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510(k) Data Aggregation
(514 days)
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
The Synthes Reusable Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.
Synthes containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.
Reusable lifting platforms are intended to hold enclosed medical devices above the filter areas of a perforated bottom container during sterilization and storage of the container.
Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific (pre-vacuum steam) external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.
The Synthes Reusable Sterilization Container System is a rigid, reusable, container intended to be used to sterilize other Synthes 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 document describes the Synthes Reusable Sterilization Container System and its substantial equivalence to a predicate device (Genesis Reusable Rigid Sterilization Container System K112535). The acceptance criteria and performance are based on non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Characteristic | Performance Requirement (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy (Pre-Vacuum Steam) | 12 log reduction and a sterility assurance level (SAL) of 10^-6 using biological overkill method and half-cycle validation. | Met: 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 | Minimum dry time of 30 minutes for pre-vacuum steam sterilization modality. | Met: Dry time studies established a minimum dry time of 30 minutes for pre-vacuum steam sterilization modality. |
| 180 Day Event Related Shelf Life | Sterility maintenance for 180 days. | Met: 180 Day Event Related Shelf life studies demonstrated sterility maintenance for the recommended pre-vacuum steam sterilization modality. |
| Microbial Barrier (Whole Package Integrity) | 100% negative growth when subjected to an aerosol challenge of 1 x 10^6 Bacillus atrophaeus colony forming units (CFU). | Met: Whole package microbial challenge test, exposing a container to a minimum of 1 x 10^6 Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge demonstrating 100% negative growth. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test set, nor does it specify the country of origin or whether the data was retrospective or prospective. It mentions "all test samples" or "a container" without providing numerical details for the sample size. However, the data represents non-clinical testing performed to validate the device's efficacy and integrity.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device, a sterilization container, is established through standardized performance testing (e.g., microbial challenge, sterility assurance level determination) rather than expert consensus on interpretive data like medical images. The acceptance criteria are based on established scientific and regulatory standards (ANSI/AAMI ST77:2006, ANSI/AAMI ST79:2010).
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is established via objective, standardized laboratory testing, not through expert adjudication of subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a sterilization container, and its effectiveness is determined through physical and microbiological tests, not through human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a passive sterilization container, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective, quantifiable results from non-clinical performance tests, specifically:
- Microbiological assays: Demonstrating a 12 log reduction and a 10^-6 sterility assurance level, and 100% negative growth in microbial challenge tests.
- Physical measurements/observations: Related to dry time and maintenance of sterility over a specified shelf life.
These align with established scientific and regulatory standards for sterilization efficacy and package integrity for medical devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as explained in point 8.
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