(26 days)
The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant.
The unprocessed enspire 3000 Chemical Indicator is blue. When exposed in the enspire 3000 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 color changes from the start to the pass color. See reference colors on the bottle.
The enspire 3000 Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. The product is manufactured by application of the indicator ink by screen printing to a substrate with the indicator ink printed thereon. A clear, sterilant-permeable polyether block amide laminate is adhesively bonded to the polypropylene strip following printing of the ink, completely covering the ink.
Modification for Which Clearance is Being Sought: There were no physical changes to the device and are no new indications for use. The labeling was modified to include an additional pass reference color and a gradient between the original and new pass reference colors to improve user interpretation of chemical indicator.
The provided FDA 510(k) Premarket Notification summary describes a Chemical Indicator for the enspire CLCSPS (LCC015). The device is substantially equivalent to a predicate device (K240032). The key difference is a modification to the labeling to include an additional pass reference color and a gradient to improve user interpretation.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Users performed all critical tasks successfully | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Users performed all critical tasks successfully" as the acceptance criteria for the Human Factors Study, and the result was "PASS". However, the sample size for the test set is not specified, nor is the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document mentions a "Human Factors Study" but does not specify the number of experts (users) involved in this study or their qualifications. The nature of the device (a chemical indicator for sterilization monitoring) suggests that "experts" in this context would likely be healthcare professionals or sterilization technicians who would use such indicators.
4. Adjudication Method for the Test Set
The document does not provide details on any specific adjudication method (e.g., 2+1, 3+1). For a human factors study, this would typically involve observing user performance and possibly qualitative feedback, rather than formal expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. The study described is a Human Factors Study related to user interpretation of the chemical indicator's color change, not a comparative effectiveness study with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This device is a physical chemical indicator, not an algorithm or AI. Therefore, the concept of "standalone performance (algorithm only without human-in-the-loop performance)" is not applicable. The device's function inherently involves human interpretation of a chemical reaction (color change).
7. Type of Ground Truth Used
For the Human Factors Study, the "ground truth" would implicitly be the correct interpretation of the chemical indicator's color change according to the established visual reference provided by the manufacturer. The acceptance criteria suggest that the ground truth was that users could correctly identify the "pass" condition based on the newly designed labeling.
8. Sample Size for the Training Set
Not applicable. This device is a physical chemical indicator, and there is no "training set" in the context of machine learning or algorithms. The device itself is designed based on known chemical reactions and visual communication principles. The human factors study evaluates the effectiveness of the labeling in conveying the correct interpretation to human users.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned for the device itself (it's a physical indicator), this question is not relevant. The ground truth for the performance evaluation (Human Factors Study) is the correct interpretation of the indicator's state as defined by the manufacturer's specified color reference for a "pass" condition.
§ 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).