(10 days)
STERRAD® SealSure™ Chemical Indicator Tape is a process indicator intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization System.
The color of the STERRAD® SealSure™ Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen pcroxide and is intended to differentiate between processed and unprocessed loads. Reference the color comparator bars on the package box label.
STERRAD® SealSure™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD® Sterilization Systems. The STERRAD® Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low temperature sterilization of medical devices.
STERRAD® SealSure™ Chemical Indicator Tape is not intended to imply that sterilization has been achieved or to assure that the sterilization cycle has been completed. Rather, it provides a visual indication that hydrogen peroxide, an essential ingredient in the operation of the STERRAD® Sterilization Process, is present in the sterilization chamber.
STERRAD® SealSure™ Chemical Indicator Tape functions by means of a chemical reaction. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow. The gold (or lighter) STERRAD logos and chemical indicator square indicate that the load has been exposed to hydrogen peroxide.
Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The device is a chemical indicator tape, and the key performance aspects relate to its stability (shelf life) and adhesive properties. The document describes the acceptance criteria implicitly by stating what was tested and what the studies "support."
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Study Purpose) | Reported Device Performance (Supports/Confirms) |
|---|---|---|
| Unopened Package Shelf Life | The tape should maintain its color and functionality for the specified shelf life when unopened. | Supports an extension of the unopened package shelf life to 22 months. |
| Opened Package Shelf Life | The tape should maintain its color and functionality for the specified shelf life once opened. | Supports an extension of the opened package shelf life to 5 months. |
| Adhesion Strength (Preprocessing) | The tape should have adequate adhesive properties before processing. | Confirms adequate pre-processing adhesive properties to support an extension of the product to 22 months. |
| Adhesion Strength (Post-processing) | The tape should have adequate adhesive properties after processing (exposure to sterilization cycle). | Confirms adequate post-processing adhesive properties to support an extension of the product to 22 months. |
Study Information:
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of samples (e.g., rolls of tape, individual pieces of tape) used for the stability or adhesion studies. It only refers to "samples of SealSure Chemical Indicator Tape."
- Data Provenance: The studies were conducted by Advanced Sterilization Products (ASP), a division of Johnson & Johnson Medical, Inc. The exact country of origin of the data is not explicitly stated, but the company address is Irvine, California, suggesting the studies were likely conducted in the US. The studies are prospective, as they involve testing the product over time (shelf-life studies) and assessing its properties under controlled conditions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of device. The ground truth for chemical indicator tapes is typically established by physical/chemical properties (color change, adhesion strength) rather than expert interpretation of images or other subjective data. No experts are mentioned in this context.
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Adjudication method for the test set:
- Not applicable. Adjudication methods are typically used for subjective assessments (e.g., medical image interpretation) where multiple readers might have differing opinions. For physical/chemical properties like color change and adhesion, the assessment is typically objective and involves quantitative measurements against defined specifications.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging AI systems where human readers interpret cases. The STERRAD® SealSure™ Chemical Indicator Tape is a physical chemical indicator, not an AI system or device requiring human interpretation in a comparative reader study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical chemical indicator, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.
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The type of ground truth used:
- The ground truth is based on physical and chemical properties of the tape:
- Color and Functionality: The ability of the chemical indicator to undergo a recognizable color change from red to yellow (or gold/lighter) upon exposure to hydrogen peroxide. This is an objective, observable chemical reaction.
- Adhesion Strength: Measured physical properties of the tape's adhesive, likely against predefined specifications for tack, peel strength, etc.
- The ground truth is based on physical and chemical properties of the tape:
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The sample size for the training set:
- Not applicable. This device is a physical chemical indicator tape, not a machine learning or AI model. Therefore, there is no "training set" in the context of data used to train an algorithm. The product development process would have involved formulation and manufacturing process development, but not algorithm training.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 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).