(222 days)
The STERLINK™ FPS-15s Plus sterilizer 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 preprogrammed sterilization lumen cycle operates at low pressure 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:
- STERPACK™ plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter
- STERLOAD™: 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 1 1b and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively,
The STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments.
This system consists of a main device and cassettes which are called the STERLINK™ FPS-15s Plus and STERPACK™ plus or STERLOAD™, respectively. The STERPACK™ plus and STERLOAD™ cassette contain 58-59.5% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.
Based on the provided text, the device in question is the STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette, a vaporized hydrogen peroxide sterilizer. The acceptance criteria and the study proving the device meets these criteria are primarily focused on the non-clinical performance of the sterilizer, specifically its ability to sterilize medical devices. The information provided is typical of a 510(k) summary for a medical device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally "Pass" for compliance with various standards and guidance documents. The reported device performance is that it "Passes" these tests.
| Test Category | Standard/Guidance Document | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Human factors and usability engineering | 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 | Pass | Pass |
| Shelf-life test (Sterilant Preservation Test) | Manufacturer's internal standard | Pass | 1 year |
| Biocompatibility | ISO 10993-5:2009 | Pass | Pass |
| Software validation | IEC 62304:2006 + AMD1:2015; Guidance for Industry and Food and Drug Administration Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device", issued on May 11, 2005 | Pass | Pass |
| Electrical safety | EN 61010-1:2010; EN 61010-2-040:2015; IEC 60601-1:2005 (3rd Ed.) + CORR.1:2006 + CORR.2:2007 + A1:2012; EN 60601-1-2:2015 | Pass | Pass |
| RF disturbance | EN 55011:2009/A1:2010 | Pass | Pass |
| Electromagnetic compatibility (EMC) | EN 61326-1:2013; EN 61000-3-2:2014; EN 61000-3-3:2013; EN 60601-1-2:2015 | Pass | Pass |
| Resistance validation for biological indicator test | ISO 11138-1:2017 | Pass | Pass |
| Lumen sterilization | ISO 14937:2009 | Pass | Pass |
| Surface sterilization | ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009 | Pass | Pass |
| Mated surface sterilization | ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009 | Pass | Pass |
| Simulated use test | ASTM E1837-96:2014; ISO 11737-1:2018 | Pass | Pass |
| In-use test | ASTM E1837-96:2014 | Pass | Pass |
| Sporicidal activity test | AOAC 966.04 (AOAC 6.3.05:2013) | Pass | Pass |
| Bacteriostasis test | ISO 11737-1:2018 | Pass | Pass |
| Material compatibility test | ASTM D638; ASTM E8/E8M-16ae1; ASTM D790; ASTM E290-14; ASTM D256; ASTM E23-18; ASTM E1164; ASTM E313; ASTM D3985; ASTM F1249 | Pass | Pass |
| Delivery validation (Sterilizer) | ASTM D4169-14 | Pass | Pass |
| Delivery validation (Sterilant) | Manufacturer's internal standard | Pass | Pass |
| Hydrogen peroxide gas detection test | OSHA analytical method 1019 | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "sample size" in terms of number of medical devices or test runs for each individual performance test (e.g., lumen sterilization). Instead, it states for lumen sizes: "The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load." It also mentions "a validation load with a total weight of 1 lb and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively."
- Sample Size for performance tests: For lumen sterilization, it mentions a maximum of five lumens per load. Other tests don't specify a detailed sample size breakdown within this document. The "Pass" results indicate that the testing met the minimum requirements for the specific standards.
- Data Provenance: The manufacturer is "Plasmapp Co., Ltd." in "Rep. of Korea (South Korea)." The document implies that the testing was conducted to meet the requirements of the U.S. FDA, but the location where the actual tests were performed is not explicitly stated. The nature of these tests (e.g., sterilization efficacy) strongly suggests they were performed as prospective validation studies to demonstrate the device's performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of information (number and qualifications of experts establishing ground truth for a test set) is generally relevant for AI/ML-driven diagnostic devices where human expert consensus forms the ground truth for image interpretation or diagnosis. For a sterilizer, the "ground truth" for its performance is typically established through objective, laboratory-based biological and physical testing using standardized methods and biological indicators (e.g., Geobacillus stearothermophilus). Therefore, the concept of "experts establishing ground truth for a test set" in the context of human interpretation of data is not applicable here. The "experts" would be the scientists and technicians conducting the validation tests according to the specified standards.
4. Adjudication Method for the Test Set
As the "ground truth" for a sterilizer's performance is objective (e.g., kill/no kill of microorganisms, meeting sensor specifications), adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not applicable. The device's performance is measured against established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. MRMC studies are typically performed for diagnostic devices (especially those involving image interpretation) to evaluate the impact of a device (e.g., AI assistance) on human reader performance. This document is for a medical device sterilizer, which does not involve human interpretation of cases or AI assistance in that context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance tests described are standalone in the sense that they evaluate the sterilizer's ability to sterilize medical devices independently of human subjective assessment. The "algorithm" here is the sterilization cycle itself, and its effectiveness is measured directly through biological and chemical indicators. The results are based on the device's inherent design and operational parameters.
7. The Type of Ground Truth Used
The ground truth used for proving the sterilizer's efficacy is based on:
- Biological Activity: The ability to inactivate microorganisms (e.g., Geobacillus stearothermophilus spores) as measured by standard biological indicator tests (e.g., ISO 11138-1:2017, ISO 11737-1:2018, AOAC 966.04).
- Physical Parameters: Confirmation that the sterilizer operates within specified parameters (temperature, pressure, time) and that the sterilant is delivered effectively.
- Material Compatibility: Ensuring that the sterilization process does not degrade the materials of the medical devices being sterilized.
- Engineering Standards: Compliance with electrical safety, EMC, software validation, and other relevant engineering standards (e.g., IEC, EN, ASTM).
8. The Sample Size for the Training Set
This document does not refer to a "training set." The concept of training sets (and validation/test sets derived from them) is specific to machine learning or AI models that learn from data. This document is about a hardware device (sterilizer) whose performance is validated through defined physical and biological tests, not through training a model on a dataset.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The sterilizer's performance is established through controlled, laboratory-based validation studies against regulatory and industry standards for sterilization efficacy.
§ 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).