(90 days)
No
The description focuses on mechanical components (peristaltic pump, suction/irrigation head) and fluid control, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is intended for cleaning and irrigating the upper digestive tract during endoscopic procedures to improve visualization, not for directly treating a disease or condition.
No
Explanation: The ClearPath-UGI System is described as being for irrigating, cleaning, and evacuating the upper digestive tract during endoscopic procedures to improve visualization. Its function is to facilitate the procedure, not to diagnose a condition or disease.
No
The device description clearly outlines hardware components: a disposable Irrigator and a reusable Control cabinet with a peristaltic pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for irrigating, cleaning, and evacuating fluids from the upper digestive tract during endoscopic procedures. This is a procedural device used directly on the patient's body for visualization and cleaning, not for analyzing samples taken from the body.
- Device Description: The description focuses on the mechanical aspects of irrigation and suction, and its attachment to an endoscope. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples. There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostics.
In summary, the ClearPath-UGI System is a medical device used for procedural support during endoscopy, not for performing diagnostic tests on biological samples outside of the body.
N/A
Intended Use / Indications for Use
The ClearPath-UGI System is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
Product codes
FDS
Device Description
The ClearPath UGI's main purpose is to improve procedure reliability by improving procedural visualization during endoscopic procedures.
The ClearPath UGI utilizes a suction / irrigation head for the purpose of irrigating or cleaning the upper digestive tract.
The ClearPath UGI is composed of two major units:
- . The disposable Irrigator and
- . the reusable Control cabinet.
The disposable Irrigator is attached to a standard endoscope by means of silicone bands and does not hinder the endoscope's functionality nor affects the procedure sequence in any way.
The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper GI tract
Indicated Patient Age Range
Individuals undergoing procedures where a gastroscope is used.
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)
We have performed testing to demonstrate that the operating performance of the ClearPath UGI is equivalent to the predicate for flow rate, irrigation and vacuum pressures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091305 – Easy Glide – ClearPath, K060907 - Karl Storz video gastroscope
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
510(k) Summary Page 1 of 2
7-Dec-09
Kog3779
EasyGlide Ltd. 30 Ha'Ella St. Kfar Truman, 73150 Israel
Tel - 011-972-528565644 Fax - 011-972-776201003
| Official Contact: | Izhak Fabian - CEO |
|---|---|
| Proprietary or Trade Name: | ClearPath UGI |
| Common/Usual Name: | Gastroscope accessory |
MAR - 9 ŽOID
Device:
ClearPath UGI
CFR 876.1500
FDS - endoscope and accessories
| Predicate Devices: | K091305 – Easy Glide – ClearPath |
|---|---|
| K060907 - Karl Storz video gastroscope |
Device Description:
Classification Name/Code:
The ClearPath UGI's main purpose is to improve procedure reliability by improving procedural visualization during endoscopic procedures.
The ClearPath UGI utilizes a suction / irrigation head for the purpose of irrigating or cleaning the upper digestive tract.
The ClearPath UGI is composed of two major units:
- . The disposable Irrigator and
- . the reusable Control cabinet.
The disposable Irrigator is attached to a standard endoscope by means of silicone bands and does not hinder the endoscope's functionality nor affects the procedure sequence in any way.
The Control cabinet supplies the water flow and vacuum control using a peristaltic pump. The standard medical facility vacuum system is the vacuum source.
Indications for Use:
The ClearPath-UGI System is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
510(k) Summary
1
Page 2 of 2 7-Dec-09
Patient Population:
Individuals undergoing procedures where a gastroscope is used.
Environment of Use:
Hospitals, clinics, and doctors' offices.
Summary of substantial equivalence:
We have performed testing to demonstrate that the operating performance of the ClearPath UGI is equivalent to the predicate for flow rate, irrigation and vacuum pressures.
| | Proposed
ClearPath UGI | ClearPath
EasyGlide |
|----------------------------------------|------------------------------------------------|------------------------------------------------|
| 510(k) number | | K091305 |
| Air / Water pressure
specifications | Up to 30 Psi | Up to 30 Psi |
| Flow rate | Up to 300 ml/min | Up to 300 ml/min |
| Suction
specifications | Standard wall suction
Approximately 0.5 Bar | Standard wall suction
Approximately 0.5 Bar |
The proposed ClearPath UGI is only a modification of the predicate ClearPath in that the disposable tubing set is shorter in length and the irrigation tip has been redesigned. No modification have been made to the controller or software.
The ClearPath UGI is viewed as substantially equivalent to the predicate devices because:
Indications -
- . Identical to predicate - K060907 - Karl Storz
Technology -
- Identical technology used K091305 EasyGlide ClearPath .
Materials -
- The materials in patient contact are identical to the predicate device, ClearPath K091305. .
Environment of Use -
- Identical to predicate K091305 EasyGlide ClearPath .
Performance specifications -
- Irrigation pressures, flow rate and suction pressures are identical to the predicate -. K091305 EasyGlide ClearPath
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircles the eagle, indicating the department's name and country.
9 2010 MAR
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
EasyGlide Ltd. % Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive BONITA SPRINGS FL 34134
K093779 Re:
Trade/Device Name: ClearPath UGI Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS Dated: December 8, 2009 Received: December 9, 2009
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related
3
Page 2 -
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/SafetyReportaProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Page 1 of 1
510(k) Number:
( 09 3779 (To be assigned)
Device Name:
ClearPath UGI
Indications for Use:
The ClearPath-UGI System is intended for irrigating or cleaning the upper digestive tract and evacuating the irrigation fluid, blood and bile in the upper GI tract during endoscopic procedures.
It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.
Prescription Use XX (Part 21 CFR 801 Subpart D)
.
or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hul Remu
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number