(237 days)
The System 83 Revolve® Endoscope Washer/Disinfector is designed for the high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts. Flexible endoscopes that undergo bedside cleaning, are manually cleaned, and then exposed to the wash/disinfect cycle of the System 83 Revolve® may be high-level disinfected when the validated disinfection cycle of the System 83 Revolve® corresponds with the labeled contact conditions of the high-level disinfectant.
The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical.
The System 83 Revolve® utilizes a processing chamber and the perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the rhannels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer.
Built-in sensors detect fluid levels, fluid flow, and the operating states of the components within System 83 Revolve". The system contains a Touchscreen (Graphical User Interface), a Barcode Scanner, an LED Indicator Strip that displays the process status, and a reprocessing chamber lid operation that is hands free.
The provided text is a 510(k) summary for a medical device (System 83 Revolve® Endoscope Washer/Disinfector), which is a premarket notification for a Class II medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than detailed performance study results of an AI algorithm or a standalone diagnostic device.
Therefore, the information typically requested for AI-driven diagnostic devices (such as a table of acceptance criteria vs. reported device performance for an AI, sample sizes for training/test sets for AI, expert qualifications, ground truth establishment methods for AI, or MRMC studies for AI assistance) is not present in this document. This document is about an endoscope washer/disinfector, an electromechanical system, not an AI or diagnostic imaging device.
Based on the provided document, here's what can be extracted regarding acceptance criteria and performance:
The document describes the acceptance criteria and performance for the endoscope washer/disinfector itself, ensuring it functions correctly and is safe, rather than evaluating an AI's diagnostic performance.
1. A table of acceptance criteria and the reported device performance
The document provides two tables:
- Table 2. New Testing: This table outlines testing performed for the subject device to ensure it meets safety and software standards. These are not performance metrics like sensitivity/specificity but rather compliance with engineering and software standards.
- Table 3. Testing performed for Predicate Device: This table lists performance testing conducted on the predicate device, which the subject device aims to be substantially equivalent to. The results from the predicate device's testing are used to support the subject device's equivalence.
Table 2. New Testing (for Subject Device: System 83 Revolve® Endoscope Washer/Disinfector)
| Testing | Acceptance Criteria | Pass/Fail |
|---|---|---|
| Electrical Safety Conformance | Meets requirements per: UL 61010-1:2012 Ed.3+R:06Jun2023 - Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements CSA C22.2#61010-1:2012 Ed.3+U1;U2;A1;U3 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General Requirements IEC 61010-2-040:2021 Ed.3 - 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 Materials CSA C22.2#61010-2-040:2021 Ed.3 - 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 Materials | Pass |
| EMC Testing | IEC 60601-1-2 ed 4.1 (2020-09) - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests | Pass |
| Software Validation | Meets requirements per: BS EN 62304, 2006+A1:2015 - Medical Device Software - software life cycle processes | Pass |
| Cybersecurity | Meets requirements per: AAMI TIR57, 2016(R)2019 - Principles of medical device security - risk management | Pass |
Table 3. Testing performed for Predicate Device (Used to support SE of Subject Device)
| Performance Testing | Description | Acceptance Criteria | Pass/Fail |
|---|---|---|---|
| Simulated use testing | High-level disinfection validation of representative worst case endoscopes under worst case simulated use conditions | ≥6 Log reduction of M.terrae at all inoculated sites | Pass |
| In-use testing | High-level disinfection validation of representative worst case endoscopes and valves under in-use conditions | <1 CFU at all processed test sites | Pass |
| Alcohol and detergent line disinfection | Disinfection of the alcohol and detergent injection lines | ≥6 Log reduction of M.terrae | Pass |
| Toxicological evaluation of residues and rinsing validation | The safety of residual chemicals remaining on endoscopes after high level disinfection was evaluated. The testing was conducted in accordance with ISO 10993-5:2009 | Reactivity grade of 2 or less | Pass |
| Channel volume flushing | Flushing validation testing of representative worst case endoscopes under worst case simulated use conditions | Satisfy endoscope manufacturer's manual flushing requirements | Pass |
| Water filtration system validation | Validation testing under worst case simulated use conditions | <10 CFU per 100 mL | Pass |
| In-line Disc filter validation | Validation testing under worst case simulated use conditions | ≥99% efficient at removing particles ≥250μm | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI algorithm, but rather describes "testing" for the electromechanical device.
- Sample size: Not explicitly stated in terms of number of endoscopes or tests for each specific performance test (e.g., how many endoscopes were tested for simulated use or in-use testing). It refers to "representative worst case endoscopes."
- Data provenance: Not mentioned. It's for an endoscope reprocessing device, so data would likely come from laboratory testing rather than patient data. The document does not specify retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is not an AI diagnostic device that relies on expert ground truth for image interpretation or similar. The "truth" in this context is the successful disinfection or functionality of the device, measured by objective microbiological and engineering criteria.
4. Adjudication method for the test set
Not applicable for this type of device testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable as this is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the electromechanical device itself, not a separate AI algorithm's standalone performance. The device's "standalone" performance is what is evaluated through the listed tests.
7. The type of ground truth used
The ground truth for the predicate device's performance (and implicitly for the subject device through substantial equivalence) is based on:
- Microbiological assay results: e.g., "≥6 Log reduction of M.terrae" and "<1 CFU at all processed test sites."
- Chemical/Toxicological assessments: e.g., "Reactivity grade of 2 or less."
- Engineering and functional requirements: e.g., "Satisfy endoscope manufacturer's manual flushing requirements," "Water filtration system validation," "In-line Disc filter validation."
- Compliance with electrical, EMC, software, and cybersecurity standards.
8. The sample size for the training set
Not applicable as this is not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable as this is not an AI model that requires a training set.
In summary: The provided document is a regulatory submission for an electromechanical medical device. It demonstrates safety and effectiveness through adherence to engineering standards and performance comparable to a predicate device, as proven by various physical and chemical tests, not through the evaluation of an AI algorithm's diagnostic performance on patient data. Therefore, many of the requested points related to AI/diagnostic studies are not applicable to this specific regulatory filing.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2024
Wassenburg Medical, Inc. Mario Infanti Quality Assurance and Regulatory Affairs Manager 144 Railroad Drive Ivyland, Pennsylvania 18974
Re: K241168
Trade/Device Name: System 83 Revolve® Endoscope Washer/Disinfector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: June 06, 2024 Received: November 26, 2024
Dear Mario Infanti:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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).
Sincerely,
Katharine Segars -S
Katharine Segars, Ph.D. Assistant Director DHT4C: Division of Infection Control 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) K241168
Device Name
System 83 Revolve® Endoscope Washer/Disinfector
Indications for Use (Describe)
The System 83 Revolve® Endoscope Washer!Disinfector is designed for the high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts. Flexible endoscopes that undergo bedside cleaning, are manually cleaned, and then exposed to the wash/disinfect cycle of the System 83 Revolve® may be high-level disinfected when the validated disinfection cycle of the System 83 Revolve® corresponds with the labeled contact conditions of the high-level disinfectant.
Type of Use (Select one or both, as applicable)
| ☐ Remediation Use (Part 21 CFR 201 Subpart D) | ☑ Own-Use Stock Use (21 CFR 201 Subpart G) |
|---|---|
| ----------------------------------------------- | -------------------------------------------- |
|_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Wassenburg Medical. The word "Wassenburg" is written in large, green, sans-serif letters. Below it, there is a thin gray line, and below that, the word "medical" is written in smaller, gray, sans-serif letters.
144 Railroad Drive lvyland, PA 18974
510(k) Summary K241168
510(k) Submitter/Owner
| 144 Railroad DriveIvyland, PA 18974Phone: (215) 364-1477Fax: (215) 364-7674 |
|---|
| Contact Person: Mario InfantiQuality Assurance / Regulatory Affairs ManagerPhone: (215) 364-1477 Ext: 242Email: mario.infanti@wassenburgmedical.com |
Wassenburg Medical, Inc.
Date Prepared: December 19, 2024
Subject Device
| Trade Name: | System 83 Revolve® Endoscope Washer/Disinfector |
|---|---|
| Common Name: | Automated Endoscope Reprocessor |
| Classification Name: | Endoscope and accessories (21 CFR § 876.1500) |
| Regulatory Class: | II |
| Product Code: | FEB |
Predicate Device
Wassenburg Medical, Inc., System 83 Plus Endoscope Washer/Disinfector, K173590
Device Description
The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical.
The System 83 Revolve® utilizes a processing chamber and the perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the rhannels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer.
Built-in sensors detect fluid levels, fluid flow, and the operating states of the components within System 83 Revolve". The system contains a Touchscreen (Graphical User Interface), a Barcode Scanner, an LED Indicator Strip that displays the process status, and a reprocessing chamber lid operation that is hands free.
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Indication for Use
The System 83 Revolve® Endoscope Washer/Disinfector is designed for the high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts. Flexible endoscopes that undergo bedside cleaning, are manually cleaned, and then exposed to the System 83 Revolve® may be high-level disinfected when the validated disinfection cycle of the System 83 Revolve® corresponds with the labeled contact conditions of the high-level disinfectant.
Summary of Technological Characteristics Compared to the Predicate Device
The subject and the predicate device have the same technological elements.
- Washer / Disinfector ●
- Operator and Software controlled processes .
- 120 VAC Energy Source
- Materials ●
Technological Characteristic Comparison
The following table compares the subject device to the predicate device with respect to intended use, indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence.
| Subject | Predicate (K173590) | ||
|---|---|---|---|
| Feature | Wassenburg Medical, Inc. | Wassenburg Medical, Inc. | Comparison |
| System 83 Revolve | System 83 Plus | ||
| Indicationsfor Use | The System 83 Revolve® EndoscopeWasher/Disinfector is designed for thehigh-level disinfection of one or twoflexible submersible endoscopes that areused in the gastrointestinal and pulmonarytracts. Flexible endoscopes that undergobedside cleaning, are manually cleaned,and then exposed to the wash/disinfectcycle of the System 83 Revolve® may behigh-level disinfected when the validateddisinfection cycle of the System 83Revolve® corresponds with the labeledcontact conditions of the high-leveldisinfectant. | System 83 Plus Washer/Disinfector isdesigned for the simultaneous high leveldisinfection of up to two flexiblesubmersible endoscopes that are used inthe gastrointestinal and/or pulmonarytracts. Flexible endoscopes that are pre-cleaned and manually cleaned, and thenexposed to the washing/disinfectioncycle of the System 83 Plus, may be highlevel disinfected when the disinfectioncycle corresponds to the System 83 Plusvalidated contact conditions of the highlevel disinfectant.Note: The System 83 Plus deviceincludes two models.• The System 83 Plus 2 has oneprocessing chamber that can process1 to 2 flexible endoscopes at a time.• The System 83 Plus 9 has twoprocessing chambers that can process1 to 2 flexible endoscopes at a time ineach independently operatedprocessing chamber for a total of up to4 endoscopes simultaneously. | Similar; however,the note is notapplicable for twomodels, becausethere is only asingle model,similar to theSystem 83 Plus 2. |
| IntendedUse | Washing and high-level disinfection of oneor two submersible flexible endoscopes | Washing and high-level disinfection of oneor two submersible flexible endoscopes | Identical. |
| Subject | Predicate (K173590) | ||
| Feature | Wassenburg Medical, Inc. | Wassenburg Medical, Inc. | Comparison |
| System 83 Revolve® | System 83 Plus | ||
| OperatingPrinciples /Technology | • The System 83 Revolve is amicroprocessor controlled device thatprovides delivery of solutions and fluidsto the endoscope, endoscopechannels, and accessories. Tergal 800detergent and Ortho-PhthalaldehydeSolution high-level disinfectants (OPA)are utilized to provide high leveldisinfection of an endoscope andaccessories. | • The System 83 Revolve is amicroprocessor controlled device thatprovides delivery of solutions and fluidsto the endoscope, endoscope channels,and accessories. Tergal 800 detergentand Ortho-Phthalaldehyde Solutionhigh-level disinfectants (OPA) areutilized to provide high level disinfectionof an endoscope and accessories. | Identical. |
| ProcessParameters | • Standardized cycle parameters thatcannot be altered by the operator. Thecritical process parameters monitoredduring processing:• HLD contact time• HLD temperature• Water Volume• HLD Volume• Channel flow and pressure | • Standardized cycle parameters thatcannot be altered by the operator. Thecritical process parameters monitoredduring processing:• HLD contact time• HLD temperature• Water Volume• HLD Volume• Channel flow and pressure | Identical. |
| ProcessMonitors | • Flow Switches monitor fluid flow perchannel• Sensors monitor fluid levels, draincompletion• Pressure switch detects pressureoutput• Thermostatic switches monitortemperature of the HLD in the Reservoirand Processing Chamber• Software monitors Ultrasonics duringWash / Rinse Phase• Optical sensor that monitor fluid overfill | • Flow Switches monitor fluid flow perchannel• Sensors monitor fluid levels, draincompletion• Pressure switch detects pressure output• Thermostatic switches monitortemperature of the HLD in the Reservoirand Processing Chamber• Software monitors Ultrasonics duringWash / Rinse Phase• Optical sensor that monitor fluid overfill | Identical. |
| DesignFeatures | • Intended for use with Tergal 800®Detergent and Ortho-PhthalaldehydeSolution high-level disinfectants (OPA)• Microprocessor controlled• Graphical User Interface that allowsthe operator to initiate and monitordevice functions (Touch screen)• Processor Lid is opened with handsfree operation• Devices with internal lumens areinterfaced with the processingchamber using adapters• HLD is transfer from/to Reservoir –Processing Chamber• Device automatically rinses the loadwith 0.1µ filtered water after the Washand HLD phases• Alcohol Injection / HEPA filtered air toaid in drying• Virtual Keyboard• Channel Monitoring LED (InternalMount)• Electromechanical foot-activatedswitch processing chamber lidoperation (Touch Pad) | • Intended for use with Tergal 800®Detergent and Ortho-PhthalaldehydeSolution high-level disinfectants (OPA)• Microprocessor controlled• Graphical User Interface that allows theoperator to initiate and monitor devicefunctions• Processor Lid is opened with hands freeoperation• Devices with internal lumens areinterfaced with the processing chamberusing adapters• HLD is transfer from/to Reservoir –Processing Chamber• Device automatically rinses the load with0.1µ filtered water after the Wash andHLD phases• Alcohol Injection / HEPA filtered air toaid in drying• Keyboard• Channel Monitoring LED (ExternalMount)• Foot Pedal processing chamber lidoperation | Similar. Subjectdevice includes aBarcode Scannerand LED ProcessStatus |
| Subject | Predicate (K173590) | ||
| Feature | Wassenburg Medical, Inc. | Wassenburg Medical, Inc. | Comparison |
| System 83 Revolve® | System 83 Plus | ||
| DesignFeatures(Continued) | • Mounted Printer• Circuit Breaker (Relocated to Rear)• Front Door Switches• Chassis/Lids design change• Barcode Scanner utilized for dataentry for users, patients,physicians, and instruments• LED Process Status Indicator | • Printer• Circuit Breaker• Front Door Switches• Hand Sprayer• Disinfectant Transfer | Similar. Subject deviceincludes a Barcode Scannerand LED Process Status |
Table 1. Predicate Device Comparison Table
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Image /page/6/Picture/0 description: The image is a logo for Wassenburg Medical. The word "Wassenburg" is in large, green, sans-serif font. Below that, there is a thin gray line that extends from under the left side of "Wassenburg" to the right. To the right of the gray line, the word "medical" is in a smaller, gray, sans-serif font.
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Image /page/7/Picture/0 description: The image shows the logo for Wassenburg Medical. The word "wassenburg" is written in large, green, sans-serif font. Below this, the word "medical" is written in a smaller, gray, sans-serif font. There is a gray line that extends from the left side of the word "wassenburg" to the left side of the word "medical."
The software verification and validation, EMC, electrical safety and cybersecurity testing performed (See Table 2) demonstrated that the software and electrical changes in the proposed device supports substantial equivalence to the predicate. The differences in technological characteristics between the subject System 83 Revolve and the predicate are minor and the testing demonstrates that the subject device performs comparably to the predicate device for the same intended use.
| Feature | SubjectWassenburg Medical, Inc.System 83 Revolve® | Predicate (K173590)Wassenburg Medical, Inc.System 83 Plus | Comparison |
|---|---|---|---|
| Cycle Parameters | |||
| HLD Contact Time | Minimum contact conditions of 12 minutes | Minimum contact conditions of 12 minutes | Identical. |
| HLD ContactTemperature | Minimum 20°C | Minimum 20°C | Identical. |
| Re-use Period | Not to exceed 14 days | Not to exceed 14 days | Identical. |
| HLD Reservoir Capacity | 8 gallons | 8 gallons | Identical. |
| Processing Chambers | Single Bay(Processing Chamber) | System 83 Plus 2 | Identical. |
| Processing ChamberCapacity | 6.5 gallons | 6.5 gallons | Identical. |
| Maximum Endoscopes | 2 | 2 | Identical. |
| Ultrasonic Function | 12 piezoelectric transducers operated at 40 kHz (±2) | 12 piezoelectric transducers operated at 40 kHz (±2) | Identical. |
| Cycles | • Wash Only• Wash/Disinfect• Disinfect; three rinses | • Wash Only• Wash/Disinfect• Disinfect; three rinses | Identical. |
| Full Wash/Disinfect CycleProcess Parameters | Wash, One Rinse, Disinfect, ThreeRinses, Alcohol and Air Purge | Wash, One Rinse, Disinfect, ThreeRinses, Alcohol and Air Purge | Identical. |
| Wash | 180 Seconds | 180 Seconds | Identical. |
| Rinse | 90 Seconds | 90 Seconds | Identical. |
| Air | 40 Seconds | 40 Seconds | Identical. |
| Disinfect | 720 Seconds | 720 Seconds | Identical. |
| Rinse 1 | 60 Seconds | 60 Seconds | Identical. |
| Rinse 2 | 60 Seconds | 60 Seconds | Identical. |
| Rinse 3 | 90 Seconds | 90 Seconds | Identical. |
| Air | 40 Seconds | 40 Seconds | Identical. |
| Alcohol and Air Purge | 120 Seconds | 120 Seconds | Identical. |
| Full Cycle Time | ≈23 minutes¹ | ≈23 minutes¹ | Identical. |
| ReprocessingOutput/Method | Electronic record; Printout | Electronic record; Printout | Identical. |
1Time does not include fill and drain time which can vary full cycle time.
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Image /page/8/Picture/0 description: The image shows the logo for Wassenburg medical. The word "Wassenburg" is written in green, block letters. Underneath the word "Wassenburg" is a gray line, and the word "medical" is written in gray, lowercase letters.
| Accessories | |||
|---|---|---|---|
| Detergent | Tergal 800® detergent | Tergal 800® detergent | Identical |
| High-LevelDisinfectant(HLD) | Ortho- Phthalaldehyde Solution high-leveldisinfectants (OPA) with a nominal activeingredient composition of 0.55%, having aMinimum Recommended Concentration(MRC) of 0.3% | Ortho- Phthalaldehyde Solution high-leveldisinfectants (OPA) with a nominal activeingredient composition of 0.55%, having aMinimum Recommended Concentration(MRC) of 0.3% | Identical |
| ScopeAdapters | Adapters are required to connect to alllumens of the endoscope | Adapters are required to connect to all lumensof the endoscope |
Summary of Non-Clinical Testing
Shown in Table 2 is the new testing that was performed to evaluate the System 83 Revolve Washer/Disinfector.
| Table 2. New Testing | |
|---|---|
| Testing | Acceptance Criteria | Pass/Fail |
|---|---|---|
| Electrical SafetyConformance | Meets requirements per:UL 61010-1:2012 Ed.3+R:06Jun2023 - Electrical Equipment for Measurement, Control, andLaboratory Use; Part 1: General Requirements CSA C22.2#61010-1:2012 Ed.3+U1;U2;A1;U3 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General Requirements IEC 61010-2-040:2021 Ed.3 - 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 Materials CSA C22.2#61010-2-040:2021 Ed.3 - 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 Materials | Pass |
| EMC Testing | IEC 60601-1-2 ed 4.1 (2020-09) - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests | Pass |
| SoftwareValidation | Meets requirements per:BS EN 62304, 2006+A1:2015 - Medical Device Software - software life cycle processes | Pass |
| Cybersecurity | Meets requirements per:AAMI TIR57, 2016(R)2019 - Principles of medical device security - risk management | Pass |
The subject device is the same device as the predicate with changes indicated in Table 1. The changes made to the subject device had no impact on the intended use of the subject device and no increased risk to reprocessing methods of the subject device. The following performance testing was performed for the predicate device and is used to support a determination of substantial equivalence.
| Table 3. Testing performed for Predicate Device | |||||
|---|---|---|---|---|---|
| ------------------------------------------------- | -- | -- | -- | -- | -- |
| Performance Testing | Description | Acceptance Criteria | Pass /Fail |
|---|---|---|---|
| Simulated use testing | High-level disinfection validation of representative worst caseendoscopes under worst case simulated use conditions | ≥6 Log reduction of M.terraeat all inoculated sites | Pass |
| In-use testing | High-level disinfection validation of representative worst caseendoscopes and valves under in-use conditions | <1 CFU at all processed testsites | Pass |
| Alcohol and detergentline disinfection | Disinfection of the alcohol and detergent injection lines | ≥6 Log reduction of M.terrae | Pass |
| Toxicologicalevaluation of residuesand rinsing validation | The safety of residual chemicals remaining on endoscopesafter high level disinfection was evaluated. The testing wasconducted in accordance with ISO 10993-5:2009 | Reactivity grade of 2 or less | Pass |
| Channel volumeflushing | Flushing validation testing of representative worst caseendoscopes under worst case simulated use conditions | Satisfy endoscopemanufacturer's manualflushing requirements | Pass |
| Water filtration systemvalidation | Validation testing under worst case simulated use conditions | <10 CFU per 100 mL | Pass |
| In-line Disc filtervalidation | Validation testing under worst case simulated use conditions | ≥99% efficient at removingparticles ≥250μm | Pass |
Clinical Testing: Not applicable
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Conclusion
The conclusions drawn from the testing demonstrates that the System 83 Revolve® Endoscope Washer/Disinfector is as safe, as effective, and performs as well as, or better than the legally marketed predicate device (K173590), Class II (21 CFR 876.1500), product code FEB.
§ 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.