(20 days)
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.
The Pure Vu system comprises the following components:
Oversleeve - The Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the colon.
Workstation (WS) - The Workstation operates by using simultaneous irrigation and evacuation of colon content. Irrigation is based on a mixture of liquid (water or saline) and gas (air). The workstation includes:
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.
WS Connector (WSC) connects the Oversleeve to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Oversleeve onto a colonoscope.
This 510(k) submission is for the Pure Vu System, which is intended to connect to standard colonoscopes to facilitate intra-procedural cleaning of a poorly prepared colon. The submission is for a modification of the device to comply with Slim colonoscopes and extends the hydrophilic coating on the Oversleeve.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics of the device itself (e.g., a specific percentage improvement in cleaning, or a defined force of suction).
However, the "Performance Data" section states: "Performance tests were conducted for all modifications to the Pure Vu System. Specifically, the company performed the following bench tests: Steering test, Head pull test, Loading and maintenance of pressure during the loading procedure."
The "Substantial Equivalence Discussion" then concludes: "Performance data demonstrate that the Pure-Vu System is substantially equivalent." This implies that the results of these bench tests met internal acceptance criteria for demonstrating that the modified device performs comparably to the predicate device. Without further details on the specific values or thresholds used in these tests, a quantitative table of acceptance criteria and reported performance cannot be generated from this document.
2. Sample Size Used for the Test Set and Data Provenance
The document only mentions "bench tests" for performance data. It does not provide details on specific sample sizes for these tests, nor does it indicate the provenance of any data (e.g., country of origin, retrospective/prospective). As an accessory to a medical device (colonoscope), it's possible that clinical studies involving patient data were not part of this specific 510(k) submission focused on modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance data mentioned are "bench tests," which typically do not involve establishing ground truth by human experts in the way clinical studies do.
4. Adjudication Method for the Test Set
This information is not provided in the document. As the performance data are "bench tests," an adjudication method by human experts is not applicable in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this document. The submission focuses on modifications to an accessory device and bench testing for substantial equivalence, not a comparative effectiveness study involving human readers and AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, the Pure Vu System is a mechanical device designed to assist a human operator (trained medical personnel) during a colonoscopy. It is not an AI algorithm with standalone performance.
7. The Type of Ground Truth Used
For the mentioned "bench tests" (Steering test, Head pull test, Loading and maintenance of pressure during the loading procedure), the "ground truth" would be the engineering specifications and expected physical properties or performance thresholds of the device components. This is not "expert consensus, pathology, or outcomes data" in the typical sense for medical image analysis or diagnostic devices.
8. The Sample Size for the Training Set
No training set is mentioned as this device is not an AI or machine learning algorithm requiring training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
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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 the FDA logo, which 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 KerenHa'yesod Str.Tirat Carmel, 3902638IsraelTel.: +972-4-6214446Fax: +972-4-6214442 |
|---|---|
| Contact Person: | Hagit Ephrath |
| Phone Number: | +972-4-6214447 |
| Fax Number: | +972-4-6214442 |
| 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: IIPanel: Gastroenterology and Urology |
| Predicate Device(s): | Pure Vu System (K173392) |
| Intended Use: | The Pure-Vu System is intended to connect to standard colonoscopes tohelp facilitate intra-procedural cleaning of a poorly prepared colon byirrigating 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. |
| Reason for Submission: | The purpose of this special 510(k) is to modify the Pure Vu System to complywith Slim colonoscope. Modifications include the followings:1) Add SLIM Oversleeve which is a modification of the Oversleeve designincluding narrowing the inner dimensions of the flexible head and leaf sealof the inflation hub.2) Revision of the IFU including adding reference to the Pure-Vu SLIM,specify the range of colonoscope diameters for Pure-Vu and Pure-VuSLIM disposables.3) Add SLIM Seal plug to the Loading Fixture to enable loading with therevised SLIM Oversleeve.In addition, the Oversleeves hydrophilic coating was extended to 60cm toenhance advancement. |
| TechnologicalCharacteristics: | The Pure Vu system comprises the following components:Oversleeve - The Oversleeve is mounted on Standard or Slimcommercially available colonoscopes to allow a physician to cleansethe colon.Workstation (WS) - The Workstation operates by using simultaneous irrigationand evacuation of colon content. Irrigation is based on a mixture of liquid (wateror saline) and gas (air). The workstation includes: |
| 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. | |
| WS Connector (WSC) connects the Oversleeve to the WS and saline or water bag.Loading fixture to aid the nurse in mounting the Oversleeve onto acolonoscope. | |
| Performance Data: | Performance tests were conducted for all modifications to the Pure Vu System.Specifically, the company performed the following bench tests: Steering test Head pull test Loading and maintenance of pressure during the loading procedure |
| SubstantialEquivalenceDiscussion: | The Pure Vu System has the same indications and similar technologicalcharacteristics and principles of operation as its predicate device. Expendingthe variety of colonoscopes to be used with the Pure-Vu System and the minordifferences between the device and its predicate device do not raise any newissues of safety or effectiveness.Performance data demonstrate that the Pure-Vu System is substantiallyequivalent. |
| 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 toconnect to standard colonoscopes tohelp facilitate intra-proceduralcleaning ofa poorly prepared colon by irrigating orcleaning the colon and evacuating theirrigation fluid (water), feces and otherbodily fluids and matter, e.g. blood.It is for use only by trained medicalpersonnel 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 ofoperation | Same | 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 removing | |
| OperationalProcedures | 1) Attachment to a standard and Slimcolonoscopes2) Same3) Same | 1) Attachment to a standardcolonoscope2) Intra-procedure coloncleansingduring standard colonoscopy3) Evacuation of water and feces | |
| SystemComponents | 1) Pure-Vu Workstation (Same)2) Pure-Vu Standard Oversleeve(Same) or Motus GI SLIMOversleeve3) Pure-Vu WS Connector (Same)4) Pure-Vu Loading Fixture (Same) | 1) Pure-Vu Workstation2) Pure-Vu Oversleeve3) Pure-Vu WS Connector4) Pure-Vu Loading Fixture | |
| Oversleeve outerdiameter | Same | 21 mm | |
| - | Modified Device | Predicate Device | |
| Irrigation &suction system | Same | Irrigation: 4 nozzle x 0.7 mm²Suction: 2 nozzles x 12.5 mm² | |
| Disposable length | Same | 167 cm attached to colonoscope | |
| Air / Waterpressurespecification | Same | Up to 23 psi | |
| Flow rate(cc / min) | Same | Suction specifications: 0.5 Bar | |
| DimensionsWorkstation | Same | Water - Up to 645 cc/minAir - up to 1350 cc/min | |
| Weight Workstation | Same | W460 \ D 520 \ H340 mm | |
| Electrical Input | Same | 25Kg | |
| Material | Same | 100V-240V50/60 Hz | |
| Sterilization | Same | Complies with ISO 10993 | |
| Safety Standards | Same | Clean, Non-sterile | |
| Same | Complies with:• IEC 60601-1• 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.
§ 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.