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Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days.

The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.

The proposed pouches are constructed from Tyvek® / plastic films, with the STERRAD® Chemical Indicator printed onto the Tyvek® film. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.

The STERRAD® Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. STERRAD® Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to yellow (or lighter) when exposed to hydrogen peroxide.

The document provided describes a medical device, the "Tyvek® Pouch/Roll with STERRAD® Chemical Indicator," and its performance testing in comparison to a predicate device. This is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo clinical trial data as would be expected for novel devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• A sterility assurance level (SAL) of 10$^{-6}$ is demonstrated.
• Sterilant affects Chemical Indicator (CI) color change to endpoint (red to yellow or lighter) under suboptimal conditions. | Passed |
  | Chemical Indicator (CI) Functionality and Endpoint | CI changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing. The endpoint color is consistent with being processed. | Passed (Explicitly stated CI function in description and endpoint color stability in separate study) |
  | Package Integrity: Seal Strength | Seal strength performance characteristics are maintained for manufactured seal and user-made seal after STERRAD® processing. | Passed |
  | Package Integrity: Microbial Barrier | Contents of pouches are sterile when processed pouches are subjected to the microbial aerosol challenge test. | Passed |
  | Package Integrity: Burst | Ability to withstand internal pressurization is maintained after STERRAD® processing. | Passed |
  | Package Integrity: Peel Open | Peel open characteristics of the Tyvek® Pouch/Roll are maintained after STERRAD® processing. | Passed |
  | Maintenance of Package Integrity | Sterility is maintained in the Tyvek® Pouches/Rolls for 30 days after STERRAD® processing. | Passed |
  | Material Compatibility | Seal strength, microbial barrier properties, burst, and peel open characteristics are maintained after STERRAD® processing. (Tested to demonstrate material compatibility). | Passed |
  | End Point / Post Processing Color Stability | Tyvek® Pouches/Rolls, after STERRAD® processing, maintain the endpoint CI color reaction. | Passed |
  | Shelf Life: CI Functionality | CI functionality (color change from red to yellow or lighter) of processed Tyvek® Pouches/Rolls is verified at the end of shelf life. | Passed |
  | Shelf Life: Seal Strength | Seal strength of the processed Tyvek® Pouches/Rolls is verified at the end of shelf life. | Passed |
  | Biocompatibility | Pouch samples, after STERRAD® processing, meet acceptance criteria per ISO 10993-11 (Systemic Toxicity) and 10993-10 (Irritation and Skin Sensitization) (Implied acceptance criteria from ISO standards). | Passed |

2. Sample Size Used for the Test Set and Data Provenance

The document provides a summary of "nonclinical tests." While it lists various performance studies, it does not specify the sample sizes used for the test sets in these studies. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not explicitly stated, but since it's for a US FDA submission, it's presumed to be relevant to US regulatory standards. These are laboratory/engineering tests, not clinical studies with patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this involves chemical indicators and package integrity tests, the "ground truth" is established by the physical and chemical properties of the materials and the functionality of the device under test conditions, as measured by established laboratory methods. There is no mention of "experts" in the context of human interpretation or ground truth establishment for these types of performance tests, as one might find in an imaging AI study.

4. Adjudication Method for the Test Set

As the "ground truth" is determined by objective physical and chemical tests (e.g., color change, sterility assurance level, seal strength measurements), no adjudication method involving human interpretation (like 2+1 or 3+1 consensus) is applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was mentioned or performed. This device is a sterilization packaging system with a chemical indicator, not an AI-assisted diagnostic tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a physical product (pouch/roll with a chemical indicator), not an algorithm or software. The "performance" of the device itself (e.g., its color change, seal integrity) is what was tested.

7. The Type of Ground Truth Used

The ground truth for these tests is based on:

• Physical and Chemical Measurement Standards: Such as predefined sterilant concentrations, specific temperature/pressure conditions in sterilizers, and objective color change definitions for the chemical indicator.
• Microbiological Standards: Demonstrated sterility assurance level (SAL) of 10$^{-6}$.
• Mechanical Property Standards: For seal strength, burst, and peel-open tests (e.g., ISO or ASTM standards, though not explicitly cited beyond ISO 11140-1:2005 for the CI).
• Biocompatibility Standards: ISO 10993-10 and ISO 10993-11 for biological responses.

8. The Sample Size for the Training Set

This device does not involve machine learning or AI, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Since there is no training set, this question is not applicable.

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