(83 days)
The PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer.
The PRIMUS Healthcare Sterilizer model PSS11-HA & PSS11-HB are designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer models PSS11-HA and PSS11-HB are used with eleven standard pre-programmed cycles (factory preset), which are listed in Table 2 All cycles in the PSS11-HA and PSS11-HB are validated and compliant with AAMI ST8:2013/(R) 2018. The unit is manufactured in compliance with ISO 13485:2016 and the FDA's Good Manufacturing Practice (GMP) for Medical Devices. The sterilizer unit 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 Steam Sterilizer consists of the following components and accessories:
- Jacket Assembly (sterilizer vessel)
- Chamber Finish
- Chamber Door
- Insulation
- Chamber Drain System
- Drain Water Quench (Piping System)
- Vacuum system
- Steam Source
- Control system: PRIMUS Healthcare Sterilizer model PSS11-HA and PSS11-HB can use either the IDEC FC6A Microsystem or the Allen Bradley CompactLogix system platforms, depending on availability. The PSS11-H PRIMATIC 100 control software remains the same, and all functional and software specifications remain consistent between the platforms. The programmable logic controller (PLC) provides process control, while the human-machine interface (HMI) serves as the interface between the operator and the PLC.
The provided document describes the PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) and its non-clinical testing to demonstrate substantial equivalence to a predicate device (PRIMUS Healthcare Sterilizer, Model PSS11-HC, K221474).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| 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 with 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 the data provenance
The document does not specify general "samples" in terms of number of devices for these tests. Instead, it states that the performance testing was conducted on "all the cycles in the PRIMUS healthcare steam sterilizer." This implies that the tests were performed on the device models (PSS11-HA and PSS11-HB) and their defined sterilization cycles as per the standards.
The document indicates "Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors." It does not provide information on the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The "ground truth" for a medical device like a sterilizer is typically established by recognized national and international standards (e.g., ANSI/AAMI ST8, ASME codes, IEC standards) and their specified testing methodologies, rather than expert consensus on individual cases. The tests described are engineering and performance validation tests against these established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective human assessment of diagnostic output, particularly for AI/machine learning devices. The document concerns a steam sterilizer, and the tests are objective engineering and performance validations against predefined 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
This information is not applicable. The device is a steam sterilizer, not an AI-assisted diagnostic or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a steam sterilizer, not an algorithm, and its performance is assessed directly, not through an algorithm in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the PRIMUS Healthcare Sterilizer is based on compliance with established national and international standards. Specifically, for performance testing, it is "Compliance to performance requirements defined in ANSI/AAMI/ST8:2013 (R2018)." Other ground truths are compliance with relevant electrical safety (UL, CSA), EMC (IEC), control panel (UL), and pressure vessel (ASME) standards.
8. The sample size for the training set
This information is not applicable. The device is a hardware sterilizer, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of 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).