(350 days)
Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:
- · Gravity steam at 121°C (250°F) for 30 minutes: 25 minutes dry time
- · Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
- · Pre-vacuum steam at 134°C (273°F) for 3 minutes: 20 minutes dry time
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
· Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60oC (140oF). - · The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle.
The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam. EO, or hydrogen peroxide sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.
The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).
Tyvek Sterilization Pouches with Chevron Seal are constructed Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylene- vinylacetate copolymer film.
The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed.
The self-seal pouch permits sealing of the pouch without heat-sealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle.
Chemical Indicators, are placed on the outside of the sterilization pouches indicate sterilant exposure, and a way to differentiate pouches that have been processed in sterilization cycles from unprocessed units.
The color of the Indicators (3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248) changes from blue to pink after exposer to hydrogen peroxide sterilization. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least five years.
The document outlines the K180139 510(k) premarket notification for "Safe Secure Sterilization Pouches and Rolls." While it details numerous tests and states "Pass" for results, it does not provide specific acceptance criteria or quantitative performance data for each test. Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed with numerical values from the provided text.
Based on the information provided, here's a breakdown of the requested elements:
1. A table of acceptance criteria and the reported device performance
The document lists various tests but does not explicitly state the numerical acceptance criteria or the quantitative reported performance for most of them. It generally indicates that the device "Pass"ed the tests and "meet acceptable criteria" or "meet ISO and ASTM requirements."
| Test Name | Acceptance Criteria (as implied) | Reported Device Performance (as implied) |
|---|---|---|
| Package Integrity | ||
| Seal Strength Test | Meet ASTM F88/F88M-15 requirements | Pass |
| Seal Leak Test | Meet ASTM F1929-15 requirements | Pass |
| Sterilization Chemical Indicator Test and Visual Inspection | Visual examination to confirm proper color change after exposure to sterilant. | Pass (Chemical indicators change color as expected for steam, EO, and hydrogen peroxide: green to purple for steam, yellow to brown for EO, blue to pink for hydrogen peroxide). |
| Material Compatibility | Demonstrate material compatibility characteristics of Tyvek Sterilization Pouches through seal strength, microbial barrier, burst, and peel open tests. | Pass |
| Biocompatibility | Materials are non-toxic, biological evaluations meet acceptable criteria, provides reasonable assurance for safety (referenced ISO 10993-1 and ISO 10993-5). | Pass (Both subject and predicate devices were non-cytotoxic post-sterilization). |
| Shelf Life | Physical properties and microbial barrier of processed Tyvek Pouches maintained at end of shelf life. | Pass (Validated for 2 years before sterilization; maintains sterility for 6 months after steam, 2 years after hydrogen peroxide, 5 years after EO (Tyvek Pouch), 24 months after EO (paper pouch)). |
| Sterilization Validation | Validate sterilization cycle using full, half, and partial/fail cycles (referenced ISO 11140-1, ISO 11138, ISO 14161). | Pass |
| Chemical Indicator | Demonstrate compliance to "Submissions for Chemical Indicators - Guidance for Industry and FDA Staff" (as applicable under K170321). | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the test set for any of the non-clinical tests.
Data Provenance: The submission sponsor is "Safe Secure Packing (Shenzhen) Co., Ltd" located in Guangdong Province, China. This suggests the testing data likely originates from China. The document does not specify if the studies were retrospective or prospective, but non-clinical performance and validation tests are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this type of device and study. The document describes non-clinical performance testing of a sterilization pouch, not a diagnostic or AI-based medical device that would require expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this type of device and study. Adjudication methods are typically used in clinical studies involving interpretation of medical images or data by multiple experts, which is not the case here.
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 information is not applicable to this type of device and study. An MRMC study is relevant for AI-powered diagnostic devices involving human readers, which this sterilization pouch is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this type of device and study. A standalone algorithm performance study is relevant for AI-powered diagnostic devices, which this sterilization pouch is not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/relevant in the typical sense for this device. The "ground truth" for the non-clinical tests would be the established scientific principles and standards for sterility, package integrity, and material biocompatibility. For example, for sterilization validation, the ground truth is the successful inactivation of microbes to a specified sterility assurance level (SAL). For chemical indicators, the ground truth is the expected color change upon exposure to the sterilant under specified conditions.
8. The sample size for the training set
This information is not applicable to this type of device. There is no AI or machine learning algorithm involved that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable to this type of device, as there is no training set.
§ 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).