(323 days)
Not Found
No
The description focuses on automated reprocessing, chemical monitoring, RFID for consumables, and electronic record-keeping, with no mention of AI or ML technologies.
No
This device is an automated endoscope reprocessor designed for high-level disinfection of semi-critical endoscopes, which is a sterilization and cleaning function, not a direct therapeutic intervention for a patient.
No
The device is an automatic endoscope reprocessor, designed to clean and disinfect flexible endoscopes, not to diagnose medical conditions or diseases. Its function is to perform high-level disinfection.
No
The device description clearly outlines a system that includes hardware components such as the AER machine itself, an integrated MRC monitor, and utilizes RFID technology. While it is software-driven, it is not solely software.
Based on the provided information, the ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to achieve high-level disinfection of flexible semi-critical endoscopes. This is a process for reprocessing medical devices, not for diagnosing a condition or disease in a patient.
- Device Description: The device is described as an automatic endoscope reprocessor designed for disinfection. While it uses a reagent (AUTOSURE MRC) to monitor the concentration of the disinfectant, this monitoring is part of the reprocessing cycle to ensure the effectiveness of the disinfection, not to provide diagnostic information about a patient sample.
- Lack of Diagnostic Purpose: The device does not analyze biological samples (like blood, urine, tissue) to provide information about a patient's health status or to diagnose a disease.
- Predicate Devices: The predicate devices listed are other endoscope reprocessors and test strips for monitoring disinfectant concentration, which are also not IVD devices.
The AUTOSURE MRC Monitor and reagent are components that support the disinfection process by verifying the concentration of the disinfectant. While they involve a chemical reaction to measure a substance, their purpose is to ensure the proper functioning of the reprocessing equipment, not to provide a diagnosis.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FEB, MED, JOJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Summary of Performance Testing:
- Process Parameter Physical Testing: To demonstrate the ability of the AEROFLEX AER system to achieve and maintain process parameters, standard and duodenoscope cycles were run with and without a scope (standard only). For each cycle type, sensor data recorded time, temperature, OPA concentration, channel flow, detergent delivery, and alcohol delivery. This information was compiled and summarized; all cycle parameters were within specification and tolerance and met acceptance criteria. (Pass)
- Simulated Use Testing: Study demonstrated the high-level disinfection capabilities of the AEROFLEX AER under worst-case conditions as recommended in FDA Guidance Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (August 1993). (Pass)
- In-Use Testing: Study demonstrated the high-level disinfection capabilities of the AEROFLEX AER per FDA Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care 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 technicians and nurses, with user profiles typical of health care professionals involved in reprocessing flexible endoscopes for re-use. (Pass)
- System Verification Testing: Testing demonstrated that the system is functional and performs as intended. (Pass)
- MRC Monitor Testing: Testing demonstrated that the MRC Monitor successfully reads and reports AERO-OPA concentration. (Pass)
- AUTOSURE MRC Reagent Verification: Testing demonstrated 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: Testing verified that common cleaning chemicals, such as bleach, alcohol, and common germicides or detergents do not affect the surfaces of the AEROFLEX AER. (Pass)
- AEROFLEX Chemical Compatibility with PMMA: Testing verified the compatibility of a PMMA component with liquids utilized in the AEROFLEX AER. (Pass)
- Basin and Lid Subsystem Verification: Testing verified that this subsystem fulfils its design requirements and performs as intended. (Pass)
- Consumables Management: Testing verified the ability of the consumables management subsystem to use RFID technology to ensure that only ASP AERO-OPA and AEROZYME XTRA consumables are used with the AEROFLEX AER. (Pass)
- Biocompatibility, Residuals and Rinsing Validation: Testing demonstrated that any residues associated with OPA, including any inert ingredients, by-products of chemical device reactions, derivatives of the treated devices, or other chemical residues that may be deposited/absorbed onto an endoscope under worst-case conditions, including 0.6% OPA and longest exposure time for a non-duodenoscope and duodenoscope during disinfection using the AEROFLEX AER, are nontoxic. (Pass)
- Stability and Reuse of OPA Solution: Testing demonstrated that the AERO-OPA Solution at onboard maintenance temperature, combined with worst case simulated use conditions for dilution and bioburden (introduced with endoscope reprocessing), can be used for up to 14 days or until the on-board MRC monitor cancels the cycle. (Pass)
- Bacterial Water Filter Validation: Testing demonstrated that the integrity of the bacterial water filter continues to meet acceptance criteria after 275 cycles. A recommended use life of 220 cycles has been established to provide a safety margin for replacement. (Pass)
- Flow Characteristic Evaluation: Numerous volume changes during purge-and-fill steps in the disinfection stage ensure that fresh disinfectant is consistently delivered to all areas of the endoscope channels well beyond time and temperature nominally required for achieving high-level disinfection. This margin of safety was demonstrated in simulated use testing that showed greater than 6-log10 reduction even under worst-case conditions. (Pass)
Electrical Safety testing was conducted to verify compliance to the standards listed below: IEC/EN 61010-1:2010, IEC/EN 61010-2-040:2015, UL 61010-1:2012, UL 61010-2-040:2016, CAN/CSA-C22.2 No. 61010-1 (2012), CAN/CSA-22.2 No. 61010-2-040 (2016).
Electromagnetic Compatibility testing was completed to verify electromagnetic compatibility (Radiated and Conducted Emissions) according to IEC 60601-1-2:2014 and CISPR 11:2010. Test results met the requirements of these standards. (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.
No clinical data was generated in support of this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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
2
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 Products |
| Division of Ethicon, Inc., a Johnson & Johnson company | |
| Address: | 33 Technology Drive |
| Irvine, CA 92618 | |
| Contact Person: | Laurie Cartwright |
| Director, Worldwide Regulatory Affairs | |
| Phone: 949-789-3877 | |
| Email: lcartwr@its.jnj.com | |
| Or | |
| Jamie Byun | |
| Manager, Regulatory Affairs | |
| Phone: 949-788-2067 | |
| Email: jbyun@its.jnj.com | |
| Date Prepared: | 20 April 2019 |
| Device Name | |
| Proprietary Name: | AEROFLEX™ Automatic Endoscope Reprocessor (AER) with |
| AUTOSURE™ 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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Image /page/5/Picture/0 description: The image shows a logo with the letters "ASP" inside of a rounded rectangle. The letters are white, and the rectangle is light blue. The "A" is shaped like a triangle, and there is a registered trademark symbol in the upper right corner of the rectangle.
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.
| Device
Characteristics | Predicate Device
Olympus OER-Pro
(K103264) | Subject Device
AEROFLEX AER |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | High-level disinfection of Olympus flexible
endoscopes and its accessories. | High-level disinfection for flexible, submersible
endoscopes. |
| Indications for Use | The OER-Pro is intended for use in cleaning and
high-level disinfection of heat sensitive Olympus
flexible endoscopes and their accessories. Safe
use requires detergent and an FDA-cleared
high-level disinfectant/sterilant that Olympus has
validated to be efficacious and compatible with
the materials of the OER-Pro and Olympus
flexible endoscopes and their accessories. Use
of a detergent or high-level disinfectant/sterilant
that has not been validated by Olympus may be
ineffective and can damage the OER-Pro
components and the endoscopes being
reprocessed. Endoscopes must be subject to
cleaning by the user prior to reprocessing;
however, use of the OER-Pro enables the user
to perform modified manual cleaning of the
endoscope prior to automated cleaning and
high-level disinfection in the OER-Pro. | 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. |
| Operational
Principles | Inputs of water, proprietary detergent, and
proprietary disinfectant. Contact for appropriate
time 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 |
| Disinfectant
Concentration
Monitor | Test strips (visually read color change) provided
by disinfectant manufacturer to test for minimum
effective concentration (MEC) | Built-in minimum recommended concentration
(MRC) monitor (colorimetric reading) to ensure
that the disinfectant concentration is above
minimum effective concentration (MEC) |
| Embedded RFID | Yes (for endoscope identification) | Yes (for disinfectant, detergent identification) |
| Operational
Ambient
Temperature | 10-40 °C | 15-30 °C |
AER Comparison Table
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Image /page/6/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' represented by a triangle and the 'S' and 'P' connected. A registered trademark symbol is located in the upper right corner of the logo.
| Device
Characteristics | Predicate Device
Olympus OER-Pro
(K103264) | Subject Device
AEROFLEX AER |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Operational
Relative Humidity | 30-85% | 10% to 85% |
| Operational Water
temperature | Maximum 28 °C | 5 °C to 35°C |
| Cycle Stages | Include wash, disinfection, rinse, air purge, and
alcohol flush (Note: irrespective of nomenclature
or order within the cycle) | Same |
| Fluid Heating | Present | Same |
| Cleaning method | Using EndoQuick® detergent.
Exterior surfaces: Ultrasonic cleaning, turbulent
bath
Channel interiors: Fluid flushing | Using AEROZYME® detergent.
Exterior surfaces: Turbulent bath, spray.
Channel interiors: Fluid flushing |
| Cleaning time
setting | 3 - 10 minutes
(Setting variable in 1 minute increments) | Not Applicable |
| Disinfection method | Exterior surfaces: Disinfectant solution
immersion
Channel interiors: Disinfectant solution flushing
and filling
Accessories: Disinfectant solution immersion | Same |
| Disinfection time
setting | Acecide-C®: 7 minutes
ALDAHOL® 1.8: 10 minutes | AERO-OPA®:
Standard endoscopes: 8:05 minutes
Duodenoscopes: 16:35 minutes |
| Disinfectant solution
temperature 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 AC
Frequency: 60Hz
Input current: 5.5A
Voltage fluctuation: +/-10% | Voltage: 120-240 Volts AC
Frequency: 60Hz
Input current: 12A
Voltage 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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MRC Monitor Comparison Table
| Device
Characteristics | Predicate Device
Browne CIDEX OPA Test Strips
(K991709 & K081427) | Subject Device
AUTOSURE MRC Monitor |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Concentration monitor for use in ortho-
phthalaldehyde containing germicide solutions
with a minimum effective concentration of 0.3% | Same |
| Functionality | Monitors active OPA concentration of CIDEX
OPA 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 is
above the minimum effective concentration
(MEC). | Automated colorimetric reading that ensures that
the disinfectant is above the minimum effective
concentration (MEC). If the MRC Monitor detects
that the OPA is not at the appropriate
concentration level, the user is notified via the
AEROFLEX AER GUI and printer, the cycle is
cancelled, and the user is advised to replace the
OPA solution before the cycle is restarted. |
| Color Change | Test Strip color change is based on interaction
of the test strip with aldehyde moiety of OPA
which triggers a pH change reflected by color
change based on OPA concentration. | Automated MRC assessment is based on OPA
reaction with the MRC reagent which triggers a
pH change. The pH is measured by the MRC
monitor using visible light absorbance of a pH
indicator in the reagent. |
| Test result
interpretation | Processed test strip compared to color chart to
determine if MRC check passed or not. | Automated process to determine if MRC check
passed or not by indicating results on GUI
screen |
| Shelf life | 10 months | 2 years |
| Sensitive to
moisture | Yes | No |
| Reaction (OPA
reaction forms base
and causes PH
change) | OPA reacts with sulfite | Same |
| Reaction (Acid
neutralizes base
formed by OPA
reaction) | Acid is dosed in test strip | Acid is dosed in MRC reagent |
| Packaging | Test strips contained in polypropylene container
with a flip top. | MRC Monitor built in to AEROFLEX AER. MRC
Reagent contained in HDPE container with
screw top lid. |
| Reaction (Color
change with PH
indicator) | 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 check
based on Color
change | Compare to color chart visually | Absorbance measurement and recording done
by 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 Physical | ||
| Testing | To demonstrate the ability of the AEROFLEX AER system to | |
| achieve and maintain process parameters, standard and | ||
| duodenoscope cycles were run with and without a scope (standard | ||
| only). For each cycle type, sensor data recorded time, | ||
| temperature, OPA concentration, channel flow, detergent delivery, | ||
| and alcohol delivery. This information was compiled and | ||
| summarized; all cycle parameters were within specification and | ||
| tolerance and met acceptance criteria. | Pass | |
| Simulated Use Testing | Study demonstrated the high-level disinfection capabilities of the | |
| AEROFLEX AER under worst-case conditions as recommended in | ||
| FDA Guidance Premarket Notification [510(k)] Submissions for | ||
| Automated Endoscope Washers, Washer/Disinfectors, and | ||
| Disinfectors Intended for Use in Health Care Facilities | ||
| (August 1993). | Pass | |
| In-Use Testing | Study demonstrated the high-level disinfection capabilities of the | |
| AEROFLEX AER per FDA Guidance on Premarket Notification | ||
| [510(k)] Submissions for Automated Endoscope Washers, | ||
| Washer/Disinfectors, and Disinfectors Intended for Use in Health | ||
| Care 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 technicians | |
| and nurses, with user profiles typical of health care professionals | ||
| involved in reprocessing flexible endoscopes for re-use. | Pass | |
| System Verification Testing | Testing demonstrated that the system is functional and performs as | |
| intended. | Pass | |
| MRC Monitor Testing | Testing demonstrated that the MRC Monitor successfully reads and | |
| reports 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 Reagent | ||
| Verification | Testing demonstrated 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 | Testing verified that common cleaning chemicals, such as bleach, | |
| alcohol, and common germicides or detergents do not affect the | ||
| surfaces of the AEROFLEX AER. | Pass | |
| AEROFLEX Chemical | ||
| Compatibility with PMMA | Testing verified the compatibility of a PMMA component with liquids | |
| utilized in the AEROFLEX AER. | Pass | |
| Basin and Lid Subsystem | ||
| Verification | Testing verified that this subsystem fulfils its design requirements | |
| and performs as intended. | Pass | |
| Consumables Management | Testing verified the ability of the consumables management | |
| subsystem to use RFID technology to ensure that only ASP AERO- | ||
| OPA and AEROZYME XTRA consumables are used with the | ||
| AEROFLEX AER. | Pass | |
| Biocompatibility, Residuals and | ||
| Rinsing Validation | Testing demonstrated that any residues associated with OPA, | |
| including any inert ingredients, by-products of chemical device | ||
| reactions, derivatives of the treated devices, or other chemical | ||
| residues that may be deposited/absorbed onto an endoscope under | ||
| worst-case conditions, including 0.6% OPA and longest exposure | ||
| time for a non-duodenoscope and duodenoscope during | ||
| disinfection using the AEROFLEX AER, are nontoxic. | Pass | |
| Stability and Reuse of OPA | ||
| Solution | Testing demonstrated that the AERO-OPA Solution at onboard | |
| maintenance temperature, combined with worst case simulated use | ||
| conditions for dilution and bioburden (introduced with endoscope | ||
| reprocessing), can be used for up to 14 days or until the on-board | ||
| MRC monitor cancels the cycle. | Pass | |
| Bacterial Water Filter Validation | Testing demonstrated that the integrity of the bacterial water filter | |
| continues to meet acceptance criteria after 275 cycles. A | ||
| recommended use life of 220 cycles has been established to | ||
| provide a safety margin for replacement. | Pass | |
| Flow Characteristic Evaluation | Numerous volume changes during purge-and-fill steps in the | |
| disinfection stage ensure that fresh disinfectant is consistently | ||
| delivered to all areas of the endoscope channels well beyond time | ||
| and temperature nominally required for achieving high-level | ||
| disinfection. This margin of safety was demonstrated in simulated | ||
| use testing that showed greater than 6-log10 reduction even under | ||
| worst-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 Emissions | ||
| Class A | IEC 60601-1-2:2014 | |
| CISPR 11:2010 | Pass | |
| Conducted Emissions | ||
| Class A | IEC 60601-1-2:2014 | |
| CISPR 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.