(72 days)
The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer and can be used in conjunction with a integrator test pack.
The SPSmedical SporView® Steam Bl Test Pack consists of a SporView® steam biological indicator placed inside a package of porous and non-porous material. The SPSmedical SporVlew® Steam Bl Test Pack is designed to create a significant challenge to air removal and steam penetration.
Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the SPSmedical SporView® Steam BI Test Pack:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly linked to the performance of the predicate device, the AAMI biological indicator test pack. The study aims to demonstrate equivalence, meaning the new device should perform similarly.
| Acceptance Criterion (Implicit) | Reported Device Performance (SPSmedical SporView® Steam BI Test Pack) |
|---|---|
| Equivalence to AAMI biological indicator test pack for: | |
| * Routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time. | The SPSmedical SporView® Steam BI Pack consistently showed results comparable to the AAMI biological indicator test pack for both pass and failure sterilization testing. The device provides a sufficient load challenge to monitor these cycles. |
| * Prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer. | The SPSmedical SporView® Steam BI Pack consistently showed results comparable to the AAMI biological indicator test pack for both pass and failure sterilization testing. The device provides a sufficient load challenge to monitor these cycles. |
| Ability to create a significant challenge to air removal and steam penetration. | The SPSmedical SporView® Steam BI Test Pack is designed to create a significant challenge to air removal and steam penetration. It adds resistance and impedes steam penetration to the SporView® steam biological indicator located within the pack. This provides a significant challenge to the steam sterilization process. |
| Effective and reliable, single use device. | The study concludes that the SPSmedical SporView® Steam BI Pack is an effective and reliable, single use device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 210 sterilization tests were conducted.
- 60 comparison tests for failures were orchestrated.
- 90 comparison tests for pass/failures were orchestrated (this phrasing is ambiguous, likely meaning situations where both pass and failure results were anticipated/orchestrated for comparison).
- 60 tests for passing results were orchestrated.
- Data Provenance: The document does not explicitly state the country of origin. Given the submitter (SPSmedical Supply Corp.) is located in the U.S.A. (Rush, NY), it's highly probable the testing was conducted in the United States. The study appears to be a prospective comparison study designed to test the new device against a known standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" here is the biological indicator's response (growth or no growth) to sterilization processes, and the performance of the predicate device (AAMI biological indicator test pack). The text doesn't mention expert review for establishing this ground truth, as it's typically based on established protocols for biological indicator performance.
4. Adjudication Method for the Test Set
This information is not provided and is likely not applicable in the context of biological indicator testing. The "truth" of a pass or fail is determined by the growth/no growth of the biological indicator, not by expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with medical imaging or diagnostic devices where human interpretation plays a significant role. This study focuses on the objective performance of a physical test pack.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, this was a standalone performance study. The device (SPSmedical SporView® Steam BI Test Pack) was tested in a standalone manner against the predicate device (AAMI biological indicator test pack) within sterilization cycles. There is no human-in-the-loop component for the device's function or interpretation beyond reading the biological indicator's result (which is a standard practice).
7. The Type of Ground Truth Used
The ground truth used was the performance of a legally marketed predicate device (AAMI biological indicator test pack) and the biological response (growth/no growth of Geobacillus stearothermophilus spores) to varying sterilization conditions. This is essentially a reference standard comparison.
8. The Sample Size for the Training Set
This information is not applicable as this device is a physical biological indicator test pack, not an AI/machine learning algorithm that requires a training set. The study describes comparison testing, not a model training process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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).