(185 days)
Gemini Bonded Sterilization Wrap is 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 for 180 days following sterilization. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.
- Pre-vacuum steam cycles
- Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time
- Gravity steam cycles
- Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time
- STERRAD® Sterilization
- STERRAD® 100NX, Flex cycle
- STERRAD® 100NX, Standard cycle
- STERRAD® 100NX, Express cycle
- STERRAD® 100S. Standard cycle
- STERRAD® NX, Advanced cycle
- STERRAD® NX, Standard cycle
Gemini Bonded Sterilization Wrap is comprised of two ply sheets ultrasonically bonded together for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collections of medical devices are wrapped. The Gemini Bonded Sterilization Wrap provides the protection of double-wrapping in an efficient manner; reducing wrapping/unwrapping time significantly compared to traditional double-wrapping methods. Gemini Bonded Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbondspunbond-meltblown-meltblown-spunbond) process. The standard blue wrap fabric is made of polypropylene with the addition of blue and white pigmentation. The wrap allows for aseptic opening of the sterilized package. The two-tone blue/pink wrap fabric is made of polypropylene with the addition of blue, white and red pigmentation. The wrap allows for aseptic opening of the sterilized package. Gemini sterilization wrap is available in sizes ranging from 12"x12" to 54"x72" across five different material weights/models.
The provided text describes the acceptance criteria and the study that proves the Gemini Bonded Sterilization Wrap meets these criteria.
Here's the breakdown:
1. Table of acceptance criteria and the reported device performance
| Test Objective | Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation Testing | Meets ISO 10993-10 Requirements | Meets ISO Requirements |
| Microbial Barrier Properties | Meets ISO 11607-1 and ASTM F1980 Requirements | Meets ISO and ASTM Requirements |
| Sterilization Efficacy (General) | Allow sterilization and maintain sterility for 180 days | Validated for use in steam or STERRAD® sterilization processes and maintains sterility for 180 days. |
| Specific Sterilization Cycles: | Minimum exposure/dry times, and specific loads | The device was validated for the following: |
| Pre-vacuum steam cycles | Minimum 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time | Validated for the specified cycle with various loads (Lightweight 6 lbs, Regular Weight 9 lbs, Medium Weight 13 lbs, Heavyweight 17 lbs, Super Heavyweight 25 lbs). |
| Gravity steam cycles | Maximum 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time | Validated for the specified cycle with various loads (Lightweight 6 lbs, Regular Weight 9 lbs, Medium Weight 13 lbs, Heavyweight 17 lbs, Super Heavyweight 25 lbs). |
| STERRAD® 100NX, Flex cycle | Specific lumen dimensions and max load (10.7 lbs) | Validated for the specified cycle with a max load of 10.7 lbs and specific flexible endoscope configurations. |
| STERRAD® 100NX, Standard cycle | Specific lumen dimensions and max load (10.7 lbs) | Validated for the specified cycle with a max load of 10.7 lbs and specific lumen configurations. |
| STERRAD® 100NX, Express cycle | Specific device types (non-lumened) and max load (10.7 lbs) | Validated for the specified cycle with a max load of 10.7 lbs for non-lumened devices. |
| STERRAD® 100S, Standard cycle | Specific lumen dimensions and max load (Light Weight 6 lbs to Super Heavyweight 10.7 lbs) | Validated for the specified cycle with various loads (Light Weight 6 lbs to Super Heavyweight 10.7 lbs) and specific lumen configurations. |
| STERRAD® NX, Advanced cycle | Specific lumen dimensions/flexible endoscope configurations and max load (10.7 lbs) | Validated for the specified cycle with a max load of 10.7 lbs and specific lumen/flexible endoscope configurations. |
| STERRAD® NX, Standard cycle | Specific lumen dimensions and max load (10.7 lbs) | Validated for the specified cycle with a max load of 10.7 lbs and specific lumen configurations. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the numerical sample size for the test set for each specific sterilization or biocompatibility test. It lists the types of loads used for sterilization validation studies, which could be considered the "test samples" in these evaluations.
- Sterilization Validation Studies:
- Pre-vacuum steam and gravity steam: Various loads were used, described by components (e.g., "2 huck towels (17 in. x 29 in.), 3 fluid-resistant drapes", "16 huck towels... 5 lbs of metal mass"). The exact number of times each load/wrap combination was tested is not provided.
- Advanced Sterilization Products (ASP) STERRAD 100S: Various loads using "15 in. x 10 in. x 1.2 in. tray containing metal instruments" for different weight categories.
- Advanced Sterilization Products (ASP) STERRAD NX and STERRAD 100NX: Various loads using "23 in. x 11 in. x 4 in tray containing metal instruments" for different weight categories.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it's a premarket notification for the FDA, it is highly likely that the testing was performed prospectively as part of product development and validation for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies listed are laboratory-based performance tests (material barrier, irritation, sterilization efficacy), not studies requiring expert interpretation of clinical data or images.
4. Adjudication method for the test set
This information is not applicable as the studies are laboratory-based performance tests, not studies requiring human interpretation or adjudication of results.
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
This information is not applicable. The device is a sterilization wrap, not an AI-assisted 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
This information is not applicable as the device is a physical sterilization wrap, not an algorithm.
7. The type of ground truth used
The ground truth for the performance validation is based on:
- Established standards and specifications: ISO 10993-10 for biocompatibility, ISO 11607-1 and ASTM F1980 for microbial barrier properties.
- Sterility Assurance Level (SAL): While not explicitly stated as a numerical SAL, sterilization efficacy studies inherently use biological indicators or other methods to demonstrate a certain level of sterility (e.g., 10^-6), which serves as the "ground truth" for successful sterilization. The text states the wrap "maintains sterility of such content for 180 days following sterilization," implying successful sterility testing.
- Physical and chemical measurements/observations: Tests for skin irritation involve biological response observation against established criteria. Microbial barrier properties involve challenging the material with microbes and demonstrating its effectiveness. Sterilization cycle validations involve verifying the eradication of microbes under specific conditions.
8. The sample size for the training set
This information is not applicable. The device is a physical product and does not involve machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this 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).