(230 days)
SteriTec Bowie-Dick Mini Pak is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "SteriTec Bowie-Dick Mini Pak, Model No. BD 115." It is not a study report or clinical trial. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study methodology, sample sizes, ground truth establishment, or expert involvement for AI device evaluation.
The letter simply states that the FDA has reviewed the manufacturer's premarket notification and determined that the device is "substantially equivalent" to a legally marketed predicate device.
However, based on the "Indications for Use" section, we can infer the intended performance and what would constitute "acceptance" for the device's function:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from "Indications for Use") | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Detects residual air: The device is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132° C for 3.5 minutes. | The device is considered "substantially equivalent" to predicate devices, implying it effectively detects residual air under the specified conditions. Its performance is expected to be comparable to these legally marketed devices. |
| Uniform color change (purple to green) when proper sterilization conditions met and no air present: Under proper sterilization conditions (132° C for 3.5 minutes) and absence of residual air, the indicator will show a uniform color change from purple to green. | The device is expected to consistently demonstrate a uniform color change from purple to green when proper sterilization conditions are met and no air is present. The FDA clearance suggests this functionality has been demonstrated. |
| Non-uniform color change if sufficient air present: If enough air is present to create a 2° C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change. | The device is expected to reliably demonstrate a non-uniform color change when sufficient residual air (creating a ≥2°C temperature difference in a standard Bowie-Dick test pack) is present. The FDA clearance suggests this functionality has been demonstrated. |
The remaining information requested (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set specifics) cannot be provided from this document because:
- This is a regulatory clearance, not a scientific study report.
- The device is a chemical indicator (Bowie-Dick Mini Pak), not an AI-powered device, so concepts like "test set," "training set," "ground truth," "experts for ground truth," "MRMC study," or "AI assistance" are not applicable in this context. The "ground truth" for this type of device is the physical condition of the sterilization cycle (presence/absence of air, correct temperature/time).
- The "study" referenced in K024293 would primarily involve laboratory testing to demonstrate the chemical indicator's color change properties under various controlled conditions (e.g., proper sterilization, partial air removal, significant air presence) and comparison to a predicate device, rather than a clinical trial with human readers or image interpretation.
§ 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).