The Scope-Assist Flushing Sink is designed to mechanically assist the channel flushing portion of an endoscope's manual cleaning process. The sink facilitates compliance with endoscope manufacturer's cleaning requirements by:
• Providing a means of flushing flexible endoscope channels with detergent solution
• Providing a means of flushing endoscope channels with water
• Providing an environment for soaking and manual wiping/brushing of flexible endoscope exterior surfaces and accessories
• Providing an environment to perform wet leak testing of endoscopes
The Scope-Assist Flushing Sink is designed:
• To be used where the facility performs its endoscope cleaning functions, such as in soiled utility rooms, central processing decontamination areas, or endoscope cleaning (reprocessing) areas.
• To be used with Tergal 800 Detergent
The Scope-Assist Flushing Sink is not designed:
● To be used at bedside, in critical care units, or in sterile environments
● To be used as a terminal process or as part of the manual high level disinfection process

AI/ML Overview

This document describes a 510(k) premarket notification for the "Scope-Assist Flushing Sink" device. It is a device intended to mechanically assist the channel flushing portion of an endoscope's manual cleaning process. The information provided is for regulatory approval and does not contain a study of the type you're asking for (e.g., related to AI or diagnostic accuracy improvements). Therefore, many of your requested items regarding acceptance criteria and study details cannot be answered based on this document.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated Goal)	Reported Device Performance (Summary from document)
Flushing performance meets or exceeds endoscope manufacturer's requirements in specified flushing times.	Device is able to meet or exceed the endoscope manufacturer's flushing requirements in the specified flushing times. (Specific quantitative results not provided)
Detergent injection delivers correct amount of detergent consistently and reliably.	Device is able to consistently and reliably deliver the correct amount of detergent. (Specific quantitative results not provided)
Tergal detergent is compatible with materials in the flow path of the sink.	Use of Tergal detergent is compatible with the materials in the flow path of the sink. (Specific test results not provided)
Electrical safety according to IEC 61010-1.	Electrical safety testing according to IEC 61010-1 was conducted and demonstrated substantial equivalence. (Specific parameters/results not provided)
Electromagnetic compatibility according to IEC 60601-1-2.	Electromagnetic compatibility testing according to IEC 60601-1-2 was conducted and demonstrated substantial equivalence. (Specific parameters/results not provided)
Amount of fluid delivered is sufficient to meet or exceed endoscope manufacturer's requirements for volume.	Amount sufficient to meet or exceed the endoscope manufacturer's requirements for volume of fluid delivery through endoscope channels.
Length of fluid circulation time is sufficient to deliver fluid volumes that meet or exceed endoscope manufacturer's requirements.	Variable, the length of the fluid circulation time is sufficient to deliver fluid volumes that meet or exceed the endoscope manufacturer's requirements.

2. Sample size used for the test set and the data provenance:

This document describes performance testing for a medical device (a flushing sink), not a diagnostic or AI algorithm. Therefore, the concept of a "test set" in the context of data (like medical images or patient records) does not apply here. The testing would have involved physical devices and potentially endoscopes, but no sample size or data provenance is specified in terms of clinical or image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a physical device, and ground truth in the context of expert review for data is not part of this submission. The "ground truth" would be established by engineering specifications and industry standards for flushing efficacy.

4. Adjudication method for the test set:

Not applicable. No expert adjudication process for a data test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, What was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical medical device, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For the performance tests described (flushing, detergent injection, compatibility), the "ground truth" would likely be derived from:

Endoscope manufacturer's instructions/specifications: for required flushing volumes, times, and cleaning protocols.
Engineering specifications and standards: for detergent delivery accuracy, material compatibility.
International standards (IEC 61010-1, IEC 60601-1-2): for electrical safety and electromagnetic compatibility.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This is a physical medical device, not an AI algorithm.

Summary

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

April 28, 2017

Custom Ultrasonics Inc. Elizabeth Lazaro Regulatory Affairs Director 144 Railroad Drive Ivyland. Pennsylvania 18974

Re: K162120

Trade/Device Name: Scope-Assist Flushing Sink Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: March 28, 2017 Received: March 29, 2017

Dear Elizabeth Lazaro:

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 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.

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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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162120

Device Name Scope-Assist Flushing Sink

Indications for Use (Describe)

The Scope-Assist Flushing Sink is indicated for flushing the channels of flexible endoscopes according to the endoscope manufacturer's instructions.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K162120

510(k) Summary of Substantial Equivalence of Safety and Efficacy

Submitter:	Custom Ultrasonics Inc.
Address:	144 Railroad DriveIvyland, PA 18974
Telephone:	215-364-1477
Contact Person:	Elizabeth Lazaro
Title:	Regulatory Affairs Director
e-mail:	elizabeth.lazaro@customultrasonics.com
Date Prepared:	April 19, 2017
Name of Device:	Scope-Assist Flushing Sink
Classification Name:	Endoscope and accessories
Product Code:	FEB
Regulation:	21 CFR 876.1500
Device Classification:	Class II
Predicate Device:	PSK System (K000216)
Indications for Use:	The Scope-Assist Flushing Sink is indicated for flushing the channels of flexibleendoscopes according to the endoscope manufacturer's instructions.
Device Description:	The Scope-Assist Flushing Sink is designed to mechanically assist the channel flushingportion of an endoscope's manual cleaning process. The sink facilitates compliance withendoscope manufacturer's cleaning requirements by:
	• Providing a means of flushing flexible endoscope channels with detergent solution
	• Providing a means of flushing endoscope channels with water
	• Providing an environment for soaking and manual wiping/brushing of flexibleendoscope exterior surfaces and accessories
	• Providing an environment to perform wet leak testing ofendoscopes The Scope-Assist Flushing Sink is designed:
	• To be used where the facility performs its endoscope cleaning functions, such as insoiled utility rooms, central processing decontamination areas, or endoscope cleaning(reprocessing) areas.
	• To be used with Tergal 800 Detergent
	The Scope-Assist Flushing Sink is not designed:
	●	To be used at bedside, in critical care units, or in sterile environments
	●	To be used as a terminal process or as part of the manual high level disinfection process
Performance Data:	Performance testing conducted with the Scope-Assist Flushing Sink:
	●	Flushing performance testing to demonstrate the device is able to meet or exceed the endoscope manufacturer's flushing requirements in the specified flushing times.
	●	Detergent Injection testing to demonstrate the device is able to consistently and reliably deliver the correct amount of detergent.
	●	Detergent Compatibility testing to demonstrate the use of Tergal detergent is compatible with the materials in the flow path of the sink.
	●	Electrical safety testing according to IEC 61010-1
	●	Electromagnetic compatibility testing according to IEC 60601-1-2

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The Scope-Assist Flushing Sink is equivalent to the PSK System for flushing liquids through Equivalency: various channels of a flexible endoscope.

Substantial Equivalence Table
Trade Name	Scope-Assist FlushingSink	PSK System
Device Parameters	Subject Device	Predicate Device	Equivalence
Intended Use:	Flush the channels offlexible endoscopes	Flush the channels offlexible endoscopes	Same
Technological Characteristics:	Pump used to deliver fluidsthrough endoscope'sinternal channels	Pump used to deliver fluidsthrough endoscope'sinternal channels	Same
	Ability to flush all channelssimultaneously	Ability to flush all channelssimultaneously	Same
Endoscope Processing Capacity:	(1)	(1)	Same
Connector Tubing:	Color coded endoscopespecific adapters used toconnect scope to flushingsource	Color coded endoscopespecific adapters used toconnect scope to flushingsource	Same
Water Source:	Potable tap water	Potable tap water	Same
Amount of Fluid Delivered:	Amount sufficient to meetor exceed the endoscopemanufacturer'srequirements for volume offluid delivery throughendoscope channels	Amount sufficient to meetor exceed the endoscopemanufacturer'srequirements for volume offluid delivery throughendoscope channels	Same
Time for Fluid Circulation:	Variable, the length of thefluid circulation time issufficient to deliver fluidvolumes that meet orexceed the endoscopemanufacturer'srequirements	Variable, the length of thefluid circulation time issufficient to deliver fluidvolumes that meet orexceed the endoscopemanufacturer'srequirements	Same

Scope-Assist Flushing Sink
Custom Ultrasonics Inc.

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Conclusion:

Based on the intended use and performance testing data, the Scope-Assist Flushing Sink meets the requirements for flushing the internal channels of a flexible endoscope and is substantially equivalent to the predicate device. In addition, the Scope-Assist Flushing Sink, as demonstrated by electrical safety and electromagnetic compatibility testing, demonstrates substantial equivalence.

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.