(237 days)
No
The description focuses on automated, computer-controlled electro-mechanical processes and sensor-based detection, without mentioning AI or ML algorithms for decision-making or analysis.
No.
This device is designed for the high-level disinfection of endoscopes, not for direct therapeutic treatment of a patient. It is a reprocessor for medical devices.
No
The device is an endoscope washer/disinfector, designed for cleaning and high-level disinfection of endoscopes, not for diagnosing medical conditions.
No
The device description clearly states it is an "automated, computer controlled, electro-mechanical system" with physical components like a processing chamber, sensors, touchscreen, barcode scanner, and LED indicator strip. It is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts." This describes a process for cleaning and disinfecting medical devices, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details an automated system for washing, disinfecting, rinsing, and flushing endoscopes. It focuses on the physical process of reprocessing the endoscopes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the effectiveness of the disinfection process (log reduction of microorganisms, residual chemicals, flushing efficiency), which is relevant to device reprocessing, not diagnostic testing.
In summary, the System 83 Revolve® Endoscope Washer/Disinfector is a medical device used for reprocessing other medical devices (endoscopes), not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications 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 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.
Product codes
FEB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal and pulmonary tracts
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 | 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 |
§ 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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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.
1
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
2
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
3
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 Drive
Ivyland, PA 18974
Phone: (215) 364-1477
| Fax: (215) 364-7674 |
|---|
| Contact Person: Mario Infanti |
| Quality Assurance / Regulatory Affairs Manager |
| Phone: (215) 364-1477 Ext: 242 |
| Email: 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.
5
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 | ||
| Indications | |||
| 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 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. | System 83 Plus Washer/Disinfector is | ||
| designed for the simultaneous high level | |||
| disinfection of up to two flexible | |||
| submersible endoscopes that are used in | |||
| the gastrointestinal and/or pulmonary | |||
| tracts. Flexible endoscopes that are pre- | |||
| cleaned and manually cleaned, and then | |||
| exposed to the washing/disinfection | |||
| cycle of the System 83 Plus, may be high | |||
| level disinfected when the disinfection | |||
| cycle corresponds to the System 83 Plus | |||
| validated contact conditions of the high | |||
| level disinfectant. | |||
| Note: The System 83 Plus device | |||
| includes two models. | |||
| • The System 83 Plus 2 has one | |||
| processing chamber that can process | |||
| 1 to 2 flexible endoscopes at a time. | |||
| • The System 83 Plus 9 has two | |||
| processing chambers that can process | |||
| 1 to 2 flexible endoscopes at a time in | |||
| each independently operated | |||
| processing chamber for a total of up to | |||
| 4 endoscopes simultaneously. | Similar; however, | ||
| the note is not | |||
| applicable for two | |||
| models, because | |||
| there is only a | |||
| single model, | |||
| similar to the | |||
| System 83 Plus 2. | |||
| Intended | |||
| Use | Washing and high-level disinfection of one | ||
| or two submersible flexible endoscopes | Washing and high-level disinfection of one | ||
| or two submersible flexible endoscopes | Identical. | ||
| Subject | Predicate (K173590) | ||
| Feature | Wassenburg Medical, Inc. | Wassenburg Medical, Inc. | Comparison |
| System 83 Revolve® | System 83 Plus | ||
| Operating | |||
| Principles / | |||
| Technology | • The System 83 Revolve is a | ||
| microprocessor controlled device that | |||
| provides delivery of solutions and fluids | |||
| to the endoscope, endoscope | |||
| channels, and accessories. Tergal 800 | |||
| detergent and Ortho-Phthalaldehyde | |||
| Solution high-level disinfectants (OPA) | |||
| are utilized to provide high level | |||
| disinfection of an endoscope and | |||
| accessories. | • The System 83 Revolve is a | ||
| microprocessor controlled device that | |||
| provides delivery of solutions and fluids | |||
| to the endoscope, endoscope channels, | |||
| and accessories. Tergal 800 detergent | |||
| and Ortho-Phthalaldehyde Solution | |||
| high-level disinfectants (OPA) are | |||
| utilized to provide high level disinfection | |||
| of an endoscope and accessories. | Identical. | ||
| Process | |||
| Parameters | • Standardized cycle parameters that | ||
| cannot be altered by the operator. The | |||
| critical process parameters monitored | |||
| during processing: | |||
| • HLD contact time | |||
| • HLD temperature | |||
| • Water Volume | |||
| • HLD Volume | |||
| • Channel flow and pressure | • Standardized cycle parameters that | ||
| cannot be altered by the operator. The | |||
| critical process parameters monitored | |||
| during processing: | |||
| • HLD contact time | |||
| • HLD temperature | |||
| • Water Volume | |||
| • HLD Volume | |||
| • Channel flow and pressure | Identical. | ||
| Process | |||
| Monitors | • Flow Switches monitor fluid flow per | ||
| channel | |||
| • Sensors monitor fluid levels, drain | |||
| completion | |||
| • Pressure switch detects pressure | |||
| output | |||
| • Thermostatic switches monitor | |||
| temperature of the HLD in the Reservoir | |||
| and Processing Chamber | |||
| • Software monitors Ultrasonics during | |||
| Wash / Rinse Phase | |||
| • Optical sensor that monitor fluid overfill | • Flow Switches monitor fluid flow per | ||
| channel | |||
| • Sensors monitor fluid levels, drain | |||
| completion | |||
| • Pressure switch detects pressure output | |||
| • Thermostatic switches monitor | |||
| temperature of the HLD in the Reservoir | |||
| and Processing Chamber | |||
| • Software monitors Ultrasonics during | |||
| Wash / Rinse Phase | |||
| • Optical sensor that monitor fluid overfill | Identical. | ||
| Design | |||
| Features | • Intended for use with Tergal 800® | ||
| Detergent and Ortho-Phthalaldehyde | |||
| Solution high-level disinfectants (OPA) | |||
| • Microprocessor controlled | |||
| • Graphical User Interface that allows | |||
| the operator to initiate and monitor | |||
| device functions (Touch screen) | |||
| • Processor Lid is opened with hands | |||
| free operation | |||
| • Devices with internal lumens are | |||
| interfaced with the processing | |||
| chamber using adapters | |||
| • HLD is transfer from/to Reservoir – | |||
| Processing Chamber | |||
| • Device automatically rinses the load | |||
| with 0.1µ filtered water after the Wash | |||
| and HLD phases | |||
| • Alcohol Injection / HEPA filtered air to | |||
| aid in drying | |||
| • Virtual Keyboard | |||
| • Channel Monitoring LED (Internal | |||
| Mount) | |||
| • Electromechanical foot-activated | |||
| switch processing chamber lid | |||
| operation (Touch Pad) | • Intended for use with Tergal 800® | ||
| Detergent and Ortho-Phthalaldehyde | |||
| Solution high-level disinfectants (OPA) | |||
| • Microprocessor controlled | |||
| • Graphical User Interface that allows the | |||
| operator to initiate and monitor device | |||
| functions | |||
| • Processor Lid is opened with hands free | |||
| operation | |||
| • Devices with internal lumens are | |||
| interfaced with the processing chamber | |||
| using adapters | |||
| • HLD is transfer from/to Reservoir – | |||
| Processing Chamber | |||
| • Device automatically rinses the load with | |||
| 0.1µ filtered water after the Wash and | |||
| HLD phases | |||
| • Alcohol Injection / HEPA filtered air to | |||
| aid in drying | |||
| • Keyboard | |||
| • Channel Monitoring LED (External | |||
| Mount) | |||
| • Foot Pedal processing chamber lid | |||
| operation | Similar. Subject | ||
| device includes a | |||
| Barcode Scanner | |||
| and LED Process | |||
| Status | |||
| Subject | Predicate (K173590) | ||
| Feature | Wassenburg Medical, Inc. | Wassenburg Medical, Inc. | Comparison |
| System 83 Revolve® | System 83 Plus | ||
| Design | |||
| Features | |||
| (Continued) | • Mounted Printer | ||
| • Circuit Breaker (Relocated to Rear) | |||
| • Front Door Switches | |||
| • Chassis/Lids design change | |||
| • Barcode Scanner utilized for data | |||
| entry for users, patients, | |||
| physicians, and instruments | |||
| • LED Process Status Indicator | • Printer | ||
| • Circuit Breaker | |||
| • Front Door Switches | |||
| • Hand Sprayer | |||
| • Disinfectant Transfer | Similar. Subject device | ||
| includes a Barcode Scanner | |||
| and 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 | Subject
Wassenburg 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 Contact
Temperature | 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 Chamber
Capacity | 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 Cycle
Process Parameters | Wash, One Rinse, Disinfect, Three
Rinses, Alcohol and Air Purge | Wash, One Rinse, Disinfect, Three
Rinses, 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. |
| Reprocessing
Output/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-Level | |||
| Disinfectant | |||
| (HLD) | Ortho- Phthalaldehyde Solution high-level | ||
| disinfectants (OPA) with a nominal active | |||
| ingredient composition of 0.55%, having a | |||
| Minimum Recommended Concentration | |||
| (MRC) of 0.3% | Ortho- Phthalaldehyde Solution high-level | ||
| disinfectants (OPA) with a nominal active | |||
| ingredient composition of 0.55%, having a | |||
| Minimum Recommended Concentration | |||
| (MRC) of 0.3% | Identical | ||
| Scope | |||
| Adapters | Adapters are required to connect to all | ||
| lumens of the endoscope | Adapters are required to connect to all lumens | ||
| of 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 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 |
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 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 |