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510(k) Data Aggregation
(139 days)
VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
The VERIFY® HPU Chemical Indicator is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units when placed within packs to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.
The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Class 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non-Lumen or Flexible sterilization cycle of a V-PRO® Low Temperature Sterilization System.
The VERIFY® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to a Lumen. Non-Lumen or Flexible Cycle in a V-PRO 1, V-PRO 1 Plus, V-PRO maX, or V-PRO 60 Low Temperature Sterilizer. When exposed to the defined processing conditions, the indicator exhibits a visible color change from magenta to yellow.
The VERIFY® V-PRO Chemical Indicator is provided as two formats:
- Version 1B: VERIFY® HPU Chemical Indicator .
- Version 2B: VERIFY® Vaporized VH2O2 Process Indicator Adhesive . Label
The Version 1B: VERIFY® HPU Chemical Indicator is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate.
The Version 2B: VERIFY® Vaporized | VH2O2 Process Indicator Adhesive Label is a Class 1 process indicator in accordance with ISO 11140-1:2005 which consists of the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.
Here's a summary of the acceptance criteria and the study details for the STERIS® VERIFY® V-PRO Chemical Indicator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test of 6 Lots | Acceptance Criteria (FAIL) | Acceptance Criteria (PASS) | Reported Device Performance | Study Result |
|---|---|---|---|---|
| Class 1 Performance Testing | 100% | ≥ 90% | Not explicitly stated | Pass |
| V-PRO 60 Simulated Use Testing in Lumen, Non Lumen, and Flexible Cycles | 100% | ≥ 90% | Not explicitly stated | Pass |
| V-PRO maX Simulated Use Testing in Lumen, Non-Lumen, and Flexible Cycles | 100% | ≥ 90% | Not explicitly stated | Pass |
Note: The "Reported Device Performance" column is not explicitly detailed with numerical percentages for each test in the provided text. The document states that the studies "confirm that the proposed device's performance meets the requirements of its pre-defined acceptance criteria." and "The results... demonstrate that both formats... perform as intended." which implies they met or exceeded the "PASS" criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Test of 6 Lots" for the performance testing. This indicates that at least 6 lots of the VERIFY® V-PRO Chemical Indicator were included in the testing.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. However, the manufacturing facility is in Leicester, United Kingdom, and the sponsor facility is in Mentor, OH, USA. The testing was conducted internally by STERIS Corporation. There is no information to suggest it was a retrospective study; it is implied to be a prospective verification study for premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not specify an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance
This section is not applicable. The device is a chemical indicator for sterilization processes, not an AI-assisted diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable as the device is a chemical indicator, not an algorithm or software. The "performance" of the device is its ability to change color when exposed to sterilization conditions, which is inherently a standalone function.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the performance testing is based on the objective physical/chemical change of the indicator in response to defined sterilization conditions. The acceptance criteria are tied to the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as defined in ANSI/AAMI/ISO 11140-1:2005. This standard dictates the expected color change (magenta to yellow) under specific conditions. Therefore, the ground truth is established by the physical and chemical properties of the indicator and its adherence to an established international standard.
8. The Sample Size for the Training Set
The document does not discuss any "training set" in the context of an AI/machine learning model. The device is a physical chemical indicator, not an AI or software device that would require training data.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as the device does not involve a "training set."
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