ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM

K133747 · Endochoice, Inc. · FEQ · Jan 8, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133747
• Device Name: ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
• Applicant: Endochoice, Inc.
• Product Code: FEQ · Gastroenterology, Urology
• Decision Date: Jan 8, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The water bottle cap irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

Device Story

Device consists of polycarbonate cap, medical-grade PVC tubing, and stainless steel weight; connects to standard sterile water bottles and peristaltic irrigation pumps. Operates by drawing sterile water through tubing into endoscope irrigation port; controlled by clinician via pump footswitch. Provides irrigation to rinse tissue for improved visualization and access during GI endoscopy. Includes one-way check valve to prevent backflow. Connectors allow compatibility with various endoscope models (e.g., Olympus 160/180/190). Supplied sterile; single-use, up to 24-hour duration. Benefits patient by facilitating clearer endoscopic view.

Clinical Evidence

Bench testing only. Functional performance testing and biocompatibility testing per ISO 10993-1 were performed. All results passed, demonstrating equivalence to the predicate device.

Technological Characteristics

Materials: Polycarbonate (Makrolon 2558), medical-grade PVC (Flexchem 5051-02, MD80-GS-PVC), stainless steel. Components: Cap, flexible pump tubing, rigid tubing, luer connectors, one-way check valve. Connectivity: Mechanical interface to standard sterile water bottles and peristaltic irrigation pumps (approx. 8mm tubing diameter). Sterilization: Supplied sterile. Single-use, 24-hour limit.

Indications for Use

Indicated for patients undergoing GI endoscopic procedures requiring irrigation via sterile water supply. Compatible with various endoscopes and peristaltic irrigation pumps.

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

• EndoChoice Water bottle (K120862)

Submission Summary (Full Text)

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K133747 Page 1 of 5 JAN - 8 2014

# Special 510(k) Summary

## 1. Company Identification

EndoChoice, Inc. 11800 Wills Road Alpharetta, GA 30009 Telephone [phone] FAX [phone] Establishment Registration: 300759133

## 2. Contact Person

Daniel Hoefer Regulatory Affairs Manager

#### 3. Device Name

| Trade name: | EndoChoice Water Bottle Cap Irrigation System |
|----------------------|-----------------------------------------------|
| Common/Usual Name: | Water bottle cap irrigation system |
| Classification name: | Endoscopic irrigation/suction system |

# 4. Device Classification

| Common Name: | Colonoscope and accessories, flexible / rigid |
|----------------|-----------------------------------------------|
| Classification | Endoscope accessories, 21CFR 876.1500 |
| Product Code: | FEQ |
| Committee: | Gastroenterology/Urology |

#### 5. Intended Use

The water bottle cap irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

#### 6. Device Description

The EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade Stainless Steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down in the water bottle.

Flexible pump tubing of larger diameter is connected to the top of the water bottle cap and runs to the tubing compression ring. This flexible tubing is the part of the device that is placed into the irrigation pump. From the tubing compression ring, more rigid tubing

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runs to the rigid tubing luer connector and the one way check valve which prevents reverse direction fluid from the endoscope into the tubing set. Once connected, the device provides flow of sterile irrigation water during endoscopy procedures.

Connectors / accessories are used to connect to the different endoscopes. Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination.

A female luer connector is used to connect the device to the series 160 / 180 Olympus endoscopes. Customers may use a luered blunt needle to connect to series 140 endoscopes. The cap of the system and associated tubing is connected to standard bottles, providing sterile water to rinse tissue for improved viewing and access. The water bottle cap system is supplied sterile and can be used up to 24 hours.

EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles. The device can be used with any peristaltic irrigation pump that accepts industry standard irrigation tubing.

## 7. Substantial Equivalence

# 7.1. Predicate devices

The modified EndoChoice Water Bottle Cap Irrigation System is substantially equivalent to the unmodified EndoChoice Water bottle (K120862) manufactured by EndoChoice, Inc. The intended use, design, materials and labeling are all substantially equivalent.

This submission has been prepared to address changes in the materials to the tubing, which have been made to improve manufacturing yield of the device and to limit the amount of irrigation water that is emitted after the pump's foot pedal control has been deactivated.

## 7.2. Intended Use

The indications for use the device under review is the same as the predicate unmodified EndoChoice Water bottle (K120862) manufactured by EndoChoice. In each case, the water bottle cap irrigation system (tubing and accessories to accommodate various endoscopes and irrigation purnps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

#### 7.3. Technical Characteristics

Like the predicate device, the modified EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade Stainless Steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down in the water bottle.

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Flexible pump tubing of larger diameter is connected to the top of the water bottle cap and runs to the tubing compression ring. This flexible tubing is the part of the device that is placed into the irrigation pump. From the tubing compression ring, more rigid tubing runs to the rigid tubing luer connector and the one way check valve which prevents reverse direction fluid from the endoscope into the tubing set. Once connected, the device provides flow of sterile irrigation water during endoscopy procedures.

Connectors / accessories are used to connect to different endoscope models, including Olympus series 160, 180, and 190, and Fusc endoscopes. Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination.

The cap of the system and associated tubing is connected to standard bottles, providing sterile water to rinse tissue for improved viewing and access. The water bottle cap system is supplied sterile and can be used up to 24 hours.

EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles. The device can be used with any peristaltic irrigation pump that that accepts tubing of approximately 5/16 inch diameter (8mm).

Changes to the device include the material formulation and supplier of the tubing each type of tubing that comprises the device (see below), and inner diameter and outer diameter changes to the flexible tubing.

# 7.4. Performance Characteristics

The steps for operator use of each of the devices are equivalent. The instructions for use describe how to connect the device to standard endoscopes using connector assemblies, which are unchanged from the predicate. The device is also connected via the threaded water bottle cap to standard sterile water bottles, with the water intake tubing inserted into the bottle. The user then can use a footswitch-controlled irrigation pump to provide irrigation during endoscopy procedures.

| Comparison with Predicate Device | | | |
|----------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------|
| | EndoChoice Water<br>Bottle Cap<br>Irrigation System<br>(Predicate) | Modification to<br>EndoChoice Water<br>Bottle Cap Irrigation<br>System | Substantial<br>equivalence |
| Manufacturer | EndoChoice, Inc. | EndoChoice, Inc. | identical |
| 510k number | K120862 | Pending | |
| Compatibility with | Olympus series 160, | Olympus 160, 180, | Equivalent |

# 7.5. Substantial Equivalence Table

EndoChoice, Inc. Water bottle cap irrigation system Special 510(k) Submission December 6, 2013

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| currently available<br>endoscopes | 180, 190 | 190 | |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Supplied Sterile | Yes | Yes | identical |
| Intended use | Single-use up to 24 hours (connectors single patient use) | Single-use up to 24 hours (connectors single patient use) | identical |
| Operating principle | Peristaltic irrigation pump attached to flexible tubing draws sterile irrigation water through tubing inserted into bottle and connected to irrigation port of endoscope | Peristaltic irrigation pump attached to flexible tubing draws sterile irrigation water through tubing inserted into bottle and connected to irrigation port of endoscope | identical |
| Patient Contacting Materials: | | | |
| Flexible Pump Tubing | PVC ME62 | PVC Flexchem 5051-02 | Similar:<br>Change in formulation of PVC |
| Joint Connector | PC1100 | Polycarbonate - Makrolon 2558 | Similar:<br>Change in formulation of polycarbonate |
| Rigid Tubing | PVC 5420 | PVC MD80-GS-PVC | Similar:<br>Change in formulation of PVC |
| Rigid Tubing Luer Connector | PVC 5420 | Polycarbonate - Makrolon 2558 | Similar:<br>Change from PVC to polycarbonate |
| Bottle Tubing<br>Bottle Tubing Weight | PVC 5420<br>Stainless Steel | Same<br>Same | identical<br>identical |
| Male Luer Base<br>Female luer connector | PC1100<br>PC1100 | Same<br>Same | identical<br>identical |
| Compatibility with commercially available sterile water bottles | Yes | Yes | Identical |
| Indications for use statement | The EndoChoice water bottle cap system | The EndoChoice water bottle cap system | identical |

EndoChoice, Inc.

-

EndoChoice, Inc.
Water bottle cap irrigation system Special 510(k) Submission
December 6, 2013

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| | (tubing and accessories<br>to accommodate<br>various endoscopes and<br>irrigation pumps) is<br>intended to provide<br>irrigation via sterile<br>water supply during GI<br>endoscopic procedures<br>when used in<br>conjunction with an<br>irrigation pump. | (tubing and accessories<br>to accommodate<br>various endoscopes<br>and irrigation pumps)<br>is intended to provide<br>irrigation via sterile<br>water supply during GI<br>endoscopic procedures<br>when used in<br>conjunction with an<br>irrigation pump. | |
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|

# 8. Non-clinical testing

The following non-clinical testing has been performed on the modified EndoChoice Water Bottle Cap Irrigation System:

- � Benchtop functional performance testing
- Biocompatibility testing in conformance with ISO 10993-1. 0

All test results passed, demonstrating that the safety and efficacy is equivalent to the predicate device.

## 9. Conclusion

The EndoChoice Water Bottle Cap Irrigation System is substantially equivalent to the predicate devices listed above. It is the same or equivalent in terms of design, intended use, materials, and labeling.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2014

EndoChoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta, GA 30009

Re: K133747

Trade/Device Name: EndoChoice Water Bottle Cap Irrigation System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FEQ Dated: December 6, 2013 Received: December 9, 2013

Dear Daniel Hoefer,

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.

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Page 2 - Daniel Hoefer

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

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

510(k) Number (if known): K133747

Device Name: EndoChoice Water Bottle Cap Irrigation System

Indications for Use:

The Water Bottle Cap irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/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 In Vitro Diagnostic Devices (OIVD)

Herbert P. Lerne 2014.01.08 13:11:20 -