(76 days)
DuraBlue™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
- Pre-vacuum steam at 270°F/132°C for 4 minutes .
- 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40%-80% . relative humidity for 60 minutes
- . Advanced Sterilization Products (ASP) STERRAD® 100S system.
- . Advanced Sterilization Products (ASP) STERRAD® NX system, Standard and Advanced Cycles
- Advanced Sterilization Products (ASP) STERRAD® 100NX system, Standard, Flex, Express, and . DUO Cycles
- Lumen, Non Lumen, and Flexible Cycles in the Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus . and Amsco® V-PRO™ maX Low Temperature Sterilization Systems
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used.
DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to enclose another medical device that is to be sterilized by a health care provider using various sterilization methods (Pre-vacuum steam, 100% ethylene oxide (EO), Advanced Sterilization Products (ASP) STERRAD® systems, and STERIS Amsco® V-PRO™ systems). This wrap design allows for use of the simultaneous double-wrapping technique and also allows for a sterilized pack to be opened aseptically. The submission covers six different models of DuraBlue™ Sterilization Wrap, each made from material of a different basis weight but utilizing the same material technology.
Here's an analysis of the acceptance criteria and the study information provided for the DuraBlue™ Sterilization Wrap, structured as requested:
Acceptance Criteria and Device Performance for DuraBlue™ Sterilization Wrap
This submission (K130927) is a 510(k) summary for a modification to an already cleared device, DuraBlue™ Sterilization Wrap. The stated modification is a clarification to sterility maintenance information in the Instructions for Use labeling. Therefore, the acceptance criteria and performance data referenced are primarily from the underlying predicate device submissions (K123857, K123289, K120658) which established the original substantial equivalence based on performance testing.
The document does not explicitly state specific pass/fail acceptance criteria (e.g., "sterility assurance level of X" or "no positive microbial cultures") for each test. Instead, it refers to "validated" performance for various sterilization methods and loads. The reported device performance is that the wrap "has been validated" for these uses, meaning it met the implicit or explicit criteria of the validation studies conducted for the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter/Sterilization Method | Acceptance Criteria (Implicit from "Validated") | Reported Device Performance |
|---|---|---|
| Sterility Maintenance (General) | Ability to maintain sterility of an enclosed medical device until used. | The wrap is intended to allow for sterilization and maintenance of sterility until used. This is achieved through the material properties and validated sterile barrier system. |
| Double-Wrapping Technique | Compatibility with simultaneous double-wrapping. | Wrap design allows for simultaneous double-wrapping. |
| Aseptic Opening | Ability for a sterilized pack to be opened aseptically. | Wrap design allows for aseptic opening of a sterilized pack. |
| Pre-vacuum Steam Sterilization | Effective sterilization with dry times appropriate for wrap models. | Models CH100 & CH200: Validated for 20 minutes dry time. |
| Models CH300, CH400, CH500, CH600: Validated for 30 minutes dry time. | ||
| Models CH400, CH500, CH600: Validated for two lumens ≥ 3 mm diameter & ≤ 400 mm length. | ||
| 100% Ethylene Oxide (EO) Sterilization | Effective sterilization with appropriate aeration time for wrap models. | Validated for 8 hours aeration at 55°C. |
| Models CH400, CH500, CH600: Validated for two lumens ≥ 3 mm diameter & ≤ 400 mm length. | ||
| ASP STERRAD® 100S Sterilization | Effective sterilization for specified lumen dimensions across all models. | All models: Validated for lumens ≥ 2.5 mm diameter & ≤ 250 mm length. |
| ASP STERRAD® NX Sterilization | Effective sterilization for specified chamber load and lumen configurations. | All models: Validated for use with STERRAD® NX Standard and Advanced Cycles. Specific lumen dimensions and maximum loads are detailed in "Table 1". |
| ASP STERRAD® 100NX Sterilization | Effective sterilization for specified chamber load and lumen configurations. | All models: Validated for use with STERRAD® 100NX Standard, Flex, Express, and DUO cycles. Specific lumen dimensions and maximum loads are detailed in "Table 1". |
| STERIS Amsco® V-PRO™ Sterilization | Effective sterilization and aeration for all V-PRO™ cycles. | All models: Validated for use with Lumen, Non Lumen, and Flexible Cycles by Amsco® V-PRO™ 1, V-PRO™ 1 Plus, and V-PRO™ MAX. The wraps were validated to be effectively aerated during these cycles. Specific lumen dimensions and maximum loads are detailed in "Table 2". |
| Maximum Wrapped Package Content Weight | Ability to maintain integrity and sterility for specified weights. | CH100: Validated for 3 lbs (Pre-Vacuum Steam/EO), 3 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 3 lbs (V-PRO™). |
| CH200: Validated for 6 lbs (Pre-Vacuum Steam/EO), 6 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 6.5 lbs (V-PRO™). | ||
| CH300: Validated for 9 lbs (Pre-Vacuum Steam/EO), 9.7 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 9 lbs (V-PRO™). | ||
| CH400: Validated for 13 lbs (Pre-Vacuum Steam/EO), 9.7 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 9.1 lbs (V-PRO™). | ||
| CH500: Validated for 17 lbs (Pre-Vacuum Steam/EO), 9.7 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 9.1 lbs (V-PRO™). | ||
| CH600: Validated for 25 lbs (Pre-Vacuum Steam/EO), 9.7 lbs (STERRAD® 100S), 10.7 lbs (STERRAD® NX/100NX), 9.1 lbs (V-PRO™). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes (n) for each test conducted for the predicate device submissions. Instead, it details the types of loads used to validate each model of sterilization wrap for different sterilization methods. These loads represent the "test set" and are described as follows:
- Pre-Vacuum Steam Sterility Validation Studies:
- CH100: 16 huck towels.
- CH200: 2 huck towels, 3 fluid-resistant drapes.
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass.
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 8 lbs of metal mass in a tray.
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 12 lbs of metal mass in a tray.
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 20 lbs of metal mass in a tray.
- EO Sterility Validation Studies:
- CH100: 16 huck towels.
- CH200: 2 huck towels, 2 fluid-resistant drapes, 2.5 lbs of metal mass.
- CH300: 16 huck towels, 1 fluid-resistant table cover, 5 lbs of metal mass.
- CH400: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 7.5 lbs of metal mass in a tray.
- CH500: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 11.5 lbs of metal mass in a tray.
- CH600: 4 stacked tray liners, 2 lumens (3mm ID x 400mm), 19.5 lbs of metal mass in a tray.
- Advanced Sterilization Products (ASP) STERRAD® 100S Sterility Validation Studies:
- CH100: Metal Instruments.
- CH200 - CH600: 15 in. x 10 in. x 1.2 in. tray containing metal instruments.
- Advanced Sterilization Products (ASP) STERRAD® NX and STERRAD® 100NX Sterility Validation Studies:
- CH100 - CH600: 23 in. x 11 in. x 4 in. tray containing metal instruments.
- STERIS Amsco® V-PRO™ Sterility Validation Studies:
- CH100: Metal Instruments.
- CH200 - CH600: 17 in. x 10 in. x 3.5 in. tray containing metal instruments.
Data Provenance: The studies were done as "Sterility Validation Studies" to support predicate device submissions, likely conducted in a controlled laboratory or testing facility setting, which implies a prospective design for testing the new device. The country of origin of the data is not specified, but since Cardinal Health 200, LLC is based in Waukegan, IL, USA, and the submission is to the FDA, it is highly likely the data was generated in the US or under US regulatory guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts specifically establishing "ground truth" for these sterilization validation studies. For medical devices like sterilization wraps, ground truth for sterility is typically established through microbiology (e.g., spore log reduction, sterility tests) in conjunction with physical parameters (e.g., temperature, pressure readings) and chemical indicators, rather than human expert opinion on images or clinical cases. The validation would follow established standards (e.g., AAMI, ISO) for sterilization efficacy.
4. Adjudication Method for the Test Set
Not applicable. As this is a physical device subject to sterility validation, there is no "adjudication method" in the context of expert review for qualitative assessments (like in image analysis studies). Sterility is determined by direct measurement (e.g., microbial culture results) rather than consensus among human reviewers.
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 wrap, not an AI-powered diagnostic tool, and therefore, no MRMC comparative effectiveness study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (a sterilization wrap), not an algorithm or software requiring standalone performance testing in this context. The "standalone performance" refers to the wrap's ability to maintain sterility under various conditions when exposed to sterilization processes, independent of human interaction during the sterilization cycle itself. This is what the validation studies assessed.
7. The Type of Ground Truth Used
The ground truth used for these "Sterility Validation Studies" would be based on microbiological testing, adhering to industry standards for demonstrating sterility. This typically involves:
- Biological Indicators (BIs): Spore-laden strips or vials placed within the test loads. A successful validation demonstrates a specified log reduction of microbial spores (often a Sterility Assurance Level - SAL of 10^-6), meaning no growth of test organisms after exposure to the sterilization cycle.
- Physical Parameters: Monitoring and recording of physical parameters such as temperature, pressure, time, and sterilant concentration (for EO and vaporized hydrogen peroxide systems) to ensure they meet the defined cycle specifications.
- Chemical Indicators (CIs): Internal and external indicators showing exposure to sterilant, but not necessarily sterility.
- Package Integrity Testing: Post-sterilization testing to ensure the wrap maintains its sterile barrier integrity (e.g., burst strength, seal strength, microbial barrier testing).
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set." The performance data is derived from validation studies of the device itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set. The "ground truth" for the device's efficacy revolves around successful sterility validation as described in point 7.
§ 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).