ENDOCHOICE WATER BOTTLE CAP SYSTEM

K112576 · Endochoice, Inc. · FEQ · Jan 25, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K112576
• Device Name: ENDOCHOICE WATER BOTTLE CAP SYSTEM
• Applicant: Endochoice, Inc.
• Product Code: FEQ · Gastroenterology, Urology
• Decision Date: Jan 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The EndoChoice water bottle cap system is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.

Device Story

The EndoChoice water bottle cap system is a mechanical accessory used during endoscopic procedures. It attaches to commercially available sterile water bottles and connects to an endoscope's air source. The device facilitates the delivery of sterile water through the endoscope to the procedure site. It is operated by clinical staff in a medical setting. The system ensures consistent water flow without leakage, supporting the endoscope's irrigation function. It provides a sterile interface between the water supply and the endoscope, aiding in visualization or cleaning during the procedure.

Clinical Evidence

Bench testing only. Testing included water flow performance over multiple uses and leak testing. Biocompatibility testing was performed in accordance with ISO 10993.

Technological Characteristics

Mechanical water bottle cap system. Compatible with standard sterile water bottles. Designed for connection to endoscope air sources. Biocompatibility tested per ISO 10993. No electronic or software components.

Indications for Use

Indicated for use during endoscopic procedures to supply sterile water to an endoscope via an air source. No specific patient population, age, or gender restrictions are defined.

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

• United States Endoscopy Water bottle cap system (K101146)

Submission Summary (Full Text)

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K112576

JAN 2 5 2012

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

| Submitter Name and<br>Address: | EndoChoice, Inc.<br>11810 Wills Rd, Suite 100<br>Alpharetta, GA, 30009 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Theron Gober<br>Quality and Regulatory Manager |
| Phone Number: | 678-534-6021 |
| Fax Number: | 770-962-6981 |
| Establishment<br>Registration Number: | 300759133 |
| Date Prepared: | December 8, 2010 |
| Device Trade Name(s): | EndoChoice Water bottle cap system: |
| Device Common Name: | Water bottle cap system |
| Classification Name: | FEQ; Endoscope and accessories |
| Predicate Device(s): | United States Endoscopy Water bottle cap system (K101146) |
| General Device<br>Description: | The EndoChoice water bottle cap system is designed to<br>supply sterile water and air to the endoscope during<br>endoscopic procedures. |
| Intended Use: | The EndoChoice water bottle cap system is intended to be<br>used with an air source from an endoscope with the purpose<br>of supplying sterile water to the endoscope during endoscopic<br>procedures. It is compatible with commercially available<br>sterile water bottles. |
| Technological<br>Characteristics: | From a clinical perspective and comparing design<br>specifications, the EndoChoice water bottle cap system and<br>the predicate device are substantially equivalent. Based on<br>the technological characteristics and overall performance of<br>the devices, EndoChoice, Inc. believes that no significant<br>differences exist between the proposed water bottle cap<br>system and the predicate device. |

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any concerns regarding the overall safety or effectiveness.

- Performance Data: We tested our EndoChoice Water Bottle Cap System to ensure that our system performs as well as the predicate device. The testing included sufficient water flow through the system over multiple uses without leaking.
- Biocompatibility Data: The EndoChoice Water Bottle Cap System was tested for biocompatibility in accordance with ISO 10993.
- Based on the technological characteristics and overall Conclusion: performance of the devices, EndoChoice, Inc. believes that the water bottle cap system and the predicate device selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

## Public Health Service

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

Mr. Theron Gober RA / QA Manager EndoChoice, Inc. 11810 Wills Rd, Suite 100 ALPHARETTA GA 30009

JAN 2 5 2012

Re: K112576

Trade/Device Name: Water Bottle cap system Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FEO Dated: December 27, 2011 Received: December 29, 2011

Dear Mr. Gober:

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. Fisher, Ph.D.

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): | |
|---------------------------|--|
|---------------------------|--|

Device Name: Water Bottle cap system

Indications for Use

The EndoChoice water bottle cap system is intended to be used with an air source from an The EndoChoice water bottle cap oystem is interneta to the endoscope during endoscopic endoscope with the parposes of supplying on supplying wailable sterile water bottles.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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