(505 days)
U&U Hydrogen Peroxide Gas Plasma Sterillzation Pouch / Roll are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD 100NX Hydrogen Peroxide Gas Plasma sterilizer.
The recommended Hydrogen Peroxide Gas Plasma cycle parameter: STERRAD 100NX STANDARD Cycle
Sterilization load claim:
STERRAD 100NX Sterilizer Standard cycle:
· General medical instruments (metal and nonmetal, including hinged devices)
· Instruments with single-channel stalniess steel lumens with an Internal diameter 3 mm or larger and length 150 mm or shorter.
· Polyethylene and Teflon lumentubing with an internal diameter of 3 mm or larger and length of 500 mm or shorter.
· These items must be sterilized without any additional load items
· Limit of 20 pieces of tubing per cycle
Load condition: One device per Sterilization Pouch.
Load chamber: Two shelves (total weight: 21.4 Ibs or 9.7 kg)
Load Pouch: Leave enough material beyond the seal for the opener to easily grasp (usually 1- 1 % inches).
SHELF LIFE: It is recommended that the products are put to their end use within 2 years of manyfacture. The recommended "best before" date and the manufacturing date are stated on the label. This device was demonstrated to maintain sterility of the contents for 30 days after Sterilization.
The U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll are manufactured from TYVEK and medical plastic film that are heat sealed on three sides. The fourth side has an adhesive tape that is used to seal the pouch or heat-sealed by the heat-seal machine. The TYVEK conforms to recognized material standards and can be sterilized by STERRAD 100 NX Hydrogen Peroxide Gas Plasma. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as these predicate devices. Substantial equivalent to the predicate device was established by physical testing of the TYVEK (pressure drop vs. flow and filtration efficiency) and film (thickness, tensile strength and elongation) from non-sterile, sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, dye migration).
The pouches are manufactured from TYVEK that is thermally sealed to laminated film on the left, right, and bottom of pouch. The fourth side has an adhesive tape that is used to that is used to seal the pouch or heat-sealed by the heat-seal machine prior to sterilization of the enclosed medical device.
This document describes a 510(k) submission for "U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roll". The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing. Since this is a medical device for sterilization packaging, the "acceptance criteria" are related to the physical and biological integrity of the packaging material and its ability to maintain sterility, rather than AI model performance metrics. Similarly, there is no "study that proves the device meets the acceptance criteria" in the sense of a clinical trial for an AI system, but rather a series of laboratory tests.
Here's an analysis of the provided text based on your request, with the understanding that the nature of the "device" is a sterilization pouch/roll, not an AI system. Therefore, many of your requested items, such as expert-established ground truth, MRMC studies, standalone algorithm performance, and sample size for training sets, are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "Performance Tests" and a "Comparison Table" to demonstrate substantial equivalence to the predicate device. The acceptance criteria for these tests are implied to be "PASSED" or "YES" to match the predicate device's characteristics.
| Element of Comparison/Performance Test | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|
| Sterilant Penetration | PASSED | PASSED | |
| Package Integrity | PASSED | PASSED | |
| Maintenance of Package Integrity | PASSED | PASSED | |
| Material Compatibility | PASSED | PASSED | |
| Shelf-Life | PASSED (2 years, 30 days sterility after sterilization) | PASSED (2 years, 30 days sterility after sterilization) | Device demonstrated to maintain sterility of contents for 30 days after sterilization. |
| Biocompatibility | PASSED | PASSED | Biocompatibility is listed twice with "PASSED" |
| Performances | PASSED | PASSED | General performance is listed as "PASSED" |
| Pouch Construction: Tyvek | YES | YES | Matches predicate device. |
| Film | YES | YES | Matches predicate device. |
| User Heat Seal | YES | YES | Matches predicate device. |
| User Self Seal | YES | YES | Matches predicate device. |
| Single Use Device | YES | YES | Matches predicate device. |
| Labeling | Meet the requirements of 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 | Matches predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for the performance tests. It refers to "physical testing of the TYVEK... and film... from non-sterile, sterilized finished devices, as well as, performance of these finished devices." The provenance of the data is not specified beyond the manufacturer being based in China. The testing appears to be prospective, specifically conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/diagnostic device that relies on expert consensus for ground truth. The "ground truth" here is established by standardized laboratory testing methods for material properties and sterility maintenance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no human adjudication process described for these physical and biological tests.
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 device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is based on the results of standardized physical tests for material properties (e.g., pressure drop vs. flow, filtration efficiency, thickness, tensile strength, elongation, seal strength, package burst, dye migration) and biological tests for sterility maintenance, demonstrating equivalence to the predicate device. The specific standards or methodologies for these tests are not detailed in this summary but are implied by the "PASSED" results and the regulatory context of a 510(k) submission.
8. The sample size for the training set:
Not applicable. This is not an AI device. There is no "training set" in this context.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" in this context.
§ 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).