(202 days)
No
The summary describes a mechanical device for irrigation and suction during endoscopy and does not mention any AI/ML components or capabilities.
No
The device is described as an irrigation and evacuation tool used during endoscopic procedures, not for treating a disease or condition.
No
The device is described as an irrigation and evacuation system for the upper GI tract during endoscopic procedures. Its intended use is for cleaning and evacuating fluid, blood, and bile, which are therapeutic and procedural functions, not diagnostic ones.
No
The device description explicitly lists physical components (suction tube + tip, irrigation tube + tip, sleeve) and describes its connection to other physical devices (ClearPath Controller and ClearPath Tubing). The performance studies also involve bench and animal testing of these physical components.
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 the upper digestive tract during endoscopic procedures. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a physical tool used to facilitate a medical procedure (endoscopy). It doesn't analyze biological samples to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, tissue, or other bodily fluids for diagnostic purposes. The focus is on clearing the field of view and removing debris during the procedure.
- No Mention of Diagnostic Metrics: The performance studies focus on mechanical and functional aspects of the device during the procedure (e.g., dislodgement, maneuverability, irrigation quality, suction quality), not on diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ClearPath Upper Gl 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 (comma separated list FDA assigned to the subject device)
FDS
Device Description
The ClearPath Upper GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Upper GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the upper gastrointenstinal tract during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper gastrointenstinal tract / upper GI tract / upper digestive tract
Indicated Patient Age Range
Individuals undergoing endoscopic procedures.
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
Bench and animal testing were performed to verify that the ClearPath Upper G1 performs as expected in conjunction with standard endoscopes and with the cleared ClearPath controller and tubing K0910305. The tests included:
- Dimensional testing
- Strength testing
- Functional testing
- Mechanical testing
- Compliance with endoscopes
The animal testing evaluated:
- Any sign of dislodgement of the tip from the endoscope during the procedure
- Ease of maneuverability and advance in the GI tract
- Quality of visibility
- Quality of irrigation
- Any sign of occlusion or interruption to continuous suction.
- Quality of evacuation of blood, bile, and other bodily fluid and matter
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All testing demonstrated that the modified ClearPath Upper GI disposable performed to its specifications and / or was equivalent to the predicate.
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.
K093779 - EasyGlide - ClearPath Upper GI
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.
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.
0
Special Premarket Notification 510(k) Section 5 - Device Description
ClearPath Upper Gl
| 510(k) Summary |
|---|
| Page 1 of 3 |
| 25-Oct-11 |
| 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 Upper Gl |
| Common/Usual Name: | Irrigation/evacuation system |
| Classification Name/Code: | FDS - Endoscope and accessories, flexible/rigid
CFR 876.1500
Class 2 |
| Device: | ClearPath Upper Gl |
| Predicate Devices: | K093779 - EasyGlide - ClearPath Upper GI |
Device Description:
The Clearpath Upper GI was cleared under K093779, we have modified the design. .
The ClearPath Upper GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Upper GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the upper gastrointenstinal tract during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.
Indications for Use:
The ClearPath Upper Gl 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.
Patient population:
Individuals undergoing endoscopic procedures.
1
510(k) Summarv Page 2 of 3 . 25-Oct-11
Environment of Use:
Hospitals, clinics, and doctors' offices.
Performance testing:
We have performed bench and animal testing to verify that the ClearPath Upper G1 performs as expected in conjunction with standard endoscopes and with the cleared ClearPath controller and tubing K0910305. The tests include:
- o Dimensional testing
- 0 Strength testing
- Functional testing o
- Mechanical testing 0
- Compliance with endoscopes o
The animal testing evaluated:
- Any sign of dislodgement of the tip from the endoscope during the o procedure
- Ease of maneuverability and advance in the GI tract 0
- Quality of visibility o
- Quality of irrigation 0
- Any sign of occlusion or interruption to continuous suction. o
- Quality of evacuation of blood, bile, and other bodily fluid and matter o
All testing demonstrated that the modified ClearPath Upper GI disposable performed to its specifications and / or was equivalent to the predicate.
Summary of substantial equivalence:
We demonstrate that the modified ClearPath Upper Gl is substantially equivalent to the predicate in design and performance characteristics:
- . Indications - Identical to predicate K093779: Cleaning, irrigating, and evacuating the upper GI tract during endoscopic procedures
- . Technology - Identical to predicate: Single use disposable, applied over a standard endoscope, works in conjunction with the Clearpath Controller (K091305) to facilitate cleaning of the upper GI tract by irrigation and evacuation.
- Environment of use Identical to predicate: Hospitals, clinics, and doctors' ● offices.
2
510(k) Summary . Page 3 of 3 25-Oct-11
- Materials Materials were either identical to the predicate or shown to comply with . ISO 10993-1
- . Difference - there are no substantial differences or new features in the proposed device compared to the predicate which raises any new safety or efficacy issue
| Comparative Table - Compares the predicates and the proposed modified device | ||
|---|---|---|
| Proposed device | Predicate device | |
| EasyGlide | K093779 | |
| EasyGlide | ||
| Device | Clearpath Upper GI | Clearpath Upper GI |
| Design | Used as an add-on to standard endoscopes for | |
| irrigation and evacuation. Attaches along the | ||
| endoscope leaving the working channel free. | Used as an add-on to standard endoscopes for | |
| irrigation and evacuation. Attaches along the | ||
| endoscope leaving the working channel free. | ||
| Indications for use | The ClearPath Upper GI 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. | The ClearPath Upper GI 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. | It is for use only by trained medical personnel | |
| located in hospitals, clinics, and doctors' | ||
| offices. | ||
| Environment of use | Hospitals, clinics, and doctors' offices. | Hospitals, clinics, and doctors' offices. |
| Prescriptive | Yes, only trained medical personnel | Yes, only trained medical personnel |
| Principle of | ||
| operation | Distal attachment to an endoscope, sleeve | |
| ensuring attachment along entire length, | ||
| suction and irrigation tubes running along the | ||
| endoscope, suction and irrigations heads 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. | Distal attachment to an endoscope, sleeve | |
| ensuring attachment along entire length, | ||
| suction and irrigation tubes running along the | ||
| endoscope, suction and irrigations heads 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. | ||
| accessories | ClearPath Controller and ClearPath Tubing | |
| (K091305) | ClearPath Controller and ClearPath Tubing | |
| (K091305) | ||
| Distal tip design | Multi irrigation holes | |
| Distal suction hole | Multi irrigation holes | |
| Distal suction hole | ||
| Material | Comply with ISO 10993 | Comply with ISO 10993 |
| Performance | Like the predicate, the modified device was | |
| tested for compliance and performance under | ||
| the working conditions as prescribed by the | ||
| ClearPath Controller (K091305). | ||
| Comparative animal test compared | ||
| functionality to that of the predicates | As detailed in K093779 tests were performed | |
| to demonstrate the performance of the device | ||
| under the working conditions as prescribed | ||
| by the ClearPath Controller (K091305). | ||
| Disposable | Single patient, use, disposable | Single patient, use, disposable |
| Packaged | Clean, non-sterile | Clean, non-sterile |
Comparative Table - Compares the predicates and the proposed modified device
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
EasyGlide Ltd. % Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134
MAY 1 6 2012
Re: K113166
Trade/Device Name: ClearPath Upper GI Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II . Product Code: FDS Dated: April 15, 2012 Received: April 17, 2012
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 r lease of acreased a determination that your device complies with other requirements of the Act that + Dirderal statutes and regulations administered by other Federal agencies. You must or any I vathar other or strequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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.
Sincerély yours,
Benjamin K. Twitchell
Benjarfun R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Page 1 of 1
510(k) Number:
KJ13166 (To be assigned)
Device Name:
ClearPath Upper GI
Indications for Use:
The ClearPath Upper Gl 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)
in Sign-Off Reproductive, Gastro-Renal, and