(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.
§ 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).