(31 days)
The Pure-Vu EVS System is intended to connect to standard or slim colonoscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices.
The Pure-Vu EVS System enables cleaning of the GI tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.2mm or gastroscope with a length of 950 – 1030mm and an outer diameter of 9.2 - 10mm The EVS Flex Channel , which fits alongside the endoscope and is connected to an external Workstation, generates fluid and gas to break up debris The debris & fluids are removed through the suction channel of the EVS Flex Channel into an external waste container/bag.
The Pure-Vu EVS System consists of the following main components:
Disposable device which includes a Flex Channel section and an Umbilical Section (US) - The EVS Flex Channel fits alongside the endoscope to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates debris and fluids. The Workstation includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluid and matter from the GI tract. Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line. Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the GI tract. A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician.
The provided text describes modifications to the Pure-Vu EVS System and its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or a study proving the device meets those criteria, nor any of the detailed information requested.
The document is a 510(k) summary for the Pure-Vu EVS System, a device intended for intra-procedural GI tract cleansing during endoscopy. It focuses on demonstrating substantial equivalence to previously cleared devices (Pure-Vu System K220007 and K210981) due to design changes.
Here's an analysis of the provided information against your requested points:
1. A table of acceptance criteria and the reported device performance
- Not found. The document includes tables comparing the technological characteristics of the subject device with its predicate, such as dimensions, flow rates, and materials. However, it does not present specific acceptance criteria (e.g., minimum pressure tolerance, maximum steering angle impact) with corresponding reported performance values against those criteria. It states that "Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance," but does not provide the specifics of that performance or the criteria used to judge it.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: For "System Validation Testing," it states "Validation testing for the entire Pure Vu EVS system (WS and disposable devices) was performed with 6 physicians." This is the only mention of human-involved testing with a specific number.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not found. There is no mention of establishing ground truth or the qualifications of the 6 physicians involved in the validation testing. Their role is described as performing "Validation testing," not establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not found. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not found. This is not an AI-powered device, and no MRMC study or comparative effectiveness study involving human readers or AI assistance is mentioned. The device is a physical system for irrigation and cleaning.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. The device is a mechanical/electro-mechanical system, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not found. The document does not describe the establishment or type of ground truth for any evaluation.
8. The sample size for the training set
- N/A. As this is not an AI/machine learning device, there is no concept of a "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set, this is not applicable.
In summary, the provided document outlines the technical specifications, modifications, and verification/validation testing conducted for the Pure-Vu EVS System to demonstrate its substantial equivalence to previously cleared devices. It details various engineering tests (environmental conditioning, dimensions, head pull, steering, pressure, bond strength, software verification) and mentions system validation with 6 physicians. However, it does not provide the kind of detailed clinical study data, acceptance criteria, or ground truth information typically associated with performance evaluation against specific clinical endpoints or for AI/software-as-a-medical-device.
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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.
October 20, 2023
Motus GI Medical Technologies Ltd. Mark Pomeranz CEO and President 22 Keren Ha'vesod Str. Tirat Carmel, 3902638 Israel
Re: K232922
Trade/Device Name: Pure-Vu EVS System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDF, FDS Dated: September 19, 2023 Received: September 19, 2023
Dear Mark Pomeranz:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232922
Device Name Pure-Vu EVS System
Indications for Use (Describe)
The Pure-Vu EVS System is intended to comect to standard or slim colonoscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/1 description: The image contains the logo for "PURE-VU by MOTUS GI". The logo features a circular design on the left, composed of numerous small blue dots arranged in a spiral pattern. To the right of the circular design, the text "PURE-VU" is displayed in a sans-serif font, with the letters in varying shades of blue. Below "PURE-VU", the text "by MOTUS GI" is written in a smaller, italicized font.
510(k) Summary
This special 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Applicant Information: | Motus GI Medical Technologies Ltd.22 Keren Ha'yesod Str.Tirat Carmel, 3902638 IsraelTel .: +972-4-6214446Fax: +972-4-6214442 | |
|---|---|---|
| Contact Person: | Mark Pomeranz | |
| Phone Number: | 908 745 8599 | |
| Fax Number: | +972 733735181 | |
| EstablishmentRegistration #: | 3011816755 | |
| Date Prepared: | September 19, 2023 | |
| Trade Name(s): | Pure-Vu EVS System | |
| CommonName: | Pure-Vu EVS System | |
| Classification Name: | Endoscope and accessories | |
| Classification: | Regulation No: 876.1500 Class: IIPanel: Gastroenterology and Urology | |
| Predicate Device(s): | Pure-Vu System (K220007) | |
| Reference Device: | Pure-Vu System (K210981) | |
| Indications for Use: | The Pure-Vu EVS System is intended to connect to standard or slimcolonoscopes and gastroscopes to help facilitate intra-proceduralcleansing of the GI tract by irrigating or cleaning and evacuating irrigationfluid (water), feces, and other bodily fluids and matter, e.g. blood.It is for use only by trained medical personnel located in hospitals, clinicsand doctors' offices. | |
| TechnologicalCharacteristics: | The Pure-Vu EVS System enables cleaning of the GI tract duringendoscopy using a standard or slim colonoscope with a length of1630mm - 1710mm and an outer diameter range of 11.7mm -13.2mm or gastroscope with a length of 950 – 1030mm and an outerdiameter of 9.2 - 10mm The EVS Flex Channel , which fits alongsidethe endoscope and is connected to an external Workstation,generates fluid and gas to break up debris The debris & fluids areremoved through the suction channel of the EVS Flex Channel into anexternal waste container/bag. | |
| The Pure-Vu EVS System consists of the following main components:Disposable device which includes a Flex Channel section and an Umbilical Section (US) - The EVS Flex Channel fits alongside the endoscope to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates debris and fluids. The Workstation includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluid and matter from the GI tract. Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line. Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the GI tract. A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician. | ||
| Performance Data | Verification and Validation Testing tests were conducted for all modifications to the Pure-Vu EVS System component as follows:1) Pure-Vu EVS Disposables Environmental conditioning/Shelf-life simulation: All disposable units underwent preconditioning simulations tests at third party laboratories including but not limited to environmental conditioning and shelf-life simulation to demonstrate that the Pure-Vu EVS Disposables functionality meets the requirements following a simulated aging of one year. Dimensions test: Dimensional compliance of the disposables with the product specifications. Head Pull test: Verification of minimum force that causes linear movement of the EVS DD flexible head relative to the endoscope Steering test: Impact of the ability of the Pure-Vu EVS Flex Channel on an endoscope to bend in its distal steering section | |
| based on actuating the knobs on the handle of the colonoscope: | ||
| System test: Measurement of different pressure, air and water flow values in order to confirm that the system complies with product specifications. | ||
| Pressure test: Verification that the disposable withstands specific pressure without any leakage. | ||
| Bond strength test: Verification of the tensile force of the bonds in the disposable device. | ||
| The disposable package underwent environmental conditioning and distribution simulation by third party laboratories in order to demonstrate the integrity of the packaging and their accompanying labels following the simulation. In addition, biocompatibility testing was done to determine if there was any toxicological risk to the patient. | ||
| 2) Pure-Vu EVS Workstation (WS)The modified software of the WS underwent the following tests: | ||
| Software verification and validation for the software modifications. | ||
| 3) System Validation TestingValidation testing for the entire Pure Vu EVS system (WS and disposable devices) was performed with 6 physicians. | ||
| Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance. | ||
| SubstantialEquivalenceDiscussion: | The Pure-Vu EVS System has the same intended use, principles of operation and similar technological characteristics as its predicate and reference devices. The differences between the subject device and its predicate and reference devices due to the modifications as detailed in this submission do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Pure-Vu EVS System is substantially equivalent. | |
| Conclusion: | The Pure-Vu EVS System is substantially equivalent to the predicate and reference devices. The intended of use of this product meets the requirements of 21 CFR 801.4 | |
| Subject Device | Predicate DeviceK220007 | |
| Manufacturer | Motus GI Medical Technologies Ltd. | |
| Description | Pure-Vu EVS System | Pure-Vu EVS System |
| Indications for Use | The Pure-Vu EVS System isintended to connect to standard orslim colonoscopes and gastroscopesto help facilitate intra-proceduralcleansing of the GI tract by irrigatingor cleaning and evacuating irrigationfluid (water), feces, and other bodilyfluids and matter, e.g. blood.It is for use only by trained medicalpersonnel located in hospitals, clinicsand doctors' offices. | The Pure-Vu EVS System is intendedto connect to standard and slimcolonoscopes to help facilitate intra-procedural cleaning of a poorlyprepared colon by irrigating orcleaning the colon and evacuating theirrigation fluid (water), feces and other |
| Environment of Use | Hospitals, clinics and doctors' offices | Hospitals, clinics and doctors' offices |
| Prescriptive | Same | Yes, only trained medical personnel |
| Technological Characteristics | ||
| Disposable | Same | Single patient, single use |
| Distal tip design | Same as predicate with the exceptionthat the hole geometry that fits on theendoscope was modified to allow it tobe pushed on like an endoscopy cap. | 1) Multi irrigation hole2) One distal suction hole |
| Subject Device | Predicate DeviceK220007 | |
| Principle ofoperation | Same as the predicate device with theexception of how the device connectsto the endoscope. There is no longera loading handle to connect thedevice to the endoscope as the distalhead can just be pushed on the scope(like an endoscopy cap) and the lowfriction sleeve material is now onlycovering the dual lumen tubing andnot the endoscope with 2 or 3 retainerstrips to hold the dual lumen tube nextto the endoscope. | Distal attachment to an endoscopeusing a loading handle, sleevecovering the tubing and endoscopeensuring attachment along entirelength, dual lumen suction andirrigation tube running along theendoscope, suction and irrigationhead at the distal tip. Enablesirrigation and suction at any timeduring the procedure withoutremoving any tools, which may beinserted in the endoscope's workingchannel. |
| OperationalProcedures | 1) Attachment to Standard or Slimcolonoscope or gastroscope2) Intra-procedure cleansing of GItract during standard endoscopy3) Evacuation of water, feces andmatter | 1) Attachment to a Standard orSlim colonoscope2) Intra-procedure colon cleansingduring standard colonoscopy3) Evacuation of water and fecesand other matter |
| Oversleeve / FlexChannel maximumouter diameter | 21 mm Colon18mm Gastro | 21 mm Colon (distal head is thelargest diameter) |
| Irrigation & suctionsystem | Colon version:• same as predicateGastro version:• Irrigation 3 nozzles (1 with 0.25mm and 2 with 0.8 x 0.25mmmm | Irrigation: 5 nozzles x 0.6 mmSuction: 1 nozzle x 40 mm² |
| Disposable length | 167 cm attached to colonoscope103 cm attached to gastroscope | 167 cm attached tocolonoscope |
| Air / Suction pressurespecification | Air: Up to1.65 bar for Colon VersionUp to 2.1 bar for Gasto versionSuction specifications: (-)0.5 Bar forboth | Up to1.65 bar (24psi)Suction specifications: (-)0.5 Bar |
| Subject Device | Predicate DeviceK220007 | |
| Flow rate(cc / min) | Same | Water – Up to 645 cc/minAir - up to 1000 cc/min |
| Dimensions:Workstation: | Same | W250 mm \ D400mm \ H280 mm |
| Weight Workstation | Same | 12Kg |
| Electrical Input | Same | 100V-240V/50/60 Hz |
| Material | Same | Complies with ISO 10993 |
| Sterilization | Same | Clean, Non-sterile |
| SystemComponents | Same with the addition of thegastroscope Oversleeve now referred to as Flex Channel and a version to fit on gastroscopes | Pure-Vu WorkstationPure-Vu Colon OversleevesPure-Vu WS Connector (also, referred to as Umbilical section) |
| Safety Standards | Same | Complies with:IEC 60601-1IEC 60601-1-2 |
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Image /page/5/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo consists of a circular pattern of blue dots on the left, followed by the text "PURE-VU" in a blue gradient. Below the text is the phrase "by MOTUS GI" in a smaller, gray font.
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Image /page/6/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 dots arranged in a spiral pattern. To the right of the circular design is the text "PURE-VU" in a stylized, sans-serif font, with the letters in varying shades of blue. Below "PURE-VU" and slightly to the right is the text "by MOTUS GI" in a smaller font size.
A comparison of the subject and predicate devices is provided in the Table below.
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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 features a circular design made up of small dots on the left side. The text "PURE-VU" is in a sans-serif font, with a hyphen between "PURE" and "VU". The words "by MOTUS GI" are in a smaller font below the main text.
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Image /page/8/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is in blue and features a circular design made up of small blue dots on the left. The text "PURE-VU" is in a sans-serif font, with a hyphen between "PURE" and "VU". Below the text is the phrase "by MOTUS GI" in a smaller font.
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Image /page/9/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is in blue and features a circular design made of dots on the left. The text "PURE-VU" is in a stylized font, and "by MOTUS GI" is in smaller letters below the main text.
§ 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.