(269 days)
The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.
The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.
(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.
(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.
The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.
The provided FDA 510(k) clearance letter and summary describe a Sterilization Pouch and Roll device, which is a Class II medical device. This is NOT an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as effect size of human readers improving with AI, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Endpoint) | Reported Device Performance (Results) |
|---|---|---|
| Sterilant Penetration/Drying Time | - Meets the requirement of SAL 10-6 |
- The weight difference before sterilization and after drying shall not exceed 3% | Pass |
| Biocompatibility - Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. Pass |
| Biocompatibility - Irritation | Non-irritating | Under the conditions of the study, not an irritant. Pass |
| Biocompatibility - Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. Pass |
| Package Appearance | The appearance of the sterilization pouch is clean, intact, and sealed on all four sides. | Pass |
| Thickness | 52 ± 12% μm | Pass |
| Tensile Strength of Paper | MD ≥ 4.4 KN/m
CD ≥ 2.2 KN/m | Pass |
| Bursting Test | Burst value > 3 Kpa or No Burst | Pass |
| Dye Penetration Test | The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration) | Pass |
| Seal Strength Test | ≥ 2.5 N/15mm | Pass |
| Vacuum Leakage Test | No water can penetrate the sterilization pouch. | Pass |
| Microbial Barrier | 0 CFU No growth | Pass |
| Chemical Indicator Functionality | Color of indicator changes from blue to dark grey after Steam sterilization | Pass |
| Chemical Indicator Shelf Life & Endpoint Stability | Shelf life: 3 months
Endpoint stability: 3 months | Pass |
| Shelf Life (Product) | Shelf life: 3 months | Pass |
| Maintenance of Sterility | Maintains sterility of enclosed devices for up to 6 months post steam sterilization. (This is an indication from the "Indications for Use" and is generally supported by the package integrity and microbial barrier tests over time, often through accelerated aging studies). | The document states "The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization." The "Maintenance of Sterility" is listed as a "Different" characteristic compared to the predicate (6 months vs. 3 years for EO and 6 months for Steam). The microbial barrier test is passed, supporting the general concept of sterility maintenance, but the specific validation for the 6-month claim is not detailed in the summary table. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document details various performance tests such as sterilant penetration, biocompatibility, package integrity, and chemical indicator testing. However, it does not explicitly state the sample sizes used for each of these test sets. The tests are "bench testing" (non-clinical) and do not involve human subjects.
The data provenance is from non-clinical bench testing. The tests were performed to evaluate the performance and functionality of the device against a requirement specification. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies or data collection in human populations.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a physical sterilization pouch and roll, and its performance is evaluated through standardized laboratory and bench testing against established physical, chemical, and biological criteria, not by human expert interpretation of data or images. Ground truth is established by objective measurements and standardized test methods.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective measurements and established standards rather than expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human performance with and without AI assistance is being compared. This document is for a physical sterilization product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The ground truth for this device's testing is based on:
- Standardized Test Methodologies and Acceptance Criteria: As outlined in the "Test Methodology" and "Acceptance Criteria or End Point" columns in Table 3 of the 510(k) summary. These include standards like ISO 17665-1, ISO 10993 series, ASTM F1886, ASTM F2251, ISO 1924-2, ASTM F1140, ASTM F1929, ASTM F88, ASTM D3078, DIN 58953-6, ISO 11140-1, and ASTM F1980.
- Physical and Chemical Measurement: For properties like thickness, tensile strength, burst strength, seal strength, and the color change of the chemical indicator.
- Microbiological Evaluation: For the microbial barrier test (e.g., 0 CFU No growth).
- Biocompatibility Testing: Evaluating potential toxicity, irritation, and sensitization in laboratory settings (e.g., L-929 cells).
- Sterilization Effectiveness: Meeting a specified Sterility Assurance Level (SAL 10-6).
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML component described for this device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, 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).