm ID biopsy channel | Olympus TJF-Q160VF, | 6 hours at 50°C for | | | ≤ 1250 mm working length | Olympus TJF-Q190V, | Olympus and Pentax | | | ≥ 1.2 mm ID, ≤ 3530 mm<br>maximum length of any<br>channel | Olympus PJF-160,<br>Fujifilm ED-530XT, | endoscopes in Sterisheet | | | | Pentax ED34-i10T2, | | | >1100 mm | | Pentax ED-3490TK | 8 hours at 50°C for | | Working | Two (2) Colonoscopes* | | Fujifilm endoscopes | | Lumen | ≥ 3.7 mm ID biopsy channel | Olympus CF-Q180AL, | in Sterisheet | | Length | ≤ 1700 mm working length | Fujifilm EC-600HL, | Follow manufacturer's | | Endoscopes | ≥ 1.2 mm ID, ≤ 3530 mm<br>maximum length of any channel | Pentax EC-3490Li | instructions | * One (1) duodenoscope may also be paired with one (1) colonoscope After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 510(k) Summary K200336 | Applicant's Name and Address | Andersen Sterilizers, Inc.<br>Establishment Registration Number 3004634710<br>3154 Caroline Drive<br>Haw River, NC 27258 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Contact Person | William K. Andersen, BE, MD, FAAOS<br>President<br>Phone: 336-376-8622, Fax: 336-376-5428 | | Date of Preparation | February 3, 2020 | | Device | | | | | | | | | | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------------------------------------|-------------|---------------------|----------------|----------------------------|--------------|-----| | | <table><tr><td>Proprietary Name</td><td>Tyvek Sterilization Pouches with Chevron Seal</td></tr><tr><td>Common Name</td><td>Sterilization Pouch</td></tr><tr><td>Classification</td><td>Class II (21 CFR 880.6850)</td></tr><tr><td>Product Code</td><td>FRG</td></tr></table> | Proprietary Name | Tyvek Sterilization Pouches with Chevron Seal | Common Name | Sterilization Pouch | Classification | Class II (21 CFR 880.6850) | Product Code | FRG | | Proprietary Name | Tyvek Sterilization Pouches with Chevron Seal | | | | | | | | | | Common Name | Sterilization Pouch | | | | | | | | | | Classification | Class II (21 CFR 880.6850) | | | | | | | | | | Product Code | FRG | | | | | | | | | | Predicate Device | | | | | | | | |------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------------|---------------|---------|--------------|-----------------------| | | <table><tr><td>Device Name</td><td>Tyvek Sterilization Pouches with Chevron Seal</td></tr><tr><td>510(k) number</td><td>K152058</td></tr><tr><td>Manufacturer</td><td>Amcor Flexibles, Inc.</td></tr></table> | Device Name | Tyvek Sterilization Pouches with Chevron Seal | 510(k) number | K152058 | Manufacturer | Amcor Flexibles, Inc. | | Device Name | Tyvek Sterilization Pouches with Chevron Seal | | | | | | | | 510(k) number | K152058 | | | | | | | | Manufacturer | Amcor Flexibles, Inc. | | | | | | | The predicate Tyvek Sterilization Pouches with Chevron Seal (K152058) were cleared as an accessory for use in 3-hour gas exposures in the EOGas 4 Ethylene Oxide Gas SterilizationSystem manufactured by Andersen Sterilizers, Inc. The 510(k) submission modifies the indications for use of the predicate device in order to include Tyvek Sterilization Pouches with Chevron Seal as an accessory for use in 6-hour gas exposures in the EOGas 4 Ethylene Oxide Sterilization System manufactured by Andersen Sterilizers, Inc. No modifications were made to the manufacturing method, technology, or intended use. {6}------------------------------------------------ ### Device Description Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylene-vinyl acetate copolymer film. The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed. The self-seal pouch permits sealing of the pouch without heatsealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85 EO Indicators, when placed on the outside of the sterilization pouches. indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months. ## Indications for Use Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 5-1. | Ethylene Oxide | Temperature | Relative<br>Humidity | Ethylene Oxide<br>Exposure Time | Total Cycle Time | |----------------|-------------|----------------------|---------------------------------|------------------| | 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 3 hours | 3.5 hours | | | | | 6 hours | 7 hours | Table 5-1. Critical sterilization cycle parameters for EOGas 4 Ethylene Oxide Gas Sterilizer The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes working length shorter than 1100 mm as specified in the sterilizer labeling. The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the sterilizer labeling. {7}------------------------------------------------ | Device Type | Maximum Load | Device Examples | Required Aeration | |-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | 3-Hour EO Exposure, EOGas 4 SteriTest PCD (Blue Purge Probe) | | | | | Metal | 24 lbs<br>(11 kg) | Surgical instruments,<br>delicate sharps,<br>including those with<br>hinges and mated<br>surfaces | No additional aeration<br>required;<br>Follow pouch or wrap<br>manufacturer's<br>instructions (Example:<br>Tyvek pouches require<br>≥ 6 hours at 50°C) | | Plastic | 7.0 lbs<br>(3.2 kg) | Reusable power cords,<br>trocars, and similar<br>devices | 24 hours at 50°C; | | Fabric | 6.1 lbs<br>(2.8 kg) | Reusable cloth gowns,<br>towels, and similar<br>devices | Follow manufacturer's<br>instructions | | ≤ 1100 mm<br>Working<br>Lumen<br>Length<br>Endoscopes | One (1)<br>≥ 2.0 mm ID biopsy channel<br>≤ 1100 mm working length | Gastrovideoscopes,<br>gastrointestinal<br>videoscopes, and similar<br>devices | 8 hours at 50°C if in<br>Sterisheet; | | | Four (4)<br>≥ 1.2 mm ID biopsy channel<br>≤ 700 mm working length | Bronchoscopes,<br>bronchovideoscopes,<br>cystoscopes,<br>ureteroscopes,<br>choledocoscopes, and<br>similar devices | Follow manufacturer's<br>instructions | | 6-Hour EO Exposure, EOGas 4 Endo-SteriTest PCD (Gold Purge Probe) | | | | | >1100 mm<br>Working<br>Lumen<br>Length<br>Endoscopes | Two (2) Duodenoscopes *<br>≥ 2.0 mm ID biopsy channel<br>≤ 1250 mm working length<br>≥ 1.2 mm ID, ≤ 3530 mm<br>maximum length of any<br>channel | Olympus TJF-Q180V,<br>Olympus TJF-Q160VF,<br>Olympus TJF-Q190V,<br>Olympus PJF-160,<br>Fujifilm ED-530XT,<br>Pentax ED34-i10T2<br>Pentax ED-3490TK | 6 hours at 50°C for<br>Olympus and Pentax<br>endoscopes in<br>Sterisheet; | | | Two (2) Colonoscopes *<br>≥ 3.7 mm ID biopsy channel<br>≤ 1700 mm working length<br>≥ 1.2 mm ID, ≤ 3530 mm<br>maximum length of any<br>channel<br>* One (1) duodenoscope may also be paired with one (1) | Olympus CF-Q180AL,<br>Fujifilm EC-600HL,<br>Pentax EC-3490Li | 8 hours at 50°C for<br>Fujifilm endoscopes in<br>Sterisheet;<br>Follow manufacturer's<br>instructions | | | colonoscope | | | Table 5- 2. Load and material types validated in the EOGas 4 Ethylene Oxide Gas Sterilizer After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months. {8}------------------------------------------------ # Technological Characteristics The technological characteristics of Tyvek Sterilization Pouches with Chevron Seal are identical to the predicate device (K152058) - both are intended for the same use, use the same technology, and are designed in the same way. The subject Tyvek Sterilization Pouches with Chevron Seal differ from the predicate device only in the indicated sterilization cycles. A comparison between the devices is listed in Table 5-3. {9}------------------------------------------------ | Elements | Predicate Device: Tyvek Sterilization<br>Pouches (K152058) | Subject Device: Tyvek<br>Sterilization Pouches (K200336) | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | To enclose medical devices, allow sterilization<br>of the enclosed devices, and maintain sterility<br>of the enclosed devices | Identical | | Indications for<br>Use | Tyvek Sterilization Pouches with Chevron Seal<br>are intended to enclose medical devices that<br>are to be sterilized in a single pouch<br>configuration at a healthcare facility. They are<br>used in 3-hour gas exposures at 50°C in the<br>EOGas 4 Ethylene Oxide Gas Sterilizer. | Tyvek Sterilization Pouches with<br>Chevron Seal are intended to<br>enclose medical devices that are<br>to be sterilized in a single pouch<br>configuration at a healthcare<br>facility. They are used in 3-hour<br>and 6-hour gas exposures at 50°C<br>in the EOGas 4 Ethylene Oxide<br>Gas Sterilizer. | | Design | Adhesive laminated film is a clear, high<br>strength material;<br>Uncoated Tyvek is compatible with EO<br>sterilization, resistant to microbial penetration,<br>and resistant to puncture | Identical | | Pouch Types | Self-seal pouch; Heat seal pouch; Heat seal<br>tubing | Identical | | Device<br>Construction | Self-seal and heat seal pouches: front and back<br>materials are heat sealed together on three<br>sides; fourth side (end) remains open for<br>filling; end is sealed by heat (heat seal<br>pouches) or by removing protective liner strip,<br>folding along the pre-fold, and pressing to the<br>film (self-seal pouches).<br>Heat seal tubing: front and back materials are<br>heat sealed together on two sides; two ends are<br>open for selecting size and filling; ends are<br>sealed by heat. | Identical | | Materials | Clear laminated PET/LDPE or LDPE-EVA<br>film (front) and uncoated HDPE Tyvek (back) | Identical | | Configuration | Single pouch configuration | Identical | | Shelf Life | 5 years from date of manufacture | Identical | | Biocompatibility | Materials and biological evaluations (Agar<br>Diffusion Test, Cytotoxicity Test) meet ISO<br>11607-1 requirements | Identical | | Maintenance of<br>Sterility | Sterility is maintained for 3 months after<br>processing in the EOGas 4 Ethylene Oxide Gas<br>Sterilizer | Sterility is maintained for 6<br>months after processing in the<br>EOGas 4 Ethylene Oxide Gas<br>Sterilizer | | Aeration Time | ≥ 6 hours | ≥ 6 hours | | Package<br>Integrity | Seal strength, microbial barrier, burst, and peel<br>open characteristics meet ISO and ASTM<br>requirements | Identical | Table 5-3. Device Comparison {10}------------------------------------------------ # Summary of Non-Clinical Testing #### Performance Testing Performance testing was conducted to demonstrate that Tyvek Sterilization Pouches with Chevron Seal perform as intended to allow sterilization of the enclosed medical devices. Sterilization efficacy testing demonstrated a sterility assurance level of 10 ° using the half dose validation method under worst-case conditions. Tyvek Sterilization Pouches with Chevron Seal also maintain sterility of the enclosed devices as intended. Shelf life studies demonstrated after completion of the EOGas 4 sterilization process, sterility is maintained for 6 months. The performance of Tyvek Sterilization pouches is summarized in Table 5-4. | Table 5-4. Summary of bench tests performed to demonstrate safety and effectiveness of Tyvek | | | |----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Sterilization Pouches | | | | Test | Description | Results | | Compliance to ISO 11607-1 | | | | Package<br>Integrity | Seal strength performance characteristics were maintained for<br>the manufactured seal.<br>Microbial Barrier: the contents of pouches were sterile when<br>the processed pouches were subjected to the microbial aerosol<br>challenge test.<br>Burst: ability to withstand the internal pressurization was<br>maintained.<br>Peel open characteristics were maintained. | Meet ISO and<br>ASTM<br>requirements | | Material<br>Compatibility | Seal strength test, microbial barrier properties, burst test, and<br>peel open test were studied to demonstrate material<br>compatibility characteristics of the Tyvek<br>Sterilization Pouches | Pass | | Biocompatibility | Not direct patient-contacting devices;<br>Materials are non-toxic and meet ISO 11607-1 requirements;<br>Biological and residual evaluations meet acceptable criteria;<br>Provides reasonable assurance for safety | Pass | | Shelf Life | Physical properties and microbial barrier of the processed<br>Tyvek Pouches was verified at the end of shelf life of 5 years;<br>Stability demonstrates reasonable assurance for effectiveness | Pass | | Performance in the 6-hour Gas exposure in the EOGas 4 Ethylene Oxide Gas Sterilizer | | | | Sterilant<br>Penetration | EO penetrated the pouch under worst-case half-dose<br>conditions or a worst-case biological challenge, and<br>inactivated 6-Log biological indicators | Confirmed SAL<br>of 10-6 in 6-hour<br>gas exposures | | Maintenance of<br>Package<br>Sterility | Sterility was maintained for 6 months after processing in 6-<br>hour gas exposures in the EOGas 4 Ethylene Oxide Gas<br>Sterilizer. | Pass | {11}------------------------------------------------ # Conclusion The conclusions drawn from the nonclinical test demonstrate that the Tyvek Sterilization Pouches with Chevron Seal is as safe, as effective, and performs as well as or better than the legally marketed Tyvek Sterilization Pouches with Chevron Seal (K152058)