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510(k) Data Aggregation
(88 days)
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
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use Testing - Cleaning | Worst-case devices were soiled and processed in triplicate using the cleaning phase, then examined visually and sampled for quantitation of two soil markers: protein < 6.4 µg/cm² and TOC < 12 µg/cm². | PASS |
| Simulated Use Testing - LCS | Worst-case devices were inoculated with Geobacillus stearothermophilus in triplicate trials and processed using the LCS phase, then sampled to demonstrate no growth of organisms. | PASS |
| Simulated Use Testing - Duodenoscopes | Worst-case devices were inoculated with Geobacillus stearothermophilus in triplicate trials and processed using an abbreviated LCS phase (2.5-minute), then sampled to demonstrate no growth of organisms. | PASS |
| In Use Testing - Cleaning | Clinically used devices were placed into the enspire 3000 processor and exposed to a full processing cycle. At the end of the cycle, the devices were examined visually and sampled for quantitation of two soil markers: protein < 6.4 µg/cm² and TOC < 12 µg/cm². | PASS |
| In Use Testing - Liquid Chemical Sterilization | Clinically used devices were placed into the enspire 3000 processor and exposed to a full processing cycle. At the end of the cycle, the devices were sampled to demonstrate no growth of organisms. | PASS |
| Rinsing Efficacy | A representative endoscope was exposed to multiple processing cycles and extracted per ISO 10993-12. The device extracts were analyzed to verify chemical residual levels were below the highest acceptable levels. | PASS |
| Biocompatibility | Based on results of toxicological review per ISO 10993-1, representative endoscopes were exposed to multiple processing cycles and extracted per ISO 10993-12. The device extracts were tested for cytotoxicity per ISO 10993-5 to verify that the device extracts were non-cytotoxic. | PASS |
| Material Compatibility | Representative devices were exposed to multiple processing cycles and evaluated for physical changes to demonstrate material compatibility with the process and chemistries used. | PASS |
| Effects of Detergent on S40 | Demonstrates that residual Revital-Ox detergent does not impact the concentration or pH of the S40 use dilution during a cycle. | PASS |
| Thermometric Testing | Thermocouples placed throughout basin, sump and processed instruments to demonstrate cycle temperature is maintained at required values. | PASS |
| Human Factors | Typical users were capable of following written instructions for use to correctly load devices into the enspire 3000 processor, attach Max Flow Connectors, insert sterilant and accessories, and successfully run the processing cycle. In addition, Service Technicians were capable of following installation and maintenance instructions for the enspire 3000 processor. | PASS |
| Electrical Safety Conformance | Meets requirements per: UL 61010-1, IEC 61010-2-040:2020, IEC 60601-1-2. | PASS |
| Software Validation | Meets requirements per: IEC 62304:2006/A1:2016. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Simulated Use Testing (Cleaning, LCS, Duodenoscopes): Worst-case devices were processed in triplicate trials for each test.
- In Use Testing (Cleaning, Liquid Chemical Sterilization): Clinically used devices were tested, but no specific count is provided.
- Rinsing Efficacy, Biocompatibility, Material Compatibility: Representative endoscopes/devices were exposed to multiple processing cycles. No specific number for the test set is provided beyond "representative" and "multiple."
The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond the "in use testing" referring to "clinically used devices," which generally implies prospective collection if part of a study, but no further detail is available.
3. Number of Experts Used to Establish the 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. The tests described are primarily functional and microbiological endpoint assessments, not requiring expert human interpretation of images or other qualitative data in the same way as, for example, a medical imaging AI study.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements (e.g., chemical residual levels, microbial growth, physical changes, temperature readings, electrical safety, software requirements) rather than expert subjective assessment 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
Not applicable. This is a device for cleaning and sterilizing endoscopes, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone automated processing system. The tests evaluate the performance of the system itself in achieving cleaning, sterilization, and other functional criteria without human intervention affecting the core process. Human factors testing assessed user interaction, but the core efficacy tests are on the device's automated capabilities.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the efficacy tests is based on:
- Quantitative measurements: Protein levels (< 6.4 µg/cm²), Total Organic Carbon (TOC) levels (< 12 µg/cm²).
- Microbiological testing: "No growth of organisms" for Geobacillus stearothermophilus spores.
- Chemical analysis: Verifying chemical residual levels are below acceptable levels.
- Physical evaluation: Assessing physical changes to materials.
- Temperature monitoring: Demonstrating cycle temperature is maintained at required values.
- Regulatory compliance: Conformance to electrical safety and software validation standards.
8. The Sample Size for the Training Set
The document does not describe the development or training of any AI/algorithm components, therefore, there is no information on a training set or its size. This is a physical device and chemical process, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for an AI/algorithm.
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