(28 days)
Not Found
No
The description focuses on mechanical and fluidic components for irrigation and suction, with no mention of AI/ML, image processing, or data-driven decision making.
No.
The device facilitates intra-procedural cleansing of the GI tract, but it does not directly treat a disease or condition. Its purpose is to assist in an endoscopic procedure.
No
The device is intended to facilitate intra-procedural cleansing of the GI tract by irrigating and evacuating fluids and debris during endoscopic procedures. It does not perform any diagnostic function.
No
The device description clearly outlines multiple hardware components including an Oversleeve, Umbilical Section, Workstation (containing pumps, regulators, and a monitoring & Control Unit), a foot pedal, loading fixture, and unloading aids. The performance studies also focus on the physical interaction and performance of these hardware components.
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 facilitate intra-procedural cleansing of the GI tract by irrigating and evacuating fluids and debris. This is a physical process performed in vivo (within the body) during an endoscopic procedure.
- Device Description: The device physically interacts with the GI tract to remove material. It does not analyze biological samples in vitro (outside the body) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device analyzing samples, detecting biomarkers, or providing any diagnostic results based on the collected fluids or debris. The purpose is purely for cleansing.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnostic, monitoring, or screening purposes. The Pure-Vu System's function is entirely focused on physical cleansing during a procedure.
N/A
Intended Use / Indications for Use
Pure-Vu System is intended to connect to standard or slim colonoscopes to facilitate intra-procedural cleansing of the Gl tract by irrigating the irrigation fluids (water), bodily fluids and other debris, 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 System enables cleansing of the digestive tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.3mm (slim) and 12.8mm - 13.7mm (standard), or gastroscope with length of 950-1030mm and an outer diameter of 10mm - 10.9mm. The Oversleeve, which fits over 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 channels of the Oversleeve into an external waste container.
The Pure-Vu 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 or gastroscopes 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/saline and gas, and evacuates bodily fluid and matter. The Workstation [WS] includes the following components:
A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of bodily fluid and matter from the GI tract. 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 Gl tract. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician.
Loading fixture - The loading fixture is reusable and aids in assembling the Oversleeve onto the endoscope. Unloading aids - A disposable luer lock syringe/ duckbill check valve assembly used in unloading the Oversleeve from the endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract, colon
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 System component as follows:
Steering test: Impact of the ability of the Gastro Oversleeve on a gastroscope to bend in its distal steering section based on actuating the knobs on the handle of the endoscope: Acceptance criteria (same as for the predicate device) - The angle difference should be a maximum of 25% between a naked gastroscope and a gastroscope with an Oversleeve.
Head Pull Test: Verification of the linear movement between the Gastro Oversleeve head to the distal end of a gastroscope by simulating conditions similar to the withdrawal phase during colonoscopy procedure: Acceptance criteria (same as for the predicate device) - Gastro Oversleeve shall not move linearly in relation to the gastroscope with less than 10N of force applied.
Loading and maintenance of pressure during the loading procedure of the Gastro Oversleeve using the Gastro Sealing plug onto a gastroscope to verify a successful loading procedure without creating any damage to the device or the scope: Acceptance criteria – 100% successful loading procedures No damage to the flexible head identified by 100% visual inspection
c. Maintain pressure of up to 400 mBar
d. No damage to the gastroscope in 100% of the loading procedures verified by examining images using the gastroscope's optics.
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.
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/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.
April 29, 2021
Motus GI Medical Technologies Ltd. Mark Pomeranz President and COO 22 Keren Ha'yesod Str. Tirat Carmel, 3902638 ISRAEL
Re: K210981 Trade/Device Name: Pure Vu System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, FDS Dated: March 31, 2021 Received: April 1, 2021
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
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Indications for Use
510(k) Number (if known) K210981
Device Name Pure Vu System
Indications for Use (Describe)
Pure-Vu System is intended to connect to standard or slim colonoscopes to facilitate intra-procedural cleansing of the Gl tract by irrigating the irrigation fluids (water), bodily fluids and other debris, 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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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: | Mark Pomeranz | |
| Phone Number: | 908 745 8599 | |
| Fax Number: | 972+733735181 | |
| Establishment
Registration #: | 3011816755 | |
| Date Prepared: | March 31, 2021 | |
| Trade Name(s): | Pure Vu System | |
| CommonName: | Pure Vu 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: | Pure-Vu System is intended to connect to standard or slim colonoscopes
and gastroscopes to facilitate intra-procedural cleansing of the GI tract by
irrigating and evacuating the irrigation fluids (water), bodily fluids and other
debris, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics
and doctors' offices. | |
| Technological
Characteristics: | The Pure-Vu System enables cleansing of the digestive tract during
endoscopy using a standard or slim colonoscope with a length of
1630mm - 1710mm and an outer diameter range of 11.7mm -
13.3mm (slim) and 12.8mm - 13.7mm (standard), or gastroscope with
length of 950-1030mm and an outer diameter of 10mm - 10.9mm. The
Oversleeve, which fits over 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 channels of the
Oversleeve into an external waste container.
The Pure-Vu 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 or gastroscopes 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/saline and gas, and
evacuates bodily fluid and matter. The Workstation [WS]
includes the following components:
A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of bodily fluid and matter from the GI tract. 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 Gl tract. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician. | |
| | Loading fixture - The loading fixture is reusable and aids in assembling the Oversleeve onto the endoscope. Unloading aids - A disposable luer lock syringe/
duckbill check valve assembly used in unloading the Oversleeve from the endoscope. | |
| Performance
Data | Verification and Validation Testing tests were conducted for all
modifications to the Pure Vu System component as follows: | |
| | Steering test: Impact of the ability of the Gastro Oversleeve on a gastroscope to bend in its distal steering section based on actuating the knobs on the handle of the endoscope: Acceptance criteria (same as for the predicate device) - The angle difference should be a maximum of 25% between a naked gastroscope and a gastroscope with an Oversleeve. | |
| | Head Pull Test: Verification of the linear movement between the Gastro Oversleeve head to the distal end of a gastroscope by simulating conditions similar to the withdrawal phase during colonoscopy procedure: Acceptance criteria (same as for the predicate device) - Gastro Oversleeve shall not move linearly in relation to the gastroscope with less than 10N of force applied. | |
| | Loading and maintenance of pressure during the loading procedure of the Gastro Oversleeve using the Gastro Sealing plug onto a gastroscope to verify a successful loading procedure without creating any damage to the device or the scope: Acceptance criteria – 100% successful loading procedures No damage to the flexible head identified by
100% visual inspection | |
| | c. Maintain pressure of up to 400 mBar
d. No damage to the gastroscope in 100% of the
loading
procedures verified by examining images
using the gastroscope's optics.
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 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 System is substantially equivalent. | |
| Conclusion: | The Pure-Vu 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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A comparison of the subject and predicate devices is provided in the Table below.
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| Modified Device | Predicate Device | |
|---|---|---|
| Manufacturer | Motus GI Medical Technologies Ltd. | |
| Description | Pure-Vu System | |
| Indications for Use | The Pure-Vu System is intended to connect to standard or slim colonoscopes and gastroscopes to facilitate intra-procedural cleansing of the GI tract by irrigating and evacuating the irrigation fluids (water), bodily fluids and other debris, e.g. blood. | |
| It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices. | The Pure-Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood. | |
| It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices. | ||
| Environment of Use | Same | Hospitals, clinics and doctors' offices |
| Prescriptive | Same | Yes, only trained medical personnel |
| Disposable | Same | Single patient, single use |
| Distal tip design | Same | Multi irrigation 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 any tools, which may be inserted in the endoscope's working channel. |
| Operational Procedures | Attachment to a Standard and Slim colonoscope or gastroscope | |
| Intra-procedure cleansing during standard endoscopy | ||
| Same | 1) Attachment to a Standard and Slim colonoscope |
- Intra-procedure cleansing during standard colonoscopy
- Evacuation of bodily fluids and matter |
| System
Components | The Pure-Vu System consists of the
same main components as the
predicate device with the addition of
the Gastro Oversleeve and the minor
modifications described in Section 9,
Design Control Activities | 1) Pure-Vu Workstation - Pure-Vu Standard and Slim
colonoscope Oversleeves - Pure-Vu WS Connector
- Pure-Vu Loading Fixture |
| Oversleeve outer
diameter | Same | 21 mm |
| Irrigation &
suction system | Same | Irrigation: 4 nozzle x 0.7 mm²
Suction: 2 nozzles x 12.5 mm² |
| Disposable length | Same for colonoscope
100 cm for gastroscope | 167 cm attached to colonoscope |
| Air / Water
pressure
specification
(bar) | Same | Up to 23 psi
Suction specifications: - 0.5 Bar |
| Flow rate
(cc / min) | Same | Water - Up to 645 cc/min
Air - up to 1350 cc/min |
| Dimensions
Workstation | W250mm \ D476mm (516 with pump
head) \ H-358 mm | W460 \ D480 (520 with pump head)
H340 mm |
| Weight Workstation | 18Kg | 25Kg |
| 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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