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 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.

AI/ML Overview

This document is a 510(k) premarket notification for the EndoChoice Water Bottle Cap System. It details the device, its intended use, and its substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Benchtop Functional Performance	All test results passed
Sterilization Validation	All test results passed (conforms to validation testing)
Biocompatibility in conformance with ISO 10993-1	All test results passed

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Benchtop functional performance testing" and "Laboratory validation testing of sterilization" without specifying exact sample sizes for each test. It also states "Biocompatibility testing in conformance with ISO 10993-1." The nature of these tests (benchtop, laboratory) suggests that they would likely use a dedicated number of device units or components for each specific test, rather than a broad "test set" like clinical trials.

The document does not detail the provenance of data (e.g., country of origin, retrospective/prospective). Given these are non-clinical hardware tests, such details are typically not relevant or included.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This section is not applicable to this document. The document describes non-clinical performance and safety testing (functional, sterilization, biocompatibility). These tests do not involve human interpretation or the establishment of ground truth by clinical experts in the same way, for example, an imaging diagnostic device would. Performance is measured against engineering specifications and industry standards (e.g., ISO 10993-1) by qualified laboratory personnel.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations (e.g., in clinical trials for diagnostic devices). Since the testing described is non-clinical and objective (functional, sterilization, biocompatibility), there is no need for such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

This section is not applicable. The device (water bottle cap system for endoscopes) is a medical accessory, not an AI-assisted diagnostic or therapeutic device. It does not involve human readers interpreting data, nor does it have an AI component to assist human performance in diagnosis or treatment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This section is not applicable. As mentioned above, the device is a medical accessory and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

For the non-clinical testing:

Benchtop functional performance testing: Ground truth would be established by the functional specifications and design requirements of the device (e.g., water flow rate, pressure resistance, connection integrity).
Laboratory validation testing of sterilization: Ground truth is established by validated sterilization methods and industry standards (e.g., microbial load reduction, sterility assurance level).
Biocompatibility testing in conformance with ISO 10993-1: Ground truth is established by the requirements of the ISO 10993-1 standard for biological evaluation of medical devices.

8. The Sample Size for the Training Set:

This section is not applicable. As a hardware medical accessory, this device does not utilize a "training set" in the context of machine learning or AI development.

9. How the Ground Truth for the Training Set was Established:

This section is not applicable for the same reasons as #8.

Summary

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

January 20, 2015

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

Re: K142155

Trade/Device Name: Endochoice Water Bottle Cap System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FEQ Dated: December 9, 2014 Received: December 10, 2014

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. 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Benjamin R. Fisher -S

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):	K142155
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Device Name: Water Bottle cap system

Indications for Use

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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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510(k) Summary EndoChoice Water Bottle Cap System

1. Company Identification

Applicant:

EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Establishment Registration: 300759133

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 or CQ2 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.

6. Device Description

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7. Substantial Equivalence

The modified EndoChoice Water Bottle Cap System is substantially equivalent to the legally marketed Aquashield system CO2 (K120123, United States Endoscopy). 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 EndoChoice water bottle cap system is substantially equivalent to the predicate and that the differences between the devices do not raise new issues of safety or effectiveness.

Comparison Table
	Aquashield System CO2	EndoChoice Water Bottle Cap System
510(k) number	K120123	142155
Manufacturer	United States Endoscopy	EndoChoice, Inc.
Compatibility with currently available endoscopes	Olympus 140, 160, 180 and 190 Endoscopes	Olympus 140, 160, 180 And Fuse Endoscopes
Sterilization	Provided sterile	Provided sterile via Ethylene Oxide
Compatibility with commercially available sterile water bottles	Compatible with standard commercially available sterile water bottles	Same
Indications for use statement	The Aquashield System CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedure. It is compatible with U.S. commercially available sterile water bottles.	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 U.S. commercially available sterile water bottles.
Contraindications	Those specific to any endoscopic procedure	Those specific to any endoscopic procedure
Materials (patient contacting)	PC-1100, Stainless Steel, PVC	PC-1100, Stainless Steel, PVC, TPE 8597N
Materials (no patient contact)	Polymers, PVC, stainless steel	TPE-2102-501, Polypropylene Y2600, HDPE 530 ST, LDPE 2426H, Adhesive Paper, NBR
Packaging	Individually packaged in Tyvek Peel Pouch	Individually packaged in Tyvek Peel Pouch
Use	Disposable, maximum use 24 hours	Disposable, maximum use 24 hours

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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 water bottle cap and tubing set:

Benchtop functional performance testing .
Laboratory validation testing of sterilization
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.

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.