(43 days)
Not Found
No
The description focuses on mechanical irrigation and evacuation, with no mention of AI/ML terms or image processing for analysis or decision-making.
Yes
The device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating fluids and matter, which directly addresses a physiological condition (poorly prepared colon) to restore proper function and allow for examination.
No
The device is intended for cleaning poorly prepared colons by irrigating and evacuating fluids and matter, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines multiple hardware components including an Oversleeve, Workstation (with monitoring & control unit, inlet module, outlet module), external foot pedals, WS Connector, and loading fixture. The performance studies also include tests related to hardware like electrical safety, EMC, bench tests, bond strength, pressure test, and steering test.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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". This is a therapeutic or procedural function, not a diagnostic one.
- Device Description: The components described (Oversleeve, Workstation with pumps and controls, connectors) are all focused on the physical process of irrigation and evacuation within the colon. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of analyzing bodily fluids or tissues for diagnostic purposes, which is the core function of an IVD.
In summary, the Pure-Vu System is a medical device designed to assist in a medical procedure (colonoscopy) by improving visualization through cleaning, not to diagnose a condition based on in vitro analysis of samples.
N/A
Intended Use / Indications for Use
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.
Product codes
FDF
Device Description
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. Irrigationis 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical personnel located in hospitals, clinics and doctor offices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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
2
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 Keren
Ha'yesod Str.
Tirat Carmel, 3902638Israel
Tel.: +972-4-6214446
Fax: +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: II
Panel: Gastroenterology and Urology |
| Predicate Device(s): | Pure-Vu System (K160015) |
| Intended Use: | The Pure-Vu System is intended to connect to standard colonoscopes to help
facilitate intra-procedural cleansing 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
doctors' offices. |
| Reason for Submission: | The purpose of this special 510(k) is to modify the Pure Vu System by:
- Simplifying the process of unloading the colonoscope by using disposable
materials rather than an Unloading Fixture - Minor material modifications to the Oversleeve and Workstation Connector,
- Minor modifications to Workstation, and Loading Fixture components
- Minor software modifications
- 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.
| Technological
| Characteristics: | The Pure-Vu system comprises the following components: | |||
|---|---|---|---|---|
| Oversleeve - The Oversleeve is mounted on standard commercially | ||||
| available colonoscopes allowing thephysician to clean the colon. | ||||
| Workstation (WS) - The Workstation operates by usingcyclic irrigation and | ||||
| evacuation of colon content. Irrigationis based on mixture of liquid and air. The | ||||
| workstation includes: | ||||
| Monitoring & Control Unit that 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. | ||||
| 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. | ||||
| Substantial | ||||
| Equivalence | ||||
| Discussion: | The Pure-Vu System has the same indications and similar | |||
| technological characteristics and principles of operation as its predicate | ||||
| device. The minor technological differences between the Pure-Vu | ||||
| System and its predicate devices do not raise different issues of safety | ||||
| or effectiveness. | ||||
| Performance data demonstrate that the Pure-Vu System is | ||||
| substantially 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 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 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, sleeve |
| ensuring attachment along entire length, | ||
| suction and irrigation tubes running along the | ||
| endoscope, suction and irrigation head at the | ||
| distal tip. Enables irrigation and suction at any | ||
| time during the procedure without removing | ||
| any tools, which may be inserted in the | ||
| Operational Procedures | Same; | |
| Simplified procedure to | ||
| unload the colonoscope | Attachment to a standard colonoscopeIntra-procedure coloncleansing during | |
| standard colonoscopyEvacuation of water and feces | ||
| System Components | "Add-on" name change | |
| to "Oversleeve""WS Cartridge" name | ||
| change to "WS | ||
| Connector" | Pure-Vu Add-onPure-Vu WS Cartridge | |
| Oversleeve outer | ||
| diameter | Same | 21 mm |
| - | Modified Device | Predicate Device |
| Irrigation & suction | ||
| system | Same | Irrigation: 4 nozzle x 0.7 mm |
| Suction: 2 nozzles x 12.5 $mm^2$ | ||
| Disposable length | Same | 167 cm attached to colonoscope |
| Air / Water pressure | ||
| specification | ||
| (bar) | Up to 23 psi | Up to 26 psi |
| Suction specifications: 0.5 Bar | ||
| Flow rate | ||
| (cc / min) | Water - Up to 645 cc/min | |
| Air - Same | Water - Up to 630 cc/min | |
| Air - up to 1350 cc/min | ||
| Dimensions Workstation | Same | W460 \ D 520 \ H340 mm |
| Weight Workstation | Same | 25Kg |
| Electrical Input | Same | 100V-240V |
| 50/60 Hz | ||
| Material | Minor material modifications | |
| Re-tested to ISO 10993 | Complies with ISO 10993 | |
| Sterilization | Same | Clean, Non-sterile |
| System Components | Motus GI Workstation | |
| Motus GI Oversleeve | ||
| Loading Fixture | Motus GI Workstation | |
| Motus GI Add-on | ||
| Loading Apparatus | ||
| Unloading Apparatus | ||
| Safety Standards | Minor component | |
| modifications | ||
| Re-tested to: | ||
| IEC 60601-1; | ||
| IEC 60601-1-2 | IEC 60601-1 | |
| IEC 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.