EndoChoice Water Bottle Cap System

K153588 · Endochoice, Inc. · FEQ · Feb 24, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153588
• Device Name: EndoChoice Water Bottle Cap System
• Applicant: Endochoice, Inc.
• Product Code: FEQ · Gastroenterology, Urology
• Decision Date: Feb 24, 2016
• Decision: SESE
• Submission Type: Special
• 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 or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.

Device Story

Sterile disposable water bottle cap system; connects to air/CO2 source and standard sterile water bottle; attaches to endoscope air/water port. Pressurized air/CO2 from processor forces water through tubing to endoscope; flow controlled by endoscope air/water valve and integrated tubing clip. Used by trained endoscopy professionals in clinical settings. Facilitates irrigation during endoscopy; improves visualization; aids clinical decision-making. Disposable; 24-hour maximum use.

Clinical Evidence

Bench testing only. Includes functional performance testing post-aging and biocompatibility testing per ISO 10993-1. All tests passed.

Technological Characteristics

Materials: PC-110, Stainless Steel, PVC (DEHP-free), TPE, Polypropylene, HDPE, LDPE, NBR. Sterilization: Ethylene Oxide. Form factor: Cap with tubing and flow-control clip. Connectivity: Mechanical interface to endoscope air/water port and external air/CO2 processor. Disposable, 24-hour use.

Indications for Use

Indicated for use by trained endoscopy professionals to supply sterile water to endoscopes during endoscopic procedures. Compatible with commercially available sterile water bottles and air/CO2 sources. Contraindications are those specific to any endoscopic procedure.

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 Cap System (K142155)

Submission Summary (Full Text)

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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

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

February 24, 2016

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

> K153588 Trade/Device Name: EndoChoice Water Bottle Cap System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FEQ Dated: January 22, 2016 Received: January 27, 2016

Dear Daniel Hoefer,

Re:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K153588

Device Name

EndoChoice Water bottle cap system

#### Indications for Use (Describe)

The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with commercially available sterile water bottles.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary EndoChoice Water Bottle Cap System

## 1. Company Identification

#### Applicant:

EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Establishment Registration: 3007591333

#### 2. Contact Person

Daniel Hoefer Regulatory Affairs Manager EndoChoice, Inc.

#### 3. Device Name

| Trade name: | EndoChoice Water Bottle Cap System |
|----------------------|------------------------------------|
| Common/Usual Name: | Water bottle cap system |
| Classification name: | FEQ; Endoscope and Accessories |

#### 4. Device Classification

| Classification | Endoscope and accessories, 21CFR 876.1500 |
|----------------|-------------------------------------------|
| Product Code: | FEQ |
| Committee: | Gastroenterology/Urology |

#### 5. Intended Use

The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.

#### 6. Device Description

The EndoChoice water bottle cap system is a sterile disposable device designed to fit commercially available sterile water bottles for providing sterile water during endoscopic procedures. The water bottle cap system is designed with a clip that is placed on the tubing to stop water flow from the water bottle when the endoscope is not in use.

The device attaches via a connector to the air/water port of an endoscope. The water bottle cap itself is attached to a standard sterile water bottle. Air supplied from the processor unit then pressurizes the water bottle, providing water flow when then air/water valve of the endoscope is depressed. Some models provide a feature that provides an option to use a CO2 air source. Instructions state that the device is to be used by trained endoscopy professionals.

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## 7. Substantial Equivalence

The modified EndoChoice Water Bottle Cap System is substantially equivalent to the legally marketed unmodified EndoChoice Water Bottle Cap System (K142155). A feature comparison of the two devices is shown below.

Based on the intended use, technological characteristics and overall performance of the devices, EndoChoice, Inc. believes that the modifications to the EndoChoice water bottle cap system leave the device substantially equivalent to the unmodified predicate and that the differences between the devices do not raise new issues of safety or effectiveness.

| | Comparison Table | |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| | EndoChoice Water Bottle Cap System (Unmodified) | EndoChoice Water Bottle Cap System (Modified) |
| 510(k) number | K142155 | K153588 |
| Compatibility with currently available endoscopes | Olympus 140, 160, 180, and Fuse Endoscopes | Olympus 140, 160, 180, and Fuse Endoscopes |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Compatibility with commercially available sterile water bottles | Compatible with Standard 33 mm water bottle caps | Unchanged |
| Indications for use statement | 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. | Unchanged |
| Contraindications | Those specific to any endoscopic procedure | Unchanged |
| Materials (patient contacting) | PC-110, Stainless Steel, PVC, TPE | PC-110, Stainless Steel, PVC (not manufactured with materials that contain DEHP), TPE |
| Materials (no patient contact) | TPE 2109-35, Polypropylene, HDPE, LDPE, , adhesive paper, NBR | Unchanged |
| Packaging | Individually packaged in Tyvek Peel Pouch | Unchanged |
| Use | Disposable, maximum use 24 hours | Unchanged |

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## 8. Non-clinical testing

Non-clinical testing has been performed on the device. Specifically, the following has been completed on the accessory water bottle, cap, and tubing:

- Benchtop functional performance testing, post-aging
- Biocompatibility testing in conformance with ISO 10993-1 .

All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device.

#### 9. Conclusion

The modified EndoChoice Water Bottle Cap System is equivalent to the legally marketed predicate device. It is the same or equivalent in terms of design, intended use, materials, and labeling.