(302 days)
Gemini Sterilization Wraps are 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 such content until used. Gemini Sterilization Wrap is validated for use in steam or STERRAD sterilization processes in the following sterilization modes and cycles:
TABLE 1: Pre-vacuum team at 270°F/132°C for 4 minutes with the following dry times by weight
TABLE 2: Gravity steam at 250°F/121°C for 30 minutes with the following dry times by weight
TABLE 3: STERRAD® Sterilization
Gemini Sterilization Wrap is offered to the marketplace as bulk packages of single ply sheets for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collection of medical devices are wrapped.
Gemini Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process.
The standard blue wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation and less than 0.35% titanium dioxide white pigmentation. The wrap allows for aseptic opening of the sterilized package.
Gemini Sterilization Wrap is available in sizes ranging from 12"x12" to 54"x90" across the five different material weights/models.
Below is a summary of the acceptance criteria and study information for the Gemini Sterilization Wrap based on the provided FDA 510(k) summary (K152564).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance testing conducted and states whether the device "Passed" each test. The acceptance criteria are implicitly met by passing these tests, demonstrating substantial equivalence to the predicate device and suitability for its intended use.
| Study Description | Acceptance Criterion (Implicitly "Pass") | Reported Device Performance |
|---|---|---|
| Maintenance of Sterility (Package Integrity) - Steam Pre-Vacuum & Steam Gravity Cycles (Real Time Event Related) | Maintain sterility for two years after steam sterilization. | Passed |
| Maintenance of Sterility (Package Integrity) - STERRAD® (Real Time Event Related) | Maintain sterility for 180 days after STERRAD® sterilization. | Passed |
| Pre-Vacuum Steam and Gravity Sterilant Penetration | Allow sterilant penetration for pre-vacuum steam (270°F/132°C for 4 minutes with specified dry times) and gravity steam (250°F/121°C for 30 minutes with specified dry times) cycles, ensuring effective sterilization of enclosed medical devices. | Passed |
| STERRAD® 50 Cycle, STERRAD® 200 S Cycle and STERRAD® 100NX™ DUO Cycle Sterilant Penetration | Allow sterilant penetration for STERRAD® 50, 200S, and 100NX™ DUO cycles, ensuring effective sterilization of enclosed medical devices. | Passed |
| Post Sterilization Biocompatibility Testing (Primary Skin Irritation Testing - ISO 10993-10) | Demonstrate biocompatibility, specifically primary skin irritation, after sterilization. | Passed |
| Air permeability (per ASTM D737-04 R2012) | Meet established standards for air permeability. | Passed (Implied) |
| Basis weight (per ASTM D3776) | Meet established standards for basis weight. | Passed (Implied) |
| Material burst strength (per ASTM D3786) | Meet established standards for material burst strength. | Passed (Implied) |
| Resistance to water penetration (per AATCC127) | Meet established standards for resistance to water penetration. | Passed (Implied) |
| Tensile strength and elongation (per ASTM D5034) | Meet established standards for tensile strength and elongation. | Passed (Implied) |
| Tear strength (per ASTM D5587) | Meet established standards for tear strength. | Passed (Implied) |
Note: For the material characteristic tests (Air permeability, Basis weight, etc.), the document states these tests were conducted and then concludes "The safety and effectiveness...is adequately supported..." which implies they passed relevant acceptance criteria for those standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes used for each test. It refers to "real time stability studies" for shelf life and other performance tests.
- Sample Size for Test Set: Not explicitly stated as specific numbers of wraps or sterilization cycles.
- Data Provenance: The document does not specify the country of origin. The studies are described as "real time stability studies" and "performance testing," which implies prospective testing conducted for the purpose of the 510(k) submission. There is no indication of retrospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the evaluation of a sterilization wrap. The performance evaluation relies on objective physical and microbial barrier testing in controlled laboratory environments, not subjective expert assessment of images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable, as this is related to expert review of subjective data, which is not relevant for this device's testing.
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 a medical device (sterilization wrap), not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance of the Gemini Sterilization Wrap is established through standardized physical tests and challenge tests (e.g., sterilization penetration, package integrity, material properties, biocompatibility) designed to objectively evaluate the device's ability to maintain sterility and withstand sterilization processes. This is based on established scientific principles and industry standards (e.g., ASTM, AATCC, ISO 10993-10).
8. The Sample Size for the Training Set
Not applicable. There is no AI component or machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI component or machine learning model.
§ 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).