(378 days)
The Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is intended for qualification testing of the Amsco V-PRO™ 1 Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty V-PRO 1 Sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of the V-PRO 1 Sterilizer. It has been tested and validated solely for use in periodic testing of the V-PRO 1 Sterilizer.
The Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes is used by healthcare providers for periodic qualification testing of the Amsco® V-PROM 1 Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs. It is designed to be placed into an otherwise empty chamber.
The user places the Verify Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes into the Amsco V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the Verify Vaporized VH2O2 Process Indicator (CI) and the Verify® Self-Contained Biological Indicator for Vaporized VH2O2 Sterilization Processes (SCBI) contained in the challenge pack are retrieved. The CI is accessed for a passing color change immediately. The results of the CI, a class 1 indicator, do not provide proof of Sterilizer qualification. The SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS Verify SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.
The activated SCBI is incubated at 55 - 60 ℃. The SCBI indicates a pass if the media remains purple and non-turbid. The SCBI indicates a failure if the media changes from purple to yellow and/or if the media is turbid. The V-PRO 1 Sterilizer passes qualification testing when three Challenge Pack SCBIs, processed in separate sterilization cycles, signal sterile results.
The provided text describes the "Verify® Biological Indicator Challenge Pack for Vaporized VH2O2 Sterilization Processes" and its 510(k) submission, K073618. However, it does not contain the specific details about the acceptance criteria and the study results that would typically be described in a performance study section to prove the device meets these criteria.
The document states the device's intended use and describes its components and how it is used to qualify an Amsco V-PRO 1 Low Temperature Sterilization System. It also mentions that "The SCBI indicates a pass if the media remains purple and non-turbid. The SCBI indicates a failure if the media changes from purple to yellow and/or if the media is turbid." and "The V-PRO 1 Sterilizer passes qualification testing when three Challenge Pack SCBIs, processed in separate sterilization cycles, signal sterile results." These statements define how the device functions and what constitutes a "pass" for the sterilizer qualification, but not acceptance criteria for the device itself or the results of a study demonstrating the device meets those criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study typically applies to interpretation by human readers, which is not directly relevant to a biological indicator's function.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This is not an AI device.
- The type of ground truth used: For a biological indicator, the ground truth would typically be the known sterility status of the sterilization cycle, which is inferred, but the text doesn't describe the methodology for establishing this ground truth for the device's validation.
- The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
The document mainly focuses on the device description, its intended use, its predicate device, and the FDA's 510(k) clearance letter. It lacks the detailed performance study data requested.
§ 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).