Pure Vu

K160015 · Motus GI Medical Technologies , Ltd. · FDF · Sep 22, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160015
• Device Name: Pure Vu
• Applicant: Motus GI Medical Technologies , Ltd.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Sep 22, 2016
• Decision: SESE
• Submission Type: Traditional
• 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 intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the 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 doctor offices.

Device Story

Pure Vu System facilitates intraprocedural colon cleaning; connects to standard colonoscopes. System comprises Add-on device, Workstation (WS), WS Cartridge (WSC), and loading/unloading fixtures. WS utilizes cyclic irrigation (water/air mixture) and evacuation of colon contents (feces, blood, fluids). Physician operates cleansing process via external foot pedals. Used in hospitals/clinics by trained medical personnel. Enables irrigation/suction without removing tools from colonoscope working channel. Improves colon visualization by clearing debris; aids clinical decision-making during colonoscopy.

Clinical Evidence

Prospective animal study (swine, n=35) conducted. 100% of subjects achieved excellent colon cleansing level post-procedure, compared to 86% inadequate baseline. No mucosal injury or adverse events reported. Bench testing verified bond strength, pressure, and steering capabilities. Biocompatibility testing (cytotoxicity, irritation, sensitization) passed.

Technological Characteristics

System includes Add-on, Workstation, and WSC. Materials biocompatible per limited mucosal contact requirements. Electrical safety per IEC 60601-1 and EMC per IEC 60601-1-2. Principle: cyclic irrigation (water/air) and evacuation via pumps/regulators. Connectivity: physical connection to colonoscope and saline/water source. Software validated per IEC 62304.

Indications for Use

Indicated for intraprocedural cleaning of poorly prepared colons 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

• ClearPath Lower GI (K113050)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2016

Motus GI Medical Technologies Ltd. % Jonathan S. Kahan Partner Hogan Lovells US LLP Columbia Square, 555 13th Street, NW Washington, DC 20004

K160015 Re: Trade/Device Name: Pure Vu System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: August 22, 2016 Received: August 22, 2016

Dear Jonathan S. Kahan:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K160015

Device Name

Pure Vu System

Indications for Use (Describe)

The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the 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 doctor offices.

| Type of Use (Select one or both, as applicable) | | | | |
|--------------------------------------------------|---------------------------------------------|--|--|--|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | |

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Image /page/3/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 many small blue dots arranged in a circular 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, sans-serif font.

## 510(k) Summary

This 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.

| Submitter Name and<br>Address: | Motus GI Medical Technologies Ltd.<br>22 Keren Ha'yesod Str.<br>Tirat Carmel, 3902638<br>Israel<br>Tel.: [phone]<br>Fax: [phone] |
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| Contact Person: | Hagit Ephrath |
| Phone Number: | [phone] ext. 104 |
| Fax Number: | [phone] |
| Establishment<br>Registration Number: | K160015 |
| Date Prepared: | December 31, 2015 |
| Device Trade Name(s): | Pure Vu System |
| Device Common<br>Name: | Pure Vu System |
| Classification Name: | Endoscope and accessories |
| Classification: | Regulation No: 876.1500<br>Class: II<br>Panel: Gastroenterology and Urology |
| Predicate Device(s): | ClearPath Lower GI (manufactured by EasyGlide Ltd. and<br>the subject of 510(k) documents no. K113050) |
| General Device<br>Description: | The Pure Vu system comprises the following components:<br><br>Add-on - The Add-on is mounted on standard<br>commercially available colonoscopes allowing the<br>physician to clean the colon.<br><br>Workstation (WS) - The Workstation operates by using<br>cyclic irrigation and evacuation of colon content. Irrigation<br>is based on mixture of liquid and air. The workstation includes:<br>Monitoring & Control Unit that continuously<br>monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators<br>enabling water & airflow into the cleansing device. Outlet Module that includes pumps to evacuate<br>fecal matter and fluids from the colon. External on\off foot pedals that operate the<br>cleansing process to be used by the physician. WS Cartridge (WSC) connects the Add on to the WS and<br>saline or water bag.<br><br>Loading fixture to aid the nurse in mounting the Add-on<br>to a colonoscope.<br><br>Unloading fixture to aid the nurse in removing the Add-<br>on from a colonoscope. |
| Indications for<br>Use: | The Pure Vu System is intended to connect to standard<br>colonoscopes to help facilitate intraprocedural cleaning<br>of a poorly prepared colon by irrigating or cleaning the<br>colon and evacuating the irrigation fluid (water), feces<br>and other bodily fluids and matter, e.g. blood.<br><br>It is for use only by trained medical personnel located in<br>hospitals, clinics and doctor offices. |
| Technological<br>Characteristics: | The Pure Vu system intended use, principle of operation<br>and basic scientific technology are substantially<br>equivalent to the ClearPath Lower GI (K113050). Both are<br>connected to distal standard colonoscope during<br>colonoscopy procedure and irrigate the colon and<br>evacuate theirrigation fluid (water), feces, and other bodily<br>fluids and matter, e.g. blood. Both enable irrigation and<br>suction at any time during the procedure without removing<br>any toolswhich may be inserted in the colonoscope<br>workingchannel. Both devices have similar |
| | dimensions of the disposable, with similar irrigation and<br>evacuation head on the top of the colonoscope. |
| Substantial<br>Equivalence<br>Discussion | Comparison between Pure Vu System and its predicate<br>device regarding the intended use, principle of operation,<br>basic technological characteristics, biocompatibility and<br>their level of cleansing was conducted.<br>It is concluded that Pure Vu System is as safe and<br>effective as the ClearPath Lower GI (K113050). The Pure<br>Vu System has the same intended uses and similar<br>indications, technological characteristics, and principles of<br>operation as its predicate device. The minor technological<br>differences between the Pure Vu System and its predicate<br>devices raise no new issues of safety or effectiveness.<br>Performance data demonstrate that the Pure Vu System<br>is as safe and effective as the ClearPath Lower Gl. Thus,<br>the Motus GI System is substantially equivalent. |
| Performance Data: | Performance tests were conduct to verify that the Pure Vu<br>System meets the requirements for its intended use and is<br>substantial equivalence to the predicate device.<br><br><b>Biocompatibility</b><br>The Pure Vu Add-on is a surface contact device with a<br>limited contact (shorter than ≤24 hours) of the mucosal<br>tissue. The Pure Vu WS Cartridge (WSC) is an externally<br>communicating devices with a limited contact (shorter than<br>≤24 hours) of the mucosal tissue. As such, the following<br>biocompatibility tests were performed:<br>Cytotoxicity: Growth Inhibition Test - Extraction MethodIrritation: Intracutaneous Reactivity TestSensitization: Skin sensitizationAll materials and representative manufacturing processes<br>of the disposable kits passed the above tests and were<br>found biocompatible.<br><br><b>Electrical Safety and EMC</b><br>The Pure Vu System includes a workstation which controls irrigation and evacuation through the disposable attached to the colonoscope. In addition the System accessories, Loading and Unloading fixtures, includes inflation boxes enabling to mount the Add-on to a colonoscope prior to the clinical procedure and to remove the Add-on from a colonoscope after the procedure. |
| All 3 System components are designed and constructed<br>to conform with the IEC 60601-1 and 60601-1-2 medical<br>electrical equipment safety standard.<br>The System components were tested for mechanical and<br>electrical safety and are found as compliant with the IEC<br>60601-1 and 60601-1-2. | |
| Software validation<br>Pure Vu software has been validated per EC 62304:2006,<br>Medical Device Software and followed the companies<br>Software Life-Cycle Processes. | |
| Bench tests<br>Performance tests after preconditioning were conducted<br>and included the following aspects of the product: Bound<br>strength test, Pressure test, overall System performance,<br>Add-on movement, and steering segment abilities.<br>Bench test results confirm that the Pure Vu System meets<br>its requirements for its intended use. | |
| Pure Vu System – Animal study:<br>A prospective animal study was conducted to establish<br>the effectiveness and safety of Pure Vu.<br>The final configuration of Pure Vu System was used in 35<br>procedures in swine (66% female) performed by 4<br>experienced gastroenterologists. No immediate, such as<br>mucosal injury, or delayed adverse events were reported<br>in any of the 35 animal procedures.<br>In 30/35 (86%) of the procedures, the colon cleansing<br>level prior the use of the Pure Vu device was inadequate,<br>whereas 100% (35/35) of the animals had an excellent<br>colon cleansing level following the use of Pure Vu.<br>The physicians were satisfied with the Pure Vu ease of<br>advancement and navigation, level of stiffness, and its<br>torque response. They found Pure Vu easy to use and<br>intuitive to operate.<br>Pure Vu was found to be simple, safe and effective to be<br>used. | |

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Image /page/4/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 text "PURE-VU" is displayed in a large, sans-serif font, with each letter in blue. Below "PURE-VU", the text "by MOTUS GI" is written in a smaller, sans-serif font.

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Image /page/5/Picture/0 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 the "by MOTUS GI" text in a smaller font size below the "PURE-VU" text.

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Image /page/6/Picture/0 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 circular pattern. To the right of the circular design, the text "PURE-VU" is displayed in a sans-serif font, with the letters in a gradient of blue. Below the "PURE-VU" text, the words "by MOTUS GI" are written in a smaller, sans-serif font.

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Image /page/7/Picture/0 description: The image shows the logo for PURE-VU by MOTUS GI. The logo features a circular design made of blue dots on the left side. To the right of the dots is the text "PURE-VU" in a blue sans-serif font, with the "E" and "V" slightly lighter in color. Below the text is the phrase "by MOTUS GI" in a smaller, gray font.

| Conclusion: | Based on the technological characteristics and pre-clinical performance of the device, Motus GI medical Technologies Ltd. believes that the Pure Vu System and the predicate device selected are substantially equivalent and do not raise new issues of safety or effectiveness. |
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