(390 days)
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems:
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H or the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure.
The FDA 510(k) summary for the 3M™ Attest™ Rapid Readout Biological Indicator 1295 (K211705) describes the acceptance criteria and the study that proves the device meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Full Cycle Performance | Verify performance in each of the full cycles in the STERIZONE® VP4 Sterilizer (Cycle 1). | All biological indicators display a negative fluorescent and negative visual response. | Pass |
| Fractional Cycle Performance | Verify performance in fractional cycles for each of the cycles within the STERIZONE® VP4 Sterilizer (Cycle 1). | All biological indicators display a negative fluorescent and negative visual response. | Pass |
| Chemical Indicator (CI) Color Change | Demonstrate the color change of the CI when exposed to the STERIZONE® VP4 Sterilizer (Cycle 1). | Color change from blue toward pink. | Pass |
Note: The above table specifically refers to the nonclinical testing performed to demonstrate performance in the newly claimed sterilizer and cycles (STERIZONE® VP4 Sterilizer, Cycle 1), which is the primary reason for this new 510(k) submission as the device itself is identical to a previously cleared predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size for the test set used in the full, fractional, and chemical indicator performance tests. It states that "nonclinical testing was performed."
- Sample Size: Not explicitly quantified in the provided text.
- Data Provenance: The testing was nonclinical, performed in a laboratory setting to evaluate the device's performance with the newly included STERIZONE® VP4 Sterilizer (Cycle 1). The country of origin is not specified but implicitly linked to the sponsor, 3M Health Care, based in St. Paul, MN, USA. The study is prospective in nature as it is a validation of the device's performance under specific conditions to support regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is generally not applicable to biological indicator performance studies. The ground truth for such studies is established through objective, predefined physical and biological measurements rather than expert human interpretation.
Therefore:
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1 used in clinical imaging studies) is not applicable here because the "readout" of a biological indicator (fluorescent and visual response) is a direct, objective measurement rather than a subjective interpretation requiring consensus among multiple readers.
Therefore:
- Adjudication Method: Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices involving human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on human performance. Biological indicators like the 3M™ Attest™ are designed for objective, automated readout and do not involve human diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the studies described are essentially "standalone" in nature, focusing on the biological indicator's performance based on its inherent characteristics and interaction with the auto-reader and sterilizer. The device functions independently in terms of its biological response to sterilization conditions, and the auto-reader provides an objective "readout" (fluorescent or visual response) without human intervention in the interpretation of the core sterilization effectiveness.
7. The Type of Ground Truth Used
The ground truth for biological indicator performance studies is based on:
- Biological Activity: The viability of Geobacillus stearothermophilus spores.
- Physical Parameters: The exposure of the BI to specific sterilant concentrations (vaporized hydrogen peroxide at 10 mg/L) and time.
- Negative Fluorescent/Visual Response: The absence of growth (negative fluorescent and negative visual response) for sterilized indicators and presence of growth for unsterile/fractionally treated indicators.
- Material Science: The color change of the chemical indicator based on chemical reaction with hydrogen peroxide.
Essentially, it relies on objective biological and chemical principles, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an AI/machine learning algorithm. For biological indicators, performance is established through empirical testing against predefined standards (e.g., FDA Guidance, ANSI/AAMI/ISO 11138-1:2017) rather than training models. The document refers to "nonclinical testing" to demonstrate performance.
Therefore:
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML algorithm:
- How Ground Truth for Training Set Was Established: Not applicable. Instead, the performance of the biological indicator (including its stated D-value and Survival/Kill Window) is established through rigorous testing methods defined by recognized standards for biological indicators.
§ 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).