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.

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.

AI/ML Overview

The provided text describes the ClearPath UGI device and its 510(k) submission for substantial equivalence. However, it does not contain information about a study that proves the device meets acceptance criteria in terms of clinical performance, efficacy, or specific performance metrics beyond simple engineering specifications.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on:

Identical indications for use.
Identical technology.
Identical patient-contact materials.
Identical environment of use.
Identical performance specifications (Air/Water pressure, Flow rate, Suction specifications).

Therefore, I cannot populate the table and answer several of your questions as the requested information (related to a clinical study, reader performance, ground truth, and training data) is not present in the provided text.

Here's the information that can be extracted or inferred based on the provided document:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Predicate Device K091305)	Reported Device Performance (Proposed ClearPath UGI)
Air / Water pressure: Up to 30 Psi	Up to 30 Psi
Flow rate: Up to 300 ml/min	Up to 300 ml/min
Suction specifications: Approx. 0.5 Bar	Approx. 0.5 Bar
Primary Goal: Improve procedural visualization during endoscopic procedures	The claim is "improve procedure reliability by improving procedural visualization."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The document describes engineering specification comparisons, not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth for clinical performance was not established in the provided context. The "ground truth" here is the published specifications of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set or adjudication is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI diagnostic tool and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an AI algorithm; it's a physical medical device accessory.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the purpose of substantial equivalence, the "ground truth" used are the engineering specifications and performance characteristics of the predicate device (K091305 – Easy Glide – ClearPath). The new device's performance was compared against these established specifications.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of the Study (as described in the document):

The "study" described in the 510(k) summary is a benchtop comparison against a predicate device (K091305 – Easy Glide – ClearPath). The purpose was to demonstrate substantial equivalence for the modified ClearPath UGI device, which has a shorter disposable tubing set and a redesigned irrigation tip, but no modifications to the controller or software.

The study involved confirming that the key performance specifications of the proposed device (Air/Water pressure, Flow rate, Suction specifications) are identical to those of the predicate device. This was presented as "testing to demonstrate that the operating performance of the ClearPath UGI is equivalent to the predicate for flow rate, irrigation and vacuum pressures."

The acceptance criteria were simply that the new device's engineering performance for these specific parameters should match those of the legally marketed predicate device. The document states, "Performance specifications - Irrigation pressures, flow rate and suction pressures are identical to the predicate -. K091305 EasyGlide ClearPath."

Summary

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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

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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.

	ProposedClearPath UGI	ClearPathEasyGlide
510(k) number		K091305
Air / Water pressurespecifications	Up to 30 Psi	Up to 30 Psi
Flow rate	Up to 300 ml/min	Up to 300 ml/min
Suctionspecifications	Standard wall suctionApproximately 0.5 Bar	Standard wall suctionApproximately 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

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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

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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

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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)

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

Regulation Number and Section

§ 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.