(312 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 heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165oC-200oC (329oF-392oF).
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 800mm)
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 heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165°C – 200°C (329°F - 392°F) Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mm x 900mm).
The provided document is a 510(k) Premarket Notification summary for "Steriking Packaging for Medical Devices." It details the device's characteristics, indications for use, comparison to a predicate device, and the results of non-clinical testing to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text, formatted to address your specific points.
The document describes pre-market testing of a medical device packaging system, not an AI/ML-driven device. Therefore, many of the questions related to AI/MRMC studies, training sets, and expert consensus for ground truth are not applicable to this kind of submission. I will address the applicable parts of your request.
Acceptance Criteria and Device Performance for Steriking Packaging for Medical Devices
The study proves that the device meets its acceptance criteria through a series of non-clinical performance tests, designed to demonstrate the safety and effectiveness of the packaging for maintaining sterility of medical devices after steam sterilization.
1. A table of acceptance criteria and the reported device performance
The document provides a detailed table within the "Summary of Non-Clinical Testing" section. This table lists the test methodology, purpose, acceptance criteria, and the results (which are uniformly "Pass" or specific measurements that meet the criteria).
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 14477 - Packaging. Flexible packaging material. Determination of puncture resistance. | Puncture Resistance | No pass/fail criteria (Note: This is unusual for an acceptance criterion, but listed as such in the document) | Acceptable => 13.1N |
| ASTM F1929-15 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration" EN 868-5 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods ISO 5636-3 Paper and board — Determination of air permeance | SHELF LIFE Prior to Sterilization | Seal Strength: =>1.5N/15mm Seal Integrity: No dye leaks Air Permeability: =>3.4um/Pa Peel Properties: free of fibers after peeling | Pass |
| AAMI TIR 12:2010, Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Medical Device Manufacturers | Sterilant Penetration & Drying Time | Biological indicator 6-log reduction in half cycle providing 10-6 SAL Drying time post sterilization moisture content weight gain <3% | Pass |
| DIN EN ISO -11607-1:2017-10 Section 5.1.6. a) microbisl barrier DIN 953-6, section 4.8.6. DIN 58953-6, section 3.8 and section 4.8.6. | Microbial Barrier Properties | Transmission of CFUs (Colony Forming Units) from exterior of pouch to interior of pouch = 0 | Pass |
| DIN 58953-6, section 3.8 and section 4.8.6. 1. Tensile strength of film ASTM D882 2. Tensile strength of paper (MD) ISO 1924-3 3. Tensile strength of paper (CD) ISO 1924-3 4. Thickness 5. Tear resistance ISO 1974 6. Tear strength DIN 53363 7. Burst strength ISO 2758 8. Air permeance DIN 5636-5 9. Permeance after sterilization DIN 5636-5 10. Seal strength ASTM F88 11. Peel Characteristics EN 868-5:2009 12. Color fastness EIN DIN 646 13. No delamination or clouding 868-5:2009 14. Pinholes in film EN 868-5:2009 | Material Compatibility | 1. =>20N/15mm 2. =>66N/15mm 3. =>33N/15mm 4. =152 +/- 10% μm 5. >550mN (MD & CD) 6. >10N 7. >230kPa 8. 3.9 – 5.7 µm/PAS 9. Corresponds 10. 1.5N/15mm 11. No irregularities or splitting >10mm 12. evaluation grade = 5 13. No objections 14. No pinholes | Pass |
| ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | If viability is reduced to <70% of the medium control then test item is considered to have cytotoxic potential | Pass (88% & 92% viability) |
| ASTM F1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Shelf Life (post sterilization) | Dye Penetration: none Seal peel: =>1.5N/15mm | Pass |
| ASTM F1929 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Package Integrity | No dye penetration/channeling travelling full width of seal in ~5 seconds | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. This type of information is typically found in the full test reports referenced by the standards, not in the summary.
Data Provenance: The manufacturing entity is Wipak Oy in Nastola, Finland, indicating the origin of the device. The testing was non-clinical (laboratory/material testing) rather than clinical data from human subjects. Therefore, terms like "retrospective" or "prospective" and "country of origin of the data" in the sense of patient data are not applicable. The testing was performed according to international standards (e.g., ISO, ASTM, EN, DIN), which are universally recognized.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a medical packaging product, and its "ground truth" is established through physical and material science testing against recognized international engineering and materials standards (e.g., ISO, ASTM). These tests do not involve expert human interpretation in the way, for example, a diagnostic imaging AI would. The "ground truth" is determined by the objective measurements and criteria defined in the specific test methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in studies involving human readers or subjective interpretations, such as clinical trials or diagnostic accuracy studies. For material and physical properties testing, the results are objectively measured against predefined scientific criteria, not adjudicated.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. The submission is for a medical device packaging material, not an AI or imaging device that would involve human readers or comparative effectiveness studies of diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is physical packaging, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established by objective measurements of physical, chemical, and biological properties against established industry and international standards (e.g., seal strength, microbial barrier, puncture resistance, sterility assurance level, material compatibility, cytotoxicity). This is based on scientific and engineering principles, not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This question is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device packaging product, not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set mentioned or relevant to this type of device submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
January 23, 2022
Wipak OY % Steven Singleton Consultant Compliance Systems International LLC. 7 Windham Hill Mendon, New York 14056
Re: K210810
Trade/Device Name: Steiking Packaging for Medical Devices Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 14, 2021 Received: December 23, 2021
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K210810
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 heat sealed once a device is inserted. Heat sealing parameters to provide a sterile barrier are 165oC-200oC (329oF-392oF).
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 800mm)
| 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) |
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510k Summary K210810
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4. 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 FinlandContact: Hanna MarttilaPhone: +358 40 124 0290Date Prepared: 02/03/21 |
| 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 wrap, Peel Pouch |
| a3 | Identification of the legallymarketed device to whichthe submitter claimsequivalence(predicate device) | K953776, Wipak Steriking Sterilization Pouches & Rolls |
| a4 | Description of the device | The Steriking Packaging for Medical Devices consists of a paper backing(Bleached wood pulp, grammage $100 g/m2$ ) with transparent plastic filmlaminate 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 coextrudedpolypropylene 40 microns thick. The plastic laminate is triple heat sealed tothe backing paper. The open end of the pouch is to be heat sealed once adevice is inserted. Heat sealing parameters to provide a sterile barrier are$165°C – 200°C (329°F - 392°F)$Dimensional configurations as follows (2 sizes 200mm x 800mm, 250mmx 900mm). |
| a5 | Indications for use | Steriking Packaging for Medical Devices serve as an enclosure formedical devices during steam sterilization that maintains the sterilityof the enclosed medical devices until use of the medical devices with acombined weight of metal and plastics of 2.6 pounds or less. Therecommended sterilization cycles are as follows:Pre-vacuum steam at 132°C for 4 minutes; Drying time of 20 minutesPre-vacuum steam at 135°C for 3 minutes; Drying time of 16 minutesThe Steriking Packaging for medical devices consists of a paperbacking (Bleached wood pulp, grammage $100 g/m2$ ) with transparentplastic film laminate front (2 sheets of laminated plastic with a totalgrammage of $55 g/m2$ , 1 sheet of oriented polyester 12 microns thick,1 sheet of coextruded polypropylene 40 microns thick. The plasticlaminate is triple heat sealed to the backing paper. The open end ofthe pouch is to be heat sealed once a device is inserted. Heat sealing |
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| parameters to provide a sterile barrier are 165°C-200°C (329°F-392°F).Steriking Packaging for Medical Devices maintains the sterility of theenclosed devices for up to 12 months post Steam sterilization andbefore sterilization has a maximum shelf life of 5 years from the dateof manufacture. | Design | Pouches• plastic film triple heat sealed topaper backing• thumb notches• chevron-type seal at end for opening | Similar | Pouches• plastic film triple heat sealed topaper backing• self-seal flap• thumb notches• chevron-type seal at end for opening | |||||
|---|---|---|---|---|---|---|---|---|---|
| Steriking Packaging for Medical Devices Dimensional configurations (2sizes 200mm x 800mm, 250mm x 900mm) | Principle ofOperation | Medical device to be sterilized is putinto pouch and the open parts of thepouches are closed by heat 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 deviceis maintained for 12 months. | Same | Medical device to be sterilized isput into pouch and the open partsof the pouches are closed by heatsealing. Sterilization packages thenare subjected to validatedsterilization operation of steam.Sterilant penetration is carried outthrough the medical grade paperinto 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 are determinedaccording to the sterilization type.Chemical process indicator isprinted exterior on the pouch(printed on medical grade paper)changes color when exposed tosterilant vapor during processing.After the sterilization is completed,the sterility of the enclosedmedical device ismaintained for 60 months. | |||||
| a6 | technologicalcharacteristics comparedto predicate (asfollows) | See below as follows | Dimensions | 200mm x 800mm, 250mm x 875mm | Different | 130 mm X 300 mm,90 mm X 250 mm, 75mmX300mm | |||
| b1. | ComparisonElement | Submission Device - SterikingPackaging for Medical Devices | Comparison | Predicate Device - WipakSterikingPeel Pouch, K953776 | Backing Paper | Bleached wood pulp, grammage:100g/m2 | Similar | Bleached wood pulp, grammage: 70g/m2 | |
| Intended Use | To serve as an enclosure for medicaldevices during steam sterilization thatmaintains the sterility of the encloseddevices until used. | Same | To serve as an enclosure formedical devices during steam orgas sterilization that maintainssterility of the enclosed deviceuntil used | Tensile Strength MD-kNm | 12.7 | Similar | 10 | ||
| Tensile Strength CD-kNm | 6.7 | Similar | 5.3 | ||||||
| Tear Strength MD-mN | 1000 | Similar | 750 | ||||||
| Tear Strength CD-mN | 1100 | Similar | 800 | ||||||
| Burst Strength-kPa | 690 | Similar | 550 |
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| Porosity - Bendtsen | 425 | Same | 425 |
|---|---|---|---|
| Seal Strength – N/mm | >6.09N/15mm | Similar | 2,1 N/15 mm(Pouch up to 100mm wide)2,5 N/15 mm(pouch greater than 100mm wide) |
| 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. | Same | Two sheets of laminated plasticwith a total grammage of 55 g/m2.one sheet of oriented polyester12 microns thick.one sheet of coextrudedpolypropylene 40 micronsthick. |
| Sterilization Properties | Steam sterilization conditions are 4minutes at 132º C or 3 minutes at135º C | Different | Steam sterilization conditionsare 3 minutes at 134º C or 15minutes at121º C |
| Sterilization ProcessIndicator | NA | Different | Steam Sterilization Process:blue indicators turn brownafter steam sterilization.ISO 11140-1:2005 class 1: |
| SterilantPenetration | Full-cycle steam sterilization process willproduce sufficient lethality to achieve a 12-log reduction, thus providing a 10-6Sterility Assurance Level (SAL). Pouchesheat sealable do not impede sterilantpenetration to the double pouchedcontents. | Different | Not listed in 510K Summary |
| MaterialCompatibility | Compatible with Steam Sterilization | Same | Compatible with Steam Sterilization |
| Package IntegrityTest | Closure integrity maintained beforeand after steam sterilization | Same | Closure integrity maintained beforeand after steam sterilization |
| Maintenance ofSterility - Shelf lifepost sterilization | 12 months | Different | Not listed in 510K Summary |
| Shelf Life - Pre-sterilization | 5 years | Same | 5 Years |
| Drying Time | 20 minutes | Different | Not listed in 510K Summary |
| 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" | Different | Not listed in 510K Summary |
| Biocompatibility | Non-Cytotoxic | Different | Not listed in 510K Summary |
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Summary of Non-Clinical Testing:
Provided below are a listing of performance testing that was used to evaluate the subject device to demonstrate that the device met the specification and the acceptance criteria of the standards and test methodology found in the table below.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 14477 - Packaging. Flexible packagingmaterial. Determination of puncture resistance. | Punture Resistance | No pass/fail criteria | Acceptable=/> 13.1N |
| ASTM F1929-15 "Standard Test Method forDetecting Seal Leaks in Porous MedicalPackaging by Dye PenetrationEN 868-5 Packaging for terminally sterilizedmedical devices - Part 5:Sealable pouches and reels of porous materialsand plastic filmconstruction - Requirements and test methodsISO 5636-3 Paper and board — Determination ofair permeance | SHELF LIFE Prior to Sterilizaton | Seal Strength: =/>1.5N/15mmSeal Integrity: No dye leaksAir Permeability: =/>3.4um/PaPeel Properties: free of of fibersafter peeling | Pass |
| AAMI TIR 12:2010, Designing, Testing,and Labeling Reusable Medical Devices forReprocessing in Health Care Facilities:A Guide for Medical Device Manufacturers | Sterilant Penetration & Drying Time | Biological indicator 6-logreduction in half cycle providing10-6 SALDrying time post sterilizationmoisture content weight gain <3% | Pass |
| DIN EN ISO -11607-1:2017-10 Section 5.1.6. a)microbisl barrierDIN 953-6, section 4.8.6.DIN 58953-6, section 3.8 and section 4.8.6. | Microbial Barrier Properties | Transmission of CFUs (ColonyForming Units) fron exterior ofpouch to interior of pouch = 0 | Pass |
| DIN 58953-6, section 3.8 and section 4.8.6.1. Tensile strength of film ASTM D8822. Tensile strength of paper (MD) ISO 1924-33. Tensile trength of paper (CD) ISO 1924-34. Thickness5. Tear resistance ISO 19746. Tear strength DIN 533637. Burst strength ISO 27588. Air permeance DIN 5636-59. Permeance after sterilization DIN 5636-510. Seal strength ASTM F8811. Peel Characteristics EN 868-5:200912. Color fastness EIN DIN 64613. No delamination or clouding 868-5:200914. Pinholes in film EN 868-5:2009 | Material Compatibility | 1. =/>20N/15mm2. =/>66N/15mm3. =/>33N/15mm4. =152 +/- 10% μm5. >550mN (MD & CD)6. >10N7. >230kPa8. 3.9 – 5.7 µm/PAS9. Corresponds10. 1.5N/15mm11. No irregularities or splitting >10mm12. evaluation grade = 513. No objections14. No pinholes | Pass |
| ISO 10993-5, Biological evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | If viability is reduced to <70% ofthe medium control then test itemis considered to have cytotoxicpotential | Pass88% & 92%viability |
| ASTM F1980 - 16Standard Guide forAccelerated Aging of Sterile Barrier Systems forMedicalDevices | Shelf Life (post sterilization) | Dye Pentration: noneSeal peel: =/>1.5N/15mm | Pass |
| ASTM F1929 - Standard Test Method forDetecting Seal Leaks in Porous MedicalPackaging by DyePenetration | Package Integrity | No dye penetration/channelingtravelling full width of seal in ~5seconds | Pass |
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Conclusion
The conclusions drawn from the non-clinical performance data demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K953776), Class II 21 CFR 880.6850, ProCode FRG.
§ 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).