CLEARPATH 24

K112318 · Promedic, Inc. · OCX · Jun 29, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K112318
• Device Name: CLEARPATH 24
• Applicant: Promedic, Inc.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: Jun 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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 (ClearPath Lower GI, ClearPath Upper GI, and ClearPath Irrigator).

Device Story

ClearPath Tubing is a single-use, disposable irrigation tube used in hospitals, clinics, and doctors' offices. It connects a fluid source (e.g., water bottle) to a ClearPath irrigation system component via a peristaltic pump. The tubing includes a check valve to prevent backflow. It is operated by trained medical personnel during GI endoscopic procedures to facilitate cleaning and improve visualization. The device functions as a passive conduit for irrigation fluid; it does not perform automated analysis or processing. By enabling controlled irrigation, it assists clinicians in maintaining a clear field of view, potentially improving procedure reliability.

Clinical Evidence

Bench testing only. Testing included leak detection and assessment of tubing integrity/degradation to ensure safe and effective function in conjunction with the ClearPath system components.

Technological Characteristics

Single-use, disposable irrigation tubing. Features a check valve for backflow prevention. Designed for use with peristaltic pumps. Materials tested per ISO 10993. Non-sterile. Standalone mechanical component.

Indications for Use

Indicated for individuals undergoing gastrointestinal endoscopic procedures requiring irrigation. Contraindications not specified.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Byrne Medical - Endogator (K092429)
• EasyGlide - ClearPath (K091305)
• US Endoscopy - Velocity Irrigation system (K103239)

Reference Devices

• ClearPath Lower GI (K113050)
• ClearPath Upper GI (K093779)
• ClearPath Upper GI (K113166)
• ClearPath Irrigator (K101094)

Submission Summary (Full Text)

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K112318
page 1 of 3

| 510(k) Summary<br>Page 1 of 3<br>27-Jun-12 | | JUN 29 2012 |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------|
| EasyGlide Ltd.<br>30 Ha'Ella St.<br>Kfar Truman, 73150<br>Israel | Tel - 011-972-528565644<br>Fax - 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 system<br>Class - 2<br>CFR 876.1500 | |
| Device: | ClearPath Tubing | |
| Predicate Devices: | K092429 - Byrne Medical - Endogator<br>K091305 - EasyGlide - ClearPath<br>K103239 - 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.

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.

#### 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 numbers<br>and<br>manufacturers | Proposed device | K091305<br>EasyGlide | Predicate devices | K103239<br>US 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 source<br>through the peristaltic pump to the<br>irrigation device. Check valve prevents<br>backflow. | Tube connecting the water source<br>through the peristaltic pump to the<br>irrigation device. | Tube connecting the water source<br>through the peristaltic pump to the<br>irrigation device. Check valve<br>prevents backflow. | Tube connecting the water source to<br>the irrigation device via a manual foot<br>pump. |
| Indications for<br>use | The ClearPath Tubing is intended to<br>provide irrigation via irrigation fluids,<br>such as water, during gastrointestinal<br>endoscopic procedures when used in<br>conjunction with the ClearPath<br>irrigation system components<br>(ClearPath Lower GI, ClearPath Upper<br>GI, and ClearPath Irrigator). | The ClearPath is intended to connect to<br>standard colonoscopes to help facilitate<br>intraprocedural cleaning of a poorly<br>prepared colon by irrigating or cleaning<br>the colon and evacuating the irrigation<br>fluid (water) and feces.<br>It is for use only by trained medical<br>personnel located in hospitals, clinics,<br>and doctors' offices. | The EndoGator TM system (tubing<br>and accessories to accommodate<br>various endoscopes and irrigation<br>pumps) is intended to provide<br>irrigation via sterile water supply<br>during GI endoscopic procedures<br>when used in conjunction with an<br>irrigation pump (or cautery unit). | The Irrigation System (tubing and<br>accessories to accommodate various<br>endoscopes and irrigation pumps) is<br>intended to provide irrigation via<br>irrigation fluids, such as sterile water,<br>during gastrointestinal endoscopic<br>procedures when used in conjunction<br>with an irrigation pump or<br>electrosurgical unit. |
| Environment of<br>Use | Hospitals, clinics, and doctors' offices. | Hospitals, clinics, and doctors' offices. | Hospitals, clinics, and doctors'<br>offices. | Hospitals, clinics, and doctors'<br>offices. |
| Prescriptive | Yes, only trained medical personnel | Yes, only trained medical personnel | Yes, only trained medical<br>personnel | Yes, only trained medical personnel |
| Principle of<br>operation | Tubing passing through a peristaltic<br>pump | Tubing passing through a peristaltic<br>pump | Tubing passing through a<br>peristaltic pump | Tubing connecting to a manual foot<br>pump |
| Single use | Yes | Yes | Yes | Yes |
| Packaged<br>Sterile | 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 [phone] or [phone] 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:

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).

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