(37 days)
Not Found
No
The description focuses on mechanical and fluid control systems for cleaning the colon during a colonoscopy. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The control unit manages fluid and gas delivery and suction, which are standard functions for this type of device.
Yes.
The device is intended to facilitate intra-procedural cleaning of a poorly prepared colon, which is a medical intervention aimed at improving a patient's condition (colon preparation for colonoscopy).
No
Explanation: The Pure-Vu EVS System is designed for intra-procedural cleaning of the colon during colonoscopies by irrigating and suctioning fluids and matter. Its function is to facilitate cleaning, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines multiple hardware components including an Oversleeve, Workstation, pumps, regulators, and a foot pedal. The performance studies also detail testing of both disposable and reusable hardware components.
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 facilitate intra-procedural cleaning of a poorly prepared colon during a colonoscopy. This is a therapeutic/procedural function, not a diagnostic one.
- Device Description: The device physically interacts with the colon to irrigate and remove waste. It does not analyze biological samples (like blood, tissue, or other bodily fluids) in vitro (outside the body) to provide diagnostic information about a patient's health status.
- Lack of Diagnostic Function: The description focuses on the mechanical process of cleaning the colon. There is no mention of analyzing the removed material for diagnostic purposes.
- No Mention of IVD-related activities: The description of performance studies focuses on the device's mechanical and functional performance, safety, and biocompatibility, not on the accuracy or reliability of diagnostic results.
In summary, the Pure-Vu EVS System is a medical device used to assist in a medical procedure (colonoscopy) by improving visualization through cleaning. It does not perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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 irrigation 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 EVS System enables colon cleaning during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid and gas to break up feces. The fecal matter & fluids are removed through the suction channel of the Oversleeve into an external waste container.
The Pure-Vu EVS System consists of the following main components:
Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes 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 fecal material 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 fluids and feces from the colon.
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
colon, GI tract
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)
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 disposable with the product specifications.
Steering test: Impact of the ability of the Pure-Vu EVS Oversleeve on a colonoscope 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 transport 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 WS underwent the following tests:
Environmental conditioning and transportation simulation performed by third party laboratories as per ASTM D4169, DC13. After the preconditioning simulations, the Pure-Vu EVS WS underwent verification testing including visual inspection and functionality tests. The embedded updated software compliance with the WS design modifications was tested via software verification and validation. Cleaning verification was performed to demonstrate compatibility with cleaning agents noted in IFU. IPX2 per IEC 60529 Dimension verification Safety and EMC tests per IEC 60601 Validation testing for the WS and disposable device was performed with 4 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 (K191220)
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
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 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.
February 10, 2022
Motus GI Medical Technologies Ltd. Mark Pomeranz President and COO 22 Keren Ha'yesod Str. Tirat Carmel, 3902638 ISRAEL
Re: K220007 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 Dated: December 30, 2021 Received: January 4, 2022
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 (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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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).
Sincerely,
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
2
Indications for Use
510(k) Number (if known)
Device Name Pure-Vu EVS System
Indications for Use (Describe)
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 irrigation 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 contains 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 separating "PURE" and "VU". Below the text, in a smaller font, is the phrase "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, 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: | December 30, 2021 |
| 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 (K191220) |
| Indications for Use: | 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 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 EVS System enables colon cleaning during colonoscopy
using a standard or slim colonoscope with a length of 1630mm –
1710mm and an outer diameter range of 11.7mm – 13.7mm. The
Oversleeve, which fits over the colonoscope and is connected to an
external Workstation, generates fluid and gas to break up feces. The
fecal matter & fluids are removed through the suction channel of the
Oversleeve into an external waste container.
The Pure-Vu EVS System consists of the following main
components: |
| | Oversleeve (OS) and Umbilical Section (US) - The disposable
Oversleeve is mounted on Standard or Slim commercially
available colonoscopes 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 fecal material 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 fluids
and feces from the colon. |
| | 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 disposable
with the product specifications. Steering test: Impact of the ability of the Pure-Vu EVS Oversleeve
on a colonoscope 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 transport 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 WS underwent the following tests: Environmental conditioning and transportation simulation performed by third party laboratories as per ASTM D4169, DC13. After the preconditioning simulations, the Pure-Vu EVS WS underwent verification testing including visual inspection and functionality tests. The embedded updated software compliance with the WS design modifications was tested via software verification and validation. Cleaning verification was performed to demonstrate compatibility with cleaning agents noted in IFU. IPX2 per IEC 60529 Dimension verification Safety and EMC tests per IEC 60601 Validation testing for the WS and disposable device was performed with 4 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 device. The differences between the device and its predicate device 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 device. The intended of use of this product meets the requirements of 21 CFR 801.4 |
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Image /page/4/Picture/1 description: The image features the logo for "PURE-VU by MOTUS GI". The logo is in blue and has a circular design on the left side made up of small blue dots. The text "PURE-VU" is in a sans-serif font, with the "PURE" part being slightly darker than the "VU" part. Below "PURE-VU" is the text "by MOTUS GI" in a smaller font.
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Image /page/5/Picture/1 description: The image shows the logo for "PURE-VU by MOTUSgi". The logo features a circular pattern of blue dots on the left, followed by the word "PURE-VU" in a stylized, blue font. Below "PURE-VU" is the text "by MOTUSgi" in a smaller, futuristic-looking font.
A comparison of the subject and predicate devices is provided in the Table below.
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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 stylized design of blue dots on the left, followed by the text "PURE-VU" in a blue, sans-serif font. Below the "PURE-VU" text, there is the text "by MOTUS GI" in a smaller, gray font.
| Characteristics Comparison: | ||
|---|---|---|
| Modified Device | Predicate Device | |
| Manufacturer | Motus GI Medical Technologies Ltd. | Motus GI Medical Technologies Ltd. |
| Description | Pure-Vu EVS System | Pure-Vu EVS System |
| Indications for Use | Same | The Pure-Vu 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 bodily fluids and | ||
| matter, e.g. blood. | ||
| It is for use only by trained medical | ||
| personnel located in hospitals, clinics | ||
| and doctor 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 | 1) Same |
- One distal suction hole | 1) Multi irrigation hole
- Two distal suction holes |
| Principle of
operation | Same except for 5 tubes in predicate
versus one dual lumen tube in subject
device. | 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
endoscope's working channel. |
| Operational
Procedures | 1) Same - Same
- Same | 1) Attachment to a Standard or Slim
colonoscope - Intra-procedure colon cleansing
during standard endoscopy - Evacuation of water and feces |
| System
Components | The Pure-Vu EVS System consists of
the same main components as the
predicate device with the minor
modifications described in Section 9,
Design Control Activities including the
removal of the Pure-Vu Loading
Fixture | 1) Pure-Vu Workstation - Pure-Vu Standard and Slim
colonoscope Oversleeves - Pure-Vu WS Connector
- Pure-Vu Loading Fixture |
| Characteristics Comparison: | | |
| | Modified Device | Predicate Device |
| Oversleeve outer
diameter | Same | 21 mm |
| Irrigation &
suction system | Irrigation: 5 nozzle x 0.6 mm
Suction: 1 nozzle x 40 mm2 | Irrigation: 4 nozzle x 0.7 mm
Suction: 2 nozzles x 12.5 mm2 |
| Disposable length | Same | 167 cm attached to colonoscope |
| Air / Suction
pressure
specification
(bar) | Up to 1.65 bar (24psi) | Up to 1.55bar (23 psi)
Suction specifications: (-) 0.5 Bar |
| Flow rate
(cc / min) | Water - Same
Air - Up to 1000cc/min | Water - Up to 645 cc/min
Air - up to 1350 cc/min |
| Dimensions
Workstation | W250mm \ D400mm \ H280 mm | W250mm \ D476mm \ H358 mm |
| Weight Workstation | 12kg | 18kg |
| Electrical Input | Same | 100V-240V
50/60 Hz |
| Material | Same | Complies with ISO 10993 |
| Sterilization | Same | Clean, Non-sterile |
| Safety Standards | Same | Complies with:
IEC 60601-1
IEC 60601-1-2 |
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Image /page/7/Picture/0 description: The image shows the text "K220007 Page 5 of 5". The text is in a simple, sans-serif font. The page number indicates that this is the last page of a document. The document number is K220007.
Image /page/7/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 numerous small blue dots arranged in a spiral pattern. To the right of the circular design, the text "PURE-VU" is displayed in a bold, sans-serif font, with the letters rendered in a gradient of blue. Below "PURE-VU", the text "by MOTUS GI" is written in a smaller, sans-serif font, also in blue.