Search Results

The Verify® Steam Indicators are emulating indicators intended for use in steam sterilization. The Verify® Steam Indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The indicator models and their cycle temperatures, types, and times are:

The Verify® 275F 3 Indicator is a chemical indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The Verify® 275F 3 Indicator is an emulating indicator intended for use in steam sterilization. The indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes as indicated in the following table:

The Verify® 275F Gravity Indicators are chemical integrators which meet ANSVAAMI 1140-1:2005 for emulating indicators intended for use in steam sterilization. The Verify® 275F Gravity Indicators change color from yellow to blue/purple when exposed to 275°F (135°C) and to the appropriate cycle type and duration. The Verify® 275F Indicators models and their cycle types and times are:

The Verify® Challenge Packs -Version 2 - 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:

There is a process indicator outside of the packs which undergoes a visual color change when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).

The Verify® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier, intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization for load release. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270°F (132°C):

• · 4 minute indicator SFPP and pre-vacuum steam sterilization for 4 minutes.
• · 10 minute indicator Pre-vacuum steam sterilization for 10 minutes.
• · 20 minute indicator Pre-vacuum steam sterilization for 20 minutes.

The Browne TST Dual Use Test Pack is a chemical sterilization process monitor that can be used as either:

• Bowie Dick Test in an empty chamber to monitor air removal and steam penetration during the vacuum stage of 132°C (270°F), 134°C (273°F), and 135 °C (275 °F) test cycles.
• Challenge Pack in a loaded chamber to monitor steam penetration during the hold/plateau stage of 132°C (270°F), 134 °C (273 °F), and 135 °C (275 °F) steam sterilization cycles.

The VERIFY® SixCess Chemical Indicators consist of a 22mm x 143 mm strip (long) (7/8" x 5.6") or a 22mm X 70 mm (short) polypropylene strip with a 12 mm circular chemical indicator ink spot (or two spots in the case of the 270°F 3-10 Indicator) located on one end, adjacent to a reference circle exhibiting the endpoint color. The indicator ink on the proposed VERIFY® Steam Indicators change from yellow to blue/purple color when the steam sterilization cycle is complete.

The Verify® 275F Indicator consist of: A 22 mm x 143 mm (long) or a 22mm X 70 mm (short) polypropylene strip with one 12 mm chemical indicator ink spot. The indicator ink spots are located on each end of the strip (or one end if it is just one ink spot), adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify® 275F Indicator changes from yellow to blue/purple color when the steam sterilization cycle is complete.

The Verify® 275F Gravity Indicators consist of: A 22 mm x 143 mm polypropylene strip with two 12 mm chemical indicator ink spots (for Verify® 275F 3-10 Indicator). A 22 mm x 143 mm (long) or a or a 22mm X 70 mm (short) polypropylene strip with one 12 mm chemical indicator ink spots (for Verify® 275F 10 Indicator). The indicator ink spots are located on each end of the strip (or one end if it is just one ink spot), adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify® 275F Gravity Indicators changes from yellow to blue/purple color when the steam sterilization cycle is complete.

The VERIFY® Challenge Packs Version 2 consists 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 process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).

The VERIFY® 270FP Challenge Pack, Model LCC019, consists of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier. The indicator inks on the proposed Verify® 270FP Challenge Pack test sheet change from yellow to blue/purple color when exposed to saturated steam at 270°F (132°C) for the following times. The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).

The TST Test Pack (models EQC009 and EQC010, VERIFY Bowie Dick Test Pack) consists of a chemical integrator surrounded by a steam penetration barrier. The indicator ink used for the Integrator Test Pack integrator is identical to the ink used for the TST Control Integrator for Steam Autoclave (K965154).

This document describes the premarket notification (510(k)) for VERIFY® Steam Indicators and related products. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a standalone study with acceptance criteria for a novel device.

The study presented here is an effectiveness comparison between the proposed devices with new REACh compliant inert components in the ink formulation and their predicate devices. The goal is to show that changing these inert components does not negatively impact the performance of the sterilization indicators.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a typical quantitative clinical trial sense (e.g., sensitivity/specificity thresholds). Instead, the acceptance criteria are implicitly that the proposed device must perform identically to the predicate device for all relevant performance tests. The "reported device performance" refers to the results of these comparative tests.

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

The document does not specify the sample size used for the tests (e.g., number of indicators tested in sterilizer runs).

The data provenance is retrospective in comparison to predicate devices. The testing was conducted by STERIS Corporation (Mentor, OH, USA), implying the data is from the United States. The study focuses on comparing the new formulation with existing, cleared formulations.

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

This type of device (chemical sterilization indicator) does not typically involve human expert evaluation for "ground truth" in the same way clinical imaging or diagnostics might. The "ground truth" is based on the physical and chemical response of the indicator to controlled sterilization conditions. Therefore, there were no "experts" in the sense of clinicians establishing ground truth by interpreting visual data. The performance is assessed against established ISO standards (ISO 11140) and comparison to predicate devices, which are objective measures.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is determined by objective physical and chemical properties and adherence to ISO standards, not by human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The VERIFY® Steam Indicators are chemical indicators for sterilization processes, where the "reading" (color change) is designed to be unambiguous and objective.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable to a chemical indicator. Chemical indicators are inherently "standalone" in their function; they change color based on exposure to sterilization parameters. There is no "algorithm" or software component. Their performance is their inherent physical-chemical reaction, without human intervention in the reaction itself. The "human-in-the-loop" is the interpretation of the color change, which is designed to be a clear qualitative assessment (yellow to blue/purple).

7. The Type of Ground Truth Used

The ground truth is established by:

• Controlled sterilization parameters: Exposure to specific temperature, time, and steam conditions in sterilizers and resistometers, against which the indicator's color change is measured.
• Objective performance criteria: Adherence to ISO 11140 requirements for Type 6 and Bowie Dick indicators, and demonstrating equivalent performance to previously cleared predicate devices under these controlled conditions. The expected color change (yellow to blue/purple) for successful sterilization is the ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical indicator, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The development of the indicator chemistry itself would involve experimentation and formulation, but not a "training set" like in AI/ML.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device