(108 days)
The Medicom Sterilization Pouch and Reel are intended to provide health care workers with an effective method to enclose devices, and they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
- · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
- Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- · Pre-vacuum steam at 134°C (273°F) for 4 minutes; Drying time of 20 minutes.
- · Ethylene Oxide (EO) with a concentration of 600 mg/L at 50°C (122°F) and 60% to 85% relative humidity for 120 minutes. Single Pouch: Aeration time of 5 days at 25°C (77°F). Double Pouches: Aeration time of 3 days at 25°C (77°F).
Furthermore, there are 3 thicknesses for health care workers to choose from as follows:
- · Pouch of Combination A: Medical grade paper 60g+laminated film 44/m
- Pouch of Combination B: Medical grade paper 60g+laminated film 52um
- · Pouch of Combination C: Medical grade paper 70g+laminated film 52um
The Medicom Sterilization Pouch and Reel which are made with Paper maintains the sterility of the enclosed devices for up to 1 year post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.
The medical devices are inserted into the Medicom Sterilization Pouch and Reel, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Reel maintains the sterility of the enclosed medical devices until the seal is opened. And they can use Single Pouch or Double Pouches intended for sterilization in the Steam or via Ethylene Oxide (EO).
The device is intended to allow the sterilization of enclosed devices and maintain sterility for the enclosed devices until used up to 1-year post-steam or EO gas sterilization.
The Self-seal pouch permits the sealing of the pouch without heat-sealing equipment, while the heat-sealed pouches and reels are heat-sealed before processing in the steam/or EO Sterilization.
The chemical indicators printed on the "medical grade paper" will exhibit color change after the pouch is exposed to steam or ethylene oxide gas. The "Medicom Sterilization Pouch and Reel" is printed with dual chemical indicators that the color change from Red/Pink to Cocoa when exposed to Steam, and the color changes from Blue to Golden Yellow /Brown, when exposed to EO gas.
The Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, but not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.
Furthermore, there are 3 thicknesses with dimensions for health care workers to choose from as follows:
- Pouch of Combination A: Medical grade paper 60g+laminated film 44um Dimensions of 880 series: W: 57mm ~ 415mm; L: 127mm
727mm Dimensions of 870 series: W: 89mm ~ 457mm; L: 159mm635mm Dimensions of 95 series: W: 50mm ~ 250mm; L: ~30.5M - Pouch of Combination B: Medical grade paper 60g+laminated film 52um Dimensions of 881 series: W: 57mm ~ 381mm; L: 127mm
797mm Dimensions of 871 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 951 series: W: 50mm ~ 250mm; L: ~200M - · Pouch of Combination C: Medical grade paper 70g+laminated film 52um Dimensions of 882 series: W: 57mm ~ 381mm; L: 127mm
797mm Dimensions of 872 series: W: 89mm ~ 457mm; L: 159mm559mm Dimensions of 952 series: W: 50mm ~ 250mm; L: ~200M
The provided text is a 510(k) summary for the Medicom Sterilization Pouch and Reel. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study that proves the device meets specific acceptance criteria as would be done for a novel AI/software medical device.
Therefore, much of the requested information (e.g., sample size for test set, data provenance, expert consensus, MRMC studies, AI effect size, training set details) is not applicable to this type of device submission and is not present in the document.
However, I can extract the acceptance criteria and reported performance for the physical and chemical properties of the Medicom Sterilization Pouch and Reel, as these are the relevant performance metrics for this specific device.
Based on the provided document, here's an analysis:
Device: Medicom Sterilization Pouch and Reel (FRG, JOJ - Sterilization Wrap)
1. Table of acceptance criteria and the reported device performance:
The document provides extensive tables (Table 5-4 and Table 5-5) detailing the tests performed, the standards followed, the acceptance criteria, and the results ("Pass"). I will consolidate and present these.
| Test Completed / Feature | Standard Followed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy | |||
| Sterilant Penetration Half-Cycle Efficacy (Steam) | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) | Meet the requirement of SAL 10^-6, the test BI (Steam processed): No bacterial growth | Pass |
| Drying Time (Steam) | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) | The weight difference before sterilization and after drying shall not exceed 0% | Pass |
| Sterilant Penetration Half-Cycle Efficacy (EO Gas) | AAMI / ANSI / ISO 11135:2014 | Meet the requirement of SAL 10^-6, the test BI (EO processed): No bacterial growth | Pass |
| Aeration (EO Gas) | ISO 10993-7:2008 (R) 2012 | EO ≤ 4mg; ECH ≤ 9mg | Pass |
| Biocompatibility Testing | |||
| Cytotoxicity | ISO 10993-5 :2009 | Grade level ≤ 2 | Pass |
| Sensitization | ISO 10993-10:2021 | Sensitization rate ≤ 8% | Pass |
| Irritation | ISO 10993-23:2021 | Non-irritating: mean PII ≤ 0.4 | Pass |
| Package Integrity / Material Compatibility / Sterility Maintenance | |||
| Tensile Strength of Paper | ISO 1924-2:2008 | Machine direction (MD) ≥ 4.4 kN/m; Cross direction (CD) ≥ 2.2 kN/m | Pass |
| Air Permeance of Paper | ISO 5636-3:2013 | ≥ 3.4 µm/(Pa · s) | Pass |
| Thickness Variations | ASTM F 2251-13(2018) | Medical grade paper ≥ 78µm | Pass |
| Visual Inspection (Seal Integrity) | ASTM F1886/F1886M -16 | No visual defects | Pass |
| Burst Strength | ASTM F1140/F1140M-13 (Reapproved 2020) | Self-seal pouches: ≥ 8.0 in. H2O; Heat Seal pouches: ≥ 8.0 in. H2O; Flat reels: ≥ 18.0 in. H2O | Pass |
| Bubble Leak Test | ASTM F1929-15 | No leaks | Pass |
| Seal Peel Test | ASTM F88/F88M-21 | Post-steam /EO sterilization: ≥ 1.5N/15mm (≥ 0.57 lbf/inch) | Pass |
| Microbial Barrier Test | ASTM F1608-21 | LRV ≥ 1.0 | Pass |
| Accelerated Aging Test (Durability) | ASTM F 1980-21 | 3-Year accelerated aging Incubation: Temp: 55°C± 2°C, Relative humidity 50%± 5%; 1 Year accelerated aging Incubation: Temp: 55°C± 2°C, Relative humidity 50%± 5% (These are conditions, the implicit acceptance is that properties are maintained throughout this period) | Pass |
| Chemical Indicator Efficacy (Type 1 Indicators) | |||
| Steam CI Functionality and Endpoint | AAMI/ANSI/ISO 11140-1:2014 | Color changes from Red/Pink to Cocoa when exposed to Steam | |
| Unacceptable: 121°C/2.0 min, 132°C/0.3 min, 134°C/0.3 min, Dry heat 140°C/30 min (Color: Red/Pink) | |||
| Acceptable: 121°C/10.0 min, 132°C/2.0 min, 134°C/2.0 min (Color: Cocoa) | Pass | ||
| EO Gas CI Functionality and Endpoint | AAMI/ANSI/ISO 11140-1:2014 | Color changes from Blue to Golden Yellow /Brown when exposed to EO gas | |
| Unacceptable: EO gas Treat / 2 min, Absence of EO gas / 90 min (Color: Blue) | |||
| Acceptable: EO gas Treat /20 min (Color: Golden Yellow /Brown) | Pass | ||
| CI Shelf Life | AAMI/ANSI/ISO 11140-1:2014 | Remain stable before use based on its shelf life for 3 years. | Pass |
| CI Endpoint Color Stability | AAMI/ANSI/ISO 11140-1:2014 | Maintain the endpoint stability of the color change for 1 year after being in the presence of the sterilant. | Pass |
| Other Properties | |||
| Total Lead (Pb) Content Test | (Standard not explicitly listed, but the test is mentioned) | Not Detected (N.D.) | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each physical, chemical, and biological test. It only states that the "results of the Medicom Sterilization Pouch and Reel validation studies demonstrate that the sterilization pouches perform as intended."
- Data Provenance: Not explicitly stated regarding the origin of the test samples (e.g., country of manufacture). The studies appear to be prospective validation tests conducted by the manufacturer to demonstrate performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable. The "ground truth" for this device (sterilization pouches and reels) is established by adherence to recognized international standards (e.g., ISO, ASTM, AAMI) for physical, chemical, and biological performance. These standards define the test methods and acceptance criteria. There is no subjective human interpretation or "expert consensus" on ground truth in the way there would be for an AI diagnostic device evaluating medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like "2+1" are relevant for clinical studies involving human readers and subjective interpretations, especially in AI-assisted diagnosis. For physical product testing conforming to specific standards, the results are typically objectively measured and evaluated against predefined thresholds.
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 device is a sterilization pouch and reel, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not a software algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on objective, measurable criteria defined by recognized international standards (e.g., successful microbial inactivation as per SAL 10^-6, specific tensile strengths, lack of leaks, defined color changes for chemical indicators, biocompatibility profiles). These are established through laboratory testing following validated protocols, not through expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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).