(159 days)
The Verify® Challenge Packs are chemical indicator test packs intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicator sheet within the challenge pack changes color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle. The performance of the Verify® Challenge Packs meets the requirements of ANSI/AAMI / ISO 11140-1-2005 for emulating [Class 6] steam indicators.
The Verify® Challenge Packs are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify® 270F 4 | 270°F (132°C) | Pre-vacuum, Steam Flush | |
| Pressure Pulse (SFPP) | 4 minutes | ||
| Verify® 275F 3 | 275°F (135°C) | Pre-vacuum | 3 minutes |
The proposed Verify® Challenge Packs consist of an emulating indicator surrounded by a steam penetration barrier. The indicator ink inside the proposed Verify® Challenge Packs changes from yellow to blue/purple color when the steam sterilization cycle is complete.
- The Verify® 270°F 4 Challenge Pack can be used to monitor a 4 minute . 270°F/132°C Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
- The Verify® 275°F 3 Challenge Pack can be used to monitor a 3 minute ● 275°F/135°C pre-vacuum steam sterilization cycle.
The provided text describes the 510(k) summary for STERIS Verify® Steam Indicators (Challenge Packs). Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Verify® Challenge Packs are based on ISO 11140-1:2005 for emulating (Class 6) steam indicators. While specific numerical acceptance criteria (e.g., specific color change at a certain exposure) are not detailed within this summary, the general performance described is the color change from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle.
| Acceptance Criteria (Derived from ISO 11140-1:2005 for Class 6 Indicators - Emulating Indicators) | Reported Device Performance |
|---|---|
| Color change from initial state (yellow) to final state (blue/purple) at specified sterilization parameters (temperature, time, type). | "The indicator ink inside the proposed Verify® Challenge Packs changes from yellow to blue/purple color when the steam sterilization cycle is complete." |
| Ability to monitor specific sterilization cycles per model. | Verify® 270°F 4 Challenge Pack: Monitors a 4 minute, 270°F/132°C Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle. |
| Verify® 275°F 3 Challenge Pack: Monitors a 3 minute, 275°F/135°C pre-vacuum steam sterilization cycle. | |
| Efficacy of the barrier material in the challenge pack. | Demonstrated through testing using an AAMI 16 Towel Pack with biological indicators as references. (Specific performance results for the barrier are not detailed beyond "efficacy demonstrated"). |
| Meets the requirements for emulating [Class 6] steam indicators as defined in ANSI/AAMI / ISO 11140-1-2005. | "The performance of the Verify® Challenge Packs meets the requirements of ANSI/AAMI / ISO 11140-1-2005 for emulating [Class 6] steam indicators." |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Performance testing was conducted to verify that the proposed indicators...". It also notes "Further testing was conducted to demonstrate the efficacy of the barrier material using an AAMI 16 Towel Pack with biological indicators as references. Predicate test packs were included in this testing." The specific number of indicator packs or cycles used for testing is not provided.
- Data Provenance: The testing was conducted by STERIS Corporation. The location is not specified beyond "STERIS Corporation 5960 Heisley Road Mentor, OH 44060". It can be inferred to be prospective testing carried out for the purpose of this submission.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a chemical indicator, not a diagnostic device requiring expert interpretation of images or other subjective data. The ground truth for chemical indicators is typically established by physical/chemical changes (color change) observed under controlled sterilization conditions against established standards (ISO 11140-1:2005).
4. Adjudication Method for the Test Set
Not applicable. As described above, the function relies on a clear chemical reaction/color change.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a device where human interpretation and AI assistance are relevant.
6. Standalone (Algorithm Only) Performance
The entire performance assessment described is a "standalone" or "algorithm only" type, as the device itself is a self-contained chemical indicator. Its performance is evaluated based on its intrinsic chemical properties and response to sterilization conditions without human-in-the-loop performance influencing the primary chemical reaction.
7. Type of Ground Truth Used
The ground truth used is based on controlled exposure to defined sterilization parameters (temperature, time, pressure, steam presence) as per ANSI/AAMI ISO 11140-1:2005 standards for Class 6 indicators. This is an objective, standardized chemical and physical criterion, rather than subjective expert consensus, pathology, or outcomes data. Testing was conducted using a "prototype resistometer to ANSI/AAMI ISO 18472".
8. Sample Size for the Training Set
Not applicable. This device is a chemical indicator and does not involve AI or machine learning that would require a "training set" of data. Its performance is based on its chemical formulation and design.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is used 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).