← Product Code [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF) · K232922 # Pure-Vu EVS System (K232922) _Motus GI Medical Technologies , Ltd. · FDF · Oct 20, 2023 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K232922 ## Device Facts - **Applicant:** Motus GI Medical Technologies , Ltd. - **Product Code:** [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF.md) - **Decision Date:** Oct 20, 2023 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use The Pure-Vu EVS System is intended to connect to standard or slim colonoscopes and gastroscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning and evacuating irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood. It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices. ## Device Story Pure-Vu EVS System facilitates intra-procedural GI tract cleansing. System comprises reusable Workstation (WS) and disposable EVS Flex Channel/Umbilical Section. Flex Channel attaches to standard/slim colonoscopes or gastroscopes; delivers irrigation fluid (water/saline) and gas to break up debris; evacuates fluids/matter via suction channel to external waste container. Physician operates system via foot pedal to control cleansing, suction, and purging modes. Used in hospitals/clinics during endoscopy. Benefits include improved visualization by removing feces, blood, and other matter without removing tools from the endoscope's working channel. ## Clinical Evidence Bench testing only. Verification and validation included environmental conditioning, shelf-life simulation, dimensional compliance, head pull tests, steering tests, pressure/leakage tests, bond strength, and biocompatibility. Software verification/validation performed for modifications. System validation performed with 6 physicians. ## Technological Characteristics System includes reusable Workstation and disposable EVS Flex Channel. Materials comply with ISO 10993. Irrigation/suction principle; gas/fluid delivery. Colon version: 167cm length, 21mm max OD. Gastro version: 103cm length, 18mm max OD. Connectivity: foot pedal control. Sterilization: Clean, non-sterile. Electrical: 100V-240V/50/60 Hz. Safety: IEC 60601-1, IEC 60601-1-2. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Pure-Vu System ([K220007](/device/K220007.md)) ## Reference Devices - Pure-Vu System ([K210981](/device/K210981.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. October 20, 2023 Motus GI Medical Technologies Ltd. Mark Pomeranz CEO and President 22 Keren Ha'vesod Str. Tirat Carmel, 3902638 Israel Re: K232922 Trade/Device Name: Pure-Vu EVS System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDF, FDS Dated: September 19, 2023 Received: September 19, 2023 Dear Mark Pomeranz: 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. 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" {1}------------------------------------------------ (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 OS 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. 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 mediation-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). {2}------------------------------------------------ Sincerely, # Shanil P. Haugen -S Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K232922 Device Name Pure-Vu EVS System Indications for Use (Describe) The Pure-Vu EVS System is intended to comect to standard or slim colonoscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood. It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| |
☑ Prescription Use (Part 21 CFR 801 Subpart D)
|
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for "PURE-VU by MOTUS GI". The logo features a circular design on the left, composed of numerous small blue dots arranged in a spiral pattern. To the right of the circular design, the text "PURE-VU" is displayed in a sans-serif font, with the letters in varying shades of blue. Below "PURE-VU", the text "by MOTUS GI" is written in a smaller, italicized font. ## 510(k) Summary This special 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92. | Applicant Information: | Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod Str.
Tirat Carmel, 3902638 Israel
Tel .: +972-4-6214446
Fax: +972-4-6214442 | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Mark Pomeranz | | | Phone Number: | 908 745 8599 | | | Fax Number: | +972 733735181 | | | Establishment
Registration #: | 3011816755 | | | Date Prepared: | September 19, 2023 | | | Trade Name(s): | Pure-Vu EVS System | | | CommonName: | Pure-Vu EVS System | | | Classification Name: | Endoscope and accessories | | | Classification: | Regulation No: 876.1500 Class: II
Panel: Gastroenterology and Urology | | | Predicate Device(s): | Pure-Vu System (K220007) | | | Reference Device: | Pure-Vu System (K210981) | | | Indications for Use: | The Pure-Vu EVS System is intended to connect to standard or slim
colonoscopes and gastroscopes to help facilitate intra-procedural
cleansing of the GI tract by irrigating or cleaning and evacuating irrigation
fluid (water), feces, and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics
and doctors' offices. | | | Technological
Characteristics: | The Pure-Vu EVS System enables cleaning of the GI tract during
endoscopy using a standard or slim colonoscope with a length of
1630mm - 1710mm and an outer diameter range of 11.7mm -
13.2mm or gastroscope with a length of 950 – 1030mm and an outer
diameter of 9.2 - 10mm The EVS Flex Channel , which fits alongside
the endoscope and is connected to an external Workstation,
generates fluid and gas to break up debris The debris & fluids are
removed through the suction channel of the EVS Flex Channel into an
external waste container/bag. | | | The Pure-Vu EVS System consists of the following main components:
Disposable device which includes a Flex Channel section and an Umbilical Section (US) - The EVS Flex Channel fits alongside the endoscope to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates debris and fluids. The Workstation includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluid and matter from the GI tract. Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line. Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the GI tract. A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician. | | | | Performance Data | Verification and Validation Testing tests were conducted for all modifications to the Pure-Vu EVS System component as follows:
1) Pure-Vu EVS Disposables Environmental conditioning/Shelf-life simulation: All disposable units underwent preconditioning simulations tests at third party laboratories including but not limited to environmental conditioning and shelf-life simulation to demonstrate that the Pure-Vu EVS Disposables functionality meets the requirements following a simulated aging of one year. Dimensions test: Dimensional compliance of the disposables with the product specifications. Head Pull test: Verification of minimum force that causes linear movement of the EVS DD flexible head relative to the endoscope Steering test: Impact of the ability of the Pure-Vu EVS Flex Channel on an endoscope to bend in its distal steering section | | | | | | | | based on actuating the knobs on the handle of the colonoscope: | | | | System test: Measurement of different pressure, air and water flow values in order to confirm that the system complies with product specifications. | | | | Pressure test: Verification that the disposable withstands specific pressure without any leakage. | | | | Bond strength test: Verification of the tensile force of the bonds in the disposable device. | | | | The disposable package underwent environmental conditioning and distribution simulation by third party laboratories in order to demonstrate the integrity of the packaging and their accompanying labels following the simulation. In addition, biocompatibility testing was done to determine if there was any toxicological risk to the patient. | | | | 2) Pure-Vu EVS Workstation (WS)
The modified software of the WS underwent the following tests: | | | | Software verification and validation for the software modifications. | | | | 3) System Validation Testing
Validation testing for the entire Pure Vu EVS system (WS and disposable devices) was performed with 6 physicians. | | | | Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance. | | | Substantial
Equivalence
Discussion: | The Pure-Vu EVS System has the same intended use, principles of operation and similar technological characteristics as its predicate and reference devices. The differences between the subject device and its predicate and reference devices due to the modifications as detailed in this submission do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Pure-Vu EVS System is substantially equivalent. | | | Conclusion:… --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K232922](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K232922) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com