Tyvek Sterilization Pouches with Chevron Seal

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure in profile, with three faces overlapping to represent the department's focus on health and human well-being. The emblem is simple and modern in design. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 18, 2015 Andersen Sterilizers, Inc. William Andersen, BE, MD, FAAOS President 3154 Caroline Drive Haw River, North Carolina 27258 Re: K152058 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 20, 2015 Received: October 22, 2015 Dear Dr. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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, Erin I. Keith -S 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) K152058 Device Name Tyvek® Sterilization Pouches with Chevron Seal Indications for Use (Describe) The Tyyek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterlized in a single pouch configuration at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized below in Table 1. Table 1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer | EO Amount | Temperature | Relative Humidity | EO Exposure Time | Total Cycle Time | |-------------|-------------|-------------------|------------------|------------------| | 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 3 hours | 3.5 hours | The 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilize a load of up to 24 lbs of metal surgical instruments or 7 lbs of plastic devices (combined weight of pouched devices and tray). The product codes for Tyvek Sterilization Pouches are listed in Table 2. Table 2. Product codes for Tyvek Sterilization Pouches | Product Type | Self Seal | Heat Seal | Tubing | |---------------|-----------|-----------|-------------------------| | Product Codes | TLP-030 | TLP-031 | TLP-033 TLP-058 TLP-059 | 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. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ 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." {4}------------------------------------------------ # 510(k) Summary | 5.1 Applicant's Name and Address | Andersen Sterilizers, Inc.<br>3154 Caroline Drive<br>Haw River, NC 27258 | |---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | 5.2 Contact Person | William K. Andersen, BE, MD, FAAOS<br>President<br>Phone: 336-376-8622, Fax: 336-376-5428 | | 5.3 Date of Preparation | November 17, 2015 | | 5.4 Device<br>Proprietary Name<br>Common Name<br>Classification<br>Product Code | Tyvek® Sterilization Pouches with Chevron Seal<br>TLP-030, TLP-031, TLP-033, TLP-058, TLP-059<br>Sterilization Pouch<br>Class II (21 CFR 880.6850)<br>FRG | | 5.5 Predicate Device<br>Device Name<br>510(k) number<br>Manufacturer | Tyvek Sterilization Pouches with Chevron Seal<br>K831425<br>Amcor Flexibles | This 510(k) submission modifies the indications for use of the predicate device in order to include it as a component in the EOGas 4 ethylene oxide sterilization system. No modifications were made to the technology or intended use. ર : ર Device Description The Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous high-density polyethylene (HDPE) fibers, with front material consisting of a clear, laminated polyethylene terephthalate (PET) / low density polyethylene (LDPE) or LDPE-ethylene-vinylacetate copolymers (EVA) film. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 3 hour sterilization cycle at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer. Devices are inserted into the pouches and sealed. The self-seal pouch permits sealing of the pouch without heat-sealing equipment, while the heat sealed pouches are heat sealed prior to the cvcle. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days) or until used. The AN85/AN86 EO Indicators, when placed on the outside of the sterilization pouches, indicate ethylene oxide exposure and offer a convenient way to verify processing in the sterilization {5}------------------------------------------------ cycle. The color of the AN85/AN86 EO Indicators changes from yellow-green to blue after exposure to ethylene oxide. Indications for Use 5.7 The Tyvek Sterilization Pouches with Chevron Seal are intended to be used to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 5-1. Table 5-1. Critical parameters for the 3 hour cycle in the EOGas 4 Ethylene Oxide Gas Sterilizer | Ethylene Oxide | Temperature | Relative<br>Humidity | Ethylene Oxide<br>Exposure Time | Total Cycle<br>Time | |----------------|-------------|----------------------|---------------------------------|---------------------| | 17.6 g ± 5% | 50°C ± 3°C | 35-90% | 3 hours | 3.5 hours | The 3 hour cvcle in the EOGas 4 Ethylene Oxide Gas Sterilizer has been validated to sterilize a load of up to 24 lbs of metal surgical instruments or 7 lbs of plastic devices (combined weight of pouched devices and trav). The product codes for Tyvek Sterilization Pouches are listed in Table 5-2. | Product Type | Self-Seal | Heat Seal | Tubing | | | |---------------|-----------|-----------|---------|---------|---------| | Product Codes | TLP-030 | TLP-031 | TLP-033 | TLP-058 | TLP-059 | Table 5-2. Product codes for Tyvek Sterilization Pouches #### Device Comparison ર .8 The technological characteristics of the Tyvek Sterilization Pouches with Chevron Seal are identical to the predicate device - both are intended for the same use, use the same technology, and are designed in the same way. The Tyvek Sterilization Pouches with Chevron Seal differ from the predicate device in the sterilization cycles used. The difference raises no issues related to safety or effectiveness of the subject device in the sterilization cycle. A comparison between the devices is listed in Table 5-3. | Elements | Predicate Device: Tyvek<br>Sterilization Pouches | Subject Device: Tyvek Sterilization<br>Pouches | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K831425 | K152058 | | Intended Use | To enclose medical devices, allow<br>sterilization of the enclosed devices,<br>and maintain sterility of the enclosed<br>devices | Identical | | Indications for<br>Use | To be used in ethylene oxide<br>sterilization systems | The Tyvek Sterilization Pouches with<br>Chevron Seal are intended to be used to<br>enclose medical devices that are to be<br>sterilized in a single pouch configuration at<br>a healthcare facility. They are used in the 3<br>hour sterilization cycle at 50°C in the<br>EOGas 4 Ethylene Oxide Gas Sterilizer.<br>The 3 hour cycle in the EOGas 4 Ethylene<br>Oxide Gas Sterilizer has been validated to<br>sterilize a load of up to 24 lbs of metal<br>surgical instruments or 7 lbs of plastic<br>devices (combined weight of pouched<br>devices and tray). | | Design | Adhesive laminated film is a clear,<br>high strength material;<br>Uncoated Tyvek is compatible with<br>EO sterilization, resistant to microbial<br>penetration, and resistant to puncture | Identical | | Pouch Types | Self-seal pouch; Heat seal pouch; Heat<br>seal tubing | Identical | | Device<br>Construction | Self-seal and heat seal pouches: front<br>and back materials are heat sealed<br>together on three sides; fourth side<br>(end) remains open for filling; end is<br>sealed by heat (heat seal pouches) or<br>by removing protective liner strip,<br>folding along the pre-fold, and<br>pressing to the film (self-seal pouches).<br>Heat seal tubing: front and back<br>materials are heat sealed together on<br>two sides; two ends are open for<br>selecting size and filling; ends are<br>sealed by heat. | Identical | | Materials | Clear laminated PET/LDPE or LDPE-<br>EVA film (front) and uncoated HDPE<br>Tyvek (back) | Identical | | Configuration in<br>Load | Single pouch configuration | Identical | | Shelf Life | 5 years from date of manufacture | Identical | | Biocompatibility | Materials and biological evaluations<br>(Agar Diffusion Test, Cytotoxicity<br>Test) meet ISO 11607-1 requirements | Materials and biological evaluations (Agar<br>Diffusion Test, Cytotoxicity Test) meet<br>ISO 11607-1 requirements | | Maintenance of<br>Sterility | Tyvek pouches are capable of<br>maintaining sterility for at least 5 years | Sterility is maintained for at least 3 months<br>(90 days) after processing in an EOGas 4 sterilizer | | Aeration Time | ≥ 6 hours | ≥ 6 hours | | Package Integrity | Seal strength, microbial barrier, burst,<br>and peel open characteristics meet ISO<br>and ASTM requirements | Seal strength, microbial barrier, burst, and<br>peel open characteristics meet ISO and<br>ASTM requirements | Table 5-3. Device Comparison {6}------------------------------------------------ Г {7}------------------------------------------------ ### 5.9 Performance Testing Performance testing was conducted to show that the Tyvek Sterilization Pouches with Chevron Seal perform as intended to allow sterilization of the enclosed medical device. Sterilization efficacy testing demonstrated a 12-Log reduction and a sterility assurance level of 10° using the overkill method and half cycle or half dose validation methods under worst case conditions. The Tyvek Sterilization Pouches with Chevron Seal also maintain sterility of the enclosed device as intended. Shelf life studies demonstrated sterility maintenance for up to 5 years after completion of an ethylene oxide sterilization process. The performance of the Tyvek Sterilization pouches is summarized in Table 5-4. | Table 5-4. Summary of bench tests performed to demonstrate safety and effectiveness of the | | | | |--------------------------------------------------------------------------------------------|--|--|--| | Tyvek Sterilization Pouches | | | | | Test | Description | Results | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Compliance to ISO 11607-1 | | | | Package<br>Integrity | Seal strength performance characteristics were<br>maintained for the manufactured seal.<br>Microbial Barrier: the contents of pouches were sterile<br>when the processed pouches were subjected to the<br>microbial aerosol challenge test.<br>Burst: ability to withstand the internal pressurization<br>was maintained.<br>Peel open characteristics were maintained. | Meet ISO and ASTM<br>requirements | | Material<br>Compatibility | Seal strength test, microbial barrier properties, burst<br>test, and peel open test were studied to demonstrate<br>material compatibility characteristics of the Tyvek<br>Sterilization Pouches | Pass | | Biocompatibility | Not direct patient-contacting devices;<br>Materials are non-toxic, FDA compliant, and meet<br>ISO 11607-1 requirements;<br>Biological evaluations meet acceptable criteria;<br>Provides reasonable assurance for safety | Pass | | Shelf Life | Physical properties and microbial barrier of the<br>processed Tyvek Pouches was verified at the end of<br>shelf life of 5 years;<br>Stability demonstrates reasonable assurance for<br>effectiveness | Pass | | Performance in the EOGas 4 Cycle | | | | Sterilant<br>Penetration | The sterilant penetrated the pouch under worst case<br>half-dose conditions and inactivated 6-Log biological<br>indicators | Allow a sterility assurance<br>level of 10-6 for the<br>sterilization cycle | | Maintenance of<br>Package<br>Integrity | Sterility was maintained for at least 3 months<br>(90 days) after the EOGas 4 processing. | Pass | {8}------------------------------------------------ ### 5.10 Conclusion Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject Tyvek Sterilization Pouches with Chevron Seal is substantially equivalent to the predicate device - Tyvek Sterilization Pouches with Chevron Seal (K831425).