Tyvek Roll with CI for STERLINK Sterilizer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". May 9, 2023 Plasmapp Co., Ltd. % Candace Cederman Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401 Re: K223025 Trade/Device Name: Tyvek Roll with CI for STERLINK Sterilizer Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG. JOJ Dated: April 7, 2023 Received: April 10, 2023 Dear Candace Cederman: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ 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) 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, Christopher K. Dugard -2 for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223025 Device Name Tyvek® Roll with CI for STERLINK™ Sterilizer #### Indications for Use (Describe) Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in pouch plus mode and chamber mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization. The maximum load weight that can be placed in the Tyvek® roll is 1 lb (450g) for pouch plus mode and 3.97 bs (1.8kg) for chamber mode. The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2015) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer. The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the following one type: · Sterilization roll, Flat Type of Use (Select one or both, as applicable) | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------|-----------------------------------------------------------| |------------------------------------------------------------|-----------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.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." {3}------------------------------------------------ 510(k) Summary - K223025 ### 1. General Information | Applicant/Submitter: | Plasmapp Co., Ltd.<br>BVC-111, 125, Gwahak-ro,<br>Yuseong-gu, Daejeon, 34141,<br>Rep. of Korea (South Korea)<br>Tel: +82 (0)42 716 2115 | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Candace Cederman | | Address: | CardioMed Device Consultants LLC<br>1783 Forest Drive<br>Suite 254<br>Annapolis, MD 21401<br>Tel: +1 410 674 2060 | | Preparation Date: | May 9, 2023 | ### 2. Device Name and Code | Device Trade Name: | Tyvek® Roll with CI for STERLINK™ Sterilizer | |----------------------|----------------------------------------------| | Common Name: | Tyvek® Roll for VH2O2 Sterilizer | | Classification Name: | 1) Sterilization Wrap | | | 2) Sterilization Process Indicator | | Product Code: | 1) FRG | | | 2) JOJ | | Regulation Number: | 1) 21 CFR 880.6850 | | | 2) 21 CFR 880.2800 | | Classification: | Class II | | Review Panel: | General Hospital | ### 3. Indications / Intended Use Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in pouch plus and chamber mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization. The maximum load weight that can be placed in the Tyvek® roll is 1 1b (450 g) for pouch plus mode and 3.97 lbs (1.8 kg) for chamber mode. {4}------------------------------------------------ The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer. The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow one type: - Sterilization roll. Flat . # 4. Device Description Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization. The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer. The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2). # 5. Technical Characteristics in Comparison to the Predicate Device The proposed subject device uses identical technology as the cited predicate device and has the same intended uses. Based upon the overall performance characteristics for the sterilization wrap and process indicator used with the pouch plus mode of the STERLINK™ FPS-15s Plus sterilizer, Plasmapp Co., Ltd. believes that no significant differences in usage of its underlying technological principles between subject and predicate devices. A summary of the technical characteristics of the subject device and predicate device can be found in the table below. | | Subject Device | Predicate Device | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Sponsor | Plasmapp Co., Ltd. | Same | | Manufacturer | Sigma Medical Supplies Corp. | Same | | Device Name | Tyvek® Roll with CI for STERLINK™<br>Sterilizer | Same | | 510(k) Number | - | K212198 | | Device Classification<br>Name | 1) Sterilization Wrap<br>2) Sterilization Process Indicator | Same | | Classification Product<br>Code | 1) FRG<br>2) JOJ | Same | | | Subject Device | Predicate Device | | Regulation Number | 1) 21 CFR 880.6850<br>2) 21 CFR 880.2800 | Same | | | Tyvek® Roll with CI for STERLINK™<br>Sterilizer, when used in pouch plus and<br>chamber mode, is intended to provide health<br>care workers with an effective method to<br>enclose devices intended for sterilization in<br>the STERLINK™ sterilizer. The device is<br>intended to allow sterilization of enclosed<br>devices and also to maintain sterility of the<br>enclosed devices until used up to 1 month<br>post sterilization. | Tyvek® Roll with CI for STERLINK™<br>Sterilizer, when used in CHAMBER mode,<br>is intended to provide health care workers<br>with an effective method to enclose devices<br>intended for sterilization in the<br>STERLINK™ sterilizer. The device is<br>intended to allow sterilization of enclosed<br>devices and also to maintain sterility of the<br>enclosed devices until used up to 1 month<br>post sterilization. | | Intended Use | The maximum load weight that can be<br>placed in the Tyvek® roll is 1 lb (450 g) for<br>pouch plus mode and 3.97 lbs (1.8 kg) for<br>chamber mode. | The maximum load weight that can be<br>placed in the Tyvek® roll is 3.97lbs (1.8kg). | | | The roll is printed with a chemical indicator<br>bar which is a process indicator (ISO 11140-<br>1:2005) that changes from red to blue (or<br>lighter) when exposed to hydrogen peroxide<br>vapor during processing in the<br>STERLINK™ sterilizer. | The roll is printed with a chemical indicator<br>bar which is a process indicator (ISO 11140-<br>1:2005) that changes from red to blue (or<br>lighter) when exposed to hydrogen peroxide<br>vapor during processing in the<br>STERLINK™ sterilizer. | | | The Tyvek® Roll with CI for STERLINK™<br>Sterilizer is offered in the follow one type:<br>• Sterilization roll, Flat | The Tyvek® Roll with CI for STERLINK™<br>Sterilizer is offered in the follow one type:<br>• Sterilization roll, Flat | | Pouch Types | The subject device includes a subset of the<br>predicate device types:<br>Sterilization roll, Flat | Same | | Device models<br>(Configurations<br>/Dimensions) | Sterilization Roll, Flat | | | | Model<br>FR400100 | Same | | | Dimensions<br>400 mm × 100 M | | | Material Composition | Tyvek®, PET, PE, Water, CH3COOH,<br>Alcohol, n-Heptane adhesive, Hydrogen<br>peroxide vapor Process Indicator Print Ink | Same | | Sterilization Cycle | STERLINK™ FPS-15s Plus - Pouch plus<br>mode (overall cycle: 14 minutes) | | | | STERLINK™ FPS-15s Plus - Chamber<br>mode (overall cycle: 36 minutes) | STERLINK™ FPS-15s Plus - Chamber<br>mode (overall cycle: 36 minutes) | | Design Feature | Sterilization roll, Flat: This roll is made<br>from a Tyvek® and plastic film that are heat<br>sealed on opposite two sides. It will be cut<br>into the suitable length and the opened sides<br>will be heat-sealed. The indicators printed on<br>the Tyvek® are the same with the self-sealing<br>sterilization roll. | Same | | Chemical Indicator<br>Device Design | The color of the Chemical Indicator changes<br>from red to blue (or lighter) when exposed to<br>hydrogen peroxide. | Same | {5}------------------------------------------------ ## Tyvek® Roll with CI for STERLINK™ Sterilizer 510(k) Summary - K223025 {6}------------------------------------------------ ## 6. Summary of Non-Clinical Testing The Tyvek® Roll with CI for STERLINK™ Sterilizer has the identical intended use and indication for use as the predicate device. Testing of the roll material was previously conducted on the predicate K212198. The identical materials are used in the Tyvek® Roll with CI for STERLINK™ Sterilizer. | | Performance Testing | Standard | Result | |------------------------------------------------------|-----------------------------------------|---------------------------------------|--------| | Sterilant<br>Penetration | Sterilization efficacy test | ISO 14937 | Pass | | | CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass | | Shelf-life | Internal pressurization test | ASTM F1980-16<br>ASTM F1140/F1140M-13 | Pass | | | Visual inspection test | ASTM F1980-16<br>ASTM F1886/F1886M-16 | Pass | | | Dye penetration test | ASTM F1980-16<br>ASTM F1929-15 | Pass | | | Tensile strength of Tyvek® | ASTM F1980-16<br>ASTM D5035-11 | Pass | | | Tensile strength of plastic film | ASTM F1980-16<br>ASTM D882 | Pass | | | Seal strength | ASTM F1980-16<br>ASTM F88 | Pass | | | Tear resistance | ASTM F1980-16<br>ASTM D1922-20 | Pass | | | Microbial Barrier Test | ASTM F1980-16<br>DIN 58953-6 | Pass | | | CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass | | Toxicological Properties<br>(Biocompatibility Tests) | | ISO 10993-5 | Pass | | | Residual sterilant on Tyvek® validation | Internal test standard | Pass | ## 7. Conclusions The conclusions drawn from the non-clinical tests demonstrates that the subject device in the 510(k) submission, the Tyvek® Roll with CI for STERLINK™ Sterilizer, is as safe, as effective, and performs as well or better than the legally marketed predicate device cleared under K212198.