The device is intended for single-use, and is supplied sterile, single-use air/water and suction valves help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single patient use item. The air/water valve is designed to be attached to the air/water port of the endoscope and the suction valve to the suction port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.

AI/ML Overview

The provided document is a 510(k) premarket notification for the SmartStart™ Air/Water and Suction Valves. It aims to demonstrate substantial equivalence to predicate devices, rather than establishing de novo performance criteria. Therefore, this document does not contain the information requested in the prompt regarding acceptance criteria and the comprehensive study details for a device meeting those criteria.

Specifically, the document focuses on demonstrating that the SmartStart™ valves perform similarly to already approved devices. It does not provide:

A table of distinct acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the device's clinical performance.
Details of a study proving the device meets specific performance acceptance criteria beyond basic physical and functional tests (like air/water flow and leakage).
Information on sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types for clinical efficacy.
Details regarding training sets for an AI/algorithm-based device, as this is a medical device and not an AI-driven software.

The performance testing section (8.3) mentions "acceptance criteria for air flow, water flow and leakage," but it does not specify what those criteria are or provide detailed results from a study that quantifies the device's performance against these criteria. It simply states that the device "will perform in accordance with the acceptance criteria."

This type of submission relies on comparative analysis with existing predicate devices, focusing on technical characteristics, indications for use, and a limited set of non-clinical performance and safety tests (sterilization, shelf-life, biocompatibility, and basic functional tests).

Summary

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right.

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

May 19, 2016

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

Re: K160403 Trade/Device Name: SmartStart™ Air/Water and Suction Valves Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: ODC Dated: May 4, 2016 Received: Mav 5. 2016

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 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,

Herbert P. Lerner -S

Benjamin R. Fisher, Ph.D. for 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)

K160403

Device Name

SmartStart™ Air/Water and Suction Valves

Indications for Use (Describe)

The SmartStart™ air/water valve is intended be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The SmartStart™ suction valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

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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Traditional 510(k) Summary

1. Company Identification

EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Telephone (678) 708 4743 FAX (678) 878 3373 Establishment Registration: 3007591333

2. Contact Person

Daniel Hoefer Regulatory Affairs Manager

3. Device Name

Trade name: SmartStart™ Air/Water and Suction Valves Common/Usual Name: Single Use Air/Water and Suction Valves

4. Device Classification

Regulation Number: 21CFR § 876.1500 Regulation Name: Endoscope and Accessories Classification: 2 Product Code: ODC Committee: Gastroenterology/Urology

5. Indications for Use

The SmartStart™ air/water valve is intended be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The SmartStart™ suction valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

6. Device Description

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7. Substantial Equivalence

7.1 Predicate devices

The SmartStart™ Air/Water and Suction Valves are equivalent in function, intended use and scientific technology to its predicate devices, the DEFENDO Disposable Air/Water Valve K102409 and DEFENDO Disposable Suction Valve K102581.

7.2 Technical Characteristics

The valves are advanced into the corresponding air/water and suction cylinder until a snap is felt to ensure attachment. Once the air/water and suction valves are installed, air can be introduced through the biopsy channel of the endoscope by covering the air/water button located on the head of the endoscope. Water can be introduced to assist in cleansing the lens by depressing the air/water button located of the endoscope. Suction can be applied to remove debris and fluid by depressing the suction button located on the head of the endoscope.

7.3 Performance Characteristics

The steps for operator use of each of the devices are equivalent to the predicates. The instructions for use describe how to use the device with a standard endoscope.

Substantial Equivalence Comparison- Suction Valve
Device Parameters	EndoChoice DisposableSuction Valve	DEFENDO DisposableSuction Valve K102581	SubstantialEquivalence
Product Code	ODC	ODC	Identical
Regulation No.	21CFR § 876.1500	21CFR § 876.1500	Identical
Classification	2	2	Identical
Manufacturer	EndoChoice, Inc.	Medivators, Inc., a CantelMedical Company	NA
Supplied Sterile	Yes	Yes	Identical
Single use	Yes	Yes	Identical
Compatibility	Olympus 160/180/190 seriesendoscopes	Olympus and Pentax 90 SeriesGI Endoscopes	Similar
Indications for use	The SmartStart™ suctionvalve is intended to be used tocontrol the suction function onan endoscope during a GIendoscopic procedure.	The DEFENDO DisposableSuction Valve is intended to beused to control the suctionfunction of an endoscopeduring a GI endoscopicprocedure.	Identical
Packaging	Suction and air/water valvesare housed in a single trayand packaged in a sealedTyvek pouch	Suction and air/water valvesare housed in a single tray andpackaged in a sealed Tyvekpouch	Identical
Substantial Equivalence Comparison- Air/Water Valve

7.4 Substantial Equivalence Table

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Device Parameters	EndoChoice DisposableAir/Water Valve	DEFENDO DisposableAir/Water Valve K102409	SubstantialEquivalence
Product Code	ODC	ODC	Identical
Regulation No.	21CFR § 876.1500	21CFR § 876.1500	Identical
Classification	2	2	Identical
Manufacturer	EndoChoice, Inc.	Medivators, Inc., a CantelMedical Company	NA
Supplied Sterile	Yes	Yes	Identical
Single use	Yes	Yes	Identical
Compatibility	Olympus 160/180/190 seriesendoscopes	Olympus 140/160/180/240/260series endoscopes	Similar
Indications for use	The SmartStart™ air/watervalve is intended be used tocontrol the air/water functionon an endoscope during a GIendoscopic procedure.	The DEFENDO DisposableAir/Water Valve is intended tobe used to control the air/waterfunction on an endoscopeduring a GI endoscopicprocedure.	Identical
Packaging	Suction and air/water valvesare housed in a single trayand packaged in a sealedTyvek pouch	Suction and air/water valvesare housed in a single tray andpackaged in a sealed Tyvekpouch	Identical

8. Non-Clinical testing

8.1 Sterilization and Shelf-Life

The SmartStart™ Air/Water and Suction Valves are sterilized by Ethylene Oxide. Validation has been completed in accordance with the following standards:

. AAMI TIR 16: 2009 Microbiological aspects of ethylene oxide sterilization. 2ed
ANSI/AAMI/ISO 11135: 2014 Sterilization of Health-Care Products Ethylene Oxide -. Requirements for the Development, Validation and Routine Control of Sterilization Process for Medical Devices, 1ed
ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health-Care Products Ethylene Oxide Part ● 1: Requirements for development, validation and routine control of a sterilization process for medical devices. 4ed
ANSI/AAMI/ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene ● oxide sterilization residuals, 3ed
AAMI TIR 14:2009 Contract sterilization using ethylene oxide, 2ed .

The shelf life of the SmartStart™ Air/Water and Suction Valves is 1 year from the date of manufacture.

8.2 Biocompatibility

Biocompatibility which includes Cytotoxicity, Sensitization testing for this device has been completed and passed all acceptance criteria.

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8.3 Performance Testing

Results from various performance testing indicate that the SmartStart™ Air/Water and Suction Valves function as intended. Performance test results indicate that Air/Water and Suction Valves will perform in accordance with the acceptance criteria for air flow, water flow and leakage.

9. Conclusion

Based on the above information, the SmartStart™ Air/Water and Suction Valves are substantially equivalent to the predicate devices listed above. The information contained in this submission supports the fact that the SmartStart™ Air/Water and Suction Valves are as safe and effective as the predicate devices.

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.