(20 days)
Not Found
No
The device description focuses on mechanical components (oversleeve, workstation with pumps and regulators) for irrigation and evacuation. There is no mention of AI, ML, image processing, or data analysis for decision-making or control beyond continuous monitoring and control of fluid flow.
No.
The device is intended to facilitate cleaning of the colon during a colonoscopy, which is a procedure, not provide therapy for a disease or condition. Its function is to clear the field of view, not treat the colon.
No
The device is designed for intra-procedural cleaning of the colon by irrigating and evacuating fluids and matter, not for diagnosing disease or conditions.
No
The device description clearly lists multiple hardware components including an Oversleeve, Workstation (with Monitoring & Control Unit, Inlet Module, and Outlet Module), External foot pedals, WS Connector, and Loading fixture.
Based on the provided information, the Pure Vu System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Pure Vu System's Function: The Pure Vu System is designed to cleanse the colon during a colonoscopy procedure. It irrigates and evacuates material directly from the colon within the body. It does not analyze or test specimens for diagnostic purposes.
- Intended Use: The intended use clearly states its purpose is to "facilitate intra-procedural cleaning of a poorly prepared colon." This is a procedural aid, not a diagnostic test.
- Device Description: The description details components for irrigation and evacuation, not for analyzing biological samples.
Therefore, the Pure Vu System falls under the category of a medical device used for a procedural purpose, not an IVD.
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 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.
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 bench tests: Steering test Head pull test Loading and maintenance of pressure during the loading procedure
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pure Vu System (K173392)
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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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);
1
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) | |
|---|---|
| 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."
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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 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: | May 31st, 2018 |
| Trade Name(s): | Pure Vu System |
| Common Name: | Pure Vu System |
| Classification Name: | Endoscope and accessories |
| Classification: | Regulation No: 876.1500Class: II
Panel: Gastroenterology and Urology |
| Predicate Device(s): | Pure Vu System (K173392) |
| Intended 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 doctors' offices. |
| Reason for Submission: | The purpose of this special 510(k) is to modify the Pure Vu System to comply
with Slim colonoscope. Modifications include the followings:
- Add SLIM Oversleeve which is a modification of the Oversleeve design
including narrowing the inner dimensions of the flexible head and leaf seal
of the inflation hub. - Revision of the IFU including adding reference to the Pure-Vu SLIM,
specify the range of colonoscope diameters for Pure-Vu and Pure-Vu
SLIM disposables. - Add SLIM Seal plug to the Loading Fixture to enable loading with the
revised SLIM Oversleeve.
In addition, the Oversleeves hydrophilic coating was extended to 60cm to
enhance advancement. |
| Technological
Characteristics: | 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. |
| 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 |
| Substantial
Equivalence
Discussion: | The Pure Vu System has the same indications and similar technological
characteristics and principles of operation as its predicate device. Expending
the variety of colonoscopes to be used with the Pure-Vu System and the minor
differences between the device and its predicate device do not raise any new
issues of safety or effectiveness.
Performance data demonstrate that the Pure-Vu System is substantially
equivalent. |
| 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 to | |
| connect to standard colonoscopes to | |||
| help facilitate intra-proceduralcleaning 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 | |||
| 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 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 | |||
| Operational | |||
| Procedures | 1) Attachment to a standard and Slim | ||
| colonoscopes |
- Same
- Same | 1) Attachment to a standard
colonoscope - Intra-procedure coloncleansing
during standard colonoscopy - Evacuation of water and feces |
| System
Components | | 1) Pure-Vu Workstation (Same) - Pure-Vu Standard Oversleeve
(Same) or Motus GI SLIM
Oversleeve - Pure-Vu WS Connector (Same)
- Pure-Vu Loading Fixture (Same) | 1) Pure-Vu Workstation
- Pure-Vu Oversleeve
- Pure-Vu WS Connector
- Pure-Vu Loading Fixture |
| Oversleeve outer
diameter | | Same | 21 mm |
| - | Modified Device | Predicate Device | |
| Irrigation &
suction system | Same | Irrigation: 4 nozzle x 0.7 mm²
Suction: 2 nozzles x 12.5 mm² | |
| Disposable length | Same | 167 cm attached to colonoscope | |
| Air / Water
pressure
specification | Same | Up to 23 psi | |
| Flow rate
(cc / min) | Same | Suction specifications: 0.5 Bar | |
| Dimensions
Workstation | Same | Water - Up to 645 cc/min
Air - up to 1350 cc/min | |
| Weight Workstation | Same | W460 \ D 520 \ H340 mm | |
| Electrical Input | Same | 25Kg | |
| Material | Same | 100V-240V
50/60 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.