(224 days)
The SteriKing® LT Blueline with Tyvek® pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.
The SteriKing® LT Blueline with Tyvek® pouches are intended for use in the following STERRAD® Sterilization Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard
Max weights:
NX Standard Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 088 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.382 pounds
NX Advanced Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 084 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.393 pounds
100NX Duo Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm : 104 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds
100NX Flex Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds
100NX Standard Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm: .158 pounds
205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 4.476 pounds
Max lumens:
1 mm min ID and 1 max lumen for all cycles
NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes.
NX Advanced Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length is 50 mm for all other pouch sizes.
100NX Duo Cycle: For pouch sizes 250x500mm, 250x390mm is 875 mm max length. Max length is 850 mm for all other pouch sizes.
100NX Flex Cycle: Max length is 850 mm for all pouch sizes.
100NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length, Max length is 50 mm for all other pouch sizes.
Pouch Sizes:
250 mm x 500 mm
250 mm x 390 mm
205 mm x 390 mm
160 mm x 600 mm
160 mm x 440 mm
150 mm x 300 mm
100 mm x 250 mm
75 mm x 200 mm
Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain medical devices to be terminally sterilized in the STERRAD® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERRAD® Sterilization System. Sterilization Cycles are noted below. After completion of the sterilization process, the Pouch maintains sterility of the enclosed medical devices until the seal is opened. These pouches are made from a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left opened and will be heat-sealed when used.
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 STERRAD® Sterilization Systems.
Sterilization Systems:
STERRAD® Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard
This document is a 510(k) Premarket Notification from the FDA, and as such, it describes the non-clinical testing performed for a medical device (sterilization pouches), rather than an AI-powered software device. Therefore, many of the requested elements for describing an AI study (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable in this context.
However, I can extract the information related to the acceptance criteria and the studies that prove the device meets these criteria, focusing on the traditional medical device testing rather than AI performance.
Here's the breakdown of the acceptance criteria and study findings for the SteriKing® LT-Blueline Pouches with Tyvek®:
1. A table of acceptance criteria and the 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 |
| 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 Geobacilus stearothermophilus spores were killed in a half-cycle (6-log reduction) | Pass |
| ASTM F1929-15: Standard test method for detecting seal leaks in porous medical packaging by dye migration | Package Integrity | Dye Penetration: none | Pass |
| ANSI/AAMI ST79:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities, AAMI TIR12:2010 | Microbial Barrier Properties | A sample which demonstrates that all items remain sterile following exposure | Pass (No growth in culture tubes containing stainless-steel coupons after incubation) |
| 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 |
| ASTM F1980 – 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, ASTM F1929-15, ASTM F88 | Shelf Life Post Sterilization | Dye Penetration: none, Seal peel: =>1.5N/15mm | Pass |
| Various ASTM/ISO/TAPPI standards (F1608, F2638, D3776, D2724, T460, 1924-2, D1424, 534, 5636-3, T523, 2758, D3420) | Material Compatibility | Meets specifications per Technical Data Sheets. | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state numerical sample sizes for each test. However, it mentions "test samples" and "stainless-steel coupons" were used. The data provenance is based on lab testing of the device itself, likely conducted by the manufacturer (Wipak Oy in Finland) for submission to the FDA. The tests are non-clinical (laboratory-based) rather than retrospective or prospective human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the testing involves physical and biological properties of a medical device (sterilization pouches), not an AI model requiring human expert interpretation for ground truth. Ground truth is established through adherence to recognized international standards and documented laboratory methods (e.g., measuring direct physical properties, culturing for microbial growth, assessing cytotoxicity).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a human interpretation study. The results are based on objective measurement against predefined 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 not an AI-powered device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is evaluated through its physical and biological integrity and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on:
- Compliance with recognized international and national standards: e.g., ISO 10993-5 (Biocompatibility), AAMI TIR12:2010 (Sterilant Penetration, Microbial Barrier), ASTM F1929-15 (Seal Leaks, Dye Migration), ASTM F88 (Seal Strength), ASTM F1980 (Accelerated Aging).
- Objective laboratory measurements: Such as absence of cell growth/lysis, 6-log reduction in spores, absence of dye penetration, specified seal strength values, and "no growth in any of the culture tubes."
- Performance specifications: Material compatibility against technical data sheets.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device.
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December 22, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Wipak OY % Amanda Singleton Consultant Compliance Systems International 53 Assembly Drive, Unit 149 Mendon, New York 14506
Re: K221377
Trade/Device Name: SteriKing LT-Blueline Pouches with Tyvek Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: November 29, 2022 Received: November 29, 2022
Dear Amanda Singleton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
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,
Anne D. Talley -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K221377
Device Name SteriKing® LT Blueline Pouch with Tyvek®
Indications for Use (Describe)
The SteriKing® LT Blueline with Tyvek® pouches are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The products are for single use only.
The SteriKing® LT Blueline with Tyvek® pouches are intended for use in the following STERRAD® Sterilization Cycles:
NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard
Max weights:
NX Standard Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 088 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.382 pounds
NX Advanced Cycle:
75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm . 084 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.393 pounds
100NX Duo Cycle: 75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm : 104 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds
100NX Flex Cycle: 75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds
100NX Standard Cycle: 75 mm x 200 mm, 100 mm x 250 mm x 300 mm, 160 mm x 440 mm x 600 mm: .158 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 4.476 pounds
Max lumens:
1 mm min ID and 1 max lumen for all cycles
NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes.
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NX Advanced Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length is 50 mm for all other pouch sizes.
100NX Duo Cycle: For pouch sizes 250x500mm, 250x390mm is 875 mm max length. Max length is 850 mm for all other pouch sizes.
100NX Flex Cycle: Max length is 850 mm for all pouch sizes.
100NX Standard Cycle: For pouch sizes 250x500mm, 205x390mm is 125 mm max length, Max length is 50 mm for all other pouch sizes.
Pouch Sizes: 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary (in accordance with 21CFR807.92) -
| 510K Summary Elements per21CFR807.92 | Summary |
|---|---|
| Submitter's name, address, telephone number, a contact person, and the date the summary was prepared | Wipak OyWipaktie 2Nastola FinlandContact: Hanna Marttila Phone: +358 (0)40 124 0290Date prepared: December 21, 2022Consultant: Amanda Singleton, CSI LLC. Phone: 716.4407364 |
| Name of the device including the trade or proprietary name if applicable | Proprietary Name: Steriking® LT-Blueline Pouches with Tyvek® |
| Common or usual name | Common Name: Peel Pouch |
| Classification name | Classification Name: Sterilization wrap |
| Classification Product CodeDevice ClassificationRegulation Number | FRGClass II21 CFR 880.6850 |
| Identification of the legally marketed device to which the submitter claims equivalence(Predicate device) | K180672, Sterilization Pouch/Roll Made With Tyvek® |
| Description of the device | Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain medical devices to be terminally sterilized in the STERRAD® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERRAD® Sterilization System. Sterilization Cycles are noted below. After completion of the sterilization process, the Pouch maintains sterility of the enclosed medical devices until the seal is opened. These pouches are made from a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left opened and will be heat-sealed when used.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 STERRAD® Sterilization Systems.Sterilization Systems:STERRAD® Cycles:NX StandardNX Advanced100NX Duo100NX Flex100NX Standard |
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| Intended use of the deviceTechnologicalcharacteristicscompared to predicate(asfollows) | The Steriking® LT-Blueline Pouches with Tyvek® are intended to providehealth care workers with an effective method to enclose devices intended forsterilization in the STERRAD® Sterilizer Systems.The device is intended to allow sterilization of enclosed devices and tomaintain sterility of the enclosed devices until used up to 3 years poststerilization.See below as follows: | ||
|---|---|---|---|
| Discussion of nonclinicaltests submitted, referenced,or utilized in the premarketnotification submission for adetermination of substantialequivalence | Submission Device -Steriking® LT-Blueline Poucheswith Tyvek® | SE Determination | Predicate Device -K180672 -Sterilization Pouch/Roll MadeWith Tyvek |
| Indications for Use | The SteriKing® LT Blueline withTyvek® pouches are intended toprovide health care workerswith an effective method toenclose devices intended forsterilization in the STERRAD®Sterilizer Systems.The device is intended to allowsterilization of enclosed devicesand to maintain sterility of theenclosed devices until used upto 3 years post sterilization. Theproducts are for single use only.The SteriKing® LT Blueline withTyvek® pouches are intended foruse in the following STERRAD®Sterilization Cycles:NX StandardNX Advanced100NX Duo100NX Flex100NX StandardMax weights:NX Standard Cycle:75 mm x 200 mm, 100 mm x 250mm, 150 mm x 300 mm, 160mm x 440 mm, 160 mm x 600mm: .088 pounds | Similar | The SterilizationPouch/Roll Made withTyvek® are intended toprovide health careworkers with an effectivemethod to enclosedevices intended forsterilization in theSTERRAD® 100S Sterilizer.The device is intended toallow sterilization ofenclosed devices and alsoto maintain sterility of theenclosed devices untilused up to 3 years poststerilization. The pouchesand rolls are printed witha chemical indicator barwhich is a processindicator (ISO 11140-1:2005) that changes fromred to blue (or lighter)when exposed tohydrogen peroxide vaporduring processing in theSTERRAD® Sterilizer. TheSterilization Pouch/RollMade with Tyvek® isoffered in the follow 5types: Self-sealingsterilization pouchesSterilization pouches, FlatSterilization pouches,Gusseted Sterilization |
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| 390 mm, 250 mm x 500 mm:1.382 pounds | rolls, Flat Sterilizationrolls, Gusseted |
|---|---|
| NX Advanced Cycle:75 mm x 200 mm, 100 mm x 250mm, 150 mm x 300 mm, 160mm x 440 mm, 160 mm x 600mm: .084 pounds | |
| 205 mm x 390 mm, 250 mm x390 mm, 250 mm x 500 mm:1.393 pounds | |
| 100NX Duo Cycle:75 mm x 200 mm, 100 mm x 250mm, 150 mm x 300 mm, 160mm x 440 mm, 160 mm x 600mm: .104 pounds | |
| 205 mm x 390 mm, 250 mm x390 mm, 250 mm x 500 mm:1.400 pounds | |
| 100NX Flex Cycle:75 mm x 200 mm, 100 mm x 250mm, 150 mm x 300 mm, 160mm x 440 mm, 160 mm x 600mm: .158 pounds | |
| 205 mm x 390 mm, 250 mm x390 mm, 250 mm x 500 mm:1.400 pounds | |
| 100NX Standard Cycle:75 mm x 200 mm, 100 mm x 250mm, 150 mm x 300 mm, 160mm x 440 mm, 160 mm x 600mm: .158 pounds | |
| 205 mm x 390 mm, 250 mm x390 mm, 250 mm x 500 mm:4.476 pounds | |
| Max lumens:1 mm min ID and Max 1 lumen.for all cycles | |
| NX Standard Cycle: For pouchsizes 250x500mm, 250x390mm,205x390mm is 125 mm maxlength. Max length is 50 mm forall other pouch sizes. |
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| NX Advanced Cycle: For pouchsizes 250x500mm, 250x390mm,205x390mm is 125 mm maxlength. Max length is 50 mm forall other pouch sizes.100NX Duo Cycle: For pouchsizes 250x500mm, 250x390mm,205x390mm is 875 mm maxlength. Max length is 850 mmfor all other pouch sizes.100NX Flex Cycle: Max length is850 mm for all pouch sizes.100NX Standard Cycle: Forpouch sizes 250x500mm,250x390mm, 205x390mm is 125mm max length. Max length is50 mm for all other pouch sizes.Pouch Sizes:250 mm x 500 mm250 mm x 390 mm205 mm x 390 mm160 mm x 600 mm160 mm x 440 mm150 mm x 300 mm100 mm x 250 mm75 mm x 200 mm | |||
|---|---|---|---|
| Design | These pouches are made from aplastic film and Tyvek that isheat sealed on three sides. Thefourth side is left opened andwill be heat-sealed when used. | Same | These pouches are madefrom a plastic film andTyvek that is heat sealedon three sides. The fourthside is left opened and willbe heat-sealed whenused. |
| Backing Material | Tyvek® | Same | Tyvek® |
| Transparent Film | BOPET/PE | Similar | PE |
| Sterilization Processes | H2O2 Sterilization Process as per:STERRAD® | Similar | STERRAD® 100S |
| NX Standard | |||
| NX Advanced | |||
| 100NX Duo | |||
| 100NX Flex | |||
| 100NX Standard | |||
| Sterilant | Achieved a 10-6 Sterility Assurance | Similar | Showed a 6 log reduction of |
| Validation | Level (SAL) of Geobacillus | Geobacillus | |
| stearothermophilus. | stearothermophilus | ||
| AAMI TIR12:2010ANSI/AAMI ST79ANSI/AAMI/ISO 14937:2009ANSI/AAMI/ISO 17664:2017 | NX StandardNX Advanced100NX Duo100NX Flex100NX Standard | ||
| 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 if the incubationperiod. | 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/AAMIST8:2013/(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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K221377 Page 6 of 8
| Dimensions and max load weight | Similar | Not listed | |||||
|---|---|---|---|---|---|---|---|
| Pouch size | NXAdvancedCycle | NXStandardCycle | 100NXDuoCycle | 100NXFlexCycle | 100NXStandardCycle | ||
| weight (pounds) | |||||||
| 250 x 500 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | ||
| 250 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | ||
| 205 x 390 mm | 1.393 | 1.382 | 1.400 | 1.400 | 4.476 | ||
| 160 x 600 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| 160 x 440 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| 150 x 300 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| 100 x 250 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| 75 x 200 mm | 0.084 | 0.088 | 0.104 | 0.158 | 0.158 | ||
| Max Lumen Dimensions | 1 mm min ID Lumen and Max 1lumen for all cyclesFor NX Standard Cycle: Forpouch sizes 250x500mm,250x390mm, 205x390mm is 125mm max length. Max length is50 mm for all other pouch sizes.NX Advanced Cycle: For pouchsizes 250x500mm, 250x390mm,205x390mm is 125 mm maxlength. Max length is 50 mm forall other pouch sizes.100NX Duo Cycle: For pouchsizes 250x500mm, 250x390mm,205x390mm is 875 mm maxlength. Max length is 850 mmfor all other pouch sizes.100NX Flex Cycle: Max length is850 mm for all pouch sizes.100NX Standard Cycle: Forpouch sizes 250x500mm,250x390mm, 205x390mm is 125mm max length. Max length is50 mm for all other pouch sizes. | Different | Not listed |
Summary of Non-Clinical Testing
The Steriking® LT-Blueline Pouches with Tyvek® (submission device) has the identical intended use and indications for use as
the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, and Sterility Maintenance. The results of the Steriking® LT-Blueline Pouches with Tyvek® validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:
- The Sterilant Penetration testing performed as described in AAMI / ANSI / ISO 14937:2009, "Sterilization of Health Care Products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices". The results confirm that the 6 of 8
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sterilant is able to penetrate Steriking® LT-Blueline Pouches with Tyvek® and sustain with the medical instrument inside the subject device.
- The Biocompatibility testing performed as described in ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity. The testing results demonstrate the Steriking® LT-Blueline Pouches with Tyvek® did not elicit any cytotoxic effect.
- The Package Integrity, Material Compatibility, Sterility Maintenance, and Microbial Aerosol Challenge testing was performed as described in ISO 11607. The use of the aerosol challenge test to analyze the microbial barrier properties of the samples was considered to be rigorous. By exposing the sealed test samples' exterior with aerosolized spores, the permeability of the samples to microorganisms was challenged. A sample which demonstrates that all items remain sterile following this test is considered safe and effective at maintaining package integrity. The use of stainless-steel coupons was based on several considerations. First, they offer a convenient way to identify specific pieces to be sterility tested and to confirm that samples were indeed in the specified locations. Second, coupons are relatively easy to manipulate, and reduces the likelihood of the introduction of adventitious growth into the sterility test results. Finally, the coupons are comprised of metals consistent with metals used to manufacture medical instruments.
- The Microbial Aerosol Challenge study is a whole package test which challenges all aspects of the pouch in its final state. Conversely the ISO 11607 tests (Dye Migration and Seal Peel) test only one component of the pouch at time as it is not a whole package test. The Microbial Aerosol Challenge is a rigorous whole package test, and therefore the results are more comprehensive and supersede the results from Dye Migration and Seal Peel tests.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5 Biological Evaluation of 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 1.0x10^6Geobacilusstearothermophilus sporeswere killed in a half-cycle (6-log reduction) | Pass |
| Negative 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 migration | Shelf Life Pre Sterilization | Dye Penetration: noneSeal peel: =/>1.5N/15mm | Pass |
{11}------------------------------------------------
| ASTM F88: Standard Test Method for SealStrength of Flexible Barrier Materials | |||
|---|---|---|---|
| ASTM F1980 – 16 Standard Guide forAccelerated Aging of Sterile Barrier Systemsfor Medical Devices | Shelf Life Post Sterilization | Dye Penetration: noneSeal peel: =/>1.5N/15mm | Pass |
| ASTM F1929-15: Standard test method fordetecting seal leaks in porous medicalpackaging by dye migration | |||
| ASTM F88: Standard Test Method for SealStrength of Flexible Barrier Materials | |||
| 1. ASTM F1608, ASTM F2638 - MicrobialBarrier2. ASTM D3776 - Basis Weight of Tyvek3. ASTM D2724 - Delamination of Tyvek4. TAPPI T460 - Gurly Hill porosity of Tyvek5. ISO 1924-2 - Tensile Strength, MD of Tyvek6. ISO 1924-2 - Elongation, MD of Tyvek7. ASTM D1424 - Elmendorf Tear, MD ofTyvek8. ISO 534 - Thickness of Tyvek9. ISO 5636-3 - Bendtsen air permeability ofTyvek10. TAPPI T523 - Moisture vapor transmissionRate of Tyvek11. ISO 2758 - Mullen, burst of Tyvek12. ASTM D3420 - Spencer puncture of Tyvek | Material Compatibility | Meets specifications perTechnical Data Sheets.Included in Bench TestingSummary. | Pass |
Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K180672.
§ 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).