(169 days)
The Sterilucent Sterilization Container System is a device intended to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This container system is intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen Cycles. The sterility maintenance period has been validated for a period of up to 180 days.
Reusable baskets and accessory items (clips, posts, pins, dividers, bars and mats) are intended to organize and secure enclosed medical devices during sterilization, transport, and storage of the container.
Consumable accessory items (filter media, data card and tamper evident arrows) provide a range of functions and are indicated as single-use devices. Filter media allows ingress of sterilant while providing a microbial barrier. Data cards are used to record information regarding a specific sterilization process load. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains an external process indicator that serves as a visual indication that the system has been exposed to the Sterilization process.
The Sterilucent Sterilization Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of those devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards.
The container system houses reusable baskets of varying depths and organizing accessory items that are used to organize and secure surgical instrumentation and/or other medical devices.
The provided text describes the acceptance criteria and performance of the Sterilucent Sterilization Container System (K142109) through non-clinical studies.
Here's the breakdown of the information you requested:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Sterilization Performance (Sterilization Container System):
- Demonstrate a 12 log reduction in microbial load.
- Achieve a Sterility Assurance Level (SAL) of 10^-6.
- Demonstrate sterility maintenance for a period of up to 180 days.
- Maintain appropriate microbial barrier properties following exposure to hydrogen peroxide sterilization processes under worst-case conditions.
Reported Device Performance:
- Sterilization efficacy testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10^-6.
- Real-time event-related shelf-life studies demonstrated sterility maintenance for a 180-day time period.
- Whole package microbial challenge testing demonstrated appropriate microbial barrier properties following exposure to the Sterilucent hydrogen peroxide sterilization processes under worst-case conditions.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of number of devices or iterations for the efficacy and sterility maintenance tests. It refers to "studies" and "testing" without quantifying the number of units tested.
- Sample size for test set: Not explicitly stated (e.g., "three containers were tested" or "n=X runs"). The document refers to "studies" and "testing."
- Data provenance: Prospective non-clinical studies. The country of origin of the data is not specified, but the device is submitted for FDA clearance in the USA.
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. Non-clinical studies for sterilization effectiveness typically rely on laboratory assays and established microbiological standards, rather than expert human interpretation of results in the way, for example, a radiology AI model would.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical (laboratory-based microbiological and physical testing), not involving human readers or interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, not for sterilization container systems.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical sterilization container system, not an algorithm or AI model. The performance described is that of the physical device itself.
7. The Type of Ground Truth Used
The ground truth for the non-clinical studies was established using microbiological assays, specifically:
- Biological indicator (BI) overkill method: For sterilization efficacy (demonstrating a 12 log reduction and SAL of 10^-6).
- Microbial challenge testing: For evaluating microbial barrier properties, using a specified quantity of Bacillus atrophaeus colony forming units (CFU).
- Real-time event-related shelf-life studies: To determine sterility maintenance over time.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (a sterilization container system), not a software or AI model that requires a training set. The studies described are validation and performance tests, not training data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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).