SteriKing LT-Blueline Pouches with Tyvek

K221377 · Wipak OY · FRG · Dec 22, 2022 · General Hospital

Device Facts

• Record ID: K221377
• Device Name: SteriKing LT-Blueline Pouches with Tyvek
• Applicant: Wipak OY
• Product Code: FRG · General Hospital
• Decision Date: Dec 22, 2022
• 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 STERRAD® 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 packaging for medical devices. Constructed from plastic film (BOPET/PE) and Tyvek® heat-sealed on three sides; the fourth side is sealed by the user. Used in healthcare facilities to enclose instruments prior to processing in STERRAD® hydrogen peroxide gas plasma sterilization systems. After sterilization, the pouch maintains the sterility of the enclosed devices until use. The device provides a microbial barrier and allows sterilant penetration. Healthcare workers use the pouches to organize and protect instruments during and after the sterilization cycle. Benefits include maintaining instrument sterility for up to 3 years post-sterilization.

Clinical Evidence

Bench testing only. No clinical data. Testing included: Biocompatibility (ISO 10993-5), Sterilant Penetration (AAMI TIR12:2010), Package Integrity (ASTM F1929-15), Microbial Barrier Properties (ANSI/AAMI ST79:2017), Seal Strength (ASTM F88), and Shelf-Life/Accelerated Aging (ASTM F1980-16). All tests passed, confirming 6-log reduction of Geobacillus stearothermophilus and maintenance of sterility.

Technological Characteristics

Materials: Tyvek® backing, BOPET/PE transparent film. Construction: Heat-sealed pouch. Sterilization: Hydrogen peroxide gas plasma (STERRAD®). Standards: ISO 11607, ASTM F1929, ASTM F88, ISO 10993-5, AAMI TIR12, ANSI/AAMI ST79. Connectivity: None. Software: None.

Indications for Use

Indicated for healthcare workers to enclose medical devices for sterilization in STERRAD® Sterilizer Systems (NX Standard, NX Advanced, 100NX Duo, 100NX Flex, 100NX Standard). Maintains sterility for up to 3 years. 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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December 22, 2022

Image /page/0/Picture/1 description: The image shows 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

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

Re: K221377

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: November 29, 2022 Received: November 29, 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

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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 (OS) 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,

# Anne D. Talley -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)

#### K221377

Device Name SteriKing® LT Blueline Pouch with Tyvek®

Indications for Use (Describe)

The SteriKing® LT Blueline with Tyvek® pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 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 with Tyvek® pouches are intended for use in the following STERRAD® Sterilization Cycles:

NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard

Max weights:

NX Standard Cycle:

75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 088 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.382 pounds

NX Advanced Cycle:

75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 084 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.393 pounds

100NX Duo Cycle: 75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm : 104 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds

100NX Flex Cycle: 75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds

100NX Standard Cycle: 75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm: .158 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 4.476 pounds

Max lumens:

1 mm min ID and 1 max lumen for all cycles

NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes.

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NX Advanced Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length is 50 mm for all other pouch sizes.

100NX Duo Cycle: For pouch sizes 250x500mm, 250x390mm is 875 mm max length. Max length is 850 mm for all other pouch sizes.

100NX Flex Cycle: Max length is 850 mm for all pouch sizes.

100NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length, Max length is 50 mm for all other pouch sizes.

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

| 510K Summary Elements per<br>21CFR807.92 | Summary |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's name, address, telephone number, a contact person, and the date the summary was prepared | Wipak Oy<br>Wipaktie 2<br>Nastola Finland<br>Contact: Hanna Marttila Phone: [phone]<br>Date prepared: December 21, 2022<br>Consultant: Amanda Singleton, CSI LLC. Phone: [phone] |
| Name of the device including the trade or proprietary name 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 marketed device to which the submitter claims equivalence<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 medical devices to be terminally sterilized in the STERRAD® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERRAD® Sterilization System. Sterilization Cycles are noted below. After completion of the sterilization process, the Pouch maintains sterility of the enclosed medical devices until the seal is opened. These pouches are made from a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left opened and will be heat-sealed when used.<br><br>Steriking® LT-Blueline Pouches with Tyvek® are 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.<br><br>The pouches are constructed from Tyvek®/plastic films. The heat-sealed pouches are heat sealed prior to processing in the STERRAD® Sterilization Systems.<br><br>Sterilization Systems:<br><br>STERRAD® Cycles:<br>NX Standard<br>NX Advanced<br>100NX Duo<br>100NX Flex<br>100NX Standard |

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| Intended use of the device<br>Technological<br>characteristics<br>compared to predicate<br>(as<br>follows) | The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide<br>health care workers with an effective method to enclose devices intended for<br>sterilization in the STERRAD® Sterilizer Systems.<br><br>The device is intended to allow sterilization of enclosed devices and to<br>maintain sterility of the enclosed devices until used up to 3 years post<br>sterilization.<br><br>See below as follows: | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion of nonclinical<br>tests submitted, referenced,<br>or 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 Determination | Predicate Device -<br>K180672 -<br>Sterilization Pouch/Roll Made<br>With Tyvek |
| Indications for Use | The SteriKing® LT Blueline with<br>Tyvek® pouches are intended to<br>provide health care workers<br>with an effective method to<br>enclose devices intended for<br>sterilization in the STERRAD®<br>Sterilizer Systems.<br><br>The device is intended to allow<br>sterilization of enclosed devices<br>and to maintain sterility of the<br>enclosed devices until used up<br>to 3 years post sterilization. The<br>products are for single use only.<br><br>The SteriKing® LT Blueline with<br>Tyvek® pouches are intended for<br>use in the following STERRAD®<br>Sterilization Cycles:<br><br>NX Standard<br>NX Advanced<br>100NX Duo<br>100NX Flex<br>100NX Standard<br><br>Max weights:<br><b>NX Standard Cycle:</b><br>75 mm x 200 mm, 100 mm x 250<br>mm, 150 mm x 300 mm, 160<br>mm x 440 mm, 160 mm x 600<br>mm: .088 pounds | Similar | The Sterilization<br>Pouch/Roll Made with<br>Tyvek® are intended to<br>provide health care<br>workers with an effective<br>method to enclose<br>devices intended for<br>sterilization in the<br>STERRAD® 100S Sterilizer.<br><br>The device is intended to<br>allow sterilization of<br>enclosed devices and also<br>to maintain sterility of the<br>enclosed devices until<br>used up to 3 years post<br>sterilization. The pouches<br>and rolls are printed with<br>a chemical indicator bar<br>which is a process<br>indicator (ISO 11140-<br>1:2005) that changes from<br>red to blue (or lighter)<br>when exposed to<br>hydrogen peroxide vapor<br>during processing in the<br>STERRAD® Sterilizer. The<br>Sterilization Pouch/Roll<br>Made with Tyvek® is<br>offered in the follow 5<br>types: Self-sealing<br>sterilization pouches<br>Sterilization pouches, Flat<br>Sterilization pouches,<br>Gusseted Sterilization |

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| 390 mm, 250 mm x 500 mm:<br>1.382 pounds | rolls, Flat Sterilization<br>rolls, Gusseted |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| NX Advanced Cycle:<br>75 mm x 200 mm, 100 mm x 250<br>mm, 150 mm x 300 mm, 160<br>mm x 440 mm, 160 mm x 600<br>mm: .084 pounds | |
| 205 mm x 390 mm, 250 mm x<br>390 mm, 250 mm x 500 mm:<br>1.393 pounds | |
| 100NX Duo Cycle:<br>75 mm x 200 mm, 100 mm x 250<br>mm, 150 mm x 300 mm, 160<br>mm x 440 mm, 160 mm x 600<br>mm: .104 pounds | |
| 205 mm x 390 mm, 250 mm x<br>390 mm, 250 mm x 500 mm:<br>1.400 pounds | |
| 100NX Flex Cycle:<br>75 mm x 200 mm, 100 mm x 250<br>mm, 150 mm x 300 mm, 160<br>mm x 440 mm, 160 mm x 600<br>mm: .158 pounds | |
| 205 mm x 390 mm, 250 mm x<br>390 mm, 250 mm x 500 mm:<br>1.400 pounds | |
| 100NX Standard Cycle:<br>75 mm x 200 mm, 100 mm x 250<br>mm, 150 mm x 300 mm, 160<br>mm x 440 mm, 160 mm x 600<br>mm: .158 pounds | |
| 205 mm x 390 mm, 250 mm x<br>390 mm, 250 mm x 500 mm:<br>4.476 pounds | |
| Max lumens:<br>1 mm min ID and Max 1 lumen.<br>for all cycles | |
| NX Standard Cycle: For pouch<br>sizes 250x500mm, 250x390mm,<br>205x390mm is 125 mm max<br>length. Max length is 50 mm for<br>all other pouch sizes. | |

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| | NX Advanced Cycle: For pouch<br>sizes 250x500mm, 250x390mm,<br>205x390mm is 125 mm max<br>length. Max length is 50 mm for<br>all other pouch sizes.<br>100NX Duo Cycle: For pouch<br>sizes 250x500mm, 250x390mm,<br>205x390mm is 875 mm max<br>length. Max length is 850 mm<br>for all other pouch sizes.<br>100NX Flex Cycle: Max length is<br>850 mm for all pouch sizes.<br>100NX Standard Cycle: For<br>pouch sizes 250x500mm,<br>250x390mm, 205x390mm is 125<br>mm max length. Max length is<br>50 mm for all other pouch sizes.<br>Pouch Sizes:<br>250 mm x 500 mm<br>250 mm x 390 mm<br>205 mm x 390 mm<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 | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | These pouches are made from a<br>plastic film and Tyvek that is<br>heat sealed on three sides. The<br>fourth side is left opened and<br>will be heat-sealed when used. | Same | These pouches are made<br>from a plastic film and<br>Tyvek that is heat sealed<br>on three sides. The fourth<br>side is left opened and will<br>be heat-sealed when<br>used. |
| Backing Material | Tyvek® | Same | Tyvek® |
| Transparent Film | BOPET/PE | Similar | PE |
| Sterilization Processes | H2O2 Sterilization Process as per:<br>STERRAD® | Similar | STERRAD® 100S |
| | NX Standard | | |
| | NX Advanced | | |
| | 100NX Duo | | |
| | 100NX Flex | | |
| | 100NX Standard | | |
| Sterilant | Achieved a 10-6 Sterility Assurance | Similar | Showed a 6 log reduction of |
| Validation | Level (SAL) of Geobacillus | | Geobacillus |
| | stearothermophilus. | | stearothermophilus |
| AAMI TIR12:2010<br>ANSI/AAMI ST79<br>ANSI/AAMI/ISO 14937:2009<br>ANSI/AAMI/ISO 17664:2017 | NX Standard<br>NX Advanced<br>100NX Duo<br>100NX Flex<br>100NX Standard | | |
| 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 if the incubation<br>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<br>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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### K221377 Page 6 of 8

| Dimensions and max load weight | | | | | | Similar | Not listed |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------|------------------------|----------------------------|-----------|------------|
| Pouch size | NX<br>Advanced<br>Cycle | NX<br>Standard<br>Cycle | 100NX<br>Duo<br>Cycle | 100NX<br>Flex<br>Cycle | 100NX<br>Standard<br>Cycle | | |
| | weight (pounds) | | | | | | |
| 250 x 500 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | | |
| 250 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | | |
| 205 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | | |
| 160 x 600 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | |
| 160 x 440 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | |
| 150 x 300 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | |
| 100 x 250 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | |
| 75 x 200 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | | |
| Max Lumen Dimensions | 1 mm min ID Lumen and Max 1<br>lumen for all cycles<br><br>For NX Standard Cycle: For<br>pouch sizes 250x500mm,<br>250x390mm, 205x390mm is 125<br>mm max length. Max length is<br>50 mm for all other pouch sizes.<br><br>NX Advanced Cycle: For pouch<br>sizes 250x500mm, 250x390mm,<br>205x390mm is 125 mm max<br>length. Max length is 50 mm for<br>all other pouch sizes.<br><br>100NX Duo Cycle: For pouch<br>sizes 250x500mm, 250x390mm,<br>205x390mm is 875 mm max<br>length. Max length is 850 mm<br>for all other pouch sizes.<br><br>100NX Flex Cycle: Max length is<br>850 mm for all pouch sizes.<br><br>100NX Standard Cycle: For<br>pouch sizes 250x500mm,<br>250x390mm, 205x390mm is 125<br>mm max length. Max length is<br>50 mm for all other pouch sizes. | | | | | Different | Not listed |

#### 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 6 of 8

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sterilant is able to penetrate Steriking® LT-Blueline Pouches with Tyvek® and sustain 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.
- The Microbial Aerosol Challenge study is a whole package test which challenges all aspects of the pouch in its final state. Conversely the ISO 11607 tests (Dye Migration and Seal Peel) test only one component of the pouch at time as it is not a whole package test. The Microbial Aerosol Challenge is a rigorous whole package test, and therefore the results are more comprehensive and supersede the results from Dye Migration and Seal Peel tests.

| 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>Geobacilus<br>stearothermophilus spores<br>were killed in a half-cycle (6-log reduction) | Pass |
| | | | 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><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 | Shelf Life Pre Sterilization | Dye Penetration: none<br>Seal peel: =/>1.5N/15mm | Pass |

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| ASTM F88: Standard Test Method for Seal<br>Strength of Flexible Barrier Materials | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------------------|------|
| ASTM F1980 – 16 Standard Guide for<br>Accelerated Aging of Sterile Barrier Systems<br>for Medical Devices | Shelf Life Post Sterilization | Dye Penetration: none<br>Seal peel: =/>1.5N/15mm | Pass |
| ASTM F1929-15: Standard test method for<br>detecting seal leaks in porous medical<br>packaging by dye migration | | | |
| ASTM F88: Standard Test Method for Seal<br>Strength of Flexible Barrier Materials | | | |
| 1. ASTM F1608, ASTM F2638 - Microbial<br>Barrier<br>2. ASTM D3776 - Basis Weight of Tyvek<br>3. ASTM D2724 - Delamination of Tyvek<br>4. TAPPI T460 - Gurly Hill porosity of Tyvek<br>5. ISO 1924-2 - Tensile Strength, MD of Tyvek<br>6. ISO 1924-2 - Elongation, MD of Tyvek<br>7. ASTM D1424 - Elmendorf Tear, MD of<br>Tyvek<br>8. ISO 534 - Thickness of Tyvek<br>9. ISO 5636-3 - Bendtsen air permeability of<br>Tyvek<br>10. TAPPI T523 - Moisture vapor transmission<br>Rate of Tyvek<br>11. ISO 2758 - Mullen, burst of Tyvek<br>12. ASTM D3420 - Spencer puncture of Tyvek | Material Compatibility | Meets specifications per<br>Technical Data Sheets.<br>Included in Bench Testing<br>Summary. | Pass |

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.