(323 days)
The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor is indicated for use with high-level disinfectant ASP AERO OPA™ ortho-Phthalaldehyde Solution to achieve high-level disinfection of flexible semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the AER.
The AEROFLEX Automatic Endoscope Reprocessor (AER) with AUTOSURE MRC Monitor is designed to provide high-level disinfection for flexible, submersible endoscopes that have been manually cleaned. The AEROFLEX system consists of the software-driven AER, the AUTOSURE MRC reagent, AERO-OPA™ disinfectant solution, and AEROZYME™ enzymatic detergent.
The AEROFLEX AER with AUTOSURE MRC Monitor is indicated for use with high-level disinfectant ASP AERO-OPA ortho-Phthalaldehyde Solution to achieve high-level disintection of semi-critical endoscopes; high-level disinfection requires that the AER be used with the AERO-OPA Solution per its Instructions for Use.
Manual cleaning of endoscopes is required prior to placement in the AEROFLEX AER. After an endoscope is manually cleaned according to its manufacturer's recommended procedures, it is loaded into the AER. After starting the reprocessing cycle, the AER displays its progress during the cycle and signals that the cycle is complete on the control panel and with an audible tone.
The minimum recommended concentration (MRC) of ASP AERO-OPA ortho-Phthalaldehyde Solution is automatically checked and verified by the AER for every cycle using an integrated MRC monitor and reagent. The MRC monitor- tests the OPA concentration in every high-level disinfection cycle without the use of test strips; if the OPA concentration is below the MRC the system cancels the cycle and notifies the user.
To reduce user error and facilitate assurance of disinfection efficacy, the AEROFLEX System uses Radio Frequency Identification (RFID) technology to identify the ASP-branded consumables that are used with the system. Additionally, to enable electronic record-keeping by hospitals, the AEROFLEX system can be configured by users to transmit cycle printout information and/or print cycle records from the facility's network; the AEROFLEX System will also be compatible with ASP ACCESS™ Technology to allow automated record keeping.
This document describes the premarket notification (510(k)) for the AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a diagnostic AI device. Instead, it describes various performance tests conducted and reports a "Pass" for each. The acceptance criteria are implicitly defined by the "Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (August 1993)" and the relevant electrical safety and EMC standards.
Here's a summary of the performance testing and their reported results:
| Performance Testing Category | Description / Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Process Parameter Physical Testing | Ability of the AEROFLEX AER system to achieve and maintain process parameters (time, temperature, OPA concentration, channel flow, detergent delivery, alcohol delivery) within specification and tolerance during standard and duodenoscope cycles. | Pass |
| Simulated Use Testing | Demonstrates high-level disinfection capabilities under worst-case conditions as recommended in FDA Guidance. | Pass |
| In-Use Testing | Demonstrates high-level disinfection capabilities per FDA Guidance. | Pass |
| Self-Disinfection Efficacy | Demonstrates the efficacy of the AEROFLEX AER self-disinfection processes. | Pass |
| Summative Usability Testing | Assesses usability with representative end-user technicians and nurses, typical of health care professionals involved in reprocessing flexible endoscopes. | Pass |
| System Verification Testing | Demonstrates that the system is functional and performs as intended. | Pass |
| MRC Monitor Testing | Demonstrates that the MRC Monitor successfully reads and reports AERO-OPA concentration. | Pass |
| AUTOSURE™ MRC Reagent Verification | Demonstrates that the MRC reagent accurately detects the minimum recommended concentration (MRC) of OPA solution under various OPA solution and MRC reagent conditions. | Pass |
| AEROFLEX™ Cleaning Chemical Compatibility | Verified that common cleaning chemicals (bleach, alcohol, germicides, detergents) do not affect the surfaces of the AEROFLEX AER. | Pass |
| AEROFLEX™ Chemical Compatibility with PMMA | Verified compatibility of a PMMA component with liquids utilized in the AEROFLEX AER. | Pass |
| Basin and Lid Subsystem Verification | Verified that this subsystem fulfills its design requirements and performs as intended. | Pass |
| Consumables Management | Verified the ability of the consumables management subsystem to use RFID technology to ensure only ASP AERO-OPA and AEROZYME™ XTRA consumables are used. | Pass |
| Biocompatibility, Residuals & Rinsing Validation | Demonstrated non-toxicity of residues associated with OPA and its by-products on endoscopes under worst-case conditions. | Pass |
| Stability and Reuse of OPA Solution | Demonstrated that AERO-OPA Solution can be used for up to 14 days or until the onboard MRC monitor cancels the cycle, given onboard maintenance temperature and worst-case simulated use conditions (dilution, bioburden). | Pass |
| Bacterial Water Filter Validation | Demonstrated integrity of the bacterial water filter after 275 cycles, providing a safety margin for a 220-cycle use life. | Pass |
| Flow Characteristic Evaluation | Demonstrated greater than 6-log10 reduction under worst-case conditions in simulated use testing due to consistent delivery of fresh disinfectant to all endoscope channels. | Pass |
| Electrical Safety Testing | Compliance with IEC/EN 61010-1, IEC/EN 61010-2-040, UL 61010-1, UL 61010-2-040, CAN/CSA-C22.2 No. 61010-1, CAN/CSA-22.2 No. 61010-2-040. | Pass |
| Electromagnetic Compatibility Testing | Compliance with IEC 60601-1-2:2014 and CISPR 11:2010 for Radiated and Conducted Emissions (Class A). | Pass |
| Software Verification & Validation Testing | Successful completion of Unit, Integration, and System level testing as recommended by FDA Guidance for software in medical devices. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for most of the performance tests (e.g., number of cycles for simulated use, number of endoscopes for in-use testing). It refers to "worst-case conditions" and "various OPA solution and MRC reagent conditions," implying a robust testing methodology but lacking numerical specifics.
- Provenance: The data provenance is internal testing conducted by Advanced Sterilization Products (ASP). The geographic location of the testing facility is not explicitly stated, but the company address is Irvine, California, USA, implying the testing was likely conducted in the US.
- Retrospective or Prospective: The testing would be considered prospective as it involves controlled experiments and data collection designed specifically to evaluate the performance of the device prior to marketing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a medical device (automatic endoscope reprocessor) rather than an AI/ML clinical diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" often seen in AI/ML performance studies is not directly applicable in the same way.
- Ground Truth Establishment: The "ground truth" for this device's performance is established by physical and chemical measurements (e.g., OPA concentration, temperature, flow rates, microbial reduction for disinfection efficacy) and engineering validation against predefined specifications and regulatory guidance documents.
- Experts: While not explicitly stated as "experts establishing ground truth," the development and testing would have involved qualified engineers, microbiologists, and other scientific personnel with expertise in sterilization, disinfection, and medical device design and validation. Summative Usability Testing involved "representative end-user technicians and nurses," who can be considered "experts" in the context of device usability in a clinical setting.
4. Adjudication Method for the Test Set
Again, given that this isn't an AI-powered diagnostic device, there's no "adjudication method" in the sense of reconciling disagreements between expert readers. Performance is determined by quantitative measurements and validation against predefined technical specifications and regulatory (FDA) guidance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/ML diagnostic device that provides interpretations that human readers would then review. The device discussed is an Automatic Endoscope Reprocessor, focused on disinfection efficacy and automated processes. MRMC studies are not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "standalone" performance here refers to the device operating independently to perform its intended function. The various "Performance Testing" categories listed in the tables (Process Parameter Physical Testing, Simulated Use Testing, In-Use Testing, Self-Disinfection Efficacy, System Verification Testing, MRC Monitor Testing, etc.) represent the standalone performance of the AEROFLEX system in achieving its disinfection and monitoring goals without direct human intervention during the cycle. Human interaction occurs before loading and after completion, but the process itself is automated and tested as such.
7. The Type of Ground Truth Used
The ground truth used is primarily based on:
- Physical and Chemical Measurements: Direct measurements of parameters like OPA concentration, temperature, flow, volume, and contact time.
- Microbiological Efficacy: Likely involves challenging the system with known levels of microorganisms (bioburden) and demonstrating a specified log reduction (e.g., "greater than 6-log10 reduction" mentioned in Flow Characteristic Evaluation). This would involve laboratory-based testing using culturing methods to determine viable microbial counts before and after reprocessing.
- Engineering Specifications and Design Requirements: The device's performance is validated against its pre-established technical specifications and the requirements outlined in relevant FDA guidance documents and international standards (e.g., for electrical safety, EMC).
- Usability Feedback: For summative usability testing, the "ground truth" would be direct observations and feedback from the intended users regarding the device's ease of use and safety in a simulated environment.
8. The Sample Size for the Training Set
This product is an automatic endoscope reprocessor, not a machine learning model developed with training data. Therefore, the concept of a "training set" for an algorithm's development is not applicable. The device's internal algorithms and control systems are likely developed through traditional software engineering principles and validated through the extensive non-clinical testing described.
9. How the Ground Truth for the Training Set was Established
As explained above, there is no "training set" for an AI/ML algorithm in this context. The "ground truth" against which the device's performance is validated is established through established scientific methods, engineering principles, and adherence to regulatory standards for disinfection and medical device functionality.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.