Pure Vu System

K191220 · Motus GI Medical Technologies , Ltd. · FDF · Jun 6, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K191220
• Device Name: Pure Vu System
• Applicant: Motus GI Medical Technologies , Ltd.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Jun 6, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodly fluids and matter, e.g. blood. It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.

Device Story

Pure-Vu System attaches to standard/slim colonoscopes to facilitate intra-procedural colon cleansing. System comprises reusable Workstation (WS), disposable Oversleeve (OS), and Umbilical Section (US). WS supplies irrigation (water/saline) and gas; evacuates fecal matter/fluids via OS suction channels. Physician operates via foot pedal to control cleansing, suction, and purging. Modifications include reduced WS size/weight, simplified evacuation algorithm, and improved OS interface. OS features extended hydrophilic coating (80cm) and 80A durometer polyurethane construction. Loading fixture and sealing clamp/plug redesigned for improved usability. Device enables cleaning without removing tools from endoscope working channel. Benefits include improved visualization in poorly prepared colons, potentially reducing procedure time or need for repeat colonoscopies.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including environmental conditioning, shelf-life simulation, transport simulation (ASTM D4169-16), biocompatibility (ISO 10993-5), and electrical safety/EMC (IEC 60601). Usability validation performed with 3 physicians and 15 nurses.

Technological Characteristics

Components: Reusable WS, disposable OS/US. Materials: 80A durometer polyurethane (OS). Dimensions: OS length 167cm; WS 250mm x 476mm x 358mm. Energy: 100V-240V electrical input. Principle: Irrigation/suction via external WS connected to colonoscope-mounted OS. Connectivity: Standalone. Sterilization: Clean, non-sterile. Software: Embedded control algorithm for fluid/gas delivery and suction.

Indications for Use

Indicated for intra-procedural cleaning of a poorly prepared colon in patients undergoing colonoscopy. For use by trained medical personnel in hospitals, clinics, and doctor offices.

Regulatory Classification

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 (K181437)

Submission Summary (Full Text)

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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.

June 6, 2019

Motus GI Medical Technologies Ltd. % Randy Prebula Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004

K191220 Re:

Trade/Device Name: Pure Vu System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: May 4, 2019 Received: May 7, 2019

Dear Randy Prebula:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Shanil P. Haugen, Ph.D. Acting Assistant Division 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

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## Indications for Use

510(k) Number (if known) K191220

Device Name Pure Vu System

Indications for Use (Describe)

The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodly fluids and matter, e.g. blood.

It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> |
| <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

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Image /page/3/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 multiple blue dots arranged in a spiral pattern. To the right of the circular design, the text "PURE-VU" is displayed in a stylized, sans-serif font, with the letters rendered in a gradient of blue shades. Below "PURE-VU", the text "by MOTUS GI" is written in a smaller, sans-serif font, with the "MOTUS" portion in a darker gray and the "GI" portion in a lighter gray.

## 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<br>Ha'yesod Str.<br>Tirat Carmel, 3902638Israel<br>Tel.: [phone]<br>Fax: [phone] |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ravit Peled |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Establishment<br>Registration #: | 3011816755 |
| Date Prepared: | May 4th, 2019 |
| Trade Name(s): | Pure Vu System |
| CommonName: | Pure Vu System |
| Classification Name: | Endoscope and accessories |
| Classification: | Regulation No: 876.1500 Class: II<br>Panel: Gastroenterology and Urology |
| Predicate Device(s): | Pure Vu System (K181437) |
| Intended Use: | The Pure-Vu System is intended to connect to standard colonoscopes to<br>help facilitate intra-proceduralcleaning of a poorly prepared colon by<br>irrigating or cleaning the colon and evacuating the irrigation fluid (water),<br>feces and other bodily fluids and matter, e.g. blood.<br>It is for use only by trained medical personnel located in hospitals,<br>clinics, and doctors' offices. |

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Image /page/4/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo features a circular design made up of small blue dots on the left side. To the right of the dots, the words "PURE-VU" are written in a stylized blue font. Below "PURE-VU", the words "by MOTUS GI" are written in a smaller, gray font.

| Reason for Submission: | The purpose of this special 510(k) is to improve the overall ease of<br>use of the Pure-Vu system by reduce the size and weight of the Work<br>Station (WS) for better access in the procedure room and easier<br>mobility. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The fundamental scientific technology of the device remains<br>unchanged. Modifications have been made as listed below: |
| | • Pure-Vu Workstation modifications to improve the usability of<br>the system. The key improvements are reducing the size and<br>weight of the WS, simplifying the evacuation algorithm during<br>cleansing and improve the interface with the disposable<br>Oversleeve. The embedded software was updated to comply<br>with the WS design modifications. |
| | • Disposable Oversleeve modifications include extending the<br>length of the hydrophilic lubricious coating from 60 cm to 80<br>cm on the distal end of the Pure-Vu Oversleeve to enhance<br>advancement, Outer and inner sleeves are made of 80A<br>durometer polyurethane as opposed to combination of 80A<br>and 70A durometer polyurethane and added an In-Line<br>connector to ease management and assembly of the<br>Umbilical tubing. All manufacturing locations and key<br>processes remain the same. |
| | • The loading fixture was modified to reduce its size and weight.<br>The sealing clamp and plug used on the distal end of the<br>device was modified to be a one-piece assembly that is now<br>disposable to improve ease of loading. No new materials were<br>introduced and there were no modifications to the compressor<br>box (the only electrical assembly part of the fixture) that<br>generates the inflation pressure used to open the sleeve for<br>loading. In addition, the unloading process is performed with<br>the disposable sealing clamp as opposed to an off the shelf<br>Kelly clamp used for unloading in the predicate device. |

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Image /page/5/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo features a circular design on the left, composed of multiple blue dots arranged in a spiral pattern. To the right of the circular design is the text "PURE-VU" in a bold, sans-serif font, with the letters in varying shades of blue. Below "PURE-VU" is the text "by MOTUS GI" in a smaller, lighter font.

| Technological<br>Characteristics: | The Pure-Vu System enables colon cleansing during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and a slim colonoscope outer diameter range of 11.7mm – 13.3mm and a standard colonoscope outer diameter range of 12.8mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid to break up feces. The fecal matter & fluids are removed through the suction channels of the Oversleeve into an external waste receptacle.<br>The Pure-Vu System consists of the following main components:<br>Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the colon 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/saline and gas, and evacuates fecal material & fluids. The Workstation [WS] includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of fluids and feces from the colon. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician. Loading fixture- The loading fixture is reusable and aids in assembling the Oversleeve onto the colonoscope. Unloading aids - A disposable 60cc lure lock syringe and 3-way stopcock used in unloading the Oversleeve from the colonoscope are provided in the disposable packaging. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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Image /page/6/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is primarily blue, with a circular pattern of blue dots on the left side. The text "PURE-VU" is in a sans-serif font, with a gradient effect from dark to light blue. "by MOTUS GI" is in a smaller font size and is located below the "PURE-VU" text.

| Performance Data: | Verification and Validation Testing tests were conducted for all modifications<br>to the Pure Vu System component as follows: |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1) Pure- Vu Disposable parts (Oversleeve and Workstation connector) |
| | All disposable units undergone preconditioning simulations tests performed by<br>Carmel Environmental Laboratory (Israel) including but not limited to<br>Environmental conditioning and Shelf life simulation to demonstrate that the<br>Pure Vu Disposables functionality meets the requirements following a<br>simulated aging of one year. |
| | Simulation (bench test) was conducted and to support the sub system and<br>system's use as intended and its substantial equivalence as follows:<br>Dimensions Test Steering (Angulation) System Test Pressure Test Bond Strength Test |
| | Disposable package undergone environmental conditioning and transport<br>simulation (by DDL labs) in order to demonstrate efficiency and integrity of the<br>packaging and their accompanying labels following the simulation.<br>In addition, biocompatibility testing was done to determine if there was any<br>toxicological risk to the patient as per ISO 10993-5. |
| | 2) Pure-Vu Workstation (WS)<br>The Modified WS undergone the following tests:<br>Environmental conditions and distribution cycle simulation performed<br>by Hermon Laboratory (Israel) as per ASTM D4169-16 along with<br>shipping integrity. After the preconditioning simulations, the Pure Vu<br>WS undergone verification testing including visual inspection and<br>functionality tests. The embedded updated software to comply with the WS design<br>modifications was tested via software validation. Safety and EMC tests per IEC 60601 Usability and validation testing for the WS and disposable device has<br>been performed in two separate studies with 3 physicians and 15<br>nurses. |
| | 3) Pure-Vu Loading and Unloading<br>Validation testing for the new sealing plug used during loading and<br>unloading was performed. Environmental conditions and distribution cycle simulation performed<br>by DDL (USA) as per ASTM D4169-16 along with shipping integrity.<br>After the preconditioning simulations, the Pure Vu WS undergone<br>verification testing including visual inspection and functionality tests. |
| | Design verification and validation testing concluded that the design changes<br>have no impact on the Pure-Vu System performance. |
| | |

L

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Image /page/7/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is in blue and gray. To the left of the text is a circular design made up of many small blue circles.

| Substantial<br>Equivalence<br>Discussion: | The Pure Vu System has the same intended use, indications, principles of operation<br>and similar technological characteristics as its predicate device. The differences<br>between the device and its predicate device due to the modifications as detailed in<br>this submission do not raise any new issues of safety or effectiveness.<br>Performance data demonstrate that the Pure-Vu System is substantially equivalent. |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The Pure-Vu System is substantially equivalent to the predicate device.<br>The intended of use of this product meets the requirements of 21 CFR 801.4 |

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Image /page/8/Picture/1 description: The image shows the logo for PURE-VU by MOTUS GI. The logo features a circular design on the left, composed of many small blue circles. To the right of the circular design is the text "PURE-VU" in a blue gradient color. Below the text "PURE-VU" is the text "by MOTUS GI" in a smaller font size.

| Characteristics Comparison: | | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Modified Device | Predicate Device |
| Manufacturer | Motus GI Medical Technologies Ltd. | |
| Description | Pure-Vu System | |
| Intended Use | Same | The Pure-Vu System is intended to<br>connect to standard colonoscopes to<br>help facilitate intra-procedural cleaning of<br>a poorly prepared colon by irrigating or<br>cleaning the colon and evacuating the<br>irrigation fluid (water), feces and other<br>bodily fluids and matter, e.g. blood. |
| | | It is for use only by trained medical<br>personnel located in hospitals, clinics |
| Environment of Use | Same | Hospitals, clinics and doctors' offices |
| Prescriptive | Same | Yes, only trained medical personnel |
| Disposable | Same | Single patient, single use |
| Distal tip design | Same | Multi irrigation hole Two distal suction holes |
| Principle of<br>operation | Same | Distal attachment to an endoscope,<br>sleeve ensuring attachment along entire<br>length, suction and irrigation tubes<br>running along the endoscope, suction<br>and irrigation head at the distal tip.<br>Enables irrigation and suction at any time<br>during the procedure without removing<br>any tools, which may be inserted in the<br>endoscope's working channel. |
| Operational<br>Procedures | 1) Same<br>2) Same<br>3) Same | 1) Attachment to a standard and<br>Slim colonoscope<br>2) Intra-procedure colon cleansing<br>during standard colonoscopy<br>3) Evacuation of water and feces |
| System<br>Components | The Pure-Vu System consists of the<br>same main components as the<br>predicate device but each one has had<br>minor modifications. The detailed<br>information on the modifications doneplease refer to: Section 9: "Design<br>Control Activities" | 1) Pure-Vu Workstation<br>2) Pure-Vu Standard and Slim<br>colonoscope Oversleeves<br>3) Pure-Vu WS Connector<br>4) Pure-Vu Loading Fixture |

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Image /page/9/Picture/0 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo features a circular design on the left, composed of multiple blue dots arranged in a circular pattern. To the right of the circular design, the word "PURE-VU" is written in large, blue, sans-serif font. Below the "PURE-VU" text, the words "by MOTUS GI" are written in a smaller, gray, sans-serif font.

| Oversleeve outer<br>diameter | Same | 21 mm |
|---------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------|
| Irrigation &<br>suction system | Same | Irrigation: 4 nozzle x 0.7 mm²<br>Suction: 2 nozzles x 12.5 mm² |
| Disposable length | Same | 167 cm attached to colonoscope |
| Air / Water<br>pressure<br>specification<br>(bar) | Same<br>Same | Up to 23 psi<br>Suction specifications: - 0.5 Bar |
| Flow rate<br>(cc / min) | Same | Water - Up to 645 cc/min<br>Air - up to 1350 cc/min |
| Dimensions<br>Workstation | W250mm \ D476mm (516 with pump<br>head) \ H-358 mm | W460 \ D480 (520 with pump head) \ H340<br>mm |
| Weight Workstation | 18Kg | 25Kg |
| Electrical Input | Same | 100V-240V<br>50/60 Hz |
| Material | Same | Complies with ISO 10993 |
| Sterilization | Same | Clean, Non-sterile |
| Safety Standards | Same | Complies with:<br>• IEC 60601-1<br>• IEC 60601-1-2 |