(37 days)
The Pure-Vu EVS System is intended to connect to standard and slim colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the irrigation 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.
The Pure-Vu EVS System enables colon cleaning during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid and gas to break up feces. The fecal matter & fluids are removed through the suction channel of the Oversleeve into an external waste container.
The Pure-Vu EVS System consists of the following main components:
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 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 fecal material 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 fluids and feces from the colon.
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 the Pure-Vu EVS System, its indications for use, technological characteristics, and a comparison to its predicate device. It also briefly mentions performance data. However, the document does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes for training/test sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.
Therefore, based only on the provided text, I cannot complete the requested table and answer all questions definitively.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated, inferred from testing) | Reported Device Performance (Summary from text) |
|---|---|---|
| Pure-Vu EVS Disposables | ||
| Functionality (after aging) | Meets requirements after 1-year simulated aging | Functionality meets requirements after simulated aging of one year. |
| Dimensional Compliance | Dimensions comply with product specifications | Dimensional compliance demonstrated. |
| Steering Impact | No negative impact on colonoscope bending/steering | Oversleeve's impact on colonoscope bending/steering was evaluated. |
| System Performance | Compliance with pressure, air, and water flow specifications | System complies with product specifications for pressure, air, and water flow. |
| Pressure Resistance | Withstands specific pressure without leakage | Withstands specific pressure without leakage. |
| Bond Strength | Tensile force of bonds meets requirements | Tensile force of bonds verified. |
| Packaging Integrity | Integrity of packaging and labels maintained after environmental conditioning and transport simulation. | Packaging integrity and labels maintained. |
| Biocompatibility | No toxicological risk to the patient | Biocompatibility testing done to determine if there was any toxicological risk. |
| Pure-Vu EVS Workstation (WS) | ||
| Environmental Conditioning & Transport | Maintains visual and functional integrity after simulation (ASTM D4169, DC13) | Visual inspection and functionality tests passed after preconditioning simulations. |
| Software Compliance | Embedded updated software complies with WS design modifications | Software verification and validation demonstrated compliance. |
| Cleaning Verification | Compatibility with cleaning agents noted in IFU | Compatibility with cleaning agents demonstrated. |
| IPX Rating | Meets IPX2 per IEC 60529 | Meets IPX2 per IEC 60529. |
| Safety & EMC | Complies with IEC 60601 standards | Complies with safety and EMC tests per IEC 60601. |
| Overall System Performance | Design changes have no impact on overall system performance (compared to predicate) | Design verification and validation testing concluded that design changes have no impact on the Pure-Vu System performance. |
Detailed Study Information (Not available in the provided text):
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the provided text. The document only mentions "Validation testing for the WS and disposable device was performed with 4 physicians." This appears to refer to human factors or usability testing rather than a clinical performance study with a test set of patient data.
-
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 specified in the provided text.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
-
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 applicable/Not specified. This device is for intra-procedural cleaning during colonoscopy, not an AI-powered diagnostic imaging device requiring reader studies in this context. The document describes a physical medical device (Pure-Vu EVS System) for colon cleaning, not an AI algorithm.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not specified. As above, this is a physical medical device, not an AI algorithm. Its performance is intrinsically "human-in-the-loop" as it assists a physician during a colonoscopy.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in the provided text. The performance data section focuses on engineering verification and validation testing (e.g., pressure, flow rates, dimensional compliance, biocompatibility, software compliance) rather than a clinical ground truth for a diagnostic claim. The clinical outcome (effective colon cleaning) is assumed to be evaluated during the "Validation testing for the WS and disposable device was performed with 4 physicians," but the specific metrics and how "ground truth" for cleaning effectiveness were established are not detailed here.
-
The sample size for the training set:
- Not applicable/Not specified. There is no mention of a "training set" as this is a physical medical device, not an AI model requiring machine learning training.
-
How the ground truth for the training set was established:
- Not applicable/Not specified. See point 7.
In summary, the provided document is a 510(k) summary for a physical medical device. It covers the technical performance verification and validation to demonstrate substantial equivalence to a predicate device. It does not contain the detailed clinical study information typically found for AI/ML-based devices regarding diagnostic performance, ground truth, reader studies, and sample sizes for algorithmic evaluation. The "performance data" section focuses on engineering tests (e.g., environmental, mechanical, flow, pressure, software validation) and a mention of "validation testing for the WS and disposable device was performed with 4 physicians" which likely refers to human factors or usability rather than an effectiveness study using a "test set" of patient data for an algorithm.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 10, 2022
Motus GI Medical Technologies Ltd. Mark Pomeranz President and COO 22 Keren Ha'yesod Str. Tirat Carmel, 3902638 ISRAEL
Re: K220007 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 Dated: December 30, 2021 Received: January 4, 2022
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 (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
{1}------------------------------------------------
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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).
Sincerely,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name Pure-Vu EVS System
Indications for Use (Describe)
The Pure-Vu EVS System is intended to connect to standard and slim colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the irrigation 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image contains 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 separating "PURE" and "VU". Below the text, in a smaller font, is the phrase "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 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: | December 30, 2021 |
| 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 (K191220) |
| Indications for Use: | The Pure-Vu EVS System is intended to connect to standard and slimcolonoscopes to help facilitate intra-procedural cleaning of a poorlyprepared colon by irrigating or cleaning the colon and evacuating theirrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.It is for use only by trained medical personnel located in hospitals, clinicsand doctor offices. |
| TechnologicalCharacteristics: | The Pure-Vu EVS System enables colon cleaning during colonoscopyusing a standard or slim colonoscope with a length of 1630mm –1710mm and an outer diameter range of 11.7mm – 13.7mm. TheOversleeve, which fits over the colonoscope and is connected to anexternal Workstation, generates fluid and gas to break up feces. Thefecal matter & fluids are removed through the suction channel of theOversleeve into an external waste container.The Pure-Vu EVS System consists of the following maincomponents: |
| Oversleeve (OS) and Umbilical Section (US) - The disposableOversleeve is mounted on Standard or Slim commerciallyavailable colonoscopes to allow a physician to cleanse the GItract and is connected to the external Workstation via adisposable US. | |
| Workstation (WS) – The Workstation [WS] is reusable andsupplies an irrigation mixture of water or saline and gas, andevacuates fecal material and fluids. The Workstation includesthe following components: | |
| A monitoring & Control Unit that controls the delivery ofirrigation fluids and gas into the GI tract, and suction of fluidsand feces from the colon. | |
| Irrigation Bag/Bottle (saline or water) which is connected to theirrigation line. | |
| Waste Containers for collecting the GI content & fluids that aresuctioned 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 matterfrom the GI tract. | |
| A foot pedal activates the cleansing, suction and purgingfunctions, and enables switching between cleansing modesused by the physician. | |
| PerformanceData | Verification and Validation Testing tests were conducted for allmodifications to the Pure-Vu EVS System component as follows: |
| Pure-Vu EVS Disposables Environmental conditioning/Shelf-life simulation: All disposableunits underwent preconditioning simulations tests at third partylaboratories including but not limited to environmental conditioningand shelf-life simulation to demonstrate that the Pure-Vu EVSDisposables functionality meets the requirements following asimulated aging of one year. Dimensions test: Dimensional compliance of the disposablewith the product specifications. Steering test: Impact of the ability of the Pure-Vu EVS Oversleeveon a colonoscope to bend in its distal steering section based onactuating the knobs on the handle of the colonoscope: System test: Measurement of different pressure, air and water flowvalues in order to confirm that the system complies with productspecifications. | |
| 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 transport 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 WS underwent the following tests: Environmental conditioning and transportation simulation performed by third party laboratories as per ASTM D4169, DC13. After the preconditioning simulations, the Pure-Vu EVS WS underwent verification testing including visual inspection and functionality tests. The embedded updated software compliance with the WS design modifications was tested via software verification and validation. Cleaning verification was performed to demonstrate compatibility with cleaning agents noted in IFU. IPX2 per IEC 60529 Dimension verification Safety and EMC tests per IEC 60601 Validation testing for the WS and disposable device was performed with 4 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 device. The differences between the device and its predicate device 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 device. The intended of use of this product meets the requirements of 21 CFR 801.4 |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image features the logo for "PURE-VU by MOTUS GI". The logo is in blue and has a circular design on the left side made up of small blue dots. The text "PURE-VU" is in a sans-serif font, with the "PURE" part being slightly darker than the "VU" part. Below "PURE-VU" is the text "by MOTUS GI" in a smaller font.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for "PURE-VU by MOTUSgi". The logo features a circular pattern of blue dots on the left, followed by the word "PURE-VU" in a stylized, blue font. Below "PURE-VU" is the text "by MOTUSgi" in a smaller, futuristic-looking font.
A comparison of the subject and predicate devices is provided in the Table below.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Pure-Vu by Motus GI. The logo features a stylized design of blue dots on the left, followed by the text "PURE-VU" in a blue, sans-serif font. Below the "PURE-VU" text, there is the text "by MOTUS GI" in a smaller, gray font.
| Characteristics Comparison: | ||
|---|---|---|
| Modified Device | Predicate Device | |
| Manufacturer | Motus GI Medical Technologies Ltd. | Motus GI Medical Technologies Ltd. |
| Description | Pure-Vu EVS System | Pure-Vu EVS System |
| Indications for Use | Same | The Pure-Vu System is intended toconnect to standard and slimcolonoscopes to help facilitate intra-procedural cleaning of a poorly preparedcolon by irrigating or cleaning the colonand evacuating the irrigation fluid(water), feces and other bodily fluids andmatter, e.g. blood.It is for use only by trained medicalpersonnel located in hospitals, clinicsand doctor offices. |
| 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 | 1) Same2) One distal suction hole | 1) Multi irrigation hole2) Two distal suction holes |
| Principle ofoperation | Same except for 5 tubes in predicateversus one dual lumen tube in subjectdevice. | Distal attachment to an endoscope,sleeve ensuring attachment along entirelength, suction and irrigation tubesrunning along the endoscope, suctionand irrigation head at the distal tip.Enables irrigation and suction at any timeduring the procedure without removingany tools, which may be inserted in theendoscope's working channel. |
| OperationalProcedures | 1) Same2) Same3) Same | 1) Attachment to a Standard or Slimcolonoscope2) Intra-procedure colon cleansingduring standard endoscopy3) Evacuation of water and feces |
| SystemComponents | The Pure-Vu EVS System consists ofthe same main components as thepredicate device with the minormodifications described in Section 9,Design Control Activities including theremoval of the Pure-Vu LoadingFixture | 1) Pure-Vu Workstation2) Pure-Vu Standard and Slimcolonoscope Oversleeves3) Pure-Vu WS Connector4) Pure-Vu Loading Fixture |
| Characteristics Comparison: | ||
| Modified Device | Predicate Device | |
| Oversleeve outerdiameter | Same | 21 mm |
| Irrigation &suction system | Irrigation: 5 nozzle x 0.6 mmSuction: 1 nozzle x 40 mm2 | Irrigation: 4 nozzle x 0.7 mmSuction: 2 nozzles x 12.5 mm2 |
| Disposable length | Same | 167 cm attached to colonoscope |
| Air / Suctionpressurespecification(bar) | Up to 1.65 bar (24psi) | Up to 1.55bar (23 psi)Suction specifications: (-) 0.5 Bar |
| Flow rate(cc / min) | Water - SameAir - Up to 1000cc/min | Water - Up to 645 cc/minAir - up to 1350 cc/min |
| DimensionsWorkstation | W250mm \ D400mm \ H280 mm | W250mm \ D476mm \ H358 mm |
| Weight Workstation | 12kg | 18kg |
| Electrical Input | Same | 100V-240V50/60 Hz |
| Material | Same | Complies with ISO 10993 |
| Sterilization | Same | Clean, Non-sterile |
| Safety Standards | Same | Complies with:IEC 60601-1IEC 60601-1-2 |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the text "K220007 Page 5 of 5". The text is in a simple, sans-serif font. The page number indicates that this is the last page of a document. The document number is K220007.
Image /page/7/Picture/1 description: The image is a 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 bold, sans-serif font, with the letters rendered in a gradient of blue. Below "PURE-VU", the text "by MOTUS GI" is written in a smaller, sans-serif font, also in blue.
§ 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.