(24 days)
The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle.
The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator changes color from blue through an intermediate beige and then to the endpoint color, pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 sterilant use dilution.
The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed on one end. The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevent the indicator ink from leaching from the substrate. The indicator monitors the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in an automated liquid chemical sterilant processing system that uses S40 Sterilant Concentrate and provides a controlled 6-minute exposure at 45.5 - 60°C during a processing cycle.
The provided document is a 510(k) Premarket Notification for a chemical indicator. It explicitly states in section 6, "No new testing was performed for this submission." Therefore, it does not contain the information requested regarding acceptance criteria and performance studies.
The submission is for a modification to an existing device (predicate K173428), primarily revising the product's name, indications for use, and labeling to list specific liquid chemical processing systems where the Chemical Indicator (CI) can be used. The FDA's determination of substantial equivalence is based on the argument that these changes "raise no new questions of safety or effectiveness."
To answer your request, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document because no new performance testing was conducted for this specific submission. The document relies on the performance of the predicate device. However, the document does describe the performance characteristics of the device if new testing had been conducted.
| Acceptance Criteria (Inferred from intended use) | Reported Device Performance (Inferred from device description, not new testing) |
|---|---|
| Color Change Threshold: Indicator changes color when exposed to ≥1820 ppm (mg/L) peracetic acid (PAA) in S40 use dilution. | Color Change Performance: Changes color from blue, through intermediate beige, to pink endpoint when exposed to >1820 ppm (mg/L) peracetic acid in S40 use dilution. The indicator may become more pink with higher PAA concentrations. |
| Exposure Conditions: Color change occurs during a controlled 6-minute exposure at 45.5 - 60°C in STERIS automated liquid chemical sterilant processors (SYSTEM 1E® and SYSTEM 1® endo). | Exposure Conditions Performance: Color change occurs under the specified conditions (6-minute exposure at 45.5 - 60°C) within the SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems. |
| Initial Color: Unprocessed indicator is blue. | Initial Color Performance: The unprocessed Chemical Indicator is blue. |
| Shelf-life: 2 years. | Shelf-life Performance: 2 years (Identical to predicate). |
| Open bottle shelf-life: 6 months. | Open bottle shelf-life Performance: 6 months (Identical to predicate). |
| Mechanism of Action: Bleaching of lissamin green B dye as a result of oxidation, leading to blue to beige/pink color change. (This is a design characteristic rather than an acceptance criterion in the traditional sense, but important for its function) | Mechanism of Action Performance: Achieved through bleaching of lissamine green B dye as a result of oxidation (Identical to predicate). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as no new testing was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as no new testing was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no new testing was performed.
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
This is not applicable. The device is a chemical indicator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a chemical indicator, not an algorithm. Its "standalone" performance would be its ability to change color correctly, which is the basis of its function. The document states its performance is identical to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly provided for new testing, as no new testing was performed. For the original predicate device, the "ground truth" for a chemical indicator would typically be established by precise analytical measurements of peracetic acid concentration in the sterilant solution, confirmed by laboratory methods (e.g., titration or spectrophotometry), and correlated with the visual color change of the indicator.
8. The sample size for the training set
This information is not provided as no new testing was performed. The device is a chemical indicator, not a machine learning model that requires a training set in the typical sense.
9. How the ground truth for the training set was established
This information is not provided as no new testing was performed and it's not a machine learning model.
§ 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).