(211 days)
The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PSS Series Sterilizers are available in the following configurations:
13" x 13" x 23" Multi-Functional Sterilizer Single Door
13" x 13" x 23" Laboratory/Lo Single Door
16" x 16" x 26" Multi-Functional Sterilizer Single or Double Door
16" x 16" x 26" Laboratory/Lo Single or Double Door
20" x 20" x 38" Multi-Functional Sterilizer Single or Double Door
20" x 20" x 38" Laboratory/Lo Single or Double Door
26" x 26" x 39" Multi-Functional Sterilizer Single or Double Door
26" x 26" x 39" Laboratory/Lo Single or Double Door
26" x 26" x 49" Multi-Functional Sterilizer Single or Double Door
26" x 26" x 49" Laboratory/Lo Single or Double Door
26" x 26" x 67" Multi-Functional Sterilizer Single or Double Door
26" x 26" x 67" Laboratory/Lo Single or Double Door
26" x 36" x 39" Multi-Functional Sterilizer Single or Double Door
26" x 36" x 39" Laboratory/Lo Single or Double Door
26" x 36" x 48" Multi-Functional Sterilizer Single or Double Door
26" x 36" x 48" Laboratory/Lo Single or Double Door
26" x 36" x 60" Multi-Functional Sterilizer Single or Double Door
26" x 36" x 60" Laboratory/Lo Single or Double Door
26" x 63" x 48" Multi-Functional Sterilizer Single or Double Door
26" x 63" x 48" Laboratory/Lo Single or Double Door
26" x 63" x 76" Multi-Functional Sterilizer Single or Double Door
26" x 63" x 76" Laboratory/Lo Single or Double Door
Sterilizers are available in Multifunctional models which includes vacuum and gravity cycles and Laboratory/Lo-Temperature models which includes the wacuum and gravity cycles as well as a low temperature feature for pasteurization and inspissation processes.
The PRIMUS PSS series steam sterilizers are class II medical devices as defined by 21 CFR 880.6880. The PSS series sterilizers feature fully jacketed, rectangular 316L stainless steel chambers with sliding doors. The units are available in Multifunction or Laboratory/Lo configurations. The Multifunction units offer both prevacuum and gravity configurations, whereas the Laboratory/Lo units offer prevacuum, gravity, and a low operating temperature configuration.
The PRIMUS PSS series sterilizers are offered for sale with the following factory-set sterilization cycles and cycle values:
| CYCLES | STERILIZE TEMP | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD |
|---|---|---|---|---|
| GRAVITY | 132° C | 4 MINUTES | 1 MINUTE | HARD GOODS |
| VACUUM | 132° C | 4 MINUTES | 15 MINUTES | WRAPPED GOODS |
| LIQUIDS | 121° C | 30 MINUTES | *8 MINUTES | LIQUIDS |
| TEST (VAC) | 132° C | 4 MINUTES | 3 MINUTES | BOWIE-DICK TEST |
*Liquid Cycle is Cool Time
The provided text describes the acceptance criteria and the validation study for the PRIMUS PSS series sterilizer.
Acceptance Criteria and Device Performance
The acceptance criteria for the PRIMUS PSS series sterilizer are primarily based on achieving complete sterilization, demonstrated by the complete kill of biological indicators with an appropriate sterility assurance level (SAL) of less than 10-6. This is in compliance with the AAMI ST8-1994 standard for performance and construction of hospital sterilizers.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Complete kill of biological indicators | Complete kill of biological indicators with SAL -6 |
| Sterility Assurance Level (SAL) -6 | SAL -6 |
| Compliance to AAMI ST8-1994 (Performance) | Complied with AAMI ST8-1994 for vacuum, gravity, and liquids cycles |
| Compliance to AAMI ST8-1994 (Construction) | Met or exceeded AAMI ST8-1994 in design and construction |
| Compliance to UL Electromedical Code 544 | Complied (certified by ETL Testing Labs, Inc.) |
| Compliance to CSA CAN/CSA C22.2 NO. 601.1 | Complied (certified by ETL Testing Labs, Inc.) |
| Compliance to ASME, Section VIII, Division 1 | Complied |
| California Seismic Pre-Approval | Complied |
| NFPA Standard 99 | Complied |
Study Details
The provided text outlines a standalone (i.e., algorithm only without human-in-the-loop performance) validation study for the sterilizer's function and exposure time recommendations.
1. Sample Sized Used for the Test Set and Data Provenance:
* Test Set Sample Size: Not explicitly stated as a number of sterilizer cycles or loads. The document refers to "All tests," which implies a comprehensive testing regimen, but specific numbers are not given.
* Data Provenance: The document does not specify the country of origin. The study appears to be prospective, as it describes validation tests conducted to demonstrate safety and effectiveness.
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
* Number of Experts: Not applicable. The ground truth for sterilizers is established through scientific and microbiological testing against defined standards, not through expert human interpretation in the same way as an imaging diagnostic device.
* Qualifications of Experts: N/A.
3. Adjudication Method for the Test Set:
* Adjudication Method: Not applicable in the traditional sense. The "ground truth" for sterilization is determined by the objective outcome of biological indicator tests (complete kill or not) and adherence to physical parameters set by the AAMI ST8-1994 standard. There is no mention of a human adjudication process for interpreting these results; rather, it's a pass/fail against established criteria.
4. 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 is not applicable to a sterilizer device. MRMC studies are typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images, and the AI system is designed to assist or replace that interpretation. A sterilizer's performance is objective and not based on human reader interpretation.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, a standalone performance study was done. The validation described is focused solely on the sterilizer's ability to achieve sterilization based on its design and operational cycles, without human interpretation of results beyond verifying biological indicator kill. The sterilizer itself is the "device" or "algorithm" in this context.
6. The type of ground truth used:
* The ground truth used is primarily objective performance data reflecting the sterilization efficacy. This includes:
* Biological indicator kill: Direct evidence of microbial inactivation.
* Sterility Assurance Level (SAL) -6: A quantifiable measure of the probability of a single viable microorganism remaining after sterilization.
* Compliance to AAMI ST8-1994: An industry standard that defines performance requirements for steam sterilizers.
* Compliance to other safety and construction standards (UL, CSA, ASME, etc.): Ensuring the device is built to established engineering and safety specifications.
7. The sample size for the training set:
* Not applicable in the context of an AI training set. The sterilizer is a physical device, and its design and operational parameters are 'trained' through engineering design, prototyping, and testing, rather than an AI model training on a dataset. The "cycles" listed (Gravity, Vacuum, Liquids) are the operational modes, not training iterations for an AI.
8. How the ground truth for the training set was established:
* Not applicable for an AI training set. The "ground truth" for the sterilizer's design and operational parameters would have been established through established engineering principles, scientific understanding of sterilization processes (time, temperature, pressure relationships), and adherence to regulatory and industry standards like AAMI ST8-1994, which dictate optimal conditions for achieving sterility. These principles guide the design and manufacturing of the 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).