(84 days)
The Cottrell, Ltd., ProChek® G Glutaraldehyde Concentration Level Indicator is a 1.5% minimum effective concentration (MEC) monitor intended for use in 2-3.5% activated glutaraldehyde solutions.
The ProChek® G Glutaraldehyde Concentration Level Indicator is a chemical indicator strip with a minimum effective concentration of 1.5% glutaraldehyde designed to monitor solutions, containing up to 3.5% activated glutaraldehyde. The indicator pad changes from yellow to purple, indicating a pass, if the active glutaraldehyde concentration in the solution being tested is greater than or equal to 1.75%.
The provided text describes a medical device called the ProChek® G Glutaraldehyde Concentration Level Indicator, but it does not contain the information needed to fill out most of the requested fields regarding acceptance criteria and a study proving the device meets those criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical or performance study with acceptance criteria. The "TESTING" section describes packaging permeability, not the device's functional performance in detecting glutaraldehyde.
Therefore, many fields below will be marked as "Not provided in the text".
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Indicator pad changes from yellow to purple if active glutaraldehyde concentration is ≥ 1.75%. | Indicator pad changes from yellow to purple, indicating a pass, if the active glutaraldehyde concentration in the solution being tested is greater than or equal to 1.75%. |
Note: The text states the device is a "1.5% minimum effective concentration (MEC) monitor" but that the indicator "changes from yellow to purple, indicating a pass, if the active glutaraldehyde concentration...is greater than or equal to 1.75%." This suggests the functional threshold for a "pass" is 1.75%, which aligns with the "reported performance" as described. The 1.5% MEC refers to the threshold for the glutaraldehyde solution itself to be considered effective, which the device monitors against. The device's performance is tied to its ability to accurately reflect reaching or exceeding a specific concentration.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided in the text. The "TESTING" section describes permeability testing of shipping containers, not performance testing of the indicator itself.
- Data provenance: Not provided in the text.
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)
- Not applicable as no performance study on the indicator itself is described. The "ground truth" for glutaraldehyde concentration would typically be established by chemical analysis, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no performance study on the indicator itself is described.
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-assisted diagnostic tool requiring human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a chemical indicator, not an algorithm. Its performance is inherent in its chemical reaction. The text implies the device's functionality is directly tied to the predicate device, which is also a chemical indicator.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The ground truth for the performance of such a device would typically be the actual chemical concentration of glutaraldehyde in a solution, determined by a recognized analytical method (e.g., titration, spectrophotometry). This information is not explicitly detailed in the provided text for the indicator's performance. The "TESTING" section only addresses packaging permeability.
8. The sample size for the training set
- Not applicable/Not provided in the text. This is a chemical indicator, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided in the text. This is a chemical indicator, 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).