(237 days)
The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-PRO® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.
The Steriking® LT-Blueline Pouches with Tyvek® are intended for use in the following STERIS® V-PRO® Sterilization Cycles:
Lumen Cycle
Non Lumen Cycle
Flexible Cycle
Device lumen dimensions:
Flexible Cycle: 1 lumen x 1 mm min ID x 1050 mm max length for all pouch sizes.
Lumen Cycle: 1 lumen x 1 mm min ID for all pouch sizes. For pouch sizes 250x500mm, 250x390mm, 205x390mm, max length of 125 mm. For all other pouch sizes, max length of 50 mm.
Max Weights: 1.410 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm
.114 pounds for pouch sizes below (Flexible and Lumen Cycles) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm
.158 pounds for pouch sizes below (Non-Lumen Cycle) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm
Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain medical devices to be terminally sterilized in the STERIS® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERIS® 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.
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.
The pouches are constructed from Tyvek®/plastic films. The heat-sealed pouches are heat sealed prior to processing in the STERIS® V-PRO® Sterilization Systems.
Sterilization Systems:
STERIS® V-PRO® Cycles:
Lumen Cycle,
Non Lumen Cycle
Flexible Cycle
The information provided describes the Steriking LT-Blueline Pouches with Tyvek device, which is a sterilization wrap. The document details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-5 Biological Evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | No reduction of cell growth or cell lysis was observed | Pass (did not elicit any cytotoxic effect) |
| AAMI TIR12:2010 - Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities | Sterilant Penetration | Demonstrating that a minimum of 1.0x10^6 Geobacillus stearothermophilus spores were killed in a half-cycle (6-log reduction) | Pass (achieved 10^-6 Sterility Assurance Level of Geobacillus stearothermophilus, Negative for growth) |
| ASTM F1929-15: Standard test method for detecting seal leaks in porous medical packaging by dye migration | Package Integrity (Dye Migration) | Dye Penetration: none | Pass (no leaks detected after dye migration) |
| ANSI/AAMI ST79:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities; AAMI TIR12:2010 - Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities | Microbial Barrier Properties | A sample which demonstrates that all items remain sterile following exposure | Pass (each pouch met the sterility maintenance requirement; no growth in culture tubes containing stainless-steel coupons) |
| ASTM F1929-15: Standard test method for detecting seal leaks in porous medical packaging by dye migration; ASTM F88: Standard Test Method for Seal Strength of Flexible Barrier Materials | Shelf Life Pre Sterilization | Dye Penetration: none; Seal peel: =>1.5N/15mm | Pass (>1.5N/15mm per ASTM F88, No leaks detected after dye migration) |
| ASTM F1980 – 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; ASTM F1929-15: Standard test method for detecting seal leaks in porous medical packaging by dye migration; ASTM F88: Standard Test Method for Seal Strength of Flexible Barrier Materials | Shelf Life Post Sterilization (Accelerated Aging) | Dye Penetration: none; Seal peel: =>1.5N/15mm | Pass (>1.5N/15mm per ASTM F88, No leaks detected after dye migration) |
| Various ASTM, TAPPI, and ISO standards (listed in document) | Material Compatibility | Meets specifications per Technical Data Sheets. Included in Bench Testing Summary. | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes for each test. It refers to "samples," "items," and "pouches" but does not provide numerical quantities for the test sets.
The data provenance is from non-clinical tests conducted on the device itself (Steriking LT-Blueline Pouches with Tyvek). The country of origin of the data is not specified, but the applicant, Wipak Oy, is located in Nastola, Finland, suggesting the testing may have been conducted there or by a contracted lab. The studies are prospective in the sense that they are designed to evaluate the performance of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a non-clinical device performance study, not a study involving human interpretation of medical images or data. Therefore, the concept of "experts" to establish ground truth in the context of medical imaging interpretation is not applicable here. The "ground truth" is established by adherence to recognized international and industrial standards (e.g., ISO, ASTM, AAMI) for testing materials and sterilization packaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical device performance study, not a study involving diagnostic interpretation or human consensus. Test results are determined by quantitative measurements and observations against pre-defined criteria from recognized standards.
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
Not applicable. This is a non-clinical device performance study for a sterilization pouch, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a non-clinical device performance study for a sterilization pouch, not an algorithm. The device performance itself is "standalone" in the sense that it is evaluated directly against physical and biological criteria.
7. The type of ground truth used
The ground truth is based on established scientific and engineering standards and validated test methodologies.
- Biocompatibility: Absence of cytotoxicity as per ISO 10993-5.
- Sterilant Penetration: 6-log reduction of Geobacillus stearothermophilus spores, demonstrating a 10^-6 Sterility Assurance Level. This is a biological indicator's response to sterilization.
- Package Integrity (Dye Migration): Absence of dye penetration as per ASTM F1929-15.
- Microbial Barrier Properties: Maintenance of sterility (no microbial growth) after exposure to aerosolized spores as per ISO 11607 and related AAMI standards.
- Seal Strength: A minimum peel strength of 1.5N/15mm as per ASTM F88.
- Material Compatibility: Meeting specifications defined in technical data sheets.
8. The sample size for the training set
Not applicable. This is a non-clinical device performance study, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not a machine learning study, there is no training set or associated ground truth for that purpose.
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January 4, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Wipak OY % Amanda Singleton Consultant Compliance Systems International 53 Assembly Drive, Unit 149 Mendon, New York 14506
Re: K221379
Trade/Device Name: Steriking LT-Blueline Pouches with Tyvek Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 27, 2022 Received: December 27, 2022
Dear Amanda Singleton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221379
Device Name Steriking® LT-Blueline Pouches with Tyvek®
Indications for Use (Describe)
The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-PRO® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.
The Steriking® LT-Blueline Pouches with Tyvek® are intended for use in the following STERIS® V-PRO® Sterilization Cycles:
Lumen Cycle Non Lumen Cycle Flexible Cycle
Device lumen dimensions:
Flexible Cycle: 1 lumen x 1 mm min ID x 1050 mm max length for all pouch sizes.
Lumen Cycle: 1 lumen x 1 mm min ID for all pouch sizes. For pouch sizes 250x500mm, 250x390mm, 205x390mm, max length of 125 mm. For all other pouch sizes, max length of 50 mm.
Max Weights: 1.410 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm
.114 pounds for pouch sizes below (Flexible and Lumen Cycles) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm
.158 pounds for pouch sizes below (Non-Lumen Cycle) 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm
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Pouch Sizes: 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K221379 Page 1 of 7
5. 510K Summary (in accordance with 21CFR807.92)
| 510K Summary elements per21CFR807.92 | Summary |
|---|---|
| Submitter's name, address, telephonenumber, a contact person, and the date thesummary was prepared | Wipak OyWipaktie 2Nastola FinlandContacts:Hanna Marttila Phone: +358 (0)40 124 0290Consultant: Amanda Singleton, CSI LLC. Phone: 716.440736453 Assembly Drive, Unit 149, Mendon, NY 14506Date prepared: January 4, 2023 |
| Name of the device includingthe trade or proprietary nameif 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 CodeDevice ClassificationRegulation Number | FRGClass II21 CFR 880.6850 |
| Identification of the legallymarketed device to whichthe submitter claimsequivalence (PrimaryPredicate device) | K180672, Sterilization Pouch/Roll Made With Tyvek® |
| Description of the device | Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to containmedical devices to be terminally sterilized in the STERIS® Sterilization System. Themedical devices are inserted into the Pouch, sealed, and then sterilized in theSTERIS® Sterilization System. Sterilization Cycles are noted below. Aftercompletion of the sterilization process, the Pouch maintains sterility of theenclosed medical devices until the seal is opened. These pouches are made froma plastic film and Tyvek that is heat-sealed on three sides. The fourth side is leftopened and will be heat-sealed when used.Steriking® LT-Blueline Pouches with Tyvek® are intended to allow sterilization ofenclosed devices and to maintain sterility of the enclosed devices until used upto 3 years post sterilization. The products are for single use only.The pouches are constructed from Tyvek®/plastic films. The heat-sealed pouchesare heat sealed prior to processing in the STERIS® V-PRO® Sterilization Systems.Sterilization Systems:STERIS® V-PRO® Cycles:Lumen Cycle,Non Lumen Cycle |
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| Flexible Cycle | mm. For all other pouch sizes, maxlength of 50 mm.Max Weights:1.410 pounds for pouch sizesbelow (Flexible, Lumen, and Non-Lumen Cycles)250 mm x 500 mm250 mm x 390 mm205 mm x 390 mm.114 pounds for pouch sizesbelow (Flexible and LumenCycles)160 mm x 600 mm160 mm x 440 mm150 mm x 300 mm100 mm x 250 mm75 mm x 200 mm.158 pounds for pouch sizesbelow (Non-Lumen Cycle)160 mm x 600 mm160 mm x 440 mm150 mm x 300 mm100 mm x 250 mm75 mm x 200 mmFlat Sterilization Pouch Sizes:75 x 200 mm100x 250 mm150 x 300 mm160 x 440 mm160 x 600 mm205 x 390 mm250 x 390 mm250 x 500 mm | ||||||
|---|---|---|---|---|---|---|---|
| Intended use of the device | The Steriking® LT-Blueline Pouches with Tyvek® are intended to provide healthcare workers with an effective method to enclose devices intended forsterilization in the STERIS® V-PRO® Sterilizer Systems.The device is intended to allow sterilization of enclosed devices and to maintainsterility of the enclosed devices until used up to 3 years post sterilization. | Design | These pouches are made from aplastic film and Tyvek that is heatsealed on three sides. The fourthside is left opened and will beheat-sealed when used. | Same | These pouches are made from amedical grade plastic film that isheat sealed on three sides. Thefourth side is left opened and willbe heat-sealed when used. | ||
| Technologicalcharacteristics comparedto predicate (asfollows) | See below as follows: | Backing Material | Tyvek® | Same | Tyvek® | ||
| Discussion of nonclinical testssubmitted, referenced, orutilized in the premarketnotification submission for adetermination of substantialequivalence | Submission Device –Steriking® LT-Blueline Poucheswith Tyvek® | SEDetermination | Predicate Device –K180672 –Sterilization Pouch/Roll Made WithTyvek | Transparent Film | BOPET/PE | Same | PE |
| Indications for Use | The Steriking® LT-Blueline Poucheswith Tyvek® are intended toprovide health care workers with aneffective method to enclose devicesintended for sterilization in theSTERIS® V-PRO® Sterilizer Systems.The device is intended to allowsterilization of enclosed devices andto maintain sterility of the encloseddevices until used up to 3 yearspost sterilization. The products arefor single use only.The Steriking® LT-Blueline Poucheswith Tyvek® are intended for use inthe following STERIS® V-PRO®Sterilization Cycles:Lumen CycleNon Lumen CycleFlexible CycleDevice lumen dimensions:Flexible Cycle: 1 lumen x 1 mm minID x 1050 mm max length for allpouch sizes.Lumen Cycle: 1 lumen x 1 mm minID for all pouch sizes. For pouchsizes 250x500mm, 250x390mm,205x390mm, max length of 125 | Similar | The Sterilization Pouch/RollMade with Tyvek® are intendedto provide health care workerswith an effective method toenclose devices intended forsterilization in the STERRAD ®100S Sterilizer. The device isintended to allow sterilization ofenclosed devices and also tomaintain sterility of theenclosed devices until used upto 3 years post sterilization. Thepouches and rolls are printedwith a chemical indicator barwhich is a process indicator (ISO11140-1:2005) that changesfrom red to blue (or lighter)when exposed to hydrogenperoxide vapor duringprocessing in the STERRAD®100S Sterilizer. The SterilizationPouch/Roll Made with Tyvek® isoffered in the follow 5 types:Self-sealing sterilization pouchesSterilization pouches, FlatSterilization pouches, GussetedSterilization rolls, FlatSterilization rolls, Gusseted | Sterilization Processes | H2O2 Sterilization Process as per:STERIS® V-PRO®Lumen CycleNon-Lumen Cycle | Similar | H2O2 Sterilization Process as per:STERRAD® 100S |
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| Flexible Cycle | |||
|---|---|---|---|
| SterilantValidationAAMI TIR12:2010ANSI/AAMI ST79ANSI/AAMI/ISO 14937:2009ANSI/AAMI/ISO 17664:2017 | Achieved a 10-6 Sterility AssuranceLevel (SAL) of Geobacillusstearothermophilus.V-Pro® MAX and Max 2 FlexibleCycleV-Pro® 1 Plus Lumen CycleV-Pro® 1 Plus Non-Lumen Cycle | Similar | Showed a 6 log reduction ofGeobacillus stearothermophilus. |
| Dye MigrationISO 11607ASTM F1929AAMI TIR12:2010 | No leaks detected after dyemigration | Same | No leaks detected after dyemigration |
| Seal StrengthASTM F88AAMI TIR12:2010AAMI/ISO TIR16775:2014ISO 11607 | > 1.5N/15mm per ASTM F88 | Same | > 1.5N/15mm per ASTM F88 |
| Microbial BarrierPropertiesISO 11607-1AAMI TIR12:2010ANSI/AAMI ST79:2017 | PassEach pouch met the sterilitymaintenance requirement as therewas no growth in any of the culturetubes containing the stainless-steelcoupons at the end of theincubation period. | Similar | Pass |
| Biocompatibility | PassISO 10993-5 | Similar | PassISO 10993-12 |
| Shelf-Life Pre-SterilizationASTM F1929-15ASTM F88 | 5 years | Similar | 3 years |
| Maintenance of Sterility –Accelerated AgingANSI/AAMI ST8:2013/(R)2018AAMI TIR12:2010ANSI/AAMI ST77:2017ANSI/AAMI ST79:2017ISO 11607-1ASTM F1980ASTM F1929-15ASTM F88 | 3 years | Same | 3 Years |
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| Dimensions and max load weight | Similar | Not Listed | |||||
|---|---|---|---|---|---|---|---|
| Non- | |||||||
| Flexible Cycle | Lumen Cycle | Lumen Cycle | |||||
| Pouch size | max weight (pounds) | ||||||
| 250 x 500 mm | 1.410 | 1.410 | 1.410 | ||||
| 250 x 390 mm | 1.410 | 1.410 | 1.410 | ||||
| 205 x 390 mm | 1.410 | 1.410 | 1.410 | ||||
| 160 x 600 mm | 0.114 | 0.114 | 0.158 | ||||
| 160 x 440 mm | 0.114 | 0.114 | 0.158 | ||||
| 150 x 300 mm | 0.114 | 0.114 | 0.158 | ||||
| 100 x 250 mm | 0.114 | 0.114 | 0.158 | ||||
| 75 x 200 mm | 0.114 | 0.114 | 0.158 | ||||
| Max Lumen Dimensions | Flexible Cycle: 1 lumen x 1 mm minID x 1050 mm max length for allpouch sizes. | Different | Not Listed | ||||
| Lumen Cycle: 1 lumen x 1 mm minID for all pouch sizes. For pouchsizes 250x500mm, 250x390mm,205x390mm, max length of 125mm. For all other pouch sizes, maxlength of 50 mm. |
Summary of Non-Clinical Testing
The Steriking® LT-Blueline Pouches with Tyvek® (submission device) has the identical intended use and indications for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, and Sterility Maintenance. The results of the Steriking® LT-Blueline Pouches with Tyvek® validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:
- . The Sterilant Penetration testing performed as described in AAMI / ANSI / ISO 14937:2009, "Sterilization of Health Care Products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices". The results confirm that the sterilant is able to penetrate Steriking® LT-Blueline Pouches with Tyvek® and sustain direct contact with the medical instrument inside the subject device.
- . The Biocompatibility testing performed as described in ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity. The testing results demonstrate the Steriking® LT-Blueline Pouches with Tyvek® did not elicit any cytotoxic effect.
- The Package Integrity, Material Compatibility, Sterility Maintenance, and Microbial Aerosol Challenge testing was performed as described in ISO 11607. The use of the aerosol challenge test to analyze the microbial barrier properties of the samples was considered to be rigorous. By exposing the sealed test samples' exterior with aerosolized spores, the permeability of the samples to microorganisms was challenged. A sample which demonstrates that all items remain sterile following this test is considered safe and effective at maintaining package integrity. The use of stainless-steel coupons was based on several considerations. First, they offer a convenient way to identify specific pieces to be sterility tested and to confirm that samples were indeed in the specified locations. Second, coupons are relatively easy to manipulate, and reduces the likelihood of the introduction of adventitious growth into the sterility test results. Finally, the coupons are comprised of metals consistent with metals used to manufacture medical instruments.
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| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5 Biological Evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicity | Biocompatibility | no reduction of cell growthor cell lysis was observed | Pass |
| AAMI TIR12:2010 - Designing, testing, andlabeling reusable medical devices forreprocessing in health care facilities | Sterilant Penetration | Demonstrating that aminimum of 1.0x10^6Geobacillusstearothermophilus sporeswere killed in a half-cycle (6-log reduction) | PassNegative for growth |
| ASTM F1929-15: Standard test method fordetecting seal leaks in porous medicalpackaging by dye migration | Package Integrity | Dye Penetration: none | Pass |
| ANSI/AAMI ST79:2017 - Comprehensive guideto steam sterilization and sterility assurancein health care facilitiesAAMI TIR12:2010 - Designing, testing, andlabeling reusable medical devices forreprocessing in health care facilities | Microbial Barrier Properties | A sample whichdemonstrates that all itemsremain sterile followingexposure | PassEach pouch met thesterility maintenancerequirement as therewas no growth in anyof the culture tubescontaining thestainless-steelcoupons at the end ifthe incubation period. |
| ASTM F1929-15: Standard test method fordetecting seal leaks in porous medicalpackaging by dye migrationASTM F88: Standard Test Method for SealStrength of Flexible Barrier Materials | Shelf Life Pre Sterilization | Dye Penetration: noneSeal peel: =/>1.5N/15mm | Pass |
| ASTM F1980 – 16 Standard Guide forAccelerated Aging of Sterile Barrier Systemsfor Medical DevicesASTM F1929-15: Standard test method fordetecting seal leaks in porous medicalpackaging by dye migrationASTM F88: Standard Test Method for SealStrength of Flexible Barrier Materials | Shelf Life Post Sterilization | Dye Penetration: noneSeal peel: =/>1.5N/15mm | Pass |
| 1. ASTM F1608, ASTM F2638 - MicrobialBarrier 2. ASTM D3776 - Basis Weight of Tyvek 3. ASTM D2724 - Delamination of Tyvek 4. TAPPI T460 - Gurly Hill porosity of Tyvek 5. ISO 1924-2 - Tensile Strength, MD of Tyvek 6. ISO 1924-2 - Elongation, MD of Tyvek 7. ASTM D1424 - Elmendorf Tear, MD ofTyvek 8. ISO 534 - Thickness of Tyvek 9. ISO 5636-3 - Bendtsen air permeability ofTyvek 10. TAPPI T523 - Moisture vapor transmissionRate of Tyvek 11. ISO 2758 - Mullen, burst of Tyvek 12. ASTM D3420 - Spencer puncture of Tyvek | Material Compatibility | Meets specifications perTechnical Data Sheets.Included in Bench TestingSummary. | Pass |
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K221379 Page 7 of 7
Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K180672.
§ 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).