(294 days)
The DePuy Synthes Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.
The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.
The DePuy Synthes Reusable Sterilization Container System is a rigid, reusable, container intended to be used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid with gasket, base, filter, tamper evident arrows, and data cards. The container system includes a lifting platform to hold Synthes graphic cases containing orthopedic medical devices (instruments and implants) within the container.
The DePuy Synthes Sterilization Container System (K181933) is intended to enclose medical devices for sterilization and maintain their sterility for up to 180 days. The device uses dynamic air removal (pre-vacuum) steam sterilization. No clinical tests were performed, but extensive non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device, Synthes Reusable Sterilization Container System (K130720).
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Efficacy: Pre-Vacuum Steam | Objective: To validate the efficacy of the DePuy Synthes Sterilization Container System using pre-vacuum sterilization cycle of 270°F (132°C) with 4 minutes of exposure. |
| Result: | Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10⁻⁶ using the biological (BI) overkill method and half-cycle validation. |
| Dry Time | Objective: To determine the drying time for the DePuy Synthes Sterilization Container System following a steam pre-vacuum cycle of 270°F (132°C) with 4 minutes of exposure. |
| Result: | Dry time studies establish minimum dry time of 30 minutes for pre-vacuum steam sterilization modality. |
| 180 Day Event Related Shelf Life | Objective: To validate the 180-day event related shelf life evaluation of the DePuy Synthes Sterilization Container System following exposure to a full pre-vacuum sterilization cycle (lethality plus dry time). |
| Result: | 180 Day Event Related Shelf life studies demonstrated sterility maintenance for the recommended pre-vacuum steam sterilization modality. The device maintains sterility for a maximum of 180 days. |
| Microbial Challenge | Objective: To demonstrate the DePuy Synthes Sterilization Container System can maintain package integrity/microbial barrier after being subjected to sterilization processing and a whole package microbial (aerosol) challenge. |
| Result: | Whole package microbial challenge test, exposing a container to a minimum of 1 x 10⁶ Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge demonstrating 100% negative growth. |
| Limits of Reuse | Objective: To verify the limits of reuse of the DePuy Synthes Sterilization Container System when processed in repetitive pre-cleanings, mechanical washer cycles and steam pre-vacuum cycles. |
| Result: | After 100 cycles of processing samples showed no signs of physical or mechanical degradation and continued to function as intended. |
| Biocompatibility | Objective: To evaluate the biocompatibility of the DePuy Synthes Sterilization Container System for cytotoxicity to mammalian cells in culture by a method compliant with the requirements specified in ISO 10993-5:2009. |
| Result: | Results showed no heavy metal leaching or cytotoxicity at detectable levels. The device materials are toxicologically acceptable for their intended use. For specific materials, stainless steel, aluminum, silicone (gasket), SMS polypropylene (filter) were used in the construction and were demonstrated to withstand repeated processing with proven compatibility with the sterilization process and sterilants. Examples of intrinsically stable metals: stainless steel, titanium (CP and alloys), aluminum. Thermoplastic polymers: PEEK, PEI (Ultem), Acetal (Delrin), Radel (PPSU), Nylon, PTFE, Polypropylene, ABS (Acrylonitrile Butadiene Styrene), POM (Polyoxymethylene). Thermosetting polymers: Phenolic, Silicone. Composites: carbon fiber reinforced epoxy (CFRE). The materials are all compliant with the criteria for the stated materials. |
2. Sample size used for the test set and the data provenance
The document indicates that testing was performed on "samples" of the device, container models, and worst-case configurations of joint reconstruction devices. Specific numerical sample sizes for each test are not explicitly provided. The data provenance is described as non-clinical testing performed by the manufacturer, DePuy Synthes. The studies are retrospective as they summarize verification and validation testing results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This submission is for a sterilization container system, and the evaluation is based on engineering and microbiological performance studies (non-clinical testing). Therefore, the concept of "ground truth established by experts" in the context of interpretation (e.g., radiologist for imaging) is not directly applicable. The "truth" is established by adherence to recognized standards (e.g., ANSI/AAMI ST77:2006, ANSI/AAMI ST79:2010, ISO 10993-5:2009, USP General Chapter Heavy Metals) and objective measurements performed by qualified personnel in laboratories following Good Laboratory Practices (GLP), implied by the regulatory context.
4. Adjudication method for the test set
Not applicable, as this is a non-clinical device performance study based on objective measurements against scientific standards, not a diagnostic or interpretative study requiring expert 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 medical device sterilization container, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device sterilization container, not an AI-based algorithm.
7. The type of ground truth used
The ground truth for the non-clinical tests is based on:
- Microbiological Standards: Demonstrated sterility assurance level (SAL) of 10⁻⁶ and 12 log reduction via biological indicators (BIs) (for sterilization efficacy and microbial challenge).
- Physical and Chemical Measurement Standards: Adherence to established standards for dry time, material properties (e.g., heavy metals leaching, cytotoxicity), and physical integrity (e.g., limits of reuse, package integrity).
- Industry and Regulatory Standards: Compliance with ANSI/AAMI ST77:2006, ANSI/AAMI ST79:2010, ISO 10993-5:2009, and USP General Chapter Heavy Metals.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
§ 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).