(153 days)
The Castle ® SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated.
Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.
The Castle® SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the Steris® System 1 peracetic acid sterilization process, with Steris 20 sterilant. The product contains chromatography paper strips that are inoculated with Bacillus stearothermophilus (or G. stearothermophilus) spores at a nominal population of 105 per strip. Sterile tubes of Castle Culture Media (modified soybean casein broth) and a transfer clip are included. The materials of construction are equivalent to the Unispore® product. The product is intended to be used in an identical manner as the Steris® Process Biological Indicator Kit.
The provided document is a 510(k) summary for the Castle® SPOR-TEST PA Biological Indicator Kit. This type of document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. As such, it does not contain details of a clinical study with human subjects, test sets, training sets, or expert evaluations in the typical sense of AI/ML device studies.
Instead, the "study" described herein refers to the performance testing of the biological indicator in a laboratory setting to demonstrate its efficacy in monitoring a sterilization process compared to a predicate device.
Here's the information extracted and interpreted based on the context of a biological indicator's regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria for biological indicators are usually defined in terms of their D-value (decimal reduction time) and population count. However, this submission focuses on specific "survival" and "kill" times under defined conditions.
| Acceptance Criteria (Intended Use Statement) | Reported Device Performance (Implied by equivalence to predicate) |
|---|---|
| When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds. | The device is substantially equivalent to the predicate (Steris® Process Biological Indicator Kit), which implies it meets this survival time under the specified conditions. |
| When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will be killed at 6 minutes. | The device is substantially equivalent to the predicate, implying it meets this kill time under the specified conditions. |
| Exclusively intended to monitor the Steris System 1 liquid chemical sterilization system, with Steris 20 sterilant. | Matches the intended use of the predicate device. |
| Uses Bacillus stearothermophilus (or G. stearothermophilus) spores at a nominal population of 10^5 per strip. | Matches the predicate device's spore type and population. |
| Recovered in tubes of sterile growth medium that uses phenol red as a color change indicator (open-loop biological indicator). | Matches the predicate device's recovery and indicator method. |
| Qualified using Castle Culture Media. | Explicitly stated for the device. |
| May only monitor sterilization efficacy on exterior surfaces to loads processed in the Steris® peracetic acid process. | Matches the predicate device's monitoring capability. |
| Material of construction equivalent to Unispore® product. | Stated as equivalent. |
| Intended to be used in an identical manner as the Steris® Process Biological Indicator Kit. | Stated as identical use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of individual biological indicators tested. For this type of device, testing would involve multiple runs under controlled conditions to ensure consistency and reliability. The submission focuses on the performance parameters (survival/kill times) rather than a statistical sample size in the clinical trial sense.
- Data Provenance: The testing would have been conducted in a laboratory environment by Getinge/Castle Inc. to demonstrate the device's performance characteristics. This is a prospective test for the device's performance against established criteria, not a retrospective analysis of patient data. There is no mention of country of origin for test data, but it would typically be from the manufacturer's R&D facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable in the context of this device. Biological indicator testing involves laboratory measurements and observation of microbial growth (or lack thereof), not expert interpretation of images or clinical data. The "ground truth" is established by the clear presence or absence of spore viability after exposure to the sterilant under controlled conditions.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like "2+1" are relevant for subjective interpretations (e.g., radiology reads). For a biological indicator, the result is objective: either the spores grow (failure to sterilize) or they do not (successful sterilization).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is for evaluating human performance, often with and without AI assistance, in interpreting medical information. Biological indicators are objective tests, not subject to human interpretation in the same way.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, in spirit. The performance described is inherently "standalone" for the biological indicator. It functions mechanically and biologically without human "in-the-loop" interpretation beyond observing the color change in the culture medium. There is no algorithm, but the device's performance parameters (survival and kill times) are tested directly and objectively.
7. The Type of Ground Truth Used
- Microbial Viability/Inviability: The ground truth is the confirmed presence or absence of viable Bacillus stearothermophilus spores after exposure to the sterilant under specified conditions, as indicated by growth in the culture media (color change).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product whose performance is inherent to its design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set is involved for this type of device.
§ 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).