(266 days)
The PRIMUS Healthcare Sterilizer (Model PSS11-HC) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operatures should not be sterilized using the PRIMUS Healthcare Sterilizer.
PRIMUS Healthcare Sterilizers are compliant with AAMI ST8:2013 and manufactured in compliance with ISO 13485:2016 and FDA's Good Manufacturing Practice (GMP) for Medical Devices. Each sterilizer is equipped with a height-adjustable, steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single door, freestanding units where the unit is accessible on all sides. The PRIMUS Healthcare Series Steam Sterilizer consists of the following components and accessories: 1. Jacket Assembly (sterilizer vessel), 2. Chamber Finish, 3. Chamber Door, 4. Insulation, 5. Chamber Drain System, 6. Drain Water Quench (Piping System), 7. Vacuum system, 8. Steam Source, 9. Control system.
The provided text describes the acceptance criteria and the study that proves the PRIMUS Healthcare Sterilizer (Model PSS11-HC) meets these criteria. It's important to note that this document is for a steam sterilizer, not an AI/ML medical device, so some of the requested information (like number of experts for ground truth, MRMC study, training set details) are not applicable as they relate to AI/ML diagnostic or prognostic devices.
Here's the breakdown based on the provided information:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Name of Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Electrical Safety | To ensure that the device and its components meet the electrical safety requirements. | Compliance to meeting standard specification UL 61010-1:2012 Ed.3+R:29 Apr 2016 and UL 61010-2-040:2016 | Pass |
| EMC | To verify that the device meets EMC requirements. | Compliance with IEC 60601-1-2 ed 4.0 (2014-02) | Pass |
| Low-voltage switchgear and control gear assemblies | To verify that the Low-voltage switchgear and control gear assemblies meets the standard requirement. | Compliance with IEC 61439-2 Low-voltage switchgear and control gear assemblies - Part 2: Power switchgear and control gear assemblies | Pass |
| Pressure Vessel Testing | To verify that the pressure vessel used for the Steam sterilizer meets the requirements for pressure vessel and is safe for use. | Compliance with standard ASME Boiler and pressure vessel code, Section VIII division 1 | Pass |
| Control panel | To verify the control panel meets the requirement of UL 508A:2013. | Compliance with standard Industrial Control Panels UL 508A:2013 | Pass |
| Performance testing | To verify that all the cycles in the PRIMUS healthcare steam sterilizer meets the performance criteria defined in ANSI/AAMI/ST8. | Compliance to performance requirements defined in ANSI/AAMI/ST8:2013 (R2018) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in the context of a test set for data (like images or patient records) as this device is a physical sterilizer. Instead, testing involves the sterilizer itself and its components.
- Sample Size: Not applicable in the traditional sense of data samples. The testing relates to the device itself and its processes.
- Data Provenance: Not applicable. The testing is based on engineering and performance validation of a manufactured device against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For a physical sterilizer, "ground truth" is established by adherence to engineering and performance standards (e.g., specific temperatures, pressures, biological indicator kill rates). There is no "expert consensus" on ground truth for diagnostic image interpretation in this context. The validation is against defined physical and biological parameters.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for medical image interpretation tasks where human readers might disagree. For a sterilizer, the tests are objective: either the device meets the physical parameters and sterilization efficacy requirements, or it does not.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for diagnostic or prognostic AI/ML medical devices where human readers' performance with and without AI assistance is compared. This document concerns a physical steam sterilizer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm, but a physical device. Its "performance" is inherently "standalone" in that it performs its function (sterilization) independently, but its use requires human interaction (loading, initiating cycles, maintenance).
7. The Type of Ground Truth Used
The "ground truth" for the PRIMUS Healthcare Sterilizer is based on established industry and regulatory standards for steam sterilization. This includes:
- Physical parameters (temperature, pressure, time) according to specific cycles.
- Demonstrated sterilization efficacy (implied by compliance with standards like ANSI/AAMI ST8), which typically involves biological and chemical indicator testing.
- Compliance with electrical safety, EMC, and pressure vessel codes.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product and does not have a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).