Steriking Packaging for Medical Devices

K221016 · Wipak OY · FRG · May 5, 2022 · General Hospital

Device Facts

• Record ID: K221016
• Device Name: Steriking Packaging for Medical Devices
• Applicant: Wipak OY
• Product Code: FRG · General Hospital
• Decision Date: May 5, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 1350C for 3 minutes; Drying time of 16 minutes The Steriking Packaging for medical devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be self sealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded line. Flap should be pressed firmly against the laminate from the center working outwards to ensure a good, even seal. Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 875mm)

Device Story

Steriking Packaging for Medical Devices; peel pouch enclosure for medical devices during steam sterilization. Device consists of bleached wood pulp paper backing and transparent plastic film laminate (oriented polyester and coextruded polypropylene). User inserts device into pouch; closes via integrated adhesive strip (self-seal). Pouch allows sterilant penetration through paper while maintaining microbial barrier. Used in clinical settings; ensures sterility of instruments for up to 12 months post-sterilization. Benefits patient by preventing recontamination of sterilized medical devices prior to use.

Clinical Evidence

Bench testing only. Testing included microbial barrier properties (germ-proofness), seal strength, tensile strength, tear strength, burst strength, and porosity (ISO 5636-3/5). Sterilization efficacy validated to achieve 10^-6 SAL. Biocompatibility confirmed as non-cytotoxic. Package integrity maintained post-sterilization.

Technological Characteristics

Materials: Bleached wood pulp (100 g/m2), oriented polyester (12 microns), coextruded polypropylene (40 microns). Triple heat-sealed laminate to paper. Self-seal adhesive strip. Dimensions: 200mm x 800mm, 250mm x 875mm. Sterilization: Steam (132°C/4 min or 135°C/3 min). Porosity: 3.9–5.7 µm/Pa·s.

Indications for Use

Indicated for use as an enclosure for medical devices during steam sterilization to maintain sterility until use. Applicable for medical devices with a combined weight of metal and plastics of 2.6 pounds or less.

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

• Steriking Packaging for Medical Devices (K210810)

Submission Summary (Full Text)

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May 5, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Wipak OY % Steven Singleton Consultant Compliance Systems International LLC 7 Windham Hill Mendon, New York 14506

Re: K221016

Trade/Device Name: Steriking Packaging for Medical Devices Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: March 31, 2022 Received: April 5, 2022

Dear Steven 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,

for

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)

K221016

#### Device Name

Steriking Packaging for Medical Devices

#### Indications for Use (Describe)

Steriking Packaging for Medical Devices serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed medical devices until use of the medical devices with a combined weight of metal and plastics of 2.6 pounds or less. The recommended sterilization cycles are as follows: Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes Pre-vacuum steam at 1350C for 3 minutes; Drying time of 16 minutes

The Steriking Packaging for medical devices consists of a paper backing (Bleached wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2 sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick. The plastic laminate is triple heat sealed to the backing paper. The open end of the pouch is to be self sealed once a device is inserted. Self-sealable pouches are featured with adhesive strip allowing tight, impermeable closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded line. Flap should be pressed firmly against the laminate from the center working outwards to ensure a good, even seal.

Steriking Packaging for Medical Devices maintains the sterility of the enclosed devices for up to 12 months post Steam sterilization and before sterilization has a maximum shelf life of 5 years from the date of manufacture. Steriking Packaging for Medical Devices Dimensional configurations (2 sizes 200mm x 875mm)

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) | X |

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

| | 510K Summary Elements per<br>21CFR807.92 | Summary |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| a1 | Submitter's name,<br>address, telephone<br>number, a contact person,<br>and the date the summary<br>was prepared | Wipak Oy<br>Wipaktie 2<br>Nastola Finland<br>Contacts:<br>Hanna Marttila, Phone: [phone]<br>Date Prepared: 2/18/2022<br>Mr. Steven Singleton, Phone: [phone] |
| a2 | Name of the device, including<br>the trade or proprietary name<br>if applicable, the common or<br>usual name, and the<br>classification<br>name | Proprietary Name: Steriking Packaging for Medical Devices<br>Common Name: Peel Pouch<br>Classification Name: Sterilization wrap<br>Regulation number (21 CFR 880.6850)<br>Product code (FRG) |
| a3 | Identification of the legally<br>marketed device to which<br>the submitter claims<br>equivalence<br>(predicate device) | K210810, Steriking Packaging for Medical Devices |
| a4 | Description of the device | The Steriking Packaging for Medical Devices consists of a paper backing (Bleached<br>wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2<br>sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of oriented<br>polyester 12 microns thick, 1 sheet of coextruded polypropylene 40 microns thick.<br>The plastic laminate is triple heat sealed to the backing paper. The open end of<br>the pouch is to be self sealed once a device is inserted. Self-sealable pouches are<br>featured with adhesive strip allowing tight, impermeable closing of a<br>pack. The closing flap is pre-folded to facilitate the closure. When closing the self-<br>seal pouch the paper flap shall be folded along the pre-folded line. Flap should be<br>pressed firmly against the laminate from the centre working outwards to ensure a<br>good, even seal.<br>Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm<br>x 875mm). |
| a5 | Indications for use | Steriking Packaging for Medical Devices serve as an enclosure for medical devices<br>during steam sterilization that maintains the sterility of the enclosed medical<br>devices until use of the medical devices with a combined weight of metal and<br>plastics of 2.6 pounds or less. The recommended sterilization cycles are as<br>follows:<br>Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutes<br>Pre-vacuum steam at 135oC for 3 minutes; Drying time of 16 minutes<br>The Steriking Packaging for medical devices consists of a paper backing (Bleached<br>wood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2<br>sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of<br>oriented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40<br>microns thick. The plastic laminate is triple heat sealed to the backing paper. The |

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| a6 | technological<br>characteristics compared<br>to predicate (as<br>follows) | open end of the pouch is to be self sealed once a device is inserted. Self-sealable<br>pouches are featured with adhesive strip allowing tight, impermeable closing of a<br>pack. The closing flap is pre-folded to facilitate the closure. When closing the<br>self-seal pouch the paper flap shall be folded along the pre-folded line. Flap<br>should be pressed firmly against the laminate from the center working outwards<br>to ensure a good, even seal.<br>Steriking Packaging for Medical Devices maintains the sterility of the enclosed<br>devices for up to 12 months post Steam sterilization and before sterilization has<br>a maximum shelf life of 5 years from the date of manufacture.<br>Steriking Packaging for Medical Devices Dimensional configurations (2<br>sizes 200mm x 800mm, 250mm x 875mm)<br>See below as follows | | | |
|--------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| b1. | Comparison<br>Element | | Submission Device – Steriking<br>Packaging for Medical Devices | Comparison | Predicate Device –<br>Steriking Packaging for<br>Medical Devices<br>K210810 |
| Intended Use | | | To serve as an enclosure for medical<br>devices during steam sterilization that<br>maintains the sterility of the enclosed<br>devices until used. | No Change | To serve as an enclosure for<br>medical devices during steam or<br>gas sterilization that maintains<br>sterility of the enclosed device<br>until used. |

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| Design | Pouches plastic film triple heat sealed to paper backing thumb notches chevron-type seal at end for opening Adhesive strip for self seal | Different | Pouches plastic film triple heat sealed to paper backing thumb notches chevron-type seal at end for opening |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of<br>Operation | Medical device to be sterilized is put<br>into pouch and the open parts of the<br>pouches are closed by self-sealing.<br>Sterilization packages then are<br>subjected to validated sterilization<br>operation of steam. Sterilant<br>penetration is carried out through the<br>medical grade paper into the package<br>and microorganisms on the surface of<br>the medical device are destroyed with<br>the effect of the sterilant process.<br>Other parameters of the sterilization<br>process are temperature, pressure,<br>humidity, time and are determined<br>according to the sterilization type.<br>After the sterilization is completed, the<br>sterility of the enclosed medical device is<br>maintained for 12 months. | Different | Medical device to be sterilized is<br>put into pouch and the open<br>parts of the pouches are closed<br>by heat sealing. Sterilization<br>packages then are subjected to<br>validated sterilization operation<br>of steam. Sterilant penetration is<br>carried out through the medical<br>grade paper into the package and<br>microorganisms on the surface of<br>the medical device are destroyed<br>with the effect of the sterilant<br>process.<br>Other parameters of the<br>sterilization process are<br>temperature, pressure,<br>humidity, time and are<br>determined according to the<br>sterilization type.<br>After the sterilization is completed,<br>the sterility of the enclosed medical<br>device is maintained for 12 months. |
| Dimensions | 200mm x 800mm, 250mm x 875 mm | Different | 200mm x 800mm, 250mm x 900 mm |
| Backing Paper | Bleached wood pulp, grammage:<br>100g/m2 | No Change | Bleached wood pulp, grammage: 100 g/m2 |
| Tensile Strength MD-<br>kNm | >66 N/15mm | No Change | >66 N/15mm |
| Tensile Strength CD-<br>kNm | >33 N/15mm | No Change | >33 N/15mm |
| Tear Strength MD-mN | >550 Nm | No Change | >550 Nm |
| Tear Strength CD-mN | >550 Nm | No Change | >550 Nm |
| Burst Strength-kPa | >230 kpa | No Change | >230 kpa |
| Porosity<br>ISO 5636-3<br>ISO 5636-5 | 3.9 – 5.7 µm/Pa·s<br>24-34 s | No Change | 3.9 – 5.7 µm/Pa·s<br>24-34 s |
| Seal Strength – N/mm | Peel ≥ 1.5 N/15mm | No Change | Peel ≥ 1.5 N/15mm |
| Transparent Film | Two sheets of laminated plastic with a<br>total grammage of 55 g/m2.<br>One sheet of oriented polyester 12<br>microns thick. One sheet of coextruded<br>polypropylene 40 microns<br>Thick. | No Change | Two sheets of laminated plastic with<br>a total grammage of 55 g/m2.<br>One sheet of oriented polyester 12<br>microns thick. One sheet of<br>coextruded polypropylene 40<br>microns<br>Thick. |
| Sterilization Properties | Steam sterilization conditions are 4<br>minutes at 132° C or 3 minutes at<br>135° C | No Change | Steam sterilization conditions are 4<br>minutes at 132° C or 3 minutes at<br>135° C |
| Sterilant<br>Penetration | Full-cycle steam sterilization process will<br>produce sufficient lethality to achieve a 12-<br>log reduction, thus providing a 10-6<br>Sterility Assurance Level (SAL) | No Change | Full-cycle steam sterilization process<br>will produce sufficient lethality to<br>achieve a 12- log reduction, thus<br>providing a 10-6 Sterility Assurance<br>Level (SAL). |
| Material<br>Compatibility | Compatible with Steam Sterilization | No Change | Compatible with Steam Sterilization |
| Package Integrity<br>Test | Closure integrity maintained before<br>and after steam sterilization | No Change | Closure integrity maintained before<br>and after steam sterilization |
| Maintenance of<br>Sterility — Shelf life<br>post sterilization | 12 months | No Change | 12 months |
| Shelf Life - Pre-<br>sterilization | 5 years | No Change | 5 years |
| Drying Time | 20 minutes | No Change | 20 minutes |
| Microbial<br>Barrier<br>Properties | The paper of the sterile barrier system was<br>examined on the packaging outer side for<br>its germ proofness with air permeance<br>after steam sterilization and is evaluated<br>as "sufficiently germ-proof" | No Change | The paper of the sterile barrier<br>system was examined on the<br>packaging outer side for its germ<br>proofness with air permeance<br>after steam sterilization and is<br>evaluated as "sufficiently germ-<br>proof" |
| Biocompatibility | Non-Cytotoxic | No Change | Non-Cytotoxic |

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