(92 days)
The Serim ® Peracetic Acid Chemical Indicator test strips are designed for use in a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant to detect peracetic acid concentration in the use solution.
The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square purple reagent pad that has been chemically treated to detect the active ingredient in the Steris 20™ Sterilant® when used in the STERIS SYSTEM 1® Processor™. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
The Serim* Peracetic Acid Chemical Indicator is configured as a paper pad on a plastic strip support. A dve in the chemical indicator pad is oxidized (bleached) by the use solution. The extent of bleaching indicates whether a sufficient concentration active agent (peracetic acid) was present. At the end of the processing evele the user compares the reacted indicator to a color chart composed of two color blocks. The "START" color block is similar to the unreacted indicator strip. The =COMPLETE color block is similar to an indicator strip that has been exposed to peracetic acid at or above a concentration of 1500 ppm.
The provided text is a 510(k) Premarket Notification for the Serim® Peracetic Acid Chemical Indicator. This document focuses on establishing substantial equivalence to a previously cleared device, not on presenting a standalone study with detailed acceptance criteria and performance data as one would expect for a new, non-equivalent device or an AI/software as a medical device (SaMD).
Therefore, many of the requested points cannot be directly addressed from the provided text because the device, a chemical indicator, is not an AI/Software device, nor is the document an MRMC or standalone study report. It's a regulatory submission for a physical device.
However, I can extract information relevant to the intent of the questions where possible, and clearly state when information is not available due to the nature of the document.
1. Table of Acceptance Criteria and Reported Device Performance
The submission declares substantial equivalence to the STERIS PROCESS™ Chemical Monitoring Strips (K921559). The "acceptance criteria" for this submission appear to be the demonstrated identical nature and functionality to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Detects peracetic acid concentration in the use solution of a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant. | Intended Use: The Serim® Peracetic Acid Chemical Indicator test strips are designed for use in a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant to detect peracetic acid concentration in the use solution. (Matches) |
| Technological Characteristics: Identical to the STERIS PROCESS™ Chemical Monitoring strip (K921559) in composition and mechanism (dye oxidized/bleached by peracetic acid, color change compared to a chart). | Technological Characteristics: "The Serim® Peracetic Acid Chemical Indicator is identical to the STERIS PROCESS™ Chemical Monitoring strip (manufactured by Serim Research Corp. for Steris Corporation) that has been previously cleared by the FDA (K921559)." The device uses a color change mechanism: dye in a pad is oxidized (bleached) by peracetic acid; user compares reacted indicator to a color chart with "START" and "COMPLETE" color blocks, where "COMPLETE" indicates exposure to ≥ 1500 ppm peracetic acid. (Matches predicate) |
| Performance: Provides an indication of sufficient peracetic acid concentration (at or above 1500 ppm). | Performance: The "COMPLETE" color block of the color chart corresponds to an indicator strip exposed to peracetic acid "at or above a concentration of 1500 ppm." (Implies equivalent performance to predicate) |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) for a physical chemical indicator, not a study involving a test set of data (like medical images or clinical records). The claim is about manufacturing and functional identity to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" as typically understood in a software or AI device study is established for a test set in this 510(k) submission. The performance relies on the chemical reaction and color change.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication in this context.
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, not an AI or software device, and no MRMC study is mentioned or relevant to this type of submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a standalone chemical indicator that produces a visual result. It requires human interpretation to compare the reacted strip to a color chart. There is no "algorithm only" component. The performance discussed is the chemical reaction itself, not a digital algorithm.
7. The type of ground truth used
The "ground truth" for this chemical indicator's functionality is the known chemical concentration of peracetic acid. The device is designed to visually indicate if this concentration is at or above a specific threshold (1500 ppm).
8. The sample size for the training set
Not applicable. This device is a chemical indicator, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is used for this 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).