(31 days)
No
The description focuses on mechanical and fluid control mechanisms for cleansing the GI tract, with no mention of AI or ML.
Yes
The device is intended to facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning irrigation fluid, feces, and other bodily fluids and matter, which directly impacts a physiological function for therapeutic purposes.
No
Explanation: The device description and intended use clearly state that the Pure-Vu EVS System is designed for intra-procedural cleansing of the GI tract by irrigating and removing fluids and matter, not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a disposable device (Flex Channel and Umbilical Section), a reusable Workstation with pumps, regulators, and a monitoring & control unit, irrigation bags/bottles, waste containers, and a foot pedal. While software is mentioned as being modified and undergoing verification and validation, it is part of a larger hardware system.
Based on the provided information, the Pure-Vu EVS System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood." This describes a physical intervention to clean the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a system that physically interacts with the GI tract using irrigation and suction. It does not mention any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, chemicals, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases.
The Pure-Vu EVS System is a medical device used for a therapeutic or procedural purpose (cleansing the GI tract), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Pure-Vu EVS System is intended to connect to standard or slim colonoscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning 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.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FDS
Device Description
The Pure-Vu EVS System enables cleaning of the GI tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.2mm or gastroscope with a length of 950 – 1030mm and an outer diameter of 9.2 - 10mm The EVS Flex Channel , which fits alongside the endoscope and is connected to an external Workstation, generates fluid and gas to break up debris The debris & fluids are removed through the suction channel of the EVS Flex Channel into an external waste container/bag.
The Pure-Vu EVS System consists of the following main components:
Disposable device which includes a Flex Channel section and an Umbilical Section (US) - The EVS Flex Channel fits alongside the endoscope to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates debris and fluids. The Workstation includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluid and matter from the GI tract. Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line. Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the GI tract. A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical personnel located in hospitals, clinics and doctors' 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)
Verification and Validation Testing tests were conducted for all modifications to the Pure-Vu EVS System component as follows:
-
Pure-Vu EVS Disposables
Environmental conditioning/Shelf-life simulation: All disposable units underwent preconditioning simulations tests at third party laboratories including but not limited to environmental conditioning and shelf-life simulation to demonstrate that the Pure-Vu EVS Disposables functionality meets the requirements following a simulated aging of one year.
Dimensions test: Dimensional compliance of the disposables with the product specifications.
Head Pull test: Verification of minimum force that causes linear movement of the EVS DD flexible head relative to the endoscope
Steering test: Impact of the ability of the Pure-Vu EVS Flex Channel on an endoscope to bend in its distal steering section based on actuating the knobs on the handle of the colonoscope:
System test: Measurement of different pressure, air and water flow values in order to confirm that the system complies with product specifications.
Pressure test: Verification that the disposable withstands specific pressure without any leakage.
Bond strength test: Verification of the tensile force of the bonds in the disposable device.
The disposable package underwent environmental conditioning and distribution simulation by third party laboratories in order to demonstrate the integrity of the packaging and their accompanying labels following the simulation. In addition, biocompatibility testing was done to determine if there was any toxicological risk to the patient. -
Pure-Vu EVS Workstation (WS)
The modified software of the WS underwent the following tests:
Software verification and validation for the software modifications. -
System Validation Testing
Validation testing for the entire Pure Vu EVS system (WS and disposable devices) was performed with 6 physicians.
Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance.
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.
Pure-Vu System (K220007)
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.
Pure-Vu System (K210981)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 20, 2023
Motus GI Medical Technologies Ltd. Mark Pomeranz CEO and President 22 Keren Ha'vesod Str. Tirat Carmel, 3902638 Israel
Re: K232922
Trade/Device Name: Pure-Vu EVS System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDF, FDS Dated: September 19, 2023 Received: September 19, 2023
Dear Mark Pomeranz:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232922
Device Name Pure-Vu EVS System
Indications for Use (Describe)
The Pure-Vu EVS System is intended to comect to standard or slim colonoscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning 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.
| 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/4/Picture/1 description: The image contains the logo for "PURE-VU by MOTUS GI". The logo features a circular design on the left, composed of numerous small blue dots arranged in a spiral 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, italicized 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, 3902638 Israel
Tel .: +972-4-6214446
Fax: +972-4-6214442 | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mark Pomeranz | |
| Phone Number: | 908 745 8599 | |
| Fax Number: | +972 733735181 | |
| Establishment
Registration #: | 3011816755 | |
| Date Prepared: | September 19, 2023 | |
| Trade Name(s): | Pure-Vu EVS System | |
| CommonName: | Pure-Vu EVS System | |
| Classification Name: | Endoscope and accessories | |
| Classification: | Regulation No: 876.1500 Class: II
Panel: Gastroenterology and Urology | |
| Predicate Device(s): | Pure-Vu System (K220007) | |
| Reference Device: | Pure-Vu System (K210981) | |
| Indications for Use: | The Pure-Vu EVS System is intended to connect to standard or slim
colonoscopes and gastroscopes to help facilitate intra-procedural
cleansing of the GI tract by irrigating or cleaning and evacuating 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. | |
| Technological
Characteristics: | The Pure-Vu EVS System enables cleaning of the GI tract during
endoscopy using a standard or slim colonoscope with a length of
1630mm - 1710mm and an outer diameter range of 11.7mm -
13.2mm or gastroscope with a length of 950 – 1030mm and an outer
diameter of 9.2 - 10mm The EVS Flex Channel , which fits alongside
the endoscope and is connected to an external Workstation,
generates fluid and gas to break up debris The debris & fluids are
removed through the suction channel of the EVS Flex Channel into an
external waste container/bag. | |
| The Pure-Vu EVS System consists of the following main components:
Disposable device which includes a Flex Channel section and an Umbilical Section (US) - The EVS Flex Channel fits alongside the endoscope to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates debris and fluids. The Workstation includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluid and matter from the GI tract. Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line. Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the GI tract. A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician. | | |
| Performance Data | Verification and Validation Testing tests were conducted for all modifications to the Pure-Vu EVS System component as follows:
- Pure-Vu EVS Disposables Environmental conditioning/Shelf-life simulation: All disposable units underwent preconditioning simulations tests at third party laboratories including but not limited to environmental conditioning and shelf-life simulation to demonstrate that the Pure-Vu EVS Disposables functionality meets the requirements following a simulated aging of one year. Dimensions test: Dimensional compliance of the disposables with the product specifications. Head Pull test: Verification of minimum force that causes linear movement of the EVS DD flexible head relative to the endoscope Steering test: Impact of the ability of the Pure-Vu EVS Flex Channel on an endoscope to bend in its distal steering section | |
| | | |
| | based on actuating the knobs on the handle of the colonoscope: | |
| | System test: Measurement of different pressure, air and water flow values in order to confirm that the system complies with product specifications. | |
| | Pressure test: Verification that the disposable withstands specific pressure without any leakage. | |
| | Bond strength test: Verification of the tensile force of the bonds in the disposable device. | |
| | The disposable package underwent environmental conditioning and distribution simulation by third party laboratories in order to demonstrate the integrity of the packaging and their accompanying labels following the simulation. In addition, biocompatibility testing was done to determine if there was any toxicological risk to the patient. | |
| | 2) Pure-Vu EVS Workstation (WS)
The modified software of the WS underwent the following tests: | |
| | Software verification and validation for the software modifications. | |
| | 3) System Validation Testing
Validation testing for the entire Pure Vu EVS system (WS and disposable devices) was performed with 6 physicians. | |
| | Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance. | |
| Substantial
Equivalence
Discussion: | The Pure-Vu EVS System has the same intended use, principles of operation and similar technological characteristics as its predicate and reference devices. The differences between the subject device and its predicate and reference devices due to the modifications as detailed in this submission do not raise any new issues of safety or effectiveness. Performance data demonstrate that the Pure-Vu EVS System is substantially equivalent. | |
| Conclusion: | The Pure-Vu EVS System is substantially equivalent to the predicate and reference devices. The intended of use of this product meets the requirements of 21 CFR 801.4 | |
| | Subject Device | Predicate Device
K220007 |
| Manufacturer | Motus GI Medical Technologies Ltd. | |
| Description | Pure-Vu EVS System | Pure-Vu EVS System |
| Indications for Use | The Pure-Vu EVS System is
intended to connect to standard or
slim colonoscopes and gastroscopes
to help facilitate intra-procedural
cleansing of the GI tract by irrigating
or cleaning and evacuating 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. | The Pure-Vu EVS System is intended
to connect to standard and slim
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
|
| Environment of Use | Hospitals, clinics and doctors' offices | Hospitals, clinics and doctors' offices |
| Prescriptive | Same | Yes, only trained medical personnel |
| Technological Characteristics | | |
| Disposable | Same | Single patient, single use |
| Distal tip design | Same as predicate with the exception
that the hole geometry that fits on the
endoscope was modified to allow it to
be pushed on like an endoscopy cap. | 1) Multi irrigation hole
2) One distal suction hole |
| | Subject Device | Predicate Device
K220007 |
| Principle of
operation | Same as the predicate device with the
exception of how the device connects
to the endoscope. There is no longer
a loading handle to connect the
device to the endoscope as the distal
head can just be pushed on the scope
(like an endoscopy cap) and the low
friction sleeve material is now only
covering the dual lumen tubing and
not the endoscope with 2 or 3 retainer
strips to hold the dual lumen tube next
to the endoscope. | Distal attachment to an endoscope
using a loading handle, sleeve
covering the tubing and endoscope
ensuring attachment along entire
length, dual lumen suction and
irrigation tube 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 endoscope's working
channel. |
| Operational
Procedures | 1) Attachment to Standard or Slim
colonoscope or gastroscope
2) Intra-procedure cleansing of GI
tract during standard endoscopy
3) Evacuation of water, feces and
matter | 1) Attachment to a Standard or
Slim colonoscope
2) Intra-procedure colon cleansing
during standard colonoscopy
3) Evacuation of water and feces
and other matter |
| Oversleeve / Flex
Channel maximum
outer diameter | 21 mm Colon
18mm Gastro | 21 mm Colon (distal head is the
largest diameter) |
| Irrigation & suction
system | Colon version:
• same as predicate
Gastro version:
• Irrigation 3 nozzles (1 with 0.25
mm and 2 with 0.8 x 0.25mm
mm | Irrigation: 5 nozzles x 0.6 mm
Suction: 1 nozzle x 40 mm² |
| Disposable length | 167 cm attached to colonoscope
103 cm attached to gastroscope | 167 cm attached to
colonoscope |
| Air / Suction pressure
specification | Air: Up to1.65 bar for Colon Version
Up to 2.1 bar for Gasto version
Suction specifications: (-)0.5 Bar for
both | Up to1.65 bar (24psi)
Suction specifications: (-)0.5 Bar |
| | Subject Device | Predicate Device
K220007 |
| Flow rate
(cc / min) | Same | Water – Up to 645 cc/min
Air - up to 1000 cc/min |
| Dimensions:
Workstation: | Same | W250 mm \ D400mm \ H280 mm |
| Weight Workstation | Same | 12Kg |
| Electrical Input | Same | 100V-240V/50/60 Hz |
| Material | Same | Complies with ISO 10993 |
| Sterilization | Same | Clean, Non-sterile |
| System
Components | Same with the addition of the
gastroscope Oversleeve now referred to as Flex Channel and a version to fit on gastroscopes | Pure-Vu Workstation
Pure-Vu Colon Oversleeves
Pure-Vu WS Connector (also, referred to as Umbilical section) |
| Safety Standards | Same | Complies with:
IEC 60601-1
IEC 60601-1-2 |
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Image /page/5/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo consists of a circular pattern of blue dots on the left, followed by the text "PURE-VU" in a blue gradient. Below the text is the phrase "by MOTUS GI" in a smaller, gray font.
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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 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, sans-serif font, with the letters in varying shades of blue. Below "PURE-VU" and slightly to the right is the text "by MOTUS GI" in a smaller font size.
A comparison of the subject and predicate devices is provided in the Table below.
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Image /page/7/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is in blue and features a circular design made up of small dots on the left side. The text "PURE-VU" is in a sans-serif font, with a hyphen between "PURE" and "VU". The words "by MOTUS GI" are in a smaller font below the main text.
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Image /page/8/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is in blue and features a circular design made up of small blue dots on the left. The text "PURE-VU" is in a sans-serif font, with a hyphen between "PURE" and "VU". Below the text is the phrase "by MOTUS GI" in a smaller font.
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Image /page/9/Picture/1 description: The image shows the logo for "PURE-VU by MOTUS GI". The logo is in blue and features a circular design made of dots on the left. The text "PURE-VU" is in a stylized font, and "by MOTUS GI" is in smaller letters below the main text.