(30 days)
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 of a pack. The closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded along the pre-folded line. Flap should be pressed firmly against the laminate from the centre working outwards to ensure a good, even seal. Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm x 875mm).
This document is a 510(k) premarket notification for a medical device, which means it's a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on showing equivalence to an existing device rather than presenting new clinical study data with acceptance criteria for a novel AI device.
Therefore, the requested information about acceptance criteria, specific study details (sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details), and ground truth establishment methods is not applicable to this document. This document details the technical characteristics of a sterilization packaging material and its comparison to a predicate device, not the performance of an AI/ML algorithm.
The table for acceptance criteria and reported device performance is presented in the original document as a comparison between the submitted device and its predicate, rather than against specific pre-defined acceptance criteria for an AI model.
Here's a summary of the information provided in the document, framed in the context of device equivalence rather than AI performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison table (pages 4-6) showing the technical characteristics of the new device ("Submission Device – Steriking Packaging for Medical Devices") against its predicate device ("Predicate Device – Steriking Packaging for Medical Devices K210810"). This comparison serves as the "acceptance criteria" in the context of a 510(k) submission, where the new device must be substantially equivalent to the predicate. "Reported device performance" here refers to the measured physical and functional properties of the submitted device.
| Comparison Element | Submission Device – Steriking Packaging for Medical Devices | Comparison | Predicate Device – Steriking Packaging for Medical Devices K210810 |
|---|---|---|---|
| Intended Use | To serve as an enclosure for medical devices during steam sterilization that maintains the sterility of the enclosed devices until used. | No Change | To serve as an enclosure for medical devices during steam or gas sterilization that maintains sterility of the enclosed device until used. |
| 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 Operation | Medical device to be sterilized is put into pouch and the open parts of the pouches are closed by self-sealing. Sterilization packages then are subjected to validated sterilization operation of steam. Sterilant penetration is carried out through the medical grade paper into the package and microorganisms on the surface of the medical device are destroyed with the effect of the sterilant process. Other parameters of the sterilization process are temperature, pressure, humidity, time and are determined according to the sterilization type. After the sterilization is completed, the sterility of the enclosed medical device is maintained for 12 months. | Different | Medical device to be sterilized is put into pouch and the open parts of the pouches are closed by heat sealing. Sterilization packages then are subjected to validated sterilization operation of steam. Sterilant penetration is carried out through the medical grade paper into the package and microorganisms on the surface of the medical device are destroyed with the effect of the sterilant process. Other parameters of the sterilization process are temperature, pressure, humidity, time and are determined according to the sterilization type. After the sterilization is completed, the sterility of the enclosed medical 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: 100g/m2 | No Change | Bleached wood pulp, grammage: 100 g/m2 |
| Tensile Strength MD-kNm | >66 N/15mm | No Change | >66 N/15mm |
| Tensile Strength CD-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 ISO 5636-3 ISO 5636-5 | 3.9 – 5.7 µm/Pa·s 24-34 s | No Change | 3.9 – 5.7 µm/Pa·s 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 total grammage of 55 g/m2. One sheet of oriented polyester 12 microns thick. One sheet of coextruded polypropylene 40 microns Thick. | No Change | Two sheets of laminated plastic with a total grammage of 55 g/m2. One sheet of oriented polyester 12 microns thick. One sheet of coextruded polypropylene 40 microns Thick. |
| Sterilization Properties | Steam sterilization conditions are 4 minutes at 132° C or 3 minutes at 135° C | No Change | Steam sterilization conditions are 4 minutes at 132° C or 3 minutes at 135° C |
| Sterilant Penetration | Full-cycle steam sterilization process will produce sufficient lethality to achieve a 12-log reduction, thus providing a 10-6 Sterility Assurance Level (SAL) | No Change | Full-cycle steam sterilization process will produce sufficient lethality to achieve a 12- log reduction, thus providing a 10-6 Sterility Assurance Level (SAL). |
| Material Compatibility | Compatible with Steam Sterilization | No Change | Compatible with Steam Sterilization |
| Package Integrity Test | Closure integrity maintained before and after steam sterilization | No Change | Closure integrity maintained before and after steam sterilization |
| Maintenance of Sterility — Shelf life post sterilization | 12 months | No Change | 12 months |
| Shelf Life - Pre-sterilization | 5 years | No Change | 5 years |
| Drying Time | 20 minutes | No Change | 20 minutes |
| Microbial Barrier Properties | The paper of the sterile barrier system was examined on the packaging outer side for its germ proofness with air permeance after steam sterilization and is evaluated as "sufficiently germ-proof" | No Change | The paper of the sterile barrier system was examined on the packaging outer side for its germ proofness with air permeance after steam sterilization and is evaluated as "sufficiently germ-proof" |
| Biocompatibility | Non-Cytotoxic | No Change | Non-Cytotoxic |
The following points are N/A (Not Applicable) as the document describes a traditional medical device (sterilization packaging) and not an AI/ML powered device.
- Sample sizes used for the test set and the data provenance: N/A
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: N/A
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A
- The sample size for the training set: N/A
- How the ground truth for the training set was established: N/A
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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 per21CFR807.92 | Summary | |
|---|---|---|
| a1 | Submitter's name,address, telephonenumber, a contact person,and the date the summarywas prepared | Wipak OyWipaktie 2Nastola FinlandContacts:Hanna Marttila, Phone: 358 (0)40 124 0290Date Prepared: 2/18/2022Mr. Steven Singleton, Phone: 716 440 7364 |
| a2 | Name of the device, includingthe trade or proprietary nameif applicable, the common orusual name, and theclassificationname | Proprietary Name: Steriking Packaging for Medical DevicesCommon Name: Peel PouchClassification Name: Sterilization wrapRegulation number (21 CFR 880.6850)Product code (FRG) |
| a3 | Identification of the legallymarketed device to whichthe submitter claimsequivalence(predicate device) | K210810, Steriking Packaging for Medical Devices |
| a4 | Description of the device | The Steriking Packaging for Medical Devices consists of a paper backing (Bleachedwood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet of orientedpolyester 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 ofthe pouch is to be self sealed once a device is inserted. Self-sealable pouches arefeatured with adhesive strip allowing tight, impermeable closing of apack. The closing flap is pre-folded to facilitate the closure. When closing the self-seal pouch the paper flap shall be folded along the pre-folded line. Flap should bepressed firmly against the laminate from the centre working outwards to ensure agood, even seal.Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mmx 875mm). |
| a5 | Indications for use | Steriking Packaging for Medical Devices serve as an enclosure for medical devicesduring steam sterilization that maintains the sterility of the enclosed medicaldevices until use of the medical devices with a combined weight of metal andplastics of 2.6 pounds or less. The recommended sterilization cycles are asfollows:Pre-vacuum steam at 132oC for 4 minutes; Drying time of 20 minutesPre-vacuum steam at 135oC for 3 minutes; Drying time of 16 minutesThe Steriking Packaging for medical devices consists of a paper backing (Bleachedwood pulp, grammage 100 g/m2) with transparent plastic film laminate front (2sheets of laminated plastic with a total grammage of 55 g/m2, 1 sheet oforiented polyester 12 microns thick, 1 sheet of coextruded polypropylene 40microns thick. The plastic laminate is triple heat sealed to the backing paper. The |
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| a6 | technologicalcharacteristics comparedto predicate (asfollows) | open end of the pouch is to be self sealed once a device is inserted. Self-sealablepouches are featured with adhesive strip allowing tight, impermeable closing of apack. The closing flap is pre-folded to facilitate the closure. When closing theself-seal pouch the paper flap shall be folded along the pre-folded line. Flapshould be pressed firmly against the laminate from the center working outwardsto ensure a good, even seal.Steriking Packaging for Medical Devices maintains the sterility of the encloseddevices for up to 12 months post Steam sterilization and before sterilization hasa maximum shelf life of 5 years from the date of manufacture.Steriking Packaging for Medical Devices Dimensional configurations (2sizes 200mm x 800mm, 250mm x 875mm)See below as follows | |||
|---|---|---|---|---|---|
| b1. | ComparisonElement | Submission Device – SterikingPackaging for Medical Devices | Comparison | Predicate Device –Steriking Packaging forMedical DevicesK210810 | |
| Intended Use | To serve as an enclosure for medicaldevices during steam sterilization thatmaintains the sterility of the encloseddevices until used. | No Change | To serve as an enclosure formedical devices during steam orgas sterilization that maintainssterility of the enclosed deviceuntil 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 ofOperation | Medical device to be sterilized is putinto pouch and the open parts of thepouches are closed by self-sealing.Sterilization packages then aresubjected to validated sterilizationoperation of steam. Sterilantpenetration is carried out through themedical grade paper into the packageand microorganisms on the surface ofthe medical device are destroyed withthe effect of the sterilant process.Other parameters of the sterilizationprocess are temperature, pressure,humidity, time and are determinedaccording to the sterilization type.After the sterilization is completed, thesterility of the enclosed medical device ismaintained for 12 months. | Different | Medical device to be sterilized isput into pouch and the openparts of the pouches are closedby heat sealing. Sterilizationpackages then are subjected tovalidated sterilization operationof steam. Sterilant penetration iscarried out through the medicalgrade paper into the package andmicroorganisms on the surface ofthe medical device are destroyedwith the effect of the sterilantprocess.Other parameters of thesterilization process aretemperature, pressure,humidity, time and aredetermined according to thesterilization type.After the sterilization is completed,the sterility of the enclosed medicaldevice 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:100g/m2 | No Change | Bleached wood pulp, grammage: 100 g/m2 |
| Tensile Strength MD-kNm | >66 N/15mm | No Change | >66 N/15mm |
| Tensile Strength CD-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 |
| PorosityISO 5636-3ISO 5636-5 | 3.9 – 5.7 µm/Pa·s24-34 s | No Change | 3.9 – 5.7 µm/Pa·s24-34 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 atotal grammage of 55 g/m2.One sheet of oriented polyester 12microns thick. One sheet of coextrudedpolypropylene 40 micronsThick. | No Change | Two sheets of laminated plastic witha total grammage of 55 g/m2.One sheet of oriented polyester 12microns thick. One sheet ofcoextruded polypropylene 40micronsThick. |
| Sterilization Properties | Steam sterilization conditions are 4minutes at 132° C or 3 minutes at135° C | No Change | Steam sterilization conditions are 4minutes at 132° C or 3 minutes at135° C |
| SterilantPenetration | Full-cycle steam sterilization process willproduce sufficient lethality to achieve a 12-log reduction, thus providing a 10-6Sterility Assurance Level (SAL) | No Change | Full-cycle steam sterilization processwill produce sufficient lethality toachieve a 12- log reduction, thusproviding a 10-6 Sterility AssuranceLevel (SAL). |
| MaterialCompatibility | Compatible with Steam Sterilization | No Change | Compatible with Steam Sterilization |
| Package IntegrityTest | Closure integrity maintained beforeand after steam sterilization | No Change | Closure integrity maintained beforeand after steam sterilization |
| Maintenance ofSterility — Shelf lifepost sterilization | 12 months | No Change | 12 months |
| Shelf Life - Pre-sterilization | 5 years | No Change | 5 years |
| Drying Time | 20 minutes | No Change | 20 minutes |
| MicrobialBarrierProperties | The paper of the sterile barrier system wasexamined on the packaging outer side forits germ proofness with air permeanceafter steam sterilization and is evaluatedas "sufficiently germ-proof" | No Change | The paper of the sterile barriersystem was examined on thepackaging outer side for its germproofness with air permeanceafter steam sterilization and isevaluated as "sufficiently germ-proof" |
| Biocompatibility | Non-Cytotoxic | No Change | Non-Cytotoxic |
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§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).