Pure Vu System

K181437 · Motus GI Medical Technologies , Ltd. · FDF · Jun 21, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181437
• Device Name: Pure Vu System
• Applicant: Motus GI Medical Technologies , Ltd.
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Jun 21, 2018
• 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 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 System is an accessory for standard colonoscopes designed to improve visualization in poorly prepared colons. The system consists of a disposable oversleeve, a workstation (WS), a WS connector, and a loading fixture. The oversleeve mounts onto a colonoscope; it features irrigation nozzles and suction ports at the distal tip. The workstation provides simultaneous irrigation (water/saline and air) and evacuation of fecal matter and fluids. A physician operates the system via external foot pedals during the colonoscopy procedure. By clearing debris, blood, and feces, the device enables better mucosal visualization, potentially improving diagnostic or therapeutic outcomes. The system is used in clinical settings (hospitals, clinics, doctor offices) by trained medical personnel.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including steering tests, head pull tests, and pressure maintenance tests during the loading procedure.

Technological Characteristics

System comprises a disposable oversleeve (hydrophilic coating, 167cm length) and a workstation. Irrigation: 4 nozzles (0.7 mm²); Suction: 2 nozzles (12.5 mm²). Pressure: up to 23 psi. Flow rates: Water up to 645 cc/min, Air up to 1350 cc/min. Materials comply with ISO 10993. Electrical: 100V-240V, 50/60 Hz. Safety standards: IEC 60601-1, IEC 60601-1-2. Sterilization: Clean, non-sterile.

Indications for Use

Indicated for intra-procedural 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

• Pure Vu System (K173392)

Submission Summary (Full Text)

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June 21, 2018

Motus GI Medical Technologies Ltd. Hagit Ephrath VP of Health Economics, Clinical and Regulatory Affairs 22 Keren Ha'yesod St. Tirat Carmel, 3902638 ISRAEL

K181437 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 31, 2018 Received: June 1, 2018

Dear Hagit Ephrath:

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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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. Timothy Martin -S 2018.06.21 15:35:36 -04'00' for 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) K181437

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 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) | |
|--------------------------------------------------|---------------------------------------------|
| < 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 is in blue and features a circular pattern of dots on the left side. The text "PURE-VU" is in a sans-serif font, with a hyphen separating the words. Below the main text, in a smaller font, is the text "by MOTUS GI".

## 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: | Hagit Ephrath |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Establishment Regist.: | 3011816755 |
| Date Prepared: | May 31st, 2018 |
| Trade Name(s): | Pure Vu System |
| Common Name: | Pure Vu System |
| Classification Name: | Endoscope and accessories |
| Classification: | Regulation No: 876.1500Class: II<br>Panel: Gastroenterology and Urology |
| Predicate Device(s): | Pure Vu System (K173392) |
| Intended Use: | The Pure-Vu System is intended to connect to standard colonoscopes to<br>help facilitate intra-procedural cleaning 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, clinics,<br>and doctors' offices. |
| Reason for Submission: | The purpose of this special 510(k) is to modify the Pure Vu System to comply<br>with Slim colonoscope. Modifications include the followings:<br>1) Add SLIM Oversleeve which is a modification of the Oversleeve design<br>including narrowing the inner dimensions of the flexible head and leaf seal<br>of the inflation hub.<br>2) Revision of the IFU including adding reference to the Pure-Vu SLIM,<br>specify the range of colonoscope diameters for Pure-Vu and Pure-Vu<br>SLIM disposables.<br>3) Add SLIM Seal plug to the Loading Fixture to enable loading with the<br>revised SLIM Oversleeve.<br>In addition, the Oversleeves hydrophilic coating was extended to 60cm to<br>enhance advancement. |
| Technological<br>Characteristics: | The Pure Vu system comprises the following components:<br><br><b>Oversleeve</b> - The Oversleeve is mounted on Standard or Slim<br>commercially available colonoscopes to allow a physician to cleanse<br>the colon.<br><br><b>Workstation (WS)</b> - The Workstation operates by using simultaneous irrigation<br>and evacuation of colon content. Irrigation is based on a mixture of liquid (water<br>or saline) and gas (air). The workstation includes:<br> |
| | Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. 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. External foot pedals that control the cleansing process to be operated by a physician. |
| | <b>WS Connector (WSC)</b> connects the Oversleeve to the WS and saline or water bag.<br><br><b>Loading fixture</b> to aid the nurse in mounting the Oversleeve onto a<br>colonoscope. |
| Performance Data: | Performance tests were conducted for all modifications to the Pure Vu System.<br>Specifically, the company performed the following bench tests: Steering test Head pull test Loading and maintenance of pressure during the loading procedure |
| Substantial<br>Equivalence<br>Discussion: | The Pure Vu System has the same indications and similar technological<br>characteristics and principles of operation as its predicate device. Expending<br>the variety of colonoscopes to be used with the Pure-Vu System and the minor<br>differences between the device and its predicate device do not raise any new<br>issues of safety or effectiveness.<br>Performance data demonstrate that the Pure-Vu System is substantially<br>equivalent. |
| Conclusion: | The Pure-Vu System is substantially equivalent to the predicate device. |

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Image /page/4/Picture/0 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is in blue and gray. The "PURE-VU" part of the logo is in a sans-serif font, and the "by MOTUS GI" part of the logo is in a smaller, italicized font.

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Image /page/5/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 spiral pattern. To the right of the circular design is the text "PURE-VU" in a stylized blue font. Below the "PURE-VU" text is the text "by MOTUS GI" in a smaller, gray font.

| 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-proceduralcleaning 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.<br>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 |
| Operational<br>Procedures | | 1) Attachment to a standard and Slim<br>colonoscopes<br>2) Same<br>3) Same | 1) Attachment to a standard<br>colonoscope<br>2) Intra-procedure coloncleansing<br>during standard colonoscopy<br>3) Evacuation of water and feces |
| System<br>Components | | 1) Pure-Vu Workstation (Same)<br>2) Pure-Vu Standard Oversleeve<br>(Same) or Motus GI SLIM<br>Oversleeve<br>3) Pure-Vu WS Connector (Same)<br>4) Pure-Vu Loading Fixture (Same) | 1) Pure-Vu Workstation<br>2) Pure-Vu Oversleeve<br>3) Pure-Vu WS Connector<br>4) Pure-Vu Loading Fixture |
| Oversleeve outer<br>diameter | | Same | 21 mm |
| - | Modified Device | Predicate Device | |
| 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 | Same | Up to 23 psi | |
| Flow rate<br>(cc / min) | Same | Suction specifications: 0.5 Bar | |
| Dimensions<br>Workstation | Same | Water - Up to 645 cc/min<br>Air - up to 1350 cc/min | |
| Weight Workstation | Same | W460 \ D 520 \ H340 mm | |
| Electrical Input | Same | 25Kg | |
| Material | Same | 100V-240V<br>50/60 Hz | |
| Sterilization | Same | Complies with ISO 10993 | |
| Safety Standards | Same | Clean, Non-sterile | |
| | Same | Complies with:<br>• IEC 60601-1<br>• IEC 60601-1-2 | |

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Image /page/6/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 is the text "PURE-VU" in a stylized blue font. Below "PURE-VU" is the text "by MOTUS GI" in a smaller, gray font.