(83 days)
The Steam-Dot Process Indicator for steam sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed units or loads. The indicator dots turn from white to dark brown/black when sterilization conditions, thus providing an indication of processed items.
The Steam-Dot process indicator can be used in the following steam sterilization cycles:
*Gravity: 121 C/250 F - 30 minutes
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- Vacuum assisted (pre-vacuum): 132 C/270 F 3 minutes
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- Vacuum assisted (pre-vacuum): 132 C/270 F 4 minutes
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- Vacuum assisted (pre-vacuum): 134 C/273 F 3 minutes
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- Vacuum assisted (pre-vacuum): 134 C/273 F 4 minutes
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- Vacuum assisted (pre-vacuum): 135 C/275 F 3 minutes
The Steam-Dot Process Indicator is a single use chemical indicator designed for steam sterilization monitoring. Each indicator consists of reactive steam indicator ink printed on a substrate paper circle, 3/4" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only.
The indicator responds to the critical parameters of a steam sterilization cycle: exposure time, temperature, and presence of saturated steam sterilization process indicator ink chemicals react forming a black compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from white to black/dark brown. If the parameters do not achieve the required level, the indicator color will be light brown or crème.
The provided text describes a 510(k) summary for a medical device called the "Steam-Dot Process Indicator." The document outlines the device's indications for use, performance criteria, and the results of non-clinical testing to demonstrate its substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 indicator | 121°C-10 min: dark brown or black color | |
| 121°C-2 min: no color change or color markedly different compared to dark brown or black | ||
| 134°C-2 min: dark brown or black color | ||
| 134°C-0.3 min: no color change or color markedly different compared to dark brown or black | ||
| 140°C-30 min Dry heat: no color change | Passed | |
| FDA Guidance for industry for chemical indicators. Steam process indicator performance test. | 121°C-10 min: dark brown or black color | |
| 121°C-2 min: no color change or color markedly different compared to dark brown or black | ||
| 132-135°C-2 min: dark brown or black color | ||
| 132-135°C-20sec: no color change or color markedly different compared to dark brown or black | ||
| 140°C-30 min Dry heat: no color change | Passed | |
| Testing in hospital type sterilizers in gravity and pre-vacuum 510k cleared cycles. | Color change from white to dark brown or black | Passed |
| Biocompatibility study and ink transfer test | Individual components should not create biocompatibility issues. | |
| Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and steam processed indicators. | Passed | |
| End point stability and shelf-life study | Steam-Dot indicators processed in Pass and Fail cycles at various time points after production and at the end of shelf life should demonstrate stable color for 110 days. | |
| Meet specifications after real-time 48 months shelf-life exposure. | Passed |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of indicators or test runs) used for each test. It broadly states that the "performance of the Steam-Dot process indicator meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators and the requirements of FDA guidance for industry and FDA Staff: Pre-market notification [510(k)] submissions for chemical indicators, 2003."
The provenance of the data is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, given that it's a 510(k) submission, the testing would be prospective and conducted under controlled laboratory conditions, likely in the US or in a facility adhering to US regulatory standards for medical device testing.
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 chemical indicator like the Steam-Dot is based on the physical and chemical reaction of the indicator ink to specific temperature, time, and steam exposure parameters, as defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and FDA guidance. There are no human "experts" establishing a subjective ground truth in this context; rather, instrumental measurements of physical parameters and observable color changes define the outcome.
4. Adjudication method for the test set
Not applicable. As described above, the determination of "pass" or "fail" for the chemical indicator is objective, based on measurable physical parameters and a defined color change endpoints. There is no subjective interpretation requiring an adjudication process by multiple reviewers.
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
Not applicable. This device is a chemical indicator that changes color to confirm exposure to sterilization conditions. It is not an AI-powered diagnostic device or an imaging system requiring human interpretation or assistance from AI. Therefore, an MRMC study is irrelevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device. Its function is based on a chemical reaction, not a computational algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on defined physical and chemical parameters of steam sterilization as established by international standards (ANSI/AAMI/ISO 11140-1:2014) and regulatory guidance (FDA Guidance for industry for chemical indicators). This involves exposing the indicators to precise temperature, time, and steam conditions in controlled laboratory settings and observing the specified color change. It is an objective, laboratory-defined ground truth, not reliant on expert consensus, pathology, or clinical outcomes data.
8. The sample size for the training set
Not applicable. This device is a chemical indicator, not an AI/machine learning model that requires a training set. Its function is based on a chemical formulation and its reaction to sterilization conditions.
9. How the ground truth for the training set was established
Not applicable, as there is no training set 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).