The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Lower GI, ClearPath Upper GI, and ClearPath Irrigator).

Device Description

The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Upper GI, ClearPath Lower GI, and ClearPath Irrigator). The ClearPath Tubing is single use, disposable.

The ClearPath irrigation system is designed to improve procedure reliability by improving visualization during endoscopic procedures by performing a colon or stomach wash.

The ClearPath Tubing is used to connect the irrigation fluid source (i.e. water bottle), via the peristaltic pump, to the cleaning device of the ClearPath product family (ClearPath Lower GI, K091305 and K113050, ClearPath Upper GI, K093779 and K113166, and ClearPath Irrigator, K 101094). Note that only the ClearPath accessories are to be used with the ClearPath Tubine.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ClearPath Tubing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on establishing substantial equivalence to predicate devices for the ClearPath Tubing, which is an irrigation tube for gastrointestinal endoscopic procedures. As such, the "acceptance criteria" are more related to functional performance and safety demonstration rather than specific quantitative metrics often seen with diagnostic devices.

Acceptance Criteria (Demonstrated)	Reported Device Performance
Leak detection	Tubing functions as intended
Tubing does not deteriorate	Tubing functions as intended
No visible degradation	Tubing functions as intended
Equivalent Indications for Use	Identical to predicate devices (K092429, K103239)
Equivalent Technology	Identical to predicate device (K091305) - simple tubing with peristaltic pump and check valve
Equivalent Environment of Use	Identical to all predicate devices
Equivalent Materials	Identical to K091305 or tested per ISO 10993

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a clinical study with a defined sample size of patients or cases. The performance testing appears to be primarily engineering or bench testing focused on the physical integrity and function of the tubing itself. This type of testing typically involves a number of manufactured units but not a patient-centric test set.

Sample Size: Not specified in terms of patient/case count. The testing focused on manufactured tubing units.
Data Provenance: Not applicable in the context of patient data. The tests are likely internal laboratory tests.

3. Number of Experts and Qualifications

This information is not applicable. The device is an irrigation tube, and its performance testing as described focuses on physical properties (leakage, degradation) rather than diagnostic performance requiring expert interpretation.

4. Adjudication Method

This information is not applicable. There's no mention of a human-in-the-loop diagnostic study or a need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted. This type of study is more common for diagnostic devices where AI assistance could impact human interpretation.

6. Standalone (Algorithm Only) Performance

Not applicable. The ClearPath Tubing is a physical medical device (irrigation tube), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance acceptance is based on the satisfactory results of engineering tests (leak detection, material integrity, visible degradation) rather than clinical outcomes, pathology, or expert consensus on a diagnosis. The primary "ground truth" for regulatory approval is demonstrating substantial equivalence to predicate devices through functional and design similarities.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML-based system that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted, there is no training set for this type of device.

Summary

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K112318
page 1 of 3

510(k) SummaryPage 1 of 327-Jun-12		JUN 29 2012
EasyGlide Ltd.30 Ha'Ella St.Kfar Truman, 73150Israel	Tel - 011-972-528565644Fax - 011-972-776201003
Official Contact:	Izhak Fabian - CEO
Proprietary or Trade Name:	ClearPath Tubing
Common/Usual Name:	Irrigation tube
Classification Name/Code:	OCX - endoscopic irrigation / suction systemClass - 2CFR 876.1500
Device:	ClearPath Tubing
Predicate Devices:	K092429 - Byrne Medical - EndogatorK091305 - EasyGlide - ClearPathK103239 - US Endoscopy - Velocity Irrigation system

Device Description:

The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components (ClearPath Upper GI, ClearPath Lower GI, and ClearPath Irrigator). The ClearPath Tubing is single use, disposable.

The ClearPath irrigation system is designed to improve procedure reliability by improving visualization during endoscopic procedures by performing a colon or stomach wash.

Indications for Use:

The ClearPath Tubing is intended to provide irrigation fluids, such as water, during gastrointestinal endoscopic procedures when used in conjunction with the ClearPath irrigation system components.

Patient population:

Individuals undergoing procedures endoscopic procedures.

Environment of Use:

Hospitals, clinics, and doctors' offices.

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K112318
page 2 of 3

510(k) Summary Page 2 of 3 27-Jun-12

Performance testing:

Testing was performed to demonstrate that the ClearPath Tubing functions as intended. The testing included:

. leak detection,
. tubing does not deteriorate,
no visible degradation .

Based on test results it was concluded that the ClearPath Tubing functions safely and effectively for its intended use in conjunction with the ClearPath system components.

Summary of substantial equivalence:

We demonstrate that the ClearPath Tubing is equivalent to the predicates in design and performance characteristics:

The ClearPath Tubing is viewed as substantially equivalent to the predicate devices:

Indications -intended to provide irrigation via irrigation fluids, such as water, during . gastrointestinal endoscopic procedures and single use, disposable.
- o Identical to Byrne Medical Endogator tubing K092429 and US Endoscopy Velocity system K103239
. Technology - Simple tubing used with a peristaltic pump
- Identical technology used in predicates EasyGlide ClearPath K091305 and o EasyGlide ClearPath K103239, in compatibility to a peristaltic pump and use of a check valve to prevent back flow.

. Environment of use -

Identical to all predicates Identical to Byrne Medical Endogator tubing K092429 and o US Endoscopy Velocity system K 103239
. Materials -
- Identical to ClearPath K091305 or tested per ISO 10993 o

Difference - there are no substantial differences or new features in the proposed device compared to the predicates which raises any new safety or efficacy issues.

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510(k) Summary

510k numbersandmanufacturers	Proposed device	K091305EasyGlide	Predicate devices	K103239US Endoscopy
Device	ClearPath Tubing	ClearPath Tubing	Endogator Tubing	Velocity system
Class	Class II	Class II	Class II	Class II
Product code	OCX	FDF	KOG	OCX
CFR	876.1500	876.1500	876.1500	876.1500
Design	Tube connecting the water sourcethrough the peristaltic pump to theirrigation device. Check valve preventsbackflow.	Tube connecting the water sourcethrough the peristaltic pump to theirrigation device.	Tube connecting the water sourcethrough the peristaltic pump to theirrigation device. Check valveprevents backflow.	Tube connecting the water source tothe irrigation device via a manual footpump.
Indications foruse	The ClearPath Tubing is intended toprovide irrigation via irrigation fluids,such as water, during gastrointestinalendoscopic procedures when used inconjunction with the ClearPathirrigation system components(ClearPath Lower GI, ClearPath UpperGI, and ClearPath Irrigator).	The ClearPath is intended to connect tostandard colonoscopes to help facilitateintraprocedural cleaning of a poorlyprepared colon by irrigating or cleaningthe colon and evacuating the irrigationfluid (water) and feces.It is for use only by trained medicalpersonnel located in hospitals, clinics,and doctors' offices.	The EndoGator TM system (tubingand accessories to accommodatevarious endoscopes and irrigationpumps) is intended to provideirrigation via sterile water supplyduring GI endoscopic procedureswhen used in conjunction with anirrigation pump (or cautery unit).	The Irrigation System (tubing andaccessories to accommodate variousendoscopes and irrigation pumps) isintended to provide irrigation viairrigation fluids, such as sterile water,during gastrointestinal endoscopicprocedures when used in conjunctionwith an irrigation pump orelectrosurgical unit.
Environment ofUse	Hospitals, clinics, and doctors' offices.	Hospitals, clinics, and doctors' offices.	Hospitals, clinics, and doctors'offices.	Hospitals, clinics, and doctors'offices.
Prescriptive	Yes, only trained medical personnel	Yes, only trained medical personnel	Yes, only trained medicalpersonnel	Yes, only trained medical personnel
Principle ofoperation	Tubing passing through a peristalticpump	Tubing passing through a peristalticpump	Tubing passing through aperistaltic pump	Tubing connecting to a manual footpump
Single use	Yes	Yes	Yes	Yes
PackagedSterile	No	No	Yes	Yes

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

JUN 2 9 2012

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

Re: K112318

Trade/Device Name: ClearPath Tubing Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: June 17, 2012 Received: June 19, 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 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

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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/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/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.

Sincerely yours,

Benjamin R. Civiletti

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, . and Urological 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: K112318

Device Name:

ClearPath Tubing

Indications for Use:

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)

Helene Leun

and

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.