(105 days)
SteriTec CROSS-CHECKS Sterilization Process Indicators are a white to black chemical indicator strip that change color during steam or chemical vapor sterilization process. They are designed to be placed in each pack or package to be steam or chemical vapor sterilized, to indicate an item has been exposed to a steam or vapor process.
SteriTec CROSS-CHECKS Sterilization Process Indicators are a white to black chemical indicator strip that change color during steam or chemical vapor sterilization process.
This 510(k) submission (K955426) for the SteriTec CROSS-CHECKS chemical sterilization process indicator does not contain a detailed study proving the device meets specific acceptance criteria in the way a modern AI/software as a medical device (SaMD) submission would.
Instead, this submission relies entirely on a claim of substantial equivalence to a predicate device that was legally marketed prior to May 28, 1976. Therefore, many of the requested elements for a modern AI/SaMD study are not applicable or cannot be extracted from the provided text.
Here’s a breakdown based on the information provided and the nature of this type of submission:
Acceptance Criteria and Study for SteriTec CROSS-CHECKS (K955426)
Given the nature of a chemical process indicator and the age of this 510(k) submission, the "acceptance criteria" are implied by its function and comparison to a predicate device, rather than explicit performance metrics derived from a complex study as would be seen for AI/SaMD.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Changes color from white to black during steam or chemical vapor sterilization. | "white to black chemical indicator strip that change color during steam or chemical vapor sterilization process." |
| Indicates exposure to a steam or vapor process when placed in each pack/package. | "designed to be placed in each pack or package to be steam or chemical vapor sterilized, to indicate an item has been exposed to a steam or vapor process." |
| Performs in an equivalent safe and effective manner to the predicate device (ATI Sterilometer Steam Strip®). | "essentially equivalent in construction and operation to the predicate device... will perform in the same safe and effective manner, equivalent to the predicate device." |
| Ink composition is essentially the same as the predicate device, based on the Berman and Chaney patent (led sulfide reaction). | "composition of this ink is basically the same as the ink formulation described in patent number 2,118,144... uses this same formulation in the production of their Sterilometer Steam Strip® chemical indicator strip for steam." |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This submission relies on substantial equivalence and historical performance of the predicate. There is no mention of a specific test set or data collection for the SteriTec CROSS-CHECKS beyond its manufacturing and inherent chemical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. Ground truth, in the context of this device, is the visual color change indicating steam exposure, which is an inherent chemical property rather than an expert interpretation task.
4. Adjudication method for the test set
- Not Applicable / Not Provided. There is no mention of an adjudication process. The color change is a direct chemical reaction.
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 is a chemical process indicator, not an AI/SaMD device. No MRMC study was performed as there's no "human reader" interpreting AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical chemical indicator, not an algorithm.
7. The type of ground truth used
- The ground truth for this type of device is the actual exposure to sufficient steam/chemical vapor sterilization conditions, resulting in a visually observable chemical reaction (color change) on the indicator. This is an objective chemical phenomenon.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI/ML algorithm. The device's performance is driven by its constant chemical formulation and manufacturing process.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth establishment for one. The device's efficacy is based on the established chemical reaction and its equivalence to a predicate device that has been marketed for decades.
Summary of the "Study" Proving Acceptance Criteria:
The "study" in this 510(k) submission is effectively a detailed comparison to a predicate device and a reliance on the existing scientific understanding of the chemical reaction involved.
- Predicate Device: ATI Division of PyMah Corporation Sterilometer Steam Strip® (marketed prior to May 28, 1976).
- Basis of Equivalence:
- Similar Design, Composition, and Function: Explicitly stated as "similar in design, composition and function."
- Shared Chemical Principle: The ink formulation for both devices is based on the lead sulfide reaction described in the Berman and Chaney patent (1938).
- Minor Manufacturing Differences: The only noted differences are in the solvents used due to different printing processes (silk screen vs. rotogravure), but these solvents evaporate during manufacturing, leaving the active chemical components the same.
- "Essentially Equivalent" Conclusion: The submission concludes that the SteriTec CROSS-CHECKS is "essentially equivalent in construction and operation" to the predicate, and therefore "will perform in the same safe and effective manner."
In essence, the "proof" is that the SteriTec CROSS-CHECKS is a direct descendent and near-identical chemical twin to a long-established, legally marketed device whose safety and effectiveness for indicating sterilization exposure were implicitly accepted for decades. No new primary efficacy study was required or performed for this type of submission.
§ 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).