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510(k) Data Aggregation
(122 days)
Gemini Titan 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 the enclosed device until used.
-Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for a dry time of 30 minutes. Gemini® Titan™ Sterilization Wrap is available in square sheets ranging from 36" x 36" and can be used with trays weighing up to 25 lbs.
Gemini® Titan™ Sterilization Wrap is offered to the market place as bulk, non-sterile packages of two ply bonded sheets of wrap. The bonded wrap is comprised of Gemini® Titan™ Sterilization Wrap ultrasonically seamed on two parallel sides. This allows for convenient wrapping with two sheets simultaneously. Gemini® Titan™ is used to wrap a medical device or a collection of medical devices for sterilization.
The two tone wrap is comprised of a blue sheet bonded to a pink sheet. The fabric is made of polypropylene with the addition of less than 1% blue to pink color pigmentation.
Gemini® Titan™ Sterilization Wrap is available in square sheets ranging from 36" x 36" and can be used with trays weighing up to 25 lbs.
The provided document is a 510(k) Premarket Notification from Medline Industries, Inc. for their Gemini Titan Sterilization Wrap. It details the device description, indications for use, comparison with a predicate device, and a summary of non-clinical testing conducted to demonstrate its safety and effectiveness.
Acceptance Criteria and Device Performance Study
The study described in this document is a series of non-clinical tests designed to demonstrate that the Gemini Titan Sterilization Wrap meets specific performance criteria. Since this is a sterilization wrap, the "device" in question is the wrap itself, and its performance is evaluated based on its ability to maintain sterility, facilitate sterilization, and exhibit appropriate physical properties and biocompatibility.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Title | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Efficacy | To validate the sterilization efficacy of the Gemini Titan Sterilization Wrap when processed in a steam pre-vacuum cycle of 132°C (270°F) for four minutes. | All biological indicator test samples shall be negative for growth following the minimum incubation period. | All biological indicator test samples were negative for growth. Results from the testing conclude that the Gemini Titan can achieve a 10-6 SAL after processing in a steam pre-vacuum sterilization cycle at 132°C (270°F) for 4 minutes. |
| Maintenance of Sterility (Microbial Aerosol Challenge) | To determine the microbial barrier properties of the Gemini Titan Sterilization wrap in maintaining sterility package integrity following an aerosol challenge test. | Each wrapped tray will meet the sterility maintenance requirement if there is no growth in any of the culture tubes containing the stainless-steel test coupons at the end of the incubation period. | Each wrapped tray met the sterility maintenance requirement since there was no growth in any of the culture tubes containing the stainless-steel test coupons. |
| Biocompatibility (Cytotoxicity) | To determine the potential biological reactivity of a mammalian cell culture (L929) in response to the test article extract. | Acceptance criteria as specified in ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity. | There was no biological reactivity (Grade 0) of the cells exposed to the test article extract. Based on the criteria of the protocol and the ISO 10993-5 guidelines, the test article meets the requirements of the test and is not considered to have a cytotoxic effect. |
| Biocompatibility (Irritation) | To determine the potential irritation effects of the test article extract as a result of an intracutaneous injection in New Zealand White Rabbits. | Acceptance criteria as specified in ISO 10993-10 Biological Evaluation of Medical Devices - Part 10 Tests for Irritation and Skin Sensitization. | The test article sites did not show a significantly greater biological reaction than the sites injected with the control article. Based on the criteria of the protocol, the test article meets the requirements of the ISO 10993-10 guidelines. |
| Biocompatibility (Sensitization) | To determine the potential allergenic or sensitizing capacity of the test article. | Acceptance criteria as specified in ISO 10993-10 Biological Evaluation of Medical Devices - Part 10 Tests for Irritation and Skin Sensitization. | The USP 0.9% sodium chloride for injection and cotton seed oil extracts of the test article elicited no reaction at the challenge, following an induction phase. Therefore, as defined by the grading scale of the USP, the test article is classified as a non-sensitizer. |
| Physical Properties (Hydrostatic Pressure) | To evaluate the resistance of the material to the penetration of water under hydrostatic pressure. | Acceptance criteria as defined by AATCC 127-18 Water Resistance: Hydrostatic Pressure Test. | The processed and unprocessed Gemini Titan Sterilization Wrap met the average hydrostatic pressure acceptance criteria when tested per AATCC 127. |
| Physical Properties (Basis Weight) | To evaluate the basis weight of Gemini Titan Sterilization Wrap. | Acceptance criteria as defined by ASTM D3776/D3776M Standard Test Methods for Mass Per Unit Area (Weight) of Fabric. | The average basis weight of the processed and unprocessed Gemini Titan Sterilization Wrap met the acceptance criteria when tested per ASTM D3776/D3776M. |
| Physical Properties (Bursting Strength) | The bursting strength of Gemini Titan was evaluated using a pneumatic burst tester. | Acceptance criteria as defined by ASTM D3786/D3786M-18 Standard Test Method for Bursting Strength of Textile Fabrics Diaphragm Bursting Strength Tester Method. | The average bursting pressure of the processed and unprocessed Gemini Titan Sterilization Wrap met the acceptance criteria when tested per ASTM D3786/D3786M. |
| Physical Properties (Tensile Strength) | Testing was performed per the "Grab" tensile method with specimens evaluated for their Load at Break and % Elongation at Break. | Acceptance criteria as defined by ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test). | When tested for machine direction and cross-machine direction, the processed and unprocessed Gemini Titan Sterilization Wrap met the average load at break when tested per ASTM D5034. |
| Physical Properties (Tear Strength) | Testing was performed to evaluate the Peak and Average Tear Forces using the trapezoid procedure. | Acceptance criteria as defined by ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure. | When tested for machine direction and cross-machine direction, the processed and unprocessed Gemini Titan Sterilization Wrap met the average peak tear force acceptance criteria when tested per ASTM D5587. |
| Physical Properties (Air Permeability) | Testing to evaluate the air permeability of the Gemini Titan Sterilization Wrap. | Acceptance criteria as defined by ASTM D737 Standard Test Method for Air Permeability of Textile Fabrics. | Both the processed and unprocessed Gemini Titan Sterilization Wrap met the acceptance criteria for air permeability when tested per ASTM D737. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each test in the "Summary of Non-Clinical Testing" section. It refers to "samples" or "specimens" being tested in accordance with the specified ASTM or ISO standards.
- Data Provenance: The tests are described as non-clinical tests. They are performed in a laboratory setting to evaluate the material properties and performance of the sterilization wrap. The document does not specify the country of origin of the data directly, but Medline Industries, Inc. is based in Northfield, IL, USA. Given the context of a US FDA 510(k) submission, it's highly probable that the testing was conducted either in the US or in a facility compliant with US regulatory requirements and good laboratory practices (GLP). These are prospective tests, as they are performed specifically to demonstrate the performance of the new device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device and study. The "ground truth" for the performance of a sterilization wrap is established through adherence to recognized international standards (ISO, ASTM, AATCC) and validated laboratory testing protocols, not through expert consensus on qualitative data like images. The results are quantitative and objective (e.g., presence/absence of growth, pressure readings, weight measurements).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the "ground truth" is based on objective, quantitative measurements derived from standardized test methods, not subjective interpretation requiring adjudication.
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-assisted diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the physical and biological characteristics of the wrap itself under defined conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective, quantitative measurements obtained through validated laboratory testing protocols and adherence to recognized international standards (ISO, ASTM, AATCC). For example:
- Sterilization Efficacy: Absence of biological indicator growth (objective, quantitative).
- Maintenance of Sterility (Microbial Barrier): Absence of microbial growth on coupons (objective, quantitative).
- Biocompatibility: Quantified biological reactivity (e.g., Grade 0 for cytotoxicity, defined reaction levels for irritation/sensitization) according to ISO standards.
- Physical Properties: Measured values (e.g., pressure, weight, load at break, tear force, air permeability) falling within specified acceptance criteria defined by ASTM/AATCC standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for this device's development would involve material science development and engineering, not data-driven model training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device.
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