Steriking LT-Blueline Pouches with Tyvek

K221379 · Wipak OY · FRG · Jan 4, 2023 · General Hospital

Device Facts

• Record ID: K221379
• Device Name: Steriking LT-Blueline Pouches with Tyvek
• Applicant: Wipak OY
• Product Code: FRG · General Hospital
• Decision Date: Jan 4, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-PRO® Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.

Device Story

Steriking® LT-Blueline Pouches with Tyvek® are single-use sterilization pouches used by healthcare workers to enclose medical instruments. The pouches consist of a plastic film and Tyvek® backing, heat-sealed on three sides; the fourth side is heat-sealed by the user after inserting the device. The pouches are placed in STERIS® V-PRO® Sterilizer Systems (Lumen, Non-Lumen, or Flexible cycles) for terminal sterilization. The Tyvek® material allows sterilant penetration while acting as a microbial barrier. After processing, the pouch maintains the sterility of the enclosed instruments for up to 3 years. The device is used in clinical settings to ensure instrument sterility until the point of use, where the clinician opens the seal to retrieve the device.

Clinical Evidence

Bench testing only. Testing included sterilant penetration (AAMI TIR12), biocompatibility (ISO 10993-5), package integrity (ISO 11607), and microbial barrier properties (aerosol challenge). Results confirmed 6-log reduction of Geobacillus stearothermophilus, no cytotoxic effects, and maintenance of sterility post-accelerated aging (3 years).

Technological Characteristics

Materials: Tyvek® and plastic film (BOPET/PE). Construction: Heat-sealed pouch. Sterilization: Compatible with STERIS® V-PRO® (Lumen, Non-Lumen, Flexible cycles). Standards: ISO 11607, ISO 10993-5, ASTM F88 (seal strength), ASTM F1929 (dye migration), ASTM F1980 (accelerated aging). Connectivity: None.

Indications for Use

Indicated for healthcare workers to enclose medical devices for sterilization in STERIS® V-PRO® Sterilizer Systems (Lumen, Non-Lumen, and Flexible cycles). Supports specific lumen dimensions and weight limits. Maintains sterility for up to 3 years post-sterilization. Single-use only.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Sterilization Pouch/Roll Made With Tyvek® (K180672)

Submission Summary (Full Text)

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January 4, 2023

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Wipak OY % Amanda Singleton Consultant Compliance Systems International 53 Assembly Drive, Unit 149 Mendon, New York 14506

Re: K221379

Trade/Device Name: Steriking LT-Blueline Pouches with Tyvek Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 27, 2022 Received: December 27, 2022

### Dear Amanda Singleton:

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 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

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Colin O'neill -S

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221379

Device Name Steriking® LT-Blueline Pouches with Tyvek®

Indications for Use (Describe)

The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-PRO® Sterilizer Systems.

The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.

The Steriking® LT-Blueline Pouches with Tyvek® are intended for use in the following STERIS® V-PRO® Sterilization Cycles:

Lumen Cycle Non Lumen Cycle Flexible Cycle

Device lumen dimensions:

Flexible Cycle: 1 lumen x 1 mm min ID x 1050 mm max length for all pouch sizes.

Lumen Cycle: 1 lumen x 1 mm min ID for all pouch sizes. For pouch sizes 250x500mm, 250x390mm, 205x390mm, max length of 125 mm. For all other pouch sizes, max length of 50 mm.

Max Weights: 1.410 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm

.114 pounds for pouch sizes below (Flexible and Lumen Cycles) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm

.158 pounds for pouch sizes below (Non-Lumen Cycle) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm

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Pouch Sizes: 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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K221379 Page 1 of 7

# 5. 510K Summary (in accordance with 21CFR807.92)

| 510K Summary elements per<br>21CFR807.92 | Summary |
|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's name, address, telephone<br>number, a contact person, and the date the<br>summary was prepared | Wipak Oy<br>Wipaktie 2<br>Nastola Finland<br>Contacts:<br>Hanna Marttila Phone: [phone]<br>Consultant: Amanda Singleton, CSI LLC. Phone: [phone]<br>53 Assembly Drive, Unit 149, Mendon, NY 14506<br>Date prepared: January 4, 2023 |
| Name of the device including<br>the trade or proprietary name<br>if applicable | Proprietary Name: Steriking® LT-Blueline Pouches with Tyvek® |
| Common or usual name | Common Name: Peel Pouch |
| Classification name | Classification Name: Sterilization wrap |
| Classification Product Code<br>Device Classification<br>Regulation Number | FRG<br>Class II<br>21 CFR 880.6850 |
| Identification of the legally<br>marketed device to which<br>the submitter claims<br>equivalence (Primary<br>Predicate device) | K180672, Sterilization Pouch/Roll Made With Tyvek® |
| Description of the device | Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain<br>medical devices to be terminally sterilized in the STERIS® Sterilization System. The<br>medical devices are inserted into the Pouch, sealed, and then sterilized in the<br>STERIS® Sterilization System. Sterilization Cycles are noted below. After<br>completion of the sterilization process, the Pouch maintains sterility of the<br>enclosed medical devices until the seal is opened. These pouches are made from<br>a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left<br>opened and will be heat-sealed when used.<br><br>Steriking® LT-Blueline Pouches with Tyvek® are intended to allow sterilization of<br>enclosed devices and to maintain sterility of the enclosed devices until used up<br>to 3 years post sterilization. The products are for single use only.<br><br>The pouches are constructed from Tyvek®/plastic films. The heat-sealed pouches<br>are heat sealed prior to processing in the STERIS® V-PRO® Sterilization Systems.<br><br>Sterilization Systems:<br><br>STERIS® V-PRO® Cycles:<br>Lumen Cycle,<br>Non Lumen Cycle |

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| | Flexible Cycle | | | | mm. For all other pouch sizes, max<br>length of 50 mm.<br><br>Max Weights:<br>1.410 pounds for pouch sizes<br>below (Flexible, Lumen, and Non-<br>Lumen Cycles)<br>250 mm x 500 mm<br>250 mm x 390 mm<br>205 mm x 390 mm<br><br>.114 pounds for pouch sizes<br>below (Flexible and Lumen<br>Cycles)<br>160 mm x 600 mm<br>160 mm x 440 mm<br>150 mm x 300 mm<br>100 mm x 250 mm<br>75 mm x 200 mm<br><br>.158 pounds for pouch sizes<br>below (Non-Lumen Cycle)<br>160 mm x 600 mm<br>160 mm x 440 mm<br>150 mm x 300 mm<br>100 mm x 250 mm<br>75 mm x 200 mm<br><br>Flat Sterilization Pouch Sizes:<br>75 x 200 mm<br>100x 250 mm<br>150 x 300 mm<br>160 x 440 mm<br>160 x 600 mm<br>205 x 390 mm<br>250 x 390 mm<br>250 x 500 mm | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended use of the device | The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health<br>care workers with an effective method to enclose devices intended for<br>sterilization in the STERIS® V-PRO® Sterilizer Systems.<br><br>The device is intended to allow sterilization of enclosed devices and to maintain<br>sterility of the enclosed devices until used up to 3 years post sterilization. | | Design | These pouches are made from a<br>plastic film and Tyvek that is heat<br>sealed on three sides. The fourth<br>side is left opened and will be<br>heat-sealed when used. | Same | These pouches are made from a<br>medical grade plastic film that is<br>heat sealed on three sides. The<br>fourth side is left opened and will<br>be heat-sealed when used. | |
| Technological<br>characteristics compared<br>to predicate (as<br>follows) | See below as follows: | | Backing Material | Tyvek® | Same | Tyvek® | |
| Discussion of nonclinical tests<br>submitted, referenced, or<br>utilized in the premarket<br>notification submission for a<br>determination of substantial<br>equivalence | Submission Device –<br>Steriking® LT-Blueline Pouches<br>with Tyvek® | SE<br>Determination | Predicate Device –<br>K180672 –<br>Sterilization Pouch/Roll Made With<br>Tyvek | Transparent Film | BOPET/PE | Same | PE |
| Indications for Use | The Steriking® LT-Blueline Pouches<br>with Tyvek® are intended to<br>provide health care workers with an<br>effective method to enclose devices<br>intended for sterilization in the<br>STERIS® V-PRO® Sterilizer Systems.<br><br>The device is intended to allow<br>sterilization of enclosed devices and<br>to maintain sterility of the enclosed<br>devices until used up to 3 years<br>post sterilization. The products are<br>for single use only.<br><br>The Steriking® LT-Blueline Pouches<br>with Tyvek® are intended for use in<br>the following STERIS® V-PRO®<br>Sterilization Cycles:<br>Lumen Cycle<br>Non Lumen Cycle<br>Flexible Cycle<br><br>Device lumen dimensions:<br>Flexible Cycle: 1 lumen x 1 mm min<br>ID x 1050 mm max length for all<br>pouch sizes.<br><br>Lumen Cycle: 1 lumen x 1 mm min<br>ID for all pouch sizes. For pouch<br>sizes 250x500mm, 250x390mm,<br>205x390mm, max length of 125 | Similar | The Sterilization Pouch/Roll<br>Made with Tyvek® are intended<br>to provide health care workers<br>with an effective method to<br>enclose devices intended for<br>sterilization in the STERRAD ®<br>100S Sterilizer. The device is<br>intended to allow sterilization of<br>enclosed devices and also to<br>maintain sterility of the<br>enclosed devices until used up<br>to 3 years post sterilization. The<br>pouches and rolls are printed<br>with a chemical indicator bar<br>which is a process indicator (ISO<br>11140-1:2005) that changes<br>from red to blue (or lighter)<br>when exposed to hydrogen<br>peroxide vapor during<br>processing in the STERRAD®<br>100S Sterilizer. The Sterilization<br>Pouch/Roll Made with Tyvek® is<br>offered in the follow 5 types:<br>Self-sealing sterilization pouches<br>Sterilization pouches, Flat<br>Sterilization pouches, Gusseted<br>Sterilization rolls, Flat<br>Sterilization rolls, Gusseted | Sterilization Processes | H2O2 Sterilization Process as per:<br><br>STERIS® V-PRO®<br>Lumen Cycle<br>Non-Lumen Cycle | Similar | H2O2 Sterilization Process as per:<br><br>STERRAD® 100S |

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| | Flexible Cycle | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------------------------------------------------|
| Sterilant<br>Validation<br>AAMI TIR12:2010<br>ANSI/AAMI ST79<br>ANSI/AAMI/ISO 14937:2009<br>ANSI/AAMI/ISO 17664:2017 | Achieved a 10-6 Sterility Assurance<br>Level (SAL) of Geobacillus<br>stearothermophilus.<br><br>V-Pro® MAX and Max 2 Flexible<br>Cycle<br><br>V-Pro® 1 Plus Lumen Cycle<br><br>V-Pro® 1 Plus Non-Lumen Cycle | Similar | Showed a 6 log reduction of<br>Geobacillus stearothermophilus. |
| Dye Migration<br><br>ISO 11607<br>ASTM F1929<br>AAMI TIR12:2010 | No leaks detected after dye<br>migration | Same | No leaks detected after dye<br>migration |
| Seal Strength<br><br>ASTM F88<br>AAMI TIR12:2010<br>AAMI/ISO TIR16775:2014<br>ISO 11607 | > 1.5N/15mm per ASTM F88 | Same | > 1.5N/15mm per ASTM F88 |
| Microbial Barrier<br>Properties<br><br>ISO 11607-1<br>AAMI TIR12:2010<br>ANSI/AAMI ST79:2017 | Pass<br><br>Each pouch met the sterility<br>maintenance requirement as there<br>was no growth in any of the culture<br>tubes containing the stainless-steel<br>coupons at the end of the<br>incubation period. | Similar | Pass |
| Biocompatibility | Pass<br>ISO 10993-5 | Similar | Pass<br>ISO 10993-12 |
| Shelf-Life Pre-Sterilization<br><br>ASTM F1929-15<br>ASTM F88 | 5 years | Similar | 3 years |
| Maintenance of Sterility –<br>Accelerated Aging<br><br>ANSI/AAMI ST8:2013/(R)2018<br>AAMI TIR12:2010<br>ANSI/AAMI ST77:2017<br>ANSI/AAMI ST79:2017<br>ISO 11607-1<br>ASTM F1980<br>ASTM F1929-15<br>ASTM F88 | 3 years | Same | 3 Years |

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| | Dimensions and max load weight | | | | | Similar | Not Listed |
|--|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------|-----------|------------|------------|
| | | | | Non- | | | |
| | | Flexible Cycle | Lumen Cycle | Lumen Cycle | | | |
| | Pouch size | max weight (pounds) | | | | | |
| | 250 x 500 mm | 1.410 | 1.410 | 1.410 | | | |
| | 250 x 390 mm | 1.410 | 1.410 | 1.410 | | | |
| | 205 x 390 mm | 1.410 | 1.410 | 1.410 | | | |
| | 160 x 600 mm | 0.114 | 0.114 | 0.158 | | | |
| | 160 x 440 mm | 0.114 | 0.114 | 0.158 | | | |
| | 150 x 300 mm | 0.114 | 0.114 | 0.158 | | | |
| | 100 x 250 mm | 0.114 | 0.114 | 0.158 | | | |
| | 75 x 200 mm | 0.114 | 0.114 | 0.158 | | | |
| | Max Lumen Dimensions | Flexible Cycle: 1 lumen x 1 mm min<br>ID x 1050 mm max length for all<br>pouch sizes. | | | Different | Not Listed | |
| | | Lumen Cycle: 1 lumen x 1 mm min<br>ID for all pouch sizes. For pouch<br>sizes 250x500mm, 250x390mm,<br>205x390mm, max length of 125<br>mm. For all other pouch sizes, max<br>length of 50 mm. | | | | | |

#### Summary of Non-Clinical Testing

The Steriking® LT-Blueline Pouches with Tyvek® (submission device) has the identical intended use and indications for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, and Sterility Maintenance. The results of the Steriking® LT-Blueline Pouches with Tyvek® validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:

- . The Sterilant Penetration testing performed as described in AAMI / ANSI / ISO 14937:2009, "Sterilization of Health Care Products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices". The results confirm that the sterilant is able to penetrate Steriking® LT-Blueline Pouches with Tyvek® and sustain direct contact with the medical instrument inside the subject device.
- . The Biocompatibility testing performed as described in ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity. The testing results demonstrate the Steriking® LT-Blueline Pouches with Tyvek® did not elicit any cytotoxic effect.
- The Package Integrity, Material Compatibility, Sterility Maintenance, and Microbial Aerosol Challenge testing was performed as described in ISO 11607. The use of the aerosol challenge test to analyze the microbial barrier properties of the samples was considered to be rigorous. By exposing the sealed test samples' exterior with aerosolized spores, the permeability of the samples to microorganisms was challenged. A sample which demonstrates that all items remain sterile following this test is considered safe and effective at maintaining package integrity. The use of stainless-steel coupons was based on several considerations. First, they offer a convenient way to identify specific pieces to be sterility tested and to confirm that samples were indeed in the specified locations. Second, coupons are relatively easy to manipulate, and reduces the likelihood of the introduction of adventitious growth into the sterility test results. Finally, the coupons are comprised of metals consistent with metals used to manufacture medical instruments.

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| Test Methodology | Purpose | Acceptance Criteria | Results |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-5 Biological Evaluation of medical<br>devices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | no reduction of cell growth<br>or cell lysis was observed | Pass |
| AAMI TIR12:2010 - Designing, testing, and<br>labeling reusable medical devices for<br>reprocessing in health care facilities | Sterilant Penetration | Demonstrating that a<br>minimum of 1.0x10^6<br>Geobacillus<br>stearothermophilus spores<br>were killed in a half-cycle (6-<br>log reduction) | Pass<br>Negative for growth |
| ASTM F1929-15: Standard test method for<br>detecting seal leaks in porous medical<br>packaging by dye migration | Package Integrity | Dye Penetration: none | Pass |
| ANSI/AAMI ST79:2017 - Comprehensive guide<br>to steam sterilization and sterility assurance<br>in health care facilities<br>AAMI TIR12:2010 - Designing, testing, and<br>labeling reusable medical devices for<br>reprocessing in health care facilities | Microbial Barrier Properties | A sample which<br>demonstrates that all items<br>remain sterile following<br>exposure | Pass<br>Each pouch met the<br>sterility maintenance<br>requirement as there<br>was no growth in any<br>of the culture tubes<br>containing the<br>stainless-steel<br>coupons at the end if<br>the incubation period. |
| ASTM F1929-15: Standard test method for<br>detecting seal leaks in porous medical<br>packaging by dye migration<br>ASTM F88: Standard Test Method for Seal<br>Strength of Flexible Barrier Materials | Shelf Life Pre Sterilization | Dye Penetration: none<br>Seal peel: =/>1.5N/15mm | Pass |
| ASTM F1980 – 16 Standard Guide for<br>Accelerated Aging of Sterile Barrier Systems<br>for Medical Devices<br>ASTM F1929-15: Standard test method for<br>detecting seal leaks in porous medical<br>packaging by dye migration<br>ASTM F88: Standard Test Method for Seal<br>Strength of Flexible Barrier Materials | Shelf Life Post Sterilization | Dye Penetration: none<br>Seal peel: =/>1.5N/15mm | Pass |
| 1. ASTM F1608, ASTM F2638 - Microbial<br>Barrier 2. ASTM D3776 - Basis Weight of Tyvek 3. ASTM D2724 - Delamination of Tyvek 4. TAPPI T460 - Gurly Hill porosity of Tyvek 5. ISO 1924-2 - Tensile Strength, MD of Tyvek 6. ISO 1924-2 - Elongation, MD of Tyvek 7. ASTM D1424 - Elmendorf Tear, MD of<br>Tyvek 8. ISO 534 - Thickness of Tyvek 9. ISO 5636-3 - Bendtsen air permeability of<br>Tyvek 10. TAPPI T523 - Moisture vapor transmission<br>Rate of Tyvek 11. ISO 2758 - Mullen, burst of Tyvek 12. ASTM D3420 - Spencer puncture of Tyvek | Material Compatibility | Meets specifications per<br>Technical Data Sheets.<br>Included in Bench Testing<br>Summary. | Pass |

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K221379 Page 7 of 7

## Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K180672.