(90 days)
The Turbett Surgical Container is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with Turbett Surgical filters.
The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F (132°C) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per tray.
Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens. The total weight of instruments and trays validated is 375 lbs.
Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.
The Turbett Surgical Container is a rigid sterilization container with a fenestrated door holding a single-use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Trays within the container are separated by dividers to ensure separation and maximum steam exposure. The container has been validated to sterilize 375 lbs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. Actual expected loads in hospital settings are likely to be less. Sterilized instruments can be stored for up to 30 days within the closed container.
The Turbett Surgical Container is loaded into the autoclave with a dedicated transfer carriage. The container is constructed of 304 stainless steel with an anodized aluminum filter housing/door.
The use of a single-use disposable filter cartridge installed in the fenestrated door eliminates the need for a sealed gasket found on other rigid containers. The omission of a reusable gasket eliminates contamination risks due to failed reusable gaskets.
The provided text describes the Turbett Surgical Container and its approval through the 510(k) pathway, which means it demonstrated "substantial equivalence" to a predicate device. This process typically focuses on comparing the new device's characteristics and performance to a legally marketed predicate, rather than establishing strict acceptance criteria and proving the device meets them through a deeply detailed study in the same way a novel high-risk device might.
However, based on the provided text, we can extract the validation parameters and the evidence used to support the substantial equivalence claim.
Here's an analysis of the "acceptance criteria" and "study" information as it relates to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, specific rigid "acceptance criteria" for performance are not explicitly stated with numerical targets in the same way a clinical trial might, but rather the performance is demonstrated to be equivalent or better than the predicate device across various tests. The "reported device performance" is the outcome of these validation tests.
| Acceptance Criteria Category (Implied) | Turbett Surgical Container Reported Performance |
|---|---|
| Sterilization Efficacy (Pre-vacuum thermal profile) | Validated (Testing conducted) |
| Sterilization Efficacy (Steam pre-vacuum sterilization efficacy) | Validated (Testing conducted) |
| Drying Time (Pre-vacuum dry time) | Validated (Testing conducted) |
| Microbial Containment (Microbial aerosol challenge) | Validated (Testing conducted) |
| Sterility Maintenance (30 day shelf-life study) | Demonstrated ability to maintain sterility for up to 30 days. |
| Cleaning Efficacy (Protein analysis and Total Organic Carbon Manual cleaning methods) | Validated (Testing conducted) |
| Usability (Human factors usability study) | Validated (Testing conducted) |
| Load Capacity | Up to 15 trays at 25 lb each (Total: 375 lbs). Validated with six 1mm x 500mm lumens and six 3mm x 400mm lumens. |
| Sterilization Cycle Temperature | 270°F (132°C) |
| Sterilization Cycle Exposure Time | 4 minutes |
| Instrument Lumens (Critical characteristic for sterilization) | Validated with 1mm x 500mm lumens and 3mm x 400mm lumens (Predicate was limited to 3.8mm inner diameter and 370mm length). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical "sample size" in terms of how many units of the container were tested, or how many sterilization cycles were performed for each test. It mentions "Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens." This describes the configuration of the test load, not a statistical sample size for the test itself.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a medical device in the US, the testing would typically be conducted by the manufacturer or contracted labs under their direction, likely in a prospective manner according to established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For device validation testing as described (thermal profiles, sterilization efficacy, microbial challenges, etc.), "experts" in the sense of medical professionals establishing a ground truth (like radiologists reviewing images) are generally not involved. Instead, the "ground truth" is established by adherence to recognized consensus standards (like ANSI/AAMI ST77 and AAMI TIR 30) and the scientific principles behind sterilization and cleaning. The "experts" would be the personnel conducting and interpreting these standardized tests, whose qualifications are typically laboratory scientists or engineers specialized in sterilization validation.
4. Adjudication Method for the Test Set
This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., image analysis by multiple radiologists) to resolve discrepancies and establish a robust ground truth. For device validation tests like those listed, the results are typically quantitative measurements or pass/fail criteria against a standard, not subject to human interpretation discrepancies that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. The Turbett Surgical Container is a physical medical device (sterilization container), not an AI algorithm, so this type of study is irrelevant and was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study was not done. This question is also typically relevant for AI/software as a medical device. The Turbett Surgical Container is a physical device; its "performance" is its ability to facilitate sterilization and maintain sterility, which is tested independently of human intervention during the sterilization process itself (though human operators load and unload the device).
7. The Type of Ground Truth Used
The ground truth for the validation of the Turbett Surgical Container was established through adherence to recognized industry standards and scientific principles related to sterilization, cleaning, and human factors. Specifically, the document references:
- ANSI/AAMI ST77: Containment Devices for Reusable Medical Device Sterilization testing (which includes pre-vacuum thermal profile, steam pre-vacuum sterilization efficacy, pre-vacuum dry time, microbial aerosol challenge, and 30-day shelf-life study).
- AAMI TIR 30: A Compendium of Processes, Materials, Test Methods and Acceptance Criteria for Cleaning Reusable Medical Devices testing (protein analysis and Total Organic Carbon Manual cleaning methods).
- ANSI/AAMI HE75: Human Factors Engineering- Design of Medical Devices testing (human factors usability study).
The "ground truth" is that if the device performs successfully under these standardized testing protocols, it meets the requirements for a sterilization container.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning or AI algorithms where data is used to train a model. For a physical medical device like the Turbett Surgical Container, there is no AI model or training set in this context. The manufacturing process and design are based on engineering principles and materials science, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable because, as explained above, there is no "training set" for this physical medical 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).