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 Description

The Pure Vu system comprises the following components:

Add-on - The Add-on is mounted on standard commercially available colonoscopes allowing the physician to clean the colon.

Workstation (WS) - The Workstation operates by using cyclic irrigation and evacuation of colon content. Irrigation is based on mixture of liquid and air. The workstation includes: Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators enabling water & airflow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. External on\off foot pedals that operate the cleansing process to be used by the physician.

WS Cartridge (WSC) connects the Add on to the WS and saline or water bag.

Loading fixture to aid the nurse in mounting the Add-on to a colonoscope.

Unloading fixture to aid the nurse in removing the Add-on from a colonoscope.

AI/ML Overview

The Pure Vu System is an accessory to standard colonoscopes designed to facilitate intraprocedural cleaning of a poorly prepared colon by irrigating, cleaning, and evacuating fluids and matter. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study for de novo approval. Therefore, the information provided mainly pertains to the performance validation for demonstrating substantial equivalence.

Here's an analysis of the available information regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, explicit quantitative acceptance criteria for clinical performance are not detailed as they would be for a de novo submission or a comprehensive clinical trial for a novel device. The primary "acceptance criterion" in a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented are primarily to support this claim, focusing on safety and effectiveness.

Aspect	Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance
Biocompatibility	Pass standard biocompatibility tests for mucosal-contacting devices (cytotoxicity, irritation, sensitization).	All materials and manufacturing processes of disposable kits passed cytotoxicity (Growth Inhibition Test - Extraction Method), irritation (Intracutaneous Reactivity Test), and sensitization (Skin sensitization) tests, and were found biocompatible.
Electrical Safety & EMC	Conform to IEC 60601-1 and 60601-1-2 medical electrical equipment safety standards.	System components (workstation, loading/unloading fixtures) were tested and found compliant with IEC 60601-1 and 60601-1-2.
Software Validation	Validate software per IEC 62304:2006 (Medical Device Software).	Pure Vu software has been validated per IEC 62304:2006 and followed the company's Software Life-Cycle Processes.
Bench Tests	Meet requirements for intended use regarding bound strength, pressure, overall system performance, Add-on movement, and steering segment abilities.	Performance tests after preconditioning confirmed the Pure Vu System meets its requirements for intended use, including bound strength, pressure, overall System performance, Add-on movement, and steering segment abilities.
Clinical Effectiveness	Comparable effectiveness to predicate device in improving colon cleansing level during colonoscopy.	A prospective animal study (in swine) showed that in 30/35 (86%) of procedures where the colon cleansing level was inadequate prior to Pure Vu, 100% (35/35) of animals had an excellent colon cleansing level following the use of Pure Vu. Physicians reported satisfaction with ease of advancement, navigation, stiffness, and torque response, finding it easy and intuitive to operate. No immediate or delayed adverse events were reported.
Clinical Safety	No immediate or delayed adverse events, such as mucosal injury.	No immediate adverse events (e.g., mucosal injury) or delayed adverse events were reported in any of the 35 animal procedures.

2. Sample Size Used for the Test Set and Data Provenance

Animal Study (Effectiveness & Safety):
- Sample Size: 35 procedures in swine.
- Data Provenance: Prospective animal study (swine model), likely conducted in a research facility. The specific country of origin is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Animal Study:
- Number of Experts: 4 experienced gastroenterologists.
- Qualifications: "Experienced gastroenterologists." No further details on years of experience or specific board certifications are provided in this summary.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for the animal study. The statement "The physicians were satisfied with the Pure Vu ease of advancement and navigation, level of stiffness, and its torque response. They found Pure Vu easy to use and intuitive to operate" suggests individual assessments by the gastroenterologists involved in the procedures. The colon cleansing level was presumably assessed by these same gastroenterologists.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. without AI Assistance

No MRMC comparative effectiveness study was done. The Pure Vu System is a mechanical device for colon cleaning during colonoscopy, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Pure Vu System is a physical medical device, not an algorithm or software-only diagnostic tool. It is used with human intervention (trained medical personnel using standard colonoscopes). Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The device's cleaning function is mechanical assistance during a procedure performed by a human.

7. The Type of Ground Truth Used

Animal Study: The ground truth for effectiveness (colon cleansing level) and safety (adverse events) in the animal study was established by the performing gastroenterologists based on direct observation during the procedures. This could be considered a form of expert assessment/consensus during live procedures.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of device performance. The animal study of 35 procedures appears to be the primary performance validation used for this 510(k) submission. For software validation (IEC 62304), there would have been internal testing and verification, but details on sample size for that are not provided in this summary.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a distinct training set for performance evaluation (as would be seen in AI/machine learning models) is not detailed in this 510(k) summary for this type of device. The verification and validation of the device's functional aspects (biocompatibility, electrical safety, bench tests) would involve established engineering and quality assurance practices rather than a "ground truth" derived from a training dataset in the clinical sense.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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 andAddress:	Motus GI Medical Technologies Ltd.22 Keren Ha'yesod Str.Tirat Carmel, 3902638IsraelTel.: +972-4-6214446Fax: +972-4-6214442
Contact Person:	Hagit Ephrath
Phone Number:	+972-4-6214447 ext. 104
Fax Number:	+972-4-6214442
EstablishmentRegistration Number:	K160015
Date Prepared:	December 31, 2015
Device Trade Name(s):	Pure Vu System
Device CommonName:	Pure Vu System
Classification Name:	Endoscope and accessories
Classification:	Regulation No: 876.1500Class: IIPanel: Gastroenterology and Urology
Predicate Device(s):	ClearPath Lower GI (manufactured by EasyGlide Ltd. andthe subject of 510(k) documents no. K113050)
General DeviceDescription:	The Pure Vu system comprises the following components:Add-on - The Add-on is mounted on standardcommercially available colonoscopes allowing thephysician to clean the colon.Workstation (WS) - The Workstation operates by usingcyclic irrigation and evacuation of colon content. Irrigationis based on mixture of liquid and air. The workstation includes:Monitoring & Control Unit that continuouslymonitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulatorsenabling water & airflow into the cleansing device. Outlet Module that includes pumps to evacuatefecal matter and fluids from the colon. External on\off foot pedals that operate thecleansing process to be used by the physician. WS Cartridge (WSC) connects the Add on to the WS andsaline or water bag.Loading fixture to aid the nurse in mounting the Add-onto a colonoscope.Unloading fixture to aid the nurse in removing the Add-on from a colonoscope.
Indications forUse:	The Pure Vu System is intended to connect to standardcolonoscopes to help facilitate intraprocedural cleaningof a poorly prepared colon by irrigating or cleaning thecolon and evacuating the irrigation fluid (water), fecesand other bodily fluids and matter, e.g. blood.It is for use only by trained medical personnel located inhospitals, clinics and doctor offices.
TechnologicalCharacteristics:	The Pure Vu system intended use, principle of operationand basic scientific technology are substantiallyequivalent to the ClearPath Lower GI (K113050). Both areconnected to distal standard colonoscope duringcolonoscopy procedure and irrigate the colon andevacuate theirrigation fluid (water), feces, and other bodilyfluids and matter, e.g. blood. Both enable irrigation andsuction at any time during the procedure without removingany toolswhich may be inserted in the colonoscopeworkingchannel. Both devices have similar
	dimensions of the disposable, with similar irrigation andevacuation head on the top of the colonoscope.
SubstantialEquivalenceDiscussion	Comparison between Pure Vu System and its predicatedevice regarding the intended use, principle of operation,basic technological characteristics, biocompatibility andtheir level of cleansing was conducted.It is concluded that Pure Vu System is as safe andeffective as the ClearPath Lower GI (K113050). The PureVu System has the same intended uses and similarindications, technological characteristics, and principles ofoperation as its predicate device. The minor technologicaldifferences between the Pure Vu System and its predicatedevices raise no new issues of safety or effectiveness.Performance data demonstrate that the Pure Vu Systemis as safe and effective as the ClearPath Lower Gl. Thus,the Motus GI System is substantially equivalent.
Performance Data:	Performance tests were conduct to verify that the Pure VuSystem meets the requirements for its intended use and issubstantial equivalence to the predicate device.BiocompatibilityThe Pure Vu Add-on is a surface contact device with alimited contact (shorter than ≤24 hours) of the mucosaltissue. The Pure Vu WS Cartridge (WSC) is an externallycommunicating devices with a limited contact (shorter than≤24 hours) of the mucosal tissue. As such, the followingbiocompatibility tests were performed:Cytotoxicity: Growth Inhibition Test - Extraction MethodIrritation: Intracutaneous Reactivity TestSensitization: Skin sensitizationAll materials and representative manufacturing processesof the disposable kits passed the above tests and werefound biocompatible.Electrical Safety and EMCThe 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 constructedto conform with the IEC 60601-1 and 60601-1-2 medicalelectrical equipment safety standard.The System components were tested for mechanical andelectrical safety and are found as compliant with the IEC60601-1 and 60601-1-2.
Software validationPure Vu software has been validated per EC 62304:2006,Medical Device Software and followed the companiesSoftware Life-Cycle Processes.
Bench testsPerformance tests after preconditioning were conductedand included the following aspects of the product: Boundstrength test, Pressure test, overall System performance,Add-on movement, and steering segment abilities.Bench test results confirm that the Pure Vu System meetsits requirements for its intended use.
Pure Vu System – Animal study:A prospective animal study was conducted to establishthe effectiveness and safety of Pure Vu.The final configuration of Pure Vu System was used in 35procedures in swine (66% female) performed by 4experienced gastroenterologists. No immediate, such asmucosal injury, or delayed adverse events were reportedin any of the 35 animal procedures.In 30/35 (86%) of the procedures, the colon cleansinglevel prior the use of the Pure Vu device was inadequate,whereas 100% (35/35) of the animals had an excellentcolon cleansing level following the use of Pure Vu.The physicians were satisfied with the Pure Vu ease ofadvancement and navigation, level of stiffness, and itstorque response. They found Pure Vu easy to use andintuitive to operate.Pure Vu was found to be simple, safe and effective to beused.

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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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Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.