K Number

Device Name

CLEARPATH LOWER GI

Manufacturer

EASYGLIDE LTD.

Date Cleared

2012-05-16

(216 days)

Product Code

FDF

Regulation Number

876.1500

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K091305, K093779

Reference Devices

K091305,K0910305,K093779

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and fluid management for cleaning, with no mention of AI/ML terms or image processing.

Therapeutic

No.
The device is used to facilitate intraprocedural cleaning of the colon during endoscopic procedures by irrigating and evacuating fluids and matter. While it assists in a medical procedure, its primary function is cleaning and not directly treating a disease or condition.

Diagnostic

The device is intended for cleaning and irrigating the colon during endoscopic procedures, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly details physical components (suction tube + tip, irrigation tube + tip, sleeve, attachment ring) that attach to a conventional endoscope. It is a hardware component of a larger system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to facilitate intraprocedural cleaning of the colon during an endoscopic procedure by irrigating and evacuating fluids and matter. This is a therapeutic or procedural aid, not a diagnostic test performed on samples taken from the body.
Device Description: The device is a physical attachment to an endoscope that helps with cleaning and evacuation. It does not analyze biological samples to provide diagnostic information.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, tissue, or other bodily fluids) to detect diseases, conditions, or states of health. The focus is on physically cleaning the colon.

Therefore, the ClearPath Lower GI is a medical device used during a procedure, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

Product codes

FDF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

colon, lower GI, upper GI (for predicate device comparison)

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K091305 - EasyGlide - ClearPath Lower GI, K093779 - EasyGlide - ClearPath Upper GI

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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, 73150
Israel | Tel - 011-972-528565644
Fax - 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 accessories
21CFR 876.1500
Class 2 |
| Device: | ClearPath Lower GI |
| Predicate Devices: | K091305 - EasyGlide - ClearPath Lower GI
K093779 - 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.

Indications for Use:

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:

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 ·

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

Premarket Notification 510(k

ClearPath Lower Gl

Summary

	Proposed device	Predicate devices		Proposed device	Predicate devices
Device	EasyGlide
ClearPath Lower GI	K091305
EasyGlide
ClearPath Lower GI	K093779
EasyGlide
ClearPath Upper GI	Device	EasyGlide
ClearPath Lower GI	K091305
EasyGlide
ClearPath Lower GI	K093779
EasyGlide
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.
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.	Used as an add-on to standard endoscopes for
irrigation and evacuation. Attaches along the
endoscope leaving the working channel free.
The ClearPath 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) and feces.	Used as an add-on to standard endoscopes for
irrigation and evacuation. Attaches along the
endoscope leaving the working channel free.
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..	Accessories	ClearPath Controller and ClearPath Tubing
(K091305)	ClearPath Controller and ClearPath Tubing
(K091305)	ClearPath Controller and ClearPath Tubing
(K091305)
Indications for
use	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.	It is for use only by trained medical personnel
located in hospitals, clinics, and doctors' offices.	Distal tip design	multi irrigation holes
Distal suction hole	multi irrigation holes
Distal suction hole	multi irrigation holes
Distal suction hole
Environment
of 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 was
tested for compliance and performance under
the working conditions as prescribed by the
ClearPath Controller (K091305).	The disposable ClearPath Lower GI was tested
with the ClearPath Controller and ClearPath
Tubing (which were cleared in the same
K091305. Testing demonstrated adequate
functionality and performance under the working
conditions as prescribed by the ClearPath
Controller (K091305)	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).
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, straps
ensuring attachment along entire length, suction
and irrigation channels 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.	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

Premarket Notification 510(k)
Section 5 — Device Descriptio

ClearPath Lower Gl

510(k) Summary

Page 5.5

PDF Page 22 of 173

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

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

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