(121 days)
The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.
Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.
Data cards are used to recording a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication 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 Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.
The provided document is a 510(k) premarket notification for a medical device (Genesis™ Reusable Rigid Sterilization Container System). It outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance tests.
Here's an analysis of the acceptance criteria and study information provided, focusing on the available details:
Description of Acceptance Criteria and Device Performance
The device under review is the Genesis™ Reusable Rigid Sterilization Container System. The primary function of this system is to enclose other medical devices for sterilization and maintain their sterility for up to 180 days. The acceptance criteria for this device revolve around demonstrating its efficacy in sterilization and maintaining sterility under various conditions.
The study presented focuses on non-clinical performance testing to validate the sterilization efficacy and dry time of the container system for specific sterilization modalities and contents.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Characteristic / Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Efficacy: Pre-vacuum Steam | |
| - Standard/Test/FDA Guidance: ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated a 12 log reduction and a sterility assurance level (SAL) of 10-6 using biological (BI) overkill method. |
| Dry Time for Dynamic Air Removal (Pre-vacuum steam modality) | |
| - Standard/Test/FDA Guidance: ST 77 2013 Containment Devices for Reusable Medical Device Sterilization | Testing demonstrated validated method of drying by absence of visible moisture. |
Additional Performance Parameters and Conditions (from "Sterilization Parameters for the Genesis™ Reusable Rigid Container System by Modality" and "Accessories and Device Challenges by Sterilization Modality and Container Style" tables):
| Sterilization Method | Cycle Parameters / Contents / Configurations | Applicable Containers/Accessories / Performance |
|---|---|---|
| Dynamic Air Removal (Pre-Vacuum) Steam (Regular & Immediate Use) | - Exposure Temp: 270°F (132°C) |
- Pre-conditioning Pulses: 3
- Exposure Time: 4 Minutes
- Dry Time Cycle: 30 minutes (Regular)
- Minimum Cool Time: 60 minutes (Regular)
- Stack Height: Max 3
- Total System Weight: 25 lbs.
- Lumen Devices: 2.68 mm x 450 mm (Qty 16), 1.37 mm x 242 mm (Qty 10), 3 mm x 400 mm (Qty 2) | Demonstrated efficacy for Solid and Perforated Bottom Containers, Stacking/Non-Stacking Baskets, various Lumen Devices (specified quantities), Devices with conjoined surfaces, Silicone Support Bars/Mats, Laparoscopic Racks, Optional Protective Plates. Materials include Metals, Polymers, Composites. (Performance is "Yes" for all listed components/configurations under these steam methods). |
| 100% Ethylene Oxide | - EO Sterilant Conc: 100% EO, 725 mg/L - Pre-Conditioning Time: 30 mins
- Temperature: 130°F (55°C)
- Exposure Time: 60 mins
- Relative Humidity: 50-80%
- Aeration: 8 hours @ 109.4°F (43°C)
- No stacking
- Total System Weight: 15 lbs.
- Lumen Devices: 3.0 mm x 400 mm (Qty 5) | Demonstrated efficacy for Perforated Bottom Containers (except CD2-10BDL and DINCD2-8B), Non-Stacking Baskets, Lumen Devices (specified quantity), Devices with conjoined surfaces, Silicone Support Bars, Laparoscopic Racks. Materials include Stainless Steel, Aluminum, Silicone, Radel. (Performance is "Yes" for listed components/configurations under EO). |
The document explicitly states: "The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria." This indicates that for all the criteria mentioned in the tables, the device successfully demonstrated compliance through the stated non-clinical tests.
2. Sample size(s) used for the test set and the data provenance:
- The document mentions "Testing" for sterilization efficacy and dry time but does not specify the exact sample sizes (number of containers, number of cycles, number of biological indicators, etc.) for the test sets.
- Data provenance is not explicitly stated regarding country of origin or whether the tests were retrospective or prospective. Given it's a 510(k) submission for a medical device by a US-based company (CareFusion 2200 Inc, Vernon Hills, IL), and referring to an FDA guidance document (ST 77 2013), it is prospective testing conducted in a controlled laboratory setting, likely within the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes non-clinical performance testing of a sterilization container, not a diagnostic or AI-driven medical imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologists) is not applicable.
- The "ground truth" for sterilization efficacy is established by scientific principles and validated biological indicators (BI) and sterility assurance levels (SAL) as per recognized standards (ST 77 2013). The validation of dry time is based on the "absence of visible moisture." These are objective measurements rather than subjective expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- As this is non-clinical performance testing, adjudication methods typically used for subjective clinical assessments are not applicable. The results are based on objective laboratory measurements and adherence to specified performance standards.
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:
- No, this is not applicable. The document is for a physical medical device (sterilization container), not an AI algorithm or a diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. This document pertains to a physical sterilization container.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance of the sterilization container is based on objective measurements of sterilization efficacy and dryness as defined by recognized industry standards (ST 77 2013).
- For sterilization efficacy: achieving a 12 log reduction and a Sterility Assurance Level (SAL) of 10^-6 using biological indicators (overkill method).
- For dry time: absence of visible moisture.
8. The sample size for the training set:
- Not applicable. This relates to a physical device evaluated through non-clinical performance testing, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As indicated in point 8, there is no training set for this type of device evaluation.
§ 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).