(262 days)
Not Found
No
The description focuses on mechanical and fluid-based cleaning mechanisms, with no mention of AI or ML in the device description, intended use, or performance studies.
No
Explanation: A therapeutic device is one that treats or cures a disease or condition. This device is intended to facilitate cleaning of the colon during a procedure, which is a supportive function and not a direct treatment or cure.
No
The device is designed for cleaning the colon during procedures and does not mention any diagnostic capabilities.
No
The device description clearly outlines multiple hardware components including an Add-on, Workstation (with pumps, regulators, etc.), WS Cartridge, and loading/unloading fixtures. While software is mentioned as being validated, it is part of a larger hardware system.
Based on the provided information, the Pure Vu System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "help facilitate intraprocedural 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/procedural function, not a diagnostic one.
- Device Description: The components described (Add-on, Workstation, Cartridge, fixtures) are all designed for the physical process of cleaning the colon during a procedure. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing bodily fluids or tissues for diagnostic purposes. The system is focused on removing material from the colon.
- Performance Studies: The performance studies focus on the device's ability to clean the colon, safety (biocompatibility, electrical safety), and functionality (bench tests, animal study). There are no studies related to diagnostic accuracy or the analysis of biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Pure Vu System does not perform this function. It is a device used during a medical procedure to improve visualization by cleaning the anatomical site.
N/A
Intended Use / Indications for Use
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intraprocedural 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 (comma separated list FDA assigned to the subject device)
FDF
Device Description
The Pure Vu system comprises the following components: Add-on - The Add-on 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 Cartridge (WSC) connects the Add on to the WS and saline or water bag. Loading fixture to aid the nurse in mounting the Add-on to a colonoscope. Unloading fixture to aid the nurse in removing the Add-on from 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 conduct to verify that the Pure Vu System meets the requirements for its intended use and is substantial equivalence to the predicate device. Biocompatibility: The Pure Vu Add-on is a surface contact device with a limited contact (shorter than ≤24 hours) of the mucosal tissue. The Pure Vu WS Cartridge (WSC) is an externally communicating devices with a limited contact (shorter than ≤24 hours) of the mucosal tissue. As such, the following biocompatibility tests were performed: Cytotoxicity: Growth Inhibition Test - Extraction MethodIrritation: Intracutaneous Reactivity TestSensitization: Skin sensitizationAll materials and representative manufacturing processes of the disposable kits passed the above tests and were found biocompatible. Electrical Safety and EMC: The Pure Vu System includes a workstation which controls irrigation and evacuation through the disposable attached to the colonoscope. In addition the System accessories, Loading and Unloading fixtures, includes inflation boxes enabling to mount the Add-on to a colonoscope prior to the clinical procedure and to remove the Add-on from a colonoscope after the procedure. All 3 System components are designed and constructed to conform with the IEC 60601-1 and 60601-1-2 medical electrical equipment safety standard. The System components were tested for mechanical and electrical safety and are found as compliant with the IEC 60601-1 and 60601-1-2. Software validation: Pure Vu software has been validated per EC 62304:2006, Medical Device Software and followed the companies Software Life-Cycle Processes. Bench tests: Performance tests after preconditioning were conducted and included the following aspects of the product: Bound strength test, Pressure test, overall System performance, Add-on movement, and steering segment abilities. Bench test results confirm that the Pure Vu System meets its requirements for its intended use. Pure Vu System – Animal study: A prospective animal study was conducted to establish the effectiveness and safety of Pure Vu. The final configuration of Pure Vu System was used in 35 procedures in swine (66% female) performed by 4 experienced gastroenterologists. No immediate, such as mucosal injury, or delayed adverse events were reported in any of the 35 animal procedures. In 30/35 (86%) of the procedures, the colon cleansing level prior the use of the Pure Vu device was inadequate, whereas 100% (35/35) of the animals had an excellent colon cleansing level following the use of Pure Vu. The physicians were satisfied with the Pure Vu ease of advancement and navigation, level of stiffness, and its torque response. They found Pure Vu easy to use and intuitive to operate. Pure Vu was found to be simple, safe and effective to be used.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2016
Motus GI Medical Technologies Ltd. % Jonathan S. Kahan Partner Hogan Lovells US LLP Columbia Square, 555 13th Street, NW Washington, DC 20004
K160015 Re: Trade/Device Name: Pure Vu System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: August 22, 2016 Received: August 22, 2016
Dear Jonathan S. Kahan:
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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) K160015
Device Name
Pure Vu System
Indications for Use (Describe)
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intraprocedural 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) | ||||
|---|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/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, the text "PURE-VU" is displayed in a sans-serif font, with the letters in varying shades of blue. Below "PURE-VU", the text "by MOTUS GI" is written in a smaller, sans-serif font.
510(k) Summary
This 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.
| Submitter Name and
Address: | Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod Str.
Tirat Carmel, 3902638
Israel
Tel.: +972-4-6214446
Fax: +972-4-6214442 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hagit Ephrath |
| Phone Number: | +972-4-6214447 ext. 104 |
| Fax Number: | +972-4-6214442 |
| Establishment
Registration Number: | K160015 |
| Date Prepared: | December 31, 2015 |
| Device Trade Name(s): | Pure Vu System |
| Device Common
Name: | Pure Vu System |
| Classification Name: | Endoscope and accessories |
| Classification: | Regulation No: 876.1500
Class: II
Panel: Gastroenterology and Urology |
| Predicate Device(s): | ClearPath Lower GI (manufactured by EasyGlide Ltd. and
the subject of 510(k) documents no. K113050) |
| General Device
Description: | The Pure Vu system comprises the following components:
Add-on - The Add-on 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 Cartridge (WSC) connects the Add on to the WS and
saline or water bag.
Loading fixture to aid the nurse in mounting the Add-on
to a colonoscope.
Unloading fixture to aid the nurse in removing the Add-
on from a colonoscope. |
| Indications for
Use: | The Pure Vu System is intended to connect to standard
colonoscopes to help facilitate intraprocedural 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. |
| Technological
Characteristics: | The Pure Vu system intended use, principle of operation
and basic scientific technology are substantially
equivalent to the ClearPath Lower GI (K113050). Both are
connected to distal standard colonoscope during
colonoscopy procedure and irrigate the colon and
evacuate theirrigation fluid (water), feces, and other bodily
fluids and matter, e.g. blood. Both enable irrigation and
suction at any time during the procedure without removing
any toolswhich may be inserted in the colonoscope
workingchannel. Both devices have similar |
| | dimensions of the disposable, with similar irrigation and
evacuation head on the top of the colonoscope. |
| Substantial
Equivalence
Discussion | Comparison between Pure Vu System and its predicate
device regarding the intended use, principle of operation,
basic technological characteristics, biocompatibility and
their level of cleansing was conducted.
It is concluded that Pure Vu System is as safe and
effective as the ClearPath Lower GI (K113050). The Pure
Vu System has the same intended uses and similar
indications, technological characteristics, and principles of
operation as its predicate device. The minor technological
differences between the Pure Vu System and its predicate
devices raise no new issues of safety or effectiveness.
Performance data demonstrate that the Pure Vu System
is as safe and effective as the ClearPath Lower Gl. Thus,
the Motus GI System is substantially equivalent. |
| Performance Data: | Performance tests were conduct to verify that the Pure Vu
System meets the requirements for its intended use and is
substantial equivalence to the predicate device.
Biocompatibility
The Pure Vu Add-on is a surface contact device with a
limited contact (shorter than ≤24 hours) of the mucosal
tissue. The Pure Vu WS Cartridge (WSC) is an externally
communicating devices with a limited contact (shorter than
≤24 hours) of the mucosal tissue. As such, the following
biocompatibility tests were performed:
Cytotoxicity: Growth Inhibition Test - Extraction MethodIrritation: Intracutaneous Reactivity TestSensitization: Skin sensitizationAll materials and representative manufacturing processes
of the disposable kits passed the above tests and were
found biocompatible.
Electrical Safety and EMC
The Pure Vu System includes a workstation which controls irrigation and evacuation through the disposable attached to the colonoscope. In addition the System accessories, Loading and Unloading fixtures, includes inflation boxes enabling to mount the Add-on to a colonoscope prior to the clinical procedure and to remove the Add-on from a colonoscope after the procedure. |
| All 3 System components are designed and constructed
to conform with the IEC 60601-1 and 60601-1-2 medical
electrical equipment safety standard.
The System components were tested for mechanical and
electrical safety and are found as compliant with the IEC
60601-1 and 60601-1-2. | |
| Software validation
Pure Vu software has been validated per EC 62304:2006,
Medical Device Software and followed the companies
Software Life-Cycle Processes. | |
| Bench tests
Performance tests after preconditioning were conducted
and included the following aspects of the product: Bound
strength test, Pressure test, overall System performance,
Add-on movement, and steering segment abilities.
Bench test results confirm that the Pure Vu System meets
its requirements for its intended use. | |
| Pure Vu System – Animal study:
A prospective animal study was conducted to establish
the effectiveness and safety of Pure Vu.
The final configuration of Pure Vu System was used in 35
procedures in swine (66% female) performed by 4
experienced gastroenterologists. No immediate, such as
mucosal injury, or delayed adverse events were reported
in any of the 35 animal procedures.
In 30/35 (86%) of the procedures, the colon cleansing
level prior the use of the Pure Vu device was inadequate,
whereas 100% (35/35) of the animals had an excellent
colon cleansing level following the use of Pure Vu.
The physicians were satisfied with the Pure Vu ease of
advancement and navigation, level of stiffness, and its
torque response. They found Pure Vu easy to use and
intuitive to operate.
Pure Vu was found to be simple, safe and effective to be
used. | |
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Image /page/4/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 multiple blue dots arranged in a circular pattern. To the right of the circular design, the text "PURE-VU" is displayed in a large, sans-serif font, with each letter in blue. Below "PURE-VU", the text "by MOTUS GI" is written in a smaller, sans-serif font.
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Image /page/5/Picture/0 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is primarily blue, with a circular pattern of blue dots on the left side. The text "PURE-VU" is in a sans-serif font, with the "by MOTUS GI" text in a smaller font size below the "PURE-VU" text.
6
Image /page/6/Picture/0 description: The image contains 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 sans-serif font, with the letters in a gradient of blue. Below the "PURE-VU" text, the words "by MOTUS GI" are written in a smaller, sans-serif font.
7
Image /page/7/Picture/0 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. To the right of the dots is the text "PURE-VU" in a blue sans-serif font, with the "E" and "V" slightly lighter in color. Below the text is the phrase "by MOTUS GI" in a smaller, gray font.
| Conclusion: | Based on the technological characteristics and pre-clinical performance of the device, Motus GI medical Technologies Ltd. believes that the Pure Vu System and the predicate device selected are substantially equivalent and do not raise new issues of safety or effectiveness. |
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