(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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".
July 15, 2019
Advanced Sterilization Products (ASP) Laurie Cartwright Director 33 Technology Drive Irvine, California 92618
Re: K181472
Trade/Device Name: AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB, MED, JOJ Dated: March 26, 2019 Received: March 27, 2019
Dear Laurie Cartwright:
This letter corrects our substantially equivalent letter of April 23, 2019.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Clarence W. Murray lii III -S
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181472
Device Name
AEROFLEX(TM) Automatic Endoscope Reprocessor (AER) with AUTOSURE(TM) MRC Monitor
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo with the letters "ASP" in white against a light blue background. The "A" is represented by a triangle, and the "S" and "P" are stylized and connected. A small "R" in a circle, indicating a registered trademark, is located in the upper right corner of the logo.
Advanced Sterilization Products AEROFLEXTM Automatic Endoscope Reprocessor with AUTOSURE™ MRC Monitor
| General Information | |
|---|---|
| Submitter Name: | Advanced Sterilization ProductsDivision of Ethicon, Inc., a Johnson & Johnson company |
| Address: | 33 Technology DriveIrvine, CA 92618 |
| Contact Person: | Laurie CartwrightDirector, Worldwide Regulatory AffairsPhone: 949-789-3877Email: lcartwr@its.jnj.comOrJamie ByunManager, Regulatory AffairsPhone: 949-788-2067Email: jbyun@its.jnj.com |
| Date Prepared: | 20 April 2019 |
| Device Name | |
| Proprietary Name: | AEROFLEX™ Automatic Endoscope Reprocessor (AER) withAUTOSURE™ MRC Monitor |
| Common Name: | Endoscope washer/disinfector |
| Classification Name: | Accessories, Cleaning, For Endoscope |
| Device Class: | II |
| Product Code: | FEB |
| CFR Section: | 21 CFR 876.1500 |
Predicate Device
The predicate device for the AEROFLEX Automatic Endoscope Reprocessor is the Olympus OER-Pro cleared under 510(k) K103264 (February 23, 2011). The predicate device for the AEROFLEX AER AUTOSURE MRC Monitor is the Browne CIDEX® OPA Test Strips cleared under 510(k) K991709 (October 8, 1999) and K081427 (June 11, 2008).
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Image /page/4/Picture/0 description: The image shows a logo with the letters ASP in white against a light blue background. The letters are stylized, with the A being a triangle and the P having a curved top. The logo is enclosed in a rounded rectangle, and there is a small registered trademark symbol in the upper right corner.
Device Description
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.
Intended Use/Indications for Use
The ASP AEROFLEX Automatic Endoscope Reprocessor (AER) with AUTOSURE MRC Monitor is indicated for use with high-level disinfectant 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.
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Technological Characteristics
The subject and predicate devices have similar characteristics based on their intended use in high level disinfection of flexible endoscopes. Both the AEROFLEX AER with AUTOSURE MRC Monitor and its predicate device are automatic endoscope reprocessors intended for high-level disinfection of flexible endoscopes; this is accomplished by putting the flexible endoscopes in contact with the disinfectant for the appropriate combination of time and temperature. Refer to the following tables for comparisons of predicate and proposed device characteristics.
| DeviceCharacteristics | Predicate DeviceOlympus OER-Pro(K103264) | Subject DeviceAEROFLEX AER |
|---|---|---|
| Intended Use | High-level disinfection of Olympus flexibleendoscopes and its accessories. | High-level disinfection for flexible, submersibleendoscopes. |
| Indications for Use | The OER-Pro is intended for use in cleaning andhigh-level disinfection of heat sensitive Olympusflexible endoscopes and their accessories. Safeuse requires detergent and an FDA-clearedhigh-level disinfectant/sterilant that Olympus hasvalidated to be efficacious and compatible withthe materials of the OER-Pro and Olympusflexible endoscopes and their accessories. Useof a detergent or high-level disinfectant/sterilantthat has not been validated by Olympus may beineffective and can damage the OER-Procomponents and the endoscopes beingreprocessed. Endoscopes must be subject tocleaning by the user prior to reprocessing;however, use of the OER-Pro enables the userto perform modified manual cleaning of theendoscope prior to automated cleaning andhigh-level disinfection in the OER-Pro. | The ASP AEROFLEX Automatic EndoscopeReprocessor (AER) with AUTOSURE MRCMonitor is indicated for use with high-leveldisinfectant ASP AERO OPA ortho-Phthalaldehyde Solution to achieve high-leveldisinfection of flexible semi-critical endoscopes.Manual cleaning of endoscopes is required priorto placement in the AER. |
| OperationalPrinciples | Inputs of water, proprietary detergent, andproprietary disinfectant. Contact for appropriatetime and temperature controlled by software | Same |
| Basin | Single Basin | Same |
| Number of Scopes | Maximum two (one with certain models) | One |
| Disinfectant Used | Glutaraldehyde/Peracetic Acid | OPA |
| Disinfectant Use | Reuse | Same |
| DisinfectantConcentrationMonitor | Test strips (visually read color change) providedby disinfectant manufacturer to test for minimumeffective concentration (MEC) | Built-in minimum recommended concentration(MRC) monitor (colorimetric reading) to ensurethat the disinfectant concentration is aboveminimum effective concentration (MEC) |
| Embedded RFID | Yes (for endoscope identification) | Yes (for disinfectant, detergent identification) |
| OperationalAmbientTemperature | 10-40 °C | 15-30 °C |
AER Comparison Table
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| DeviceCharacteristics | Predicate DeviceOlympus OER-Pro(K103264) | Subject DeviceAEROFLEX AER |
|---|---|---|
| OperationalRelative Humidity | 30-85% | 10% to 85% |
| Operational Watertemperature | Maximum 28 °C | 5 °C to 35°C |
| Cycle Stages | Include wash, disinfection, rinse, air purge, andalcohol flush (Note: irrespective of nomenclatureor order within the cycle) | Same |
| Fluid Heating | Present | Same |
| Cleaning method | Using EndoQuick® detergent.Exterior surfaces: Ultrasonic cleaning, turbulentbathChannel interiors: Fluid flushing | Using AEROZYME® detergent.Exterior surfaces: Turbulent bath, spray.Channel interiors: Fluid flushing |
| Cleaning timesetting | 3 - 10 minutes(Setting variable in 1 minute increments) | Not Applicable |
| Disinfection method | Exterior surfaces: Disinfectant solutionimmersionChannel interiors: Disinfectant solution flushingand fillingAccessories: Disinfectant solution immersion | Same |
| Disinfection timesetting | Acecide-C®: 7 minutesALDAHOL® 1.8: 10 minutes | AERO-OPA®:Standard endoscopes: 8:05 minutesDuodenoscopes: 16:35 minutes |
| Disinfectant solutiontemperature setting | 20 °C | 32 °C - 36 °C |
| Alcohol flushing | Automatic flushing/draining | Same |
| Leak test | Visual-Bubble detection during immersion | Same |
| Power supply | Voltage: 120 Volts ACFrequency: 60HzInput current: 5.5AVoltage fluctuation: +/-10% | Voltage: 120-240 Volts ACFrequency: 60HzInput current: 12AVoltage fluctuation: +/-10% |
| Dimensions | 450(W) x 977(H) x 765(D) mm | 538(W) x 990(H) x 783(D) mm |
| Weight | 120 kg (Dry) | 74kg (Dry),102kg (Operational) |
| Electrical Safety | UL/IEC 61010-1, 61010-2-040 | Same |
| EMC Compliance | FCC Part 15, Subpart B, Class A | IEC 60601-1-2 and CISPR 11, Class A |
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Image /page/7/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The A is represented by a triangle, and the letters are white against a light blue background. The logo is enclosed in a rounded rectangle, and there is a small registered trademark symbol in the upper right corner.
MRC Monitor Comparison Table
| DeviceCharacteristics | Predicate DeviceBrowne CIDEX OPA Test Strips(K991709 & K081427) | Subject DeviceAUTOSURE MRC Monitor |
|---|---|---|
| Intended Use | Concentration monitor for use in ortho-phthalaldehyde containing germicide solutionswith a minimum effective concentration of 0.3% | Same |
| Functionality | Monitors active OPA concentration of CIDEXOPA Solution | Same |
| Design | Polypropylene strip with an indicator on one end. | Built-in to AEROFLEX AER. |
| Manual concentration monitoring read by eye;color change indicates whether the OPA isabove the minimum effective concentration(MEC). | Automated colorimetric reading that ensures thatthe disinfectant is above the minimum effectiveconcentration (MEC). If the MRC Monitor detectsthat the OPA is not at the appropriateconcentration level, the user is notified via theAEROFLEX AER GUI and printer, the cycle iscancelled, and the user is advised to replace theOPA solution before the cycle is restarted. | |
| Color Change | Test Strip color change is based on interactionof the test strip with aldehyde moiety of OPAwhich triggers a pH change reflected by colorchange based on OPA concentration. | Automated MRC assessment is based on OPAreaction with the MRC reagent which triggers apH change. The pH is measured by the MRCmonitor using visible light absorbance of a pHindicator in the reagent. |
| Test resultinterpretation | Processed test strip compared to color chart todetermine if MRC check passed or not. | Automated process to determine if MRC checkpassed or not by indicating results on GUIscreen |
| Shelf life | 10 months | 2 years |
| Sensitive tomoisture | Yes | No |
| Reaction (OPAreaction forms baseand causes PHchange) | OPA reacts with sulfite | Same |
| Reaction (Acidneutralizes baseformed by OPAreaction) | Acid is dosed in test strip | Acid is dosed in MRC reagent |
| Packaging | Test strips contained in polypropylene containerwith a flip top. | MRC Monitor built in to AEROFLEX AER. MRCReagent contained in HDPE container withscrew top lid. |
| Reaction (Colorchange with PHindicator) | pH indicator is included in test strip paper | pH indicator is included in MRC reagent |
| Contact/Mixing Time | 1 second dip | 60 second mixing |
| Reaction time | 60 second read | 30 second read |
| Pass/Fail checkbased on Colorchange | Compare to color chart visually | Absorbance measurement and recording doneby machine automatically |
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Image /page/8/Picture/0 description: The image features a logo with the letters 'ASP' in a stylized, modern design. The 'A' is represented by a triangle without a base, and the 'S' and 'P' are connected with smooth, rounded lines. The logo is set against a rounded, rectangular background in a light teal color. A registered trademark symbol is visible in the upper right corner of the background.
As shown in the comparison tables, the overall differences between the AEROFLEX AER and its predicate device demonstrate that the devices have the same intended use and achieve the same goal of high-level disinfection of flexible endoscopes and ensuring that in-use OPA solution concentration meets minimum recommended concentration requirements. Although technological differences exist between the MRC monitor and its predicate, these differences have been successfully assessed through performance testing. The formulation of AERO-OPA, including ingredient amount and purpose, is identical to that of the currently marketed CIDEX® OPA solution.
Non-Clinical Data
Performance testing was conducted to satisfy the requirements for the AEROFLEX Automatic Endoscope Reprocessor that is the subject of this submission, as outlined in 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). All testing yielded passing results. This testing is summarized in the following Table.
| Performance Testing | Description | Pass/ Fail |
|---|---|---|
| Process Parameter PhysicalTesting | To demonstrate the ability of the AEROFLEX AER system toachieve and maintain process parameters, standard andduodenoscope cycles were run with and without a scope (standardonly). For each cycle type, sensor data recorded time,temperature, OPA concentration, channel flow, detergent delivery,and alcohol delivery. This information was compiled andsummarized; all cycle parameters were within specification andtolerance and met acceptance criteria. | Pass |
| Simulated Use Testing | Study demonstrated the high-level disinfection capabilities of theAEROFLEX AER under worst-case conditions as recommended inFDA Guidance Premarket Notification [510(k)] Submissions forAutomated Endoscope Washers, Washer/Disinfectors, andDisinfectors Intended for Use in Health Care Facilities(August 1993). | Pass |
| In-Use Testing | Study demonstrated the high-level disinfection capabilities of theAEROFLEX AER per FDA Guidance on Premarket Notification[510(k)] Submissions for Automated Endoscope Washers,Washer/Disinfectors, and Disinfectors Intended for Use in HealthCare Facilities (August 1993). | Pass |
| Self-Disinfection Efficacy | Study demonstrated the efficacy of the AEROFLEX AER self-disinfection processes. | Pass |
| Summative Usability Testing | Testing was conducted with representative end-user techniciansand nurses, with user profiles typical of health care professionalsinvolved in reprocessing flexible endoscopes for re-use. | Pass |
| System Verification Testing | Testing demonstrated that the system is functional and performs asintended. | Pass |
| MRC Monitor Testing | Testing demonstrated that the MRC Monitor successfully reads andreports AERO-OPA concentration. | Pass |
Summary of Performance Testing
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Image /page/9/Picture/0 description: The image shows a logo with the letters "ASP" in white against a teal background. The "A" is represented by a triangle without a base, and the letters are stylized with rounded edges. A registered trademark symbol is located in the upper right corner of the logo.
| Performance Testing | Description | Pass/ Fail |
|---|---|---|
| AUTOSURE MRC ReagentVerification | Testing demonstrated that the MRC reagent accurately detects theminimum recommended concentration (MRC) of OPA solutionunder various OPA solution and MRC reagent conditions. | Pass |
| AEROFLEX Cleaning ChemicalCompatibility | Testing verified that common cleaning chemicals, such as bleach,alcohol, and common germicides or detergents do not affect thesurfaces of the AEROFLEX AER. | Pass |
| AEROFLEX ChemicalCompatibility with PMMA | Testing verified the compatibility of a PMMA component with liquidsutilized in the AEROFLEX AER. | Pass |
| Basin and Lid SubsystemVerification | Testing verified that this subsystem fulfils its design requirementsand performs as intended. | Pass |
| Consumables Management | Testing verified the ability of the consumables managementsubsystem to use RFID technology to ensure that only ASP AERO-OPA and AEROZYME XTRA consumables are used with theAEROFLEX AER. | Pass |
| Biocompatibility, Residuals andRinsing Validation | Testing demonstrated that any residues associated with OPA,including any inert ingredients, by-products of chemical devicereactions, derivatives of the treated devices, or other chemicalresidues that may be deposited/absorbed onto an endoscope underworst-case conditions, including 0.6% OPA and longest exposuretime for a non-duodenoscope and duodenoscope duringdisinfection using the AEROFLEX AER, are nontoxic. | Pass |
| Stability and Reuse of OPASolution | Testing demonstrated that the AERO-OPA Solution at onboardmaintenance temperature, combined with worst case simulated useconditions for dilution and bioburden (introduced with endoscopereprocessing), can be used for up to 14 days or until the on-boardMRC monitor cancels the cycle. | Pass |
| Bacterial Water Filter Validation | Testing demonstrated that the integrity of the bacterial water filtercontinues to meet acceptance criteria after 275 cycles. Arecommended use life of 220 cycles has been established toprovide a safety margin for replacement. | Pass |
| Flow Characteristic Evaluation | Numerous volume changes during purge-and-fill steps in thedisinfection stage ensure that fresh disinfectant is consistentlydelivered to all areas of the endoscope channels well beyond timeand temperature nominally required for achieving high-leveldisinfection. This margin of safety was demonstrated in simulateduse testing that showed greater than 6-log10 reduction even underworst-case conditions. | Pass |
Electrical Safety testing was conducted to verify compliance to the standards listed below. The testing provides a standardized level of assurance that the system is electrically safe when operated and maintained in accordance with the User's Guide.
- IEC/EN 61010-1:2010; Safety requirements for electrical equipment for measurement, control, and • laboratory use - Part 1: General requirements
- . IEC/EN 61010-2-040:2015; Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors used to treat medical material.
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Image /page/10/Picture/0 description: The image shows a logo with the letters ASP in white, enclosed in a rounded, light blue rectangle. The 'A' is represented by a triangle without its base, and the 'S' and 'P' are stylized and connected. A small registered trademark symbol is visible in the upper right corner of the logo.
- UL 61010-1:2012; UL Standard for Safety Electrical Equipment for Measurement, Control, and ● Laboratory Use; Part 1: General Requirements
- . UL 61010-2-040:2016; UL Standard for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors used to treat medical material.
- CAN/CSA-C22.2 No. 61010-1 (2012); Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements
- CAN/CSA-22.2 No. 61010-2-040 (2016); Safety requirements for electrical equipment for ● measurement, control and laboratory use - Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors used to treat medical material
Electromagnetic Compatibility testing was completed to verify electromagnetic compatibility (Radiated and Conducted Emissions) according to the standards listed below; test results met the requirements of these standards.
| Test Description | Standards | Test Result |
|---|---|---|
| Radiated EmissionsClass A | IEC 60601-1-2:2014CISPR 11:2010 | Pass |
| Conducted EmissionsClass A | IEC 60601-1-2:2014CISPR 11:2010 | Pass |
Software Verification and Validation Testing was conducted, and documentation was provided within the submission as recommended by Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. Unit, Integration, and System level testing were successfully completed.
Clinical Data
No clinical data was generated in support of this Premarket Notification.
Conclusion
Based on the intended use, indications for use, technological characteristics, and non-clinical performance data, the AEROFLEX AER with AUTOSURE MRC Monitor is as safe, as effective, and performs as well or better than the legally marketed predicate devices, the Olympus OER-Pro cleared under K103264 and the Browne CIDEX OPA Test Strips cleared under K991709 and K081427.
§ 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.