The ClearPath Lower GI is intended to connect to standard colonoscopes to help facilitate intraprocedural 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.

Device Description

The proposed modified ClearPath Lower Gl is one component of the predicate ClearPath (K091305) which included a number of components: Controller, Tubing Set, Irrigation set (now referred to as the ClearPath Lower GI). We are proposing to only modify the ClearPath Lower GI which attaches to a conventional endoscope. The ClearPath Lower GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Lower GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the colon during an endoscopic procedure. The device can accommodate several sizes and configurations of endoscopes with a change in the attachment ring.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "ClearPath Lower GI," an irrigation/evacuation system for colonoscopies. However, the document focuses on demonstrating substantial equivalence to predicate devices through a performance testing summary, rather than presenting a detailed study with specific acceptance criteria and outcome metrics that would typically be found in a clinical trial report.

The performance testing listed aims to verify that the modified device performs as expected and is equivalent to the predicate, but it does not define quantitative acceptance criteria or provide specific numerical results of a study designed to meet those criteria.

Here's an attempt to answer your questions based on the available information, noting where information is not explicitly provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in the format you requested (e.g., a specific success rate, a defined threshold for dislodgement, etc.). Instead, it mentions that "All testing demonstrated that the modified ClearPath Lower GI disposable performed to its specifications and / or was equivalent to the predicate."

Here's a summary of the performance testing categories and the general "reported performance," which is a claim of equivalence/specification compliance rather than specific numerical outcomes:

Acceptance Criteria (Implied/General)	Reported Device Performance
Bench Testing:
Dimensional testing compliance	Performed to specifications
Strength testing compliance	Performed to specifications
Functional testing compliance	Performed to specifications
Mechanical testing compliance	Performed to specifications
Endoscope compatibility	Performed to specifications
Animal Testing:
Absence of tip dislodgement	Performed to specifications / Equivalent to predicate
Ease of maneuverability in colon	Performed to specifications / Equivalent to predicate
Quality of visibility	Performed to specifications / Equivalent to predicate
Quality of irrigation	Performed to specifications / Equivalent to predicate
Absence of occlusion/suction interruption	Performed to specifications / Equivalent to predicate
Quality of evacuation	Performed to specifications / Equivalent to predicate

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

Sample Size: The document does not specify the sample size for the bench or animal testing. For animal testing, it likely refers to a number of individual animals, but this is not quantified.
Data Provenance: Not explicitly stated. The applicant is "EasyGlide Ltd." from Israel, but whether the testing was conducted in Israel or elsewhere is not mentioned.
Retrospective or Prospective: Not explicitly stated. Animal testing, by nature, is prospective. Bench testing is also inherently prospective for verifying specific design elements.

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)

This information is not provided in the document. The testing involved "trained medical personnel" for the animal studies, but their specific number or qualifications are not detailed.

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

This information is not provided in the document. It's unclear if any formal adjudication method was used for evaluating the animal testing outcomes.

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

MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not conducted. This device is an irrigation/evacuation system, not an AI-powered diagnostic tool, so such a study would not be relevant.
Effect Size: Not applicable, as no MRMC study or AI component is involved.

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

No, a standalone (algorithm-only) performance was not done. This device is a physical medical instrument requiring human operation in conjunction with an endoscope, not a standalone algorithm.

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

For the animal study, the "ground truth" would be the direct observation and assessment of the device's performance characteristics by trained personnel during the simulated procedure. This would implicitly involve expert judgment on aspects like "ease of maneuverability," "quality of visibility," and "quality of evacuation." There is no mention of pathology or broader outcomes data for these specific tests.

8. The sample size for the training set

This is not applicable as this device is a physical instrument, not a machine learning model, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this device.

Summary

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Premarket Notification 510(k) Section 5 - Device Description ClearPath Lower GI

510(k) Summary
Page 1 of 5
11-Oct-11

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 Lower GI
Common/Usual Name:	Irrigation/evacuation system
Classification Name/Code:	FDF - endoscope and accessories21CFR 876.1500Class 2
Device:	ClearPath Lower GI
Predicate Devices:	K091305 - EasyGlide - ClearPath Lower GIK093779 - EasyGlide - ClearPath Upper GI

Device Description:

The proposed modified ClearPath Lower Gl is one component of the predicate ClearPath (K091305) which included a number of components:

Controller .
Tubing Set .
. Irrigation set (now referred to as the ClearPath Lower GI)

We are proposing to only modify the ClearPath Lower GI which attaches to a conventional endoscope.

The ClearPath Lower GI includes one suction tube + tip, one irrigation tube + tip, and a sleeve to attach to the endoscope. The ClearPath Lower GI is connected to the ClearPath Controller and the ClearPath Tubing (K091305) and allows for irrigation and evacuation of debris from the colon 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 Lower Gl is intended to connect to standard colonoscopes to help facilitate intraprocedural 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.

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ClearPath Lower Gl

510(k) Summary Page 2 of 5

11-Oct-11

It is for use only by trained medical personnel located in hospitals, clinics, and doctors' offices.

Patient population:

Individuals undergoing endoscopic procedures.

Environment of Use:

Hospitals, clinics, and doctors' offices.

Performance Testing and Summary:

We have performed bench and animal testing to verify that the ClearPath Lower GI performs as expected in conjunction with standard endoscopes and with the cleared ClearPath controller and tubing K0910305. The tests included:

Dimensional testing o
o Strength testing
Functional testing O
o Mechanical testing
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 colon o
Quality of visibility o
Quality of irrigation O
Any sign of occlusion or interruption to continuous suction. 0
Quality of evacuation of feces and other bodily fluid and matter o

All testing demonstrated that the modified ClearPath Lower GI disposable performed to its specifications and / or was equivalent to the predicate.

Summarv of substantial equivalence:

We demonstrate that the modified ClearPath Lower GI is substantially equivalent to the predicates in design and performance characteristics:

Indications Similar to predicate K091305: Cleaning of a poorly prepared colon . by irrigation and evacuation ·

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ClearPath Lower Gl

510(k) Summary Page 3 of 5 11-Oct-11

Technology Identical to predicate K091305: Single use disposable, used with a . standard endoscope, works in conjunction with the ClearPath Controller (K091305) to facilitate cleaning of the colon by irrigation and evacuation.
Environment of use Identical to predicate K091305: Hospitals, clinics, and . doctors' offices.
. 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 predicates which raises any new safety or efficacy issue

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Premarket Notification 510(k

ClearPath Lower Gl

Summary

	Proposed device	Predicate devices		Proposed device	Predicate devices
Device	EasyGlideClearPath Lower GI	K091305EasyGlideClearPath Lower GI	K093779EasyGlideClearPath Upper GI	Device	EasyGlideClearPath Lower GI	K091305EasyGlideClearPath Lower GI	K093779EasyGlideClearPath Upper GI
Design	Used as an add-on to standard endoscopes forirrigation and evacuation. Attaches along theendoscope leaving the working channel free.The ClearPath Lower GI is intended toconnect to standard colonoscopes to helpfacilitate intraprocedural cleaning of a poorlyprepared colon by irrigating or cleaning thecolon and evacuating the irrigation fluid(water), feces, and other bodily fluids andmatter, e.g. blood.	Used as an add-on to standard endoscopes forirrigation and evacuation. Attaches along theendoscope leaving the working channel free.The ClearPath is intended to connect to standardcolonoscopes to help facilitate intraproceduralcleaning of a poorly prepared colon by irrigatingor cleaning the colon and evacuating the irrigationfluid (water) and feces.	Used as an add-on to standard endoscopes forirrigation and evacuation. Attaches along theendoscope leaving the working channel free.The ClearPath-UGI System is intended forirrigating or cleaning the upper digestive tractand evacuating the irrigation fluid, blood andbile in the upper GI tract during endoscopicprocedures..	Accessories	ClearPath Controller and ClearPath Tubing(K091305)	ClearPath Controller and ClearPath Tubing(K091305)	ClearPath Controller and ClearPath Tubing(K091305)
Indications foruse	It is for use only by trained medical personnellocated in hospitals, clinics, and doctors'offices.	It is for use only by trained medical personnellocated in hospitals, clinics, and doctors' offices.	It is for use only by trained medical personnellocated in hospitals, clinics, and doctors' offices.	Distal tip design	multi irrigation holesDistal suction hole	multi irrigation holesDistal suction hole	multi irrigation holesDistal suction hole
Environmentof Use	Hospitals, clinics, and doctors' offices.	Hospitals, clinics, and doctors' offices.	Hospitals, clinics, and doctors' offices.	Material	Comply with ISO 10993	Comply with ISO 10993	Comply with ISO 10993
Prescriptive	Yes, only trained medical personnel	Yes, only trained medical personnel	Yes, only trained medical personnel	Performance	Like the predicates, the modified device wastested for compliance and performance underthe working conditions as prescribed by theClearPath Controller (K091305).	The disposable ClearPath Lower GI was testedwith the ClearPath Controller and ClearPathTubing (which were cleared in the sameK091305. Testing demonstrated adequatefunctionality and performance under the workingconditions as prescribed by the ClearPathController (K091305)	As detailed in K093779 tests were performed todemonstrate the performance of the device underthe working conditions as prescribed by theClearPath Controller (K091305).
Principle ofoperation	Distal attachment to an endoscope, sleeveensuring attachment along entire length,suction and irrigation tubes running along theendoscope, suction and irrigations heads atthe distal tip. Enables irrigation and suction atany time during the procedure withoutremoving any tools which may be inserted inthe endoscope's working channel.	Distal attachment to an endoscope, strapsensuring attachment along entire length, suctionand irrigation channels running along theendoscope, suction and irrigations heads at thedistal tip. Enables irrigation and suction at anytime during the procedure without removing anytools which may be inserted in the endoscope'sworking channel.	Distal attachment to an endoscope, sleeveensuring attachment along entire length, suctionand irrigation tubes running along theendoscope, suction and irrigations heads at thedistal tip. Enables irrigation and suction at anytime during the procedure without removing anytools which may be inserted in the endoscope'sworking channel.	Disposable	Single patient, use, disposable	Single patient, use, disposable	Single patient, use, disposable
Packaged	Clean, non-sterile	Clean, non-sterile	Clean, non-sterile

K11 3050

Page 5.4

DF Page 21 of 1

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Premarket Notification 510(k)
Section 5 — Device Descriptio

ClearPath Lower Gl

510(k) Summary

Page 5.5

PDF Page 22 of 173

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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: K113050

Trade/Device Name: ClearPath Lower GI Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF 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 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.

Sincerély yours,

Benjamin K. Hicks

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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K113050

Indications for Use Statement

Page 1 of 1

510(k) Number:

KI | 3050 (To be assigned)

Device Name:

ClearPath Lower GI

Indications for Use:

lt 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)

Signature

ive, Gastro-Renal, 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.