(21 days)
The SPSmedical SporView®Plus Steam B1 Test Pack with STEAMPlus Integrator is indicated for use in routine and challenge testing of steam gravity displacement cycles at indication for ace in rouintes exposure time or longer and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.
The SPSmedical modified SporView Plus Steam BI Test pack is a single use PCD used for the monitoring of both gravity displacement and pre-vacuum steam sterilization cycles.
The provided document describes the K051173 submission for the SPSmedical SporView® Plus BI Test Pack. This is a biological indicator (BI) to monitor steam sterilization cycles. It is not an AI/ML powered device, so many of the requested fields (such as MRMC studies, training/test sets, expert adjudication, etc.) are not applicable.
Here's an analysis of the provided information, framed by your request, and addressing the relevance of each point:
Acceptance Criteria and Device Performance Study for SPSmedical SporView® Plus BI Test Pack
The acceptance criteria for this device, as implied by the non-clinical testing section, is equivalence in performance to both the established AAMI (Association for the Advancement of Medical Instrumentation) biological indicator test packs and the predicate device (SPSmedical SporView® BI Test Pack, K022706). Performance is measured by the ability of the biological indicators within the test packs to accurately reflect complete survival, partial survival, and complete kill cycles under specified sterilization conditions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to AAMI biological indicator test packs in detecting complete survival, partial survival, and complete kill cycles in gravity displacement steam sterilizers at 121°C. | The biological indicators in the SporView Plus BI Test packs were found to be equivalent in performance to those located within the AAMI biological indicator test packs during complete survival, partial survival, and complete kill cycles run in a gravity displacement steam sterilizer at 121°C (250°F). |
| Equivalence to AAMI biological indicator test packs in detecting complete survival, partial survival, and complete kill cycles in pre-vacuum steam sterilizers at 132°C. | The biological indicators in the SporView Plus BI Test packs were found to be equivalent in performance to those located within the AAMI biological indicator test packs during complete survival, partial survival, and complete kill cycles run in a pre-vacuum steam sterilizer operating at 132°C (270°F). |
| Equivalence to the predicate device (SPSmedical SporView® BI Test Pack) in detecting complete survival, partial survival, and complete kill cycles in gravity displacement steam sterilizers at 121°C. | The biological indicators in the SporView Plus BI Test packs were found to be equivalent in performance to those located within the predicate test pack during complete survival, partial survival, and complete kill cycles run in a gravity displacement steam sterilizer at 121°C (250°F). |
| Equivalence to the predicate device (SPSmedical SporView® BI Test Pack) in detecting complete survival, partial survival, and complete kill cycles in pre-vacuum steam sterilizers at 132°C. | The biological indicators in the SporView Plus BI Test packs were found to be equivalent in performance to those located within the predicate test pack during complete survival, partial survival, and complete kill cycles run in a pre-vacuum steam sterilizer operating at 132°C (270°F). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "Three separate lots of biological indicators containing G. stearothermophilus spores were used." This implies a sample size of at least three product lots. Within each lot, multiple biological indicators would have been tested. The specific number of individual BIs per lot or per test cycle is not explicitly stated.
- Data Provenance: The testing was "performed in a 121°C (250°F) gravity displacement sterilizer and in a pre-vacuum steam sterilizer operating at 132°C (270°F)." This indicates a laboratory-based, prospective experimental study. The country of origin is implicitly the USA, given the submission to the FDA by a US-based company.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable as this is a biological indicator, not an AI device relying on expert interpretation for ground truth. The "ground truth" for a biological indicator is the objective outcome of sterilization (i.e., whether the spores are killed or not), which is determined by culturing the BI.
4. Adjudication Method for the Test Set
Not applicable. The outcome of the biological indicator (survival/kill) is an objective biological determination, not subject to human adjudication in the traditional sense of clinical imaging or interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
Not applicable. This is not an AI/ML device, and its performance is not evaluated in terms of improving human reader effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI algorithm. Its performance is inherently "standalone" in that it directly measures the effectiveness of sterilization. There is no human-in-the-loop component in its core function.
7. The Type of Ground Truth Used
The ground truth used is based on biological viability (spore killing). The AAMI standard ST-46:2002 prescribes how biological indicators (containing G. stearothermophilus spores) are used and evaluated to determine if a sterilization cycle achieved its intended purpose (i.e., killing the spores). The "complete survival, partial survival, and complete kill cycles" refer to carefully controlled conditions designed to elicit these specific outcomes from the biological indicators, which then serve as the ground truth for evaluating the test pack's performance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the computational sense. The device's design is based on established biological and sterilization principles.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there's no training set for an AI/ML model, there's no ground truth established in this context. The underlying scientific principles for biological indicator performance (e.g., G. stearothermophilus resistance to steam) are well-established prior to the device's development.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).