(43 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 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 Connector (WSC) connects the Oversleeve to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Oversleeve on to a colonoscope.
The provided document is a 510(k) summary for the Pure-Vu System, which is an add-on device for colonoscopes. It describes modifications to an already cleared predicate device (Pure-Vu System K160015). As such, it focuses on demonstrating substantial equivalence rather than presenting an exhaustive clinical study to establish new performance criteria.
Therefore, the document does not contain specific acceptance criteria, a detailed study proving performance against such criteria, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or details about training sets. Instead, it relies on performance tests to ensure the modified device functions as intended and remains substantially equivalent to its predicate.
Here's a breakdown of the information that is available based on your request, and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it states that "Performance tests were conducted for all modifications to the Pure-Vu System" and concludes that "In all instances, the Pure-Vu System functioned as intended." This implies that the device met internal performance specifications for the tested modifications, which would be aligned with the performance of the predicate device.
The document lists the following performance tests conducted:
- Biocompatibility
- Electrical Safety and EMC
- Software validation
- Bench tests
- Bond strength
- Pressure test
- System test
- Steering test
It also details changes in specifications for the modified device compared to the predicate, such as:
| Characteristic | Modified Device Performance | Predicate Device Specification |
|---|---|---|
| Air / Water pressure (bar) | Up to 23 psi | Up to 26 psi |
| Water flow rate (cc / min) | Up to 645 cc/min | Up to 630 cc/min |
| Air flow rate (cc / min) | Same as predicate | Up to 1350 cc/min |
| Material (Biocompatibility) | Re-tested to ISO 10993 | Complies with ISO 10993 |
| Safety Standards (Electrical) | Re-tested to IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 |
The acceptance criteria for these tests would likely be that the modified device's performance falls within an acceptable range, ideally demonstrating equivalence or improvement without introducing new safety or effectiveness concerns, and that it passes the listed regulatory standards (ISO 10993, IEC 60601-1/-1-2).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance tests" and "Bench tests" but does not specify sample sizes for these tests or the data provenance. These are likely internal engineering and quality assurance tests rather than clinical studies with human subjects.
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)
This information is not provided. Given that the listed performance tests are primarily engineering and safety assessments (biocompatibility, electrical safety, bench tests), there would typically not be "expert ground truth" in the clinical sense established by physicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically associated with clinical studies involving expert reviews of outcomes, which is not described here.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is not an AI diagnostic tool; it's a mechanical system for intra-procedural colon cleaning. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The Pure-Vu System is a physical device that connects to colonoscopes and is operated by trained medical personnel. It is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests described (biocompatibility, electrical safety, bench tests), the "ground truth" would be engineering specifications, compliance with international standards (e.g., ISO 10993, IEC 60601-1), and the intended functional performance of the device's components against design requirements. Clinical ground truth like pathology or outcomes data is not mentioned for the modifications made in this 510(k).
8. The sample size for the training set
This information is not provided and is not applicable as this is a medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated above.
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December 12, 2017
Motus GI Medical Technologies Ltd. % Hagit Ephrath VP of Health Economics, Regulatory and Clinical Affairs Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004
Re: K173392 Trade/Device Name: Pure Vu System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: December 6, 2017 Received: December 8, 2017
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.
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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 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.
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.
For comprehensive regulatory information about mediation-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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clear and easy to read.
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) K173392
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/1 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 stylized blue font. Below the text, the words "by MOTUS GI" are written in a smaller, gray 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 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: | October 26th, 2017 |
| Trade Name(s): | Pure-Vu System |
| CommonName: | Pure-Vu System |
| Classification Name: | Endoscope and accessories |
| Classification: | Regulation No: 876.1500Class: IIPanel: Gastroenterology and Urology |
| Predicate Device(s): | Pure-Vu System (K160015) |
| Intended Use: | The Pure-Vu System is intended to connect to standard colonoscopes to helpfacilitate intra-procedural cleansing by irrigating or cleaning the colon andevacuating 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, anddoctors' offices. |
| Reason for Submission: | The purpose of this special 510(k) is to modify the Pure Vu System by:1) Simplifying the process of unloading the colonoscope by using disposablematerials rather than an Unloading Fixture2) Minor material modifications to the Oversleeve and Workstation Connector,3) Minor modifications to Workstation, and Loading Fixture components4) Minor software modifications5) Modify slight the air/water specifications |
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Image /page/4/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 sans-serif font, with the letters in varying shades of blue. Below the "PURE-VU" text is the text "by MOTUS GI" in a smaller font size.
| TechnologicalCharacteristics: | The Pure-Vu system comprises the following components: | |||
|---|---|---|---|---|
| Oversleeve - The Oversleeve is mounted on standard commerciallyavailable colonoscopes allowing thephysician to clean the colon. | ||||
| Workstation (WS) - The Workstation operates by usingcyclic irrigation andevacuation of colon content. Irrigationis based on mixture of liquid and air. Theworkstation includes: | ||||
| Monitoring & Control Unit that continuously monitors and controlsirrigation 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 andfluids from the colon. External on\off foot pedals that operate the cleansing process to beused by the physician. | ||||
| WS Connector (WSC) connects the Oversleeve to the WS and saline or waterbag. | ||||
| Loading fixture to aid the nurse in mounting the Oversleeve on to acolonoscope. | ||||
| Performance Data: | Performance tests were conducted for all modifications to the Pure-Vu System.Specifically, the company performed the following performance tests: | |||
| Biocompatibility Electrical Safety and EMC Software validation Bench tests Bond strength Pressure test System test Steering test | ||||
| In all instances, the Pure-Vu System functioned as intended. | ||||
| SubstantialEquivalenceDiscussion: | The Pure-Vu System has the same indications and similartechnological characteristics and principles of operation as its predicatedevice. The minor technological differences between the Pure-VuSystem and its predicate devices do not raise different issues of safetyor effectiveness.Performance data demonstrate that the Pure-Vu System issubstantially equivalent. |
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Image /page/5/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 multiple blue dots arranged in a ring-like pattern. To the right of the circular design, the text "PURE-VU" is displayed in a stylized blue font. Below the "PURE-VU" text, the words "by MOTUS GI" are written in a smaller, gray font.
| Characteristics Comparison: | ||
|---|---|---|
| Modified Device | Predicate Device | |
| Manufacturer | Motus GI Medical Technologies Ltd. | |
| Description | Pure-Vu System | |
| Intended Use | Same | The Pure-Vu System is intended to connectto standard colonoscopes to help facilitateintra-procedural cleaning of a poorly preparedcolon by irrigating or cleaning the colon andevacuating the irrigation fluid (water), fecesand other bodily fluids and matter, e.g. blood.It is for use only by trained medical personnellocated in hospitals, clinics and doctors'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 | Same | Multi irrigation holeTwo distal suction holes |
| Principle of operation | Same | Distal attachment to an endoscope, sleeveensuring attachment along entire length,suction and irrigation tubes running along theendoscope, suction and irrigation head at thedistal tip. Enables irrigation and suction at anytime during the procedure without removingany tools, which may be inserted in the |
| Operational Procedures | Same;Simplified procedure tounload the colonoscope | Attachment to a standard colonoscopeIntra-procedure coloncleansing duringstandard colonoscopyEvacuation of water and feces |
| System Components | "Add-on" name changeto "Oversleeve""WS Cartridge" namechange to "WSConnector" | Pure-Vu Add-onPure-Vu WS Cartridge |
| Oversleeve outerdiameter | Same | 21 mm |
| - | Modified Device | Predicate Device |
| Irrigation & suctionsystem | Same | Irrigation: 4 nozzle x 0.7 mmSuction: 2 nozzles x 12.5 $mm^2$ |
| Disposable length | Same | 167 cm attached to colonoscope |
| Air / Water pressurespecification(bar) | Up to 23 psi | Up to 26 psiSuction specifications: 0.5 Bar |
| Flow rate(cc / min) | Water - Up to 645 cc/minAir - Same | Water - Up to 630 cc/minAir - up to 1350 cc/min |
| Dimensions Workstation | Same | W460 \ D 520 \ H340 mm |
| Weight Workstation | Same | 25Kg |
| Electrical Input | Same | 100V-240V50/60 Hz |
| Material | Minor material modificationsRe-tested to ISO 10993 | Complies with ISO 10993 |
| Sterilization | Same | Clean, Non-sterile |
| System Components | Motus GI WorkstationMotus GI OversleeveLoading Fixture | Motus GI WorkstationMotus GI Add-onLoading ApparatusUnloading Apparatus |
| Safety Standards | Minor componentmodificationsRe-tested to:IEC 60601-1;IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 |
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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 made of blue dots on the left side. The text "PURE-VU" is in a stylized blue font, with the "by MOTUS GI" text in a smaller font below it.
§ 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.