(100 days)
The STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.
The STERLINK™ FPS-15s Plus can sterilize*:
- · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Medical devices with a single stainless steel lumen with:
- o An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter
- The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 3.97 lbs.
The STERLINK™ FPS-15s Plus sterilizer with STERLOAD™ cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method.
This system consists of a main device and cassette which are called the STERLINK™ and STERLOAD™, respectively. The STERLOAD™ cassette contains 59% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.
Here's a breakdown of the acceptance criteria and study information for the STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For medical device sterilization submissions, the acceptance criteria are generally defined by adherence to recognized national and international standards. The "Reported Device Performance" in this context is the statement of "Pass" for each test, indicating that the device met the requirements of the specified standard.
| Test Category | Standard/Guidance Document | Acceptance Criteria (Defined by Standard) | Reported Device Performance |
|---|---|---|---|
| Safety & Effectiveness (General) | ISO 14971:2012 (Risk management) | Adherence to risk management principles | Pass |
| Guidance for Industry and Food and Drug Administration Staff, "Appling Human Factors and Usability Engineering to Medical Devices", issued on February 3, 2016; IEC 62366-1:2015 (Human factors and usability engineering) | Compliance with human factors principles | Pass | |
| ISO 10993-5:2009 (Biocompatibility) | Non-cytotoxicity | Pass | |
| IEC 62304:2006 + AMD1:2015; "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device", issued on May 11, 2005 (Software validation) | Software functions correctly and safely | Pass | |
| EN 61010-1:2010; EN 61010-2-040:2015; IEC 60601-1:2005 (3rd Ed.) + CORR.1:2006 + CORR.2:2007 + A1:2012 (Electrical safety) | Electrical safety standards met | Pass | |
| EN 55011:2009/A1:2010 (RF disturbance) | RF emission limits met | Pass | |
| EN 61326-1:2013; EN 61000-3-2:2014; EN 61000-3-3:2013; EN 60601-1-2:2015 (Electromagnetic compatibility (EMC)) | EMC standards met | Pass | |
| OSHA analytical method 1019 (Hydrogen peroxide gas detection test) | H2O2 levels within safe limits | Pass | |
| Sterilization Efficacy | ISO 11138-1:2017 (Resistance validation for biological indicator test) | Biological indicator resistance verified | Pass |
| ISO 14937:2009 (Lumen sterilization) | Sterility Assurance Level (SAL) met for lumens | Pass | |
| ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009 (Surface sterilization) | SAL met for surfaces | Pass | |
| ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009 (Mated surface sterilization) | SAL met for mated surfaces | Pass | |
| AOAC 966.04 (Sporicidal activity test) | Demonstrated sporicidal efficacy | Pass | |
| ISO 11737-1:2018 (Bacteriostasis test) | No inhibition of microbial growth | Pass | |
| Device Performance & Durability | Manufacturer's internal standard (Shelf-life test (Sterilant Preservation Test)) | Sterilant remains viable for 1 year | 1 year |
| ASTM E1837-96(2014); ISO 11737-1:2018 (Simulated use test) | Effective under simulated use conditions | Pass | |
| ASTM E1837-96(2014) (In-use test) | Effective under actual use conditions | Pass | |
| ASTM D638; ASTM E8/E8M-16ae1; ASTM D790; ASTM E290-14; ASTM D256; ASTM E23-18; ASTM E1164; ASTM E313; ASTM D3985; ASTM F1249 (Material compatibility test) | Materials maintain integrity | Pass | |
| ASTM D4169-14 (Delivery validation) | Sterilant delivery is consistent | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of "samples" in a general sense for each test. However, it does provide some details related to test conditions:
- Lumen Sterilization: Validation testing for lumen sizes was conducted using a maximum of five (5) lumens per load.
- Validation Studies (General): Validation studies were performed using a validation load with a total weight of 3.97 lbs.
- Data Provenance: The document generally refers to "non-clinical tests" performed using listed standards. There is no specific mention of country of origin for the data or whether the studies were retrospective or prospective. Given the nature of device validation, these tests are typically performed in a laboratory setting as prospective experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is generally not applicable to the validation of a sterilization device. The "ground truth" for sterilization efficacy is established through standardized microbiological testing using biological indicators and adherence to defined Sterility Assurance Levels (SALs). These are objective biological endpoints, not subjective expert interpretations.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. The results are typically objective (e.g., growth or no growth of biological indicators, direct measurements of physical parameters) and do not require expert adjudication in the same way clinical image interpretation might.
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 is a sterilization device, not an AI-powered diagnostic tool that relies on human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical sterilizer and sterilant system, not an algorithm. Its performance is inherent to its design and chemical process, independent of human real-time interaction beyond operation.
7. The Type of Ground Truth Used
The ground truth used for sterilization efficacy is primarily microbiological endpoints, specifically:
- Sterility Assurance Level (SAL): Demonstrated by the inactivation of biological indicators (Geobacillus stearothermophilus) to a specified probability (e.g., 10^-6), as required by standards like ISO 14937.
- Sporicidal activity: Confirmed through tests like AOAC 966.04.
- Material compatibility: Assessed through various ASTM and ISO standards to ensure the device does not damage materials or leave harmful residues.
- Physical and Chemical Parameters: The ground truth for operational aspects (temperature, pressure, sterilant concentration, shelf-life, etc.) is based on established scientific principles and measured values.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." Its validation involves traditional engineering, chemistry, and microbiology testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).