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510(k) Data Aggregation
(14 days)
The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.
The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.
The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled nasoendoscopes, when used in the enspire 300 AER.
The enspire 300™ Series Automated Endoscope Reprocessor (AER) is a medical device processing system used for cleaning and high level disinfection of immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 300 AER. Revital-Ox 2X Concentrate Enzymatic Detergent (R2X), and Revital-Ox Peracetic Acid High Level Disinfectant.
The enspire 300 series AER is an automated, self-contained device for the effective cleaning and high level disinfection of semi-critical medical devices and their accessories. Prior to placement in the processor, users will be instructed to perform bedside (point of use) cleaning and manual leak testing. The devices will not require manual pre-cleaning prior to processing, with the exception of duodenoscopes which will still require manual cleaning per the manufacturer's written instructions. Channel Connectors, as identified in STERIS labeling, are used to facilitate the delivery of the R2X detergent, HLD solution and rinse water to internal channels of devices that have them.
On the first process of an endoscope, the user must create a scope profile for the endoscope in the AER. The creation of the scope profile saves key endoscope attributes to the AER which are used to monitor the cycle during processing of the device. Once the device is positioned in the enspire 300 AER and optional operator ID, case ID, procedure ID and physician information is inputted, the operator initiates the processing cycle during which the Processor will create and maintain the conditions necessary for effective cleaning and high level disinfection. At the beginning of the processing cycle, an automated pressure monitor is performed to confirm the integrity of the flexible endoscope. In parallel with the pressure monitor and prior to initiation of the cleaning phase, the processing system will evaluate the flow coefficient of each individual channel and compare to their respective reference value stored in the device profile created prior to first processing. The enspire 300 AER maintains inflation of the processed device throughout the process to prevent ingress of fluid in the event of any loss of integrity. At the end of the processing cycle, the cleaned and high level disinfected devices are rinsed with 0.2 micron filtered potable water followed by a dried, oil free, filtered compressed air purge to evacuate rinse water from the endoscope channels. The AER, which is micro-processor controlled and continually monitored, provides documentation of each cycle.
The enspire 300 AER utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and Revital-Ox Peracetic Acid High Level Disinfectant for high level disinfection. Revital-Ox PAA HLD is a two part solution consisting of Part A, 15% PAA, and Part B, conditioner.
The document discusses an Automated Endoscope Reprocessor (AER) and its comparison to a predicate device, focusing on non-clinical testing. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance testing with replacement pre-filters | The modification does not affect the performance of the device. | Pass |
Note: This table is directly extracted from the provided text. The "modified device" refers to the enspire 300 Series AER with new support material for its pre-filters.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for the performance testing with replacement pre-filters. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature). The testing is described as "new testing" performed to evaluate the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described is performance testing of a medical device, which typically involves engineering and microbiology evaluations, not expert review for ground truth in the way it might be for an AI model interpreting medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists interpreting images) to establish a consensus ground truth. This document describes performance testing of an automated reprocessing device, which doesn't involve such human interpretive 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 as the device is an Automated Endoscope Reprocessor, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study or effect size related to human readers improving with AI assistance would have been conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a "standalone" automated system for reprocessing endoscopes. The described "Performance testing with replacement pre-filters" evaluates the device's functional performance in this automated capacity. There isn't an "algorithm only" aspect in the sense of a software-based diagnostic tool, but rather the overall automated operation of the mechanical and chemical processes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the "Performance testing with replacement pre-filters," the ground truth implicitly refers to the established performance requirements for an Automated Endoscope Reprocessor (e.g., effective cleaning and high-level disinfection, proper fluid delivery, temperature control, etc., as detailed in the "Description of Device" and "Process Monitors" sections). The acceptance criterion "The modification does not affect the performance of the device" implies that the device's ability to meet these established functional and safety parameters, which would be verified through specific engineering and potentially microbiological tests, serves as the ground truth. It's not a ground truth derived from expert consensus on interpretations or patient outcomes data directly from this specific test.
8. The sample size for the training set:
This information is not applicable. The device is a physical medical device (Automated Endoscope Reprocessor), not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable since there is no training set for this type of device.
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(143 days)
The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.
The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.
The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes, when used in the enspire 300 AER.
The enspire 300™ Series Automated Endoscope Reprocessor System (AER) is a medical device processing system used for cleaning and high level disinfection of immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 300 AER, Revital-Ox 2X Concentrate Enzymatic Detergent (R2X), and Revital-Ox Peracetic Acid High Level Disinfectant (HLD).
The enspire 300 series AER is an automated, self-contained device for the effective cleaning and high level disinfection of semi-critical medical devices and their accessories. Prior to placement in the processor, users will be instructed to perform bedside (point of use) cleaning and manual leak testing. The devices will not require manual cleaning prior to processing, with the exception of duodenoscopes which will still require manual cleaning per the manufacturer's written instructions. Channel Connectors, as identified in STERIS labeling, are used to facilitate the delivery of the R2X detergent, HLD solution and rinse water to internal channels of devices that have them.
On the first process of an endoscope, the user must create a scope profile for the endoscope in the AER. The creation of the scope profile saves key endoscope attributes to the AER which are used to monitor the cycle during processing of the device. Once the device is positioned in the enspire 300 AER and optional operator ID, case ID, procedure ID and physician information is inputted, the operator initiates the processing cycle during which the Processor will create and maintain the conditions necessary for effective cleaning and high level disinfection. At the beginning of the processing cycle, an automated pressure monitor is performed to assess the integrity of the flexible endoscope. In parallel with the pressure monitor and prior to initiation of the cleaning phase, the processing system will evaluate the flow coefficient of each individual channel and compare to their respective reference value stored in the device profile created prior to first processing. The enspire 300 AER maintains inflation of the processed device throughout the process to reduce the risk of ingress of fluid in the event of any loss of integrity. At the end of the processing cycle, the cleaned and high level disinfected devices are rinsed with 0.2 micron filtered potable water followed by a dried, oil free, filtered compressed air purge to evacuate rinse water from the endoscope channels. The AER, which is micro-processor controlled and continually monitored, provides documentation of each cycle.
The enspire 300 AER utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and Revital-Ox Peracetic Acid High Level Disinfectant for high level disinfection. Revital-Ox PAA HLD is a two part solution consisting of Part A, 15% PAA, and Part B. conditioner.
The STERIS enspire 300 Series Automated Endoscope Reprocessor System underwent several non-clinical studies to demonstrate its safety and effectiveness.
Here is a summary of the acceptance criteria and reported device performance for these studies, along with other requested information where available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Simulated Use Testing - Cleaning | Worst-case devices were soiled and processed in triplicate trials using the cleaning phase of the processing cycle, 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 - HLD | Worst case devices were inoculated with Mycobacterium. terrae in triplicate trials and processed using the HLD phase of the processing cycle, then sampled to demonstrate ≥6 log10 reduction per channel of M. terrae. | PASS |
| In Use Testing - Cleaning | Clinically used devices were placed into the enspire 300 AER 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 - HLD | Clinically used devices were placed into the enspire 300 AER 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 (Cytotoxicity test) | A representative endoscope was exposed to multiple processing cycles and extracted per ISO 10993-12:2021. The device extracts were analyzed to verify chemical residual levels were below the highest acceptable levels. | PASS |
| Biocompatibility | A representative endoscope was exposed to multiple processing cycles and extracted per ISO 10993-12: 2021. The device extracts were tested for: Hemolysis per ISO 10993-4:2017 Cytotoxicity per ISO 10993-5:2009/(R) 2014 Sensitization per ISO 10993-10:2021 Acute Systemic toxicity per ISO 10993-11:2017 Irritation per ISO 10993-23:2021 | PASS |
| Toxicological Assessment | The Toxicity assessment of the cleaning and HLD Chemistries for short-term endpoints and the long term/repeated exposure should show no significant risk concerns. | 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 |
| Human Factors | Typical users were capable of following written instructions for use to correctly load devices into the enspire 300 AER, attach Scope Connectors, and successfully run the processing cycle. | PASS |
| Electrical Safety Conformance | Meets requirements per: UL 61010-1, IEC 61010-2-040:2020, IEC 60601-1-2:2015, +A1:2021 | PASS |
| Software Validation | Meets requirements per: IEC 62304:2006/A1:2016 | PASS |
2. Sample size used for the test set and the data provenance
- Simulated Use Testing: "Worst-case devices" were processed in triplicate trials. The specific number of distinct devices or trials beyond "triplicate" is not specified. The provenance of the data (e.g., country of origin) is not mentioned. This part of the testing is generally conducted in a laboratory setting.
- In Use Testing: "Clinically used devices" were used. The number of such devices is not specified. This implies prospective use in a clinical setting, but further details are not provided.
- Rinsing Efficacy, Biocompatibility, Material Compatibility: "A representative endoscope" or "Representative devices" were exposed to multiple processing cycles. The exact sample size is not specified.
- Human Factors: "Typical users" were observed, but the number of users or specific test cases is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text does not specify the number or qualifications of experts used to establish ground truth for any of the test sets. The determination of "PASS" or "FAIL" is based on meeting the defined technical acceptance criteria (e.g., protein levels, log reduction of bacteria, visual examination) rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set
The document does not describe an adjudication method (like 2+1, 3+1, or none) for test set results. The results appear to be determined by direct measurement against pre-defined quantitative and qualitative acceptance 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an Automated Endoscope Reprocessor System, not an AI-assisted diagnostic or decision support tool for human readers. "Clinical Testing: Not required for the subject device" is explicitly stated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance detailed in the non-clinical testing for cleaning, high-level disinfection, rinsing efficacy, biocompatibility, toxicological assessment, material compatibility, electrical safety, and software validation represents the standalone performance of the automated endoscope reprocessor system and its associated chemistries. Human factors testing assessed the user's ability to operate the system correctly, which is part of the overall system performance but not "human-in-the-loop" clinical interpretation.
7. The type of ground truth used
The ground truth for the various tests includes:
- Quantitative measurements: Protein levels (< 6.4 µg/cm²), TOC levels (< 12 µg/cm²), log10 reduction of M. terrae (≥ 6 log10), chemical residual levels (below acceptable levels).
- Qualitative observations: Visual examination for cleaning, no growth of organisms after HLD, evaluation for physical changes in material compatibility, proper user operation in human factors.
- Standard conformance: Adherence to specific ISO and IEC standards for biocompatibility, electrical safety, and software validation.
This is primarily based on laboratory and performance testing standards and empirical data.
8. The sample size for the training set
The provided document does not mention a training set. This is because the device is a physical reprocessor system, not a machine learning or AI algorithm that requires a training set for model development.
9. How the ground truth for the training set was established
As no training set is discussed or implied for this type of device, this information is not applicable.
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