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The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, semicritical, heat sensitive medical devices such as flexible endoscopes and their accessories.

The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor.

The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medically 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 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors.

The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels. Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to assess the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to reduce the risk of ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle.

The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The document describes the enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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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 > or equal to 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, Model P6800 is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical 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 1 endo Liquid Chemical Sterilant Processing System, Model P6900 is intended for liquid chemical sterilization of cleaned, immersible, and reusable 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 current submission is provided to describe modifications for:

• . Obsolescence and replacement of interface board and connector
• Obsolescence and replacement of silicone tubing ●
• S40 Sterilant Concentrate design modification ●

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, Model P6800 is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical 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 modifications for:

• Obsolescence and replacement of silicone tubing
• S40 Sterilant Concentrate design modification .

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. Following 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 processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.

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 SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 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 modifications for:

• Obsolescence and replacement of silicone tubing
• S40 Sterilant Concentrate design modification

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.

This document is a 510(k) Premarket Notification from STERIS Corporation to the FDA regarding several Liquid Chemical Sterilant Processing Systems. It's important to understand that this document describes a sterilization device, not an AI/ML-driven diagnostic or image analysis device. Therefore, many of the requested criteria related to AI/ML performance (e.g., sample size for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, ground truth for training data) are not applicable to this type of medical device submission.

The acceptance criteria provided are for the functional and physical performance of a chemical sterilant processing system and its associated sterilant, not for an AI model's diagnostic accuracy.

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

Device Description and Purpose:

The devices are the "SYSTEM 1E Liquid Chemical Sterilant Processing System," "SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800," and "SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900," along with the "S40 Sterilant Concentrate." These systems are intended for liquid chemical sterilization of cleaned, immersible, and reusable heat-sensitive medical devices (critical and semi-critical) in healthcare facilities. They utilize peracetic acid as the sterilant.

The submission is specifically for modifications to existing cleared devices (predicate K210737), primarily involving:

• Obsolescence and replacement of interface board and connector (for SYSTEM 1E)
• Obsolescence and replacement of silicone tubing (for all models)
• S40 Sterilant Concentrate design modification (for all models)

1. Table of Acceptance Criteria and Reported Device Performance

The tables below synthesize the acceptance criteria and the results as presented in the "Summary of verification activities" (Table 3 in each section of the document).

For SYSTEM 1E Liquid Chemical Sterilant Processing System (Page 15, Table 3)

For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800 (Page 25, Table 3)

For SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (Page 36, Table 3)

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

The document does not specify exact sample sizes (e.g., number of units tested, number of cycles performed) for the functional, reliability, EMC/EMI, form and fit, physical properties, stability, or delivery tests. It simply states "Functional testing," "Reliability testing," etc., and confirms the Pass result.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as these were laboratory-based engineering and performance tests for a sterilization device, not clinical data for an AI/ML diagnostic.

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

This criterion is not applicable. The "ground truth" for this device relates to its ability to function as a sterilizer and its components meeting engineering specifications. This is established through predefined performance requirements (e.g., UL standards for electrical safety, physical property equivalence, stability of sterilant), not through expert consensus on medical images or diagnoses. Validation would be performed by engineers and quality control personnel according to established test protocols.

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

This criterion is not applicable. Adjudication methods like 2+1 are used for resolving disagreements among human readers or between AI and human reads in diagnostic studies. For a sterilization device, test results are typically objective (e.g., does it pass/fail a function test, does it meet a physical specification).

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 criterion is not applicable. This is not an AI-assisted diagnostic device. No human readers or interpretations are involved in its primary function, which is sterilization.

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

This criterion is not applicable. This is not an algorithm, but a physical medical device.

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

The "ground truth" in this context refers to the engineering and performance specifications for the device and its components. These include:

• Predefined functional requirements (e.g., device operation, sterilant delivery).
• Compliance with recognized electrical safety and electromagnetic compatibility (EMC/EMI) standards (e.g., UL 61010-1, UL 61010-2-040).
• Physical properties matching existing components.
• Chemical stability of the sterilant.

For the basic germicidal efficacy of the sterilant mentioned in the predicate device comparison (Tables 2 on pages 11-13, 22-23, and 32-34), the ground truth for microbial efficacy (e.g., "Meets efficacy requirements," "Solution is bactericidal") would be established through laboratory microbiological testing (e.g., AOAC Official Methods, EPA Viricidal Testing), which involves culturing specific microorganisms and observing their reduction or elimination after exposure to the sterilant. This is not an AI/ML-related ground truth.

8. The sample size for the training set

This criterion is not applicable. This is not an AI/ML device; there is no "training set."

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

This criterion is not applicable. There is no AI/ML training set for this device. Ground truth for its performance is established through adherence to physical and chemical engineering specifications and established microbiological testing protocols.

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