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The BioGuard Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The BioGuard Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.

The BioGuard Air/Water Valve and the BioGuard Suction Valve are accessories to an endoscope. The Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel and also controls water used to wash the lens of the endoscope. The Suction valve allows the user to control suction through the scope's accessory channel. The valves are sterile, single-use, disposable devices.

The Air/Water valve consists of a snap cap, stem, gaskets, spring and valve base (skirt and endcap).

The Suction valve consists of a stem, spring and valve base (skirt and endcap).

This document, K203630, is a 510(k) premarket notification for a modification to the STERIS BioGuard Air/Water and Suction Valves. It's a "Special 510(k)" because the modification (adding glue to a component of the air/water valve) is minor and doesn't significantly alter the device's fundamental technology or indications for use.

Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria (especially regarding AI/human interaction, ground truth establishment, training sets, etc.) is not applicable to this type of medical device submission. This submission is for physical, disposable valves, not a diagnostic or AI-driven system.

The study presented here is a pre-clinical performance test, specifically to confirm the safety and effectiveness of the modification to the device (adding glue) and ensure it doesn't negatively impact the device's intended function.

Here's a breakdown of the relevant information provided in the document concerning the device's technical performance:

Acceptance Criteria and Device Performance (for the modification):

The document describes non-clinical performance testing conducted to ensure the safety and effectiveness of adding glue to the air/water valve stem.

Study That Proves the Device Meets Acceptance Criteria:

This was a non-clinical performance test focused on the specific design change.

1. Sample Size: Not explicitly stated for each test, but standard engineering validation would involve a statistically relevant number of samples for torque and cycling tests.
2. Data Provenance: This is internal company testing, likely conducted at STERIS's facilities. The location (Mentor, OH, USA) is provided for the company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is mechanical/physical testing, not an interpretative diagnostic study requiring expert consensus for ground truth. The "ground truth" here is the physical performance of the valve against engineering specifications.
4. Adjudication method: Not applicable. These are quantitative mechanical tests, not subjective interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an algorithm.
7. The type of ground truth used: Engineering specifications and performance standards for mechanical durability and functionality (e.g., specific torque values, successful completion of cycle tests).
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

Summary of the document's relevance:

The document describes a Special 510(k) for a physical medical device (endoscope valves), where the primary evidence of safety and effectiveness for a minor modification is through non-clinical bench testing to ensure mechanical integrity and functionality. It does not involve complex clinical studies, AI algorithms, or human reader performance assessments. The "acceptance criteria" are therefore engineering and performance specifications pertinent to the device's mechanical function.

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The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.

The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

• The extensive treatment of EPA potable water consists of:

• 1. Pre-filtration through two pre-filters:
  • · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
  • · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.

2. UV Irradiation:

• During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
• 3. 0.1 micron filtration:
  • · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.

The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Seven Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for a proprietary component of S40 Sterilant Concentrate.

The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.

The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe the addition of a second supplier for of a proprietary component of S40 Sterilant Concentrate.

The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage.

The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The provided document is a 510(k) Pre-Market Notification for the SYSTEM 1E Liquid Chemical Sterilant Processing System (K190104) and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System (K190104). This submission describes modifications to the S40 Sterilant Concentrate used with these systems, specifically the addition of a second supplier for a proprietary component of the concentrate.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (K180342 for SYSTEM 1E and K173256 for SYSTEM 1 endo). As such, the studies described are verification tests for the modified component of the sterilant rather than a full stand-alone performance study of the entire device.

Here's the breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For S40 Sterilant Concentrate with alternate source of a proprietary component:

Study Details:

The document clearly states that "New testing was performed to evaluate the modified device," specifically referring to the change in the supplier for a component of the S40 Sterilant Concentrate. The provided tables are comparison tables with predicate devices, indicating that the overall system performance (effectiveness as a sterilant) for the proposed device is considered "identical" to the predicate devices which had already demonstrated efficacy through extensive testing. The new testing is therefore focused on verifying that the change in sterilant component supplier does not negatively impact the established performance.

For the Biocompatibility and Stability Tests (Table 3 on pages 16 and 28):

2. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample size for the biocompatibility or stability tests regarding the alternate component.
   • Data Provenance: The studies were "new testing" performed to evaluate the modified device, implying prospective testing for this specific change. The country of origin for the data is not specified, but the submission is to the US FDA, so it's likely part of US-based regulatory activities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as these are laboratory-based physical/chemical/biological tests rather than expert interpretation of medical images or clinical data.

4. Adjudication method for the test set:

   • Not applicable; these are objective laboratory tests with pre-defined pass/fail criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a liquid chemical sterilizer, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a medical device for sterilization, not an algorithm. The "standalone" performance is implied by the "Pass" results of the biocompatibility and stability tests of the sterilant itself. The overall sterilization efficacy of the SYSTEM 1E and SYSTEM 1 endo Processors using S40 Sterilant is established through prior predicate device clearances and the underlying efficacy claims of the sterilant (e.g., sporicidal, fungicidal, bactericidal, virucidal, tuberculocidal activity, and simulated-use tests, summarised in the comparison tables as "Meets efficacy requirements").

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the new tests: The ground truth is laboratory-determined objective measurements against pre-defined regulatory and performance standards for biocompatibility (non-cytotoxicity) and chemical stability.
   • For the overall device's sterilization efficacy (as implied by the identical comparison with predicate devices): This would have been established through a combination of in vitro microbiological assays (e.g., AOAC methods for sporicidal, fungicidal, bactericidal activity), in vitro virucidal testing (EPA method), simulated-use tests, and clinical in-use studies. The references to specific methods (e.g., AOAC Official Method 966.04) indicate standardized laboratory protocols are the ground truth.

8. The sample size for the training set:

   • Not applicable in the context of this 510(k) submission, as it's not an AI/machine learning device.

9. How the ground truth for the training set was established:

   • Not applicable.

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The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

A version of the Celerity™ HP Chemical Indicator (CI) may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.

The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:

• . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology.

A version of the Celerity™ HP Chemical Indicator may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:

• Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle . of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology

The CI is composed of the following components:

• Substrate ●
• Indicator Ink

The PI is composed of the following components

• Substrate
• Indicator Ink
• Adhesive ●
• Backing Paper

This document describes the Celerity™ HP Chemical Indicator (CI), a Type 1 vaporized hydrogen peroxide sterilization process indicator. The device is designed to distinguish between processed and unprocessed units through a visible color change from red to orange/yellow when exposed to specific sterilization cycles of V-PRO® Low Temperature Sterilization Systems and ASP® STERRAD® Systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, it implies that the testing was conducted by STERIS Corporation or its subsidiary Albert Browne Ltd., located in the United Kingdom. Given the nature of chemical indicator testing, it is likely that the testing involved multiple samples for each stress/condition investigated. The studies are non-clinical performance data, implying these were laboratory-based experiments.

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

This information is not applicable to a chemical indicator device. The "ground truth" for chemical indicators is based on whether the indicator changes color in response to specific sterilization parameters (e.g., presence of hydrogen peroxide) and according to established international standards (ANSI/AAMI/ISO 11140-1:2014). This is a physical or chemical reaction, not a subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The color change of a chemical indicator is a direct, observable outcome, not subject to human adjudication in the same way as, for example, image interpretation. The "adjudication" is essentially a pass/fail determination based on the observable color change as per the device's design and specified standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for devices that rely on human interpretation, such as imaging AI algorithms, to assess the impact of the device on reader performance. Chemical indicators do not involve human interpretation in this manner.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance tests of the chemical indicator itself. The device is a "Type 1 process indicator," meaning it provides a visual confirmation of exposure to the sterilization process. Its function is entirely automated in terms of its chemical reaction to sterilization conditions; there is no "human-in-the-loop" performance aspect in the mechanism of the indicator itself. Its performance is assessed purely on its ability to change color accurately under specified conditions.

7. The Type of Ground Truth Used

The ground truth used for this chemical indicator's performance evaluation is based on controlled exposure to validated sterilization cycles and conformance to established international standards (ANSI/AAMI/ISO 11140-1:2014). The expected color change (red to orange/yellow) when exposed to these conditions, and the lack of change when not exposed, constitutes the ground truth.

8. The Sample Size for the Training Set

No training set is mentioned or applicable. Chemical indicators operate based on chemical reactions; they do not involve machine learning algorithms that require training data.

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

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

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Flexible, Fast and Fast Non Lumen Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s 2 Sterilizers

· STERRAD® 100S Sterilizer (default cycle)

• STERRAD® 200 Sterilizer (default cycle)

· Standard and Advanced Cycles of the STERRAD® NX Sterilizers with All Clear Technology

· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizers with All Clear technology

The VERIFY V24 BI Challenge Pack is intended for qualification testing of the V PRO 1 Plus, VPRO maX, V-PRO maX 2, V-PRO 60 and V PRO s 2 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer. The user places the VERIFY V24 SCBI into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, 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 activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included. The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and 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 activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

Here's a breakdown of the acceptance criteria and study information for the VERIFY V24 Self-Contained Biological Indicator and VERIFY V24 Biological Indicator Challenge Pack, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the document presents separate acceptance criteria and testing for the "Self-Contained Biological Indicator (SCBI)" and the "Challenge Pack."

For the VERIFY V24 Self-Contained Biological Indicator (SCBI):

For the VERIFY V24 Biological Indicator Challenge Pack:

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

The document does not explicitly state the numerical sample size used for the test set in any of the studies. It refers to "All test SCBIs" and "All processed SCBIs" without providing a count.

The data provenance is not specified beyond being "nonclinical tests" and "performance testing to demonstrate substantial equivalence to the predicate." There is no mention of country of origin or whether the studies were retrospective or prospective.

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 document describes tests related to the biological and chemical indicators themselves and their performance in sterilization cycles, not a diagnostic or interpretive task that would typically involve human expert adjudication for ground truth.

4. Adjudication Method for the Test Set

This information is not provided as the tests described are objective measures of biological indicator performance (e.g., growth/no growth, color change, spore population) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. The device described (Biological Indicator and Challenge Pack) is a sterilization process indicator, not an AI or imaging device that would typically be involved in human-in-the-loop diagnostic tasks or benefit from a reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a physical biological indicator, not an algorithm. Its performance is evaluated through laboratory and simulated use testing.

7. The Type of Ground Truth Used

The ground truth for the performance tests appears to be based on:

• Biological viability: Growth or lack thereof of Geobacillus stearothermophilus spores after exposure to sterilization cycles, as determined by a color change in the growth medium.
• Established physical and chemical properties: D-value, survival time, kill time, and viable spore population are laboratory-measured physical characteristics against established standards.
• Chemical indicator color change: A visible, objective change in color on the indicator.
• Comparative resistance: The challenge pack's resistance compared to a "worst case biological model."

Essentially, the "ground truth" is defined by the expected biological or chemical response to a sterilization process.

8. The Sample Size for the Training Set

This is not applicable. There is no concept of a "training set" for a biological indicator. The tests described are performance and validation tests, not machine learning model training.

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

This is not applicable as there is no training set for this type of device.

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The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization a biological indicator, integrating indicator or both a biological and integrating indicator from the following list.

• · 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
• · 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
• Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
• · Celerity 20 Steam Biological Indicator
• · VERIFY STEAM Integrating Indicator
• · VERIFY SixCess MF4 STEAM Emulating Indicator

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator.

The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°P/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack.

The VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly with a Celerity 20 STEAM Biological Indicator and a Celerity 10 STEAM Chemical Indicator can be used for routine monitoring of 10minute 270°F/132°C dynamic air removal steam sterilization cycles. The sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

The VERIFY All-in-One STEAM Reusable Test Pack consists of a reusable aluminum tube with a tortuous path challenge for air removal and steam penetration. The VERIFY All-in-One STEAM Reusable Test Pack will be used with the Celerity Xtend 10 Assembly containing the Celerity 20 STEAM Biological Indicator and the Celerity 10 STEAM Chemical Indicator.

The Celerity Xtend 10 Assembly consists of a tube and cap design, comprised of one (1) polypropylene tube and one (1) silicone rubber cap containing one (1) Celerity 20 STEAM Biological Indicator and one (1) Celerity 10 STEAM Chemical Indicator and can only be used with the VERIFY A11-in-One STEAM Reusable Test Pack. The Celerity Xtend 10 Assembly has a tamper evident seal that will be broken once the assembly has been opened after use. A broken tamper evident seal will indicate to the user that it cannot be reused. The Celerity Xtend 10 Assembly is a single use device used for routine monitoring of 10-minute 270°F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

The Celerity 20 STEAM Biological Indicator monitors the critical parameters of steam sterilization cycles by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity STEAM Incubator, in 20 minutes to confirm viability of the biological indicator at the end of a steam sterilization process. Both the Celerity 20 STEAM Biological Indicator has been cleared under K173634 and K181429 and the Incubator has been cleared under K173670.

The Celerity 10 STEAM Chemical Indicator is a single-use device used to monitor a 10-minute 270°F/132°C dynamic air removal steam sterilization cycle and is subject of a concurrent premarket notification.

Here's a breakdown of the acceptance criteria and study information for the VERIFY All-In-One STEAM Reusable Test Pack, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for the "Simulated Use" and "Celerity Xtend 10 Assembly in pack vs Celerity Xtend 10 Assembly outside of pack" tests. The data provenance (country of origin, retrospective/prospective) is also not specified.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. This type of information is usually relevant for studies involving subjective human interpretation (e.g., image analysis), which is not the primary focus of this device (a sterilization process indicator).

4. Adjudication Method for the Test Set:

The document does not mention an adjudication method for the test set. Given the nature of the device (a pass/fail indicator for sterilization), an adjudication method relying on multiple human readers is typically not applicable. The “ground truth” for effectiveness of sterilization indicators is typically objective, based on microbiological culture or physical/chemical changes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is a sterilization process indicator and does not involve AI assistance or human reader interpretation in the context of diagnostic decision-making.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

The performance studies described ("Simulated Use" and "Celerity Xtend 10 Assembly in pack vs Celerity Xtend 10 Assembly outside of pack") appear to be evaluating the standalone performance of the device (the VERIFY All-In-One STEAM Reusable Test Pack in conjunction with its indicators). The "pass" conclusions suggest acceptable standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For sterilization indicators like this device, the ground truth is typically based on:

• Microbiological Culture: For biological indicators (BI), "pass" means the BI did not grow microorganisms after sterilization, indicating effective sterilization. "Fail" means growth, indicating ineffective sterilization.
• Physical/Chemical Changes: For chemical indicators (CI) like the Celerity 10 STEAM Chemical Indicator, the ground truth is based on a specific, observable color change (e.g., yellow to blue/purple) which correlates with exposure to critical sterilization parameters.
• Reference Standards: Comparison against established and validated sterilization process challenges (e.g., ANSI/AAMI/ISO standards for temperature differences or air removal efficiency).

The document mentions "conditions are met and proper vacuum is achieved" and "2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature," suggesting a ground truth based on physical parameters validated against international standards for sterilization and microbiological efficacy.

8. The Sample Size for the Training Set:

The document does not provide information about a "training set" in the context of machine learning or AI. This device is a physical indicator system, not an AI/algorithm-based device that would typically use a training set. The development of such devices relies on engineering, material science, and microbiology, with validation studies rather than training sets.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no mention of a training set for this device.

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The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.

The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.

The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

• The extensive treatment of EPA potable water consists of:

• 1. Pre-filtration through two pre-filters:
  • · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants.
  • · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron.
• 2. UV Irradiation:
  • · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
• 3.0.1 micron filtration:

· The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Six Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for bacterial retentive water filter, referred to in labeling as the MaxPure filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule.

The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.

The provided text is a 510(k) Summary for a medical device called the "SYSTEM 1E Liquid Chemical Sterilant Processing System." This summary primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data as one might find for a novel device. The modifications described are mainly about alternative suppliers for components and an alternative resin for the sterilant capsule, not changes to the core functionality or claims.

However, I can extract the information related to the acceptance criteria and the type of study that demonstrates the device meets these criteria, based on the provided "Summary of verification activities."

Here's the breakdown:

Acceptance Criteria and Device Performance

Study Details

The provided document describes verification activities rather than a full-fledged clinical study or comparative effectiveness study as would be typical for a device with clinical efficacy claims. The purpose of these activities is to ensure that the modifications (alternate suppliers for filters and sterilant capsule resin) do not negatively impact the device's established safety and effectiveness.

1. Sample size used for the test set and the data provenance:

   • MaxPure Filter alternate supplier: "Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-months use life." The exact number of cycles or filters tested is not specified.
   • MaxPure Filter microbial retention challenge: Similar to above, "following the accumulation of liquid chemical sterilization cycles and diagnostic cycles representing 3 months use." The exact number of filters or challenges is not specified. The test was based on ASTM F838-15, which is a standard in vitro test method.
   • Pre-filter A and B alternate supplier: "Accumulation of successful liquid chemical sterilization cycles and diagnostic cycles to represent the filter's 3-month use life." The exact number of cycles or filters tested is not specified.
   • S40 Sterilant Concentrate Acid (alternate resin for capsule): "Evaluation of the concentration of peracetic acid over the shelf life." The specific number of samples or duration of testing is not provided.
   • Capsule Alternate Resin and Supplier: "Physical evaluation of compatibility of the alternate resin with container contents." The specific number of units or tests is not provided.
   • Data Provenance: The document does not explicitly state the country of origin of the data. Given it's a submission to the U.S. FDA, it is presumed to be from studies conducted under applicable U.S. or international standards, likely at the manufacturer's facility or accredited labs. All studies appear to be retrospective for these verification activities, as they are testing components of an already-cleared device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable to the type of studies described. These are engineering and microbiological verification tests, not diagnostic studies requiring expert human interpretation for ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This is not applicable as these are technical verification tests, not studies with human interpretation requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not applicable. The device is a liquid chemical sterilant processing system, not an AI-powered diagnostic or imaging device used by human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is not applicable, as the device is not an algorithm or AI system. Its performance is inherent in its physical and chemical processes.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the filter integrity challenge, the ground truth would be the direct measurement of microbial retention (e.g., log reduction of bacteria) using standard microbiological methods (ASTM F838-15).
   • For sterilant concentration, the ground truth is the chemical assay of peracetic acid.
   • For material compatibility, the ground truth is physical observation and testing of material integrity and interaction with contents.
   • The "type of ground truth" here refers to established physical, chemical, and microbiological standards and measurements, not clinical expert consensus or pathology.

7. The sample size for the training set:

   • This is not applicable, as this device does not use machine learning or AI algorithms that require a "training set."

8. How the ground truth for the training set was established:

   • This is not applicable, as no training set is mentioned or implied for this device.

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizers and cycles:

• · Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers
• · Standard Cycle of the STERRAD® 100S Sterilizer
• · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
• · Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer

The VERIFY V24 Challenge Pack is intended for qualification testing of the V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY V24 Self-Contained Biological Indicator 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 VERIFY V24 Self-Contained Biological Indicator is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the VERIFY V24 Self-Contained Biological Indicator vial and releases the growth media.

The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The VERIFY V24 Self-Contained Biological Indicator indicates a pass if the media remains orange and non-turbid. The VERIFY V24 Self-Contained Biological Indicator indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included.

The user places the VERIFY V24 Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and 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°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

This document describes the acceptance criteria and study proving the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Challenge Pack meet these criteria.

VERIFY® V24 Self-Contained Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance:

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