The Acu-sInQ Complete Endoscope Cleaning Aid System is intended to assist manual flexible endoscope cleaning according to the instructions provided by the endoscope manufacturer, by facilitating performance of a leak test, accurate detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.

Device Description

The Acu-sInQ Complete Endoscope Cleaning Aid System is used in the reprocessing room of a hospital or endoscopy center, and aids technicians by providing a step-by-step cleaning sequence of flexible endoscopes for process management and reports. The Acu-sInQ Complete Endoscope Cleaning Aid System is a 4-in-1 system with automated scope inflation for performance of a leak test, precision chemical dosing, and automated channel flushing with pulsating fluid technology for main and auxiliary flush ports. The System also provides: Data management via printout with every cycle, USB drive and port output for capture and recording of process data and chemical usage, Software to enable transfer of data between system and Customer's PC, Barcode scanner to input endoscope serial number and technician ID which aids in documentation process, Pre-loading with Customer's endoscope inventory.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Fluid Flushing (open)	Device provides consistent fluid flushing volume when not connected to an endoscope.	PASS
Fluid Flushing (Endoscope)	Device provides consistent fluid flushing volume when connected to an endoscope.	PASS
Dosing	Accuracy of dose of ± 5%	PASS
Temperature Accuracy	Accuracy of temperature of ± 5%	PASS
Electrical Safety	Compliant with IEC 61010-1	PASS
Electromagnetic Compatibility	Compliant with IEC 61326-1	PASS

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

The document does not specify the exact sample sizes used for each individual test. It mentions "non-clinical performance testing" was conducted. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but given it's a pre-market notification for a medical device, the testing would be prospective and conducted by the manufacturer, STERIS Corporation.

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

This information is not provided in the document. The tests described are engineering and performance-based (e.g., fluid volume consistency, dosing accuracy, temperature accuracy, electrical safety, EMC) and do not typically involve human expert interpretation for ground truth.

4. Adjudication method for the test set:

Not applicable. The tests are objective and based on measurable engineering parameters, not subjective assessments requiring adjudication.

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

Not applicable. This device is an endoscope cleaning aid system, not an AI-powered diagnostic imaging tool that would involve human readers.

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

The device itself is a "Cleaning Aid System" that assists manual cleaning. The performance tests described (fluid flushing, dosing, temperature accuracy, electrical safety, EMC) are inherently standalone device performance evaluations without a human-in-the-loop component for the device's core functions being tested. While the device assists human operators, the tests performed assess the device's technical specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the tests performed is based on established engineering and metrology standards. For example:

Fluid Flushing/Dosing/Temperature Accuracy: Likely measured against calibrated instruments to verify accuracy against specified tolerances (e.g., ±5%).
Electrical Safety/EMC: Compliance with international standards (IEC 61010-1, IEC 61326-1) which define specific test procedures and permissible limits.

8. The sample size for the training set:

Not applicable. This is a physical medical device, an endoscope cleaning aid, not an artificial intelligence algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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December 14, 2018

STERIS Corporation Gregory Land Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K181865

Trade/Device Name: Acu-sInQ Complete Endoscope Cleaning Aid System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: November 13, 2018 Received: November 14, 2018

Dear Gregory Land:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Clarence W. Murray lii III -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) K181865

Device Name

Acu-sInQ Complete Endoscope Cleaning Aid System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary For Aqu-sInQ Complete Endoscope Cleaning Aid System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact: Gregory Land Senior Regulatory Affairs Specialist Tel: 440-392-7424 Fax: 440-357-9198

November 9, 2018 Summary Date:

Premarket Notification Number: K181865

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	Acu-sInQ Complete Endoscope Cleaning AidSystem
Device Class:	II
Common/usual Name:	Circulating pump
Classification Name:	Accessories, Cleaning, For Endoscope
Classification Number:	21 CFR 876.1500
Product Code:	FEB

2. Predicate Device

US Endoscopy Fluid Pump CP-3, cleared under K914524.

3. Description of Device

The Acu-sInQ Complete Endoscope Cleaning Aid System is a 4-in-1 system with automated scope inflation for performance of a leak test, precision chemical dosing, and automated channel flushing with pulsating fluid technology for main and auxiliary flush ports. The System also provides:

Data management via printout with every cycle
USB drive and port output for capture and recording of process data and chemical usage
Software to enable transfer of data between system and Customer's PC
Barcode scanner to input endoscope serial number and technician ID which aids in documentation process
Pre-loading with Customer's endoscope inventory

Indications for Use 4.

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detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.

5. Technical Characteristics Comparison Table

A comparison of technical characteristics versus the predicate is summarized in Table 5-1

Feature	Acu-sInQ Complete EndoscopeCleaning Aid(proposed)	Fluid Pump CP-3 Predicate(K914524)	Comparison
Indicationsfor Use	The Acu-sInQ CompleteEndoscope Cleaning AidSystem is intended to assistmanual flexible endoscopecleaning according to theinstructions provided by theendoscope manufacturer, byfacilitating performance of aleak test, accurate detergentdosing with water temperaturemonitoring, channel flushing,rinsing, and processdocumentation.	The Fluid pump CP #3 isintended to pump fluid mediathru the channels of endoscopeand accessories with lumens.The various fluid media thatare compatible are soapywater, enzyme/water solution,water, 70% alcohol, and liquiddisinfectants. The pump willalso pump minimal amounts ofair to help purge the channelsor lumens of droplets of fluidmedia. Consult withinstrument manufacturer forfluid media compatibility.	Both devices areintended to flushfluid through thechannel of anendoscope to aidin the manualcleaning process.The subjectdevice has theaddedfunctionality toassist the userwith additionalsteps of theendoscopecleaning process,leak test,detergent dosingand temperaturemonitoring.
Feature	Acu-sInQ Complete EndoscopeCleaning Aid(proposed)	Fluid Pump CP-3 Predicate(K914524)	Comparison
OperatingPrinciples/Technology	A microprocessor controlledunit operates internal pumpsto aid in the cleaning ofendoscopes. An internal airpump pressurizes anendoscope through a dedicatedleak test tubing to perform aleak test. A detergent tube isplaced in a container ofdetergent and a peristalticpump pulls the detergentthrough the tubing, thedetergent is then expelledthrough a discharge tube intothe cleaning solution. Atubing set pulls fluid from thecleaning solution through aperistaltic pump and dischargetubing set where it is expelledthrough the endoscopechannels.	Flushing fluids are placed intoa container, pre-cleaning basinor sink. A tubing set pullsfluid from the container, basin,or sink into and through aninternal fluid pump. The fluidis then expelled from thepumps through dischargetubing sets which areconnected to the endoscopechannels. The fluid is thenpumped through the endoscopechannels.	Both devicesutilizeelectronicallycontrolled flushpumps to flushfluid through thechannels of anendoscope. Thepredicate deviceis controlledthrough analogcircuits while thesubject deviceuses software.
SoftwareControlledUserInterface	Yes	No	The subjectdevice usessoftware tocontrol the unitwhereas thepredicate deviceuses analogcircuits to controlto device.
FluidDeliveryFlow Rate	Meet or exceed the endoscopemanufacturer's requirementsfor fluid delivery throughendoscope channels	Meet or exceed the endoscopemanufacturer's requirementsfor fluid delivery throughendoscope channels	Same
Mechanismof Action	Software controlled air pump,peristaltic pump and flushpump	Internal flush pumps withbuilt-in timer	Like thepredicate devicethe subject devicehas a flush pump.Additionally thesubject deviceuses an air pumpand peristalticpump for leaktesting anddetergent dosing.
Feature	Acu-sInQ Complete EndoscopeCleaning Aid(proposed)	Fluid Pump CP-3 Predicate(K914524)	Comparison
Amount ofCleaningLiquid	Amount sufficient to meet orexceed the endoscopemanufacturer's requirementsfor volume of fluid deliverythrough endoscope channels.	Amount sufficient to meet orexceed the endoscopemanufacturer's requirementsfor volume of fluid deliverythrough endoscope channels.	Same
				Time forCleaningLiquidCirculation	Variable, the length of thecleaning liquid circulationtime is determined by setting atimer.	Variable, the length of thecleaning liquid circulation timeis determined by setting atimer.

Table 5-1. Physical Description and Technological Properties vs the Predicate Device.

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6. Summary of Nonclinical Tests

The non-clincal performance testing demonstrated that the subject device met the acceptance criteria for each test that is identified and summarized in Table 5-2 below.

Test	Acceptance Criteria	Conclusion
Fluid Flushing(open)	Device provides consistent fluid flushing volumewhen not connected to an endoscope.	PASS
Fluid Flushing(Endoscope)	Device provides consistent fluid flushing volumewhen connected to an endoscope.	PASS
Dosing	Accuracy of dose of $\pm$ 5%	PASS
TemperatureAccuracy	Accuracy of temperature of $\pm$ 5%	PASS
Electrical Safety	Compliant with IEC 61010-1	PASS
ElectromagneticCompatibility	Compliant with IEC 61326-1	PASS

Table 5-2. Summary of Non-clinical Testing

7. Conclusion

Based on the conclusions from the non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K914524), Class II (21 CFR 876.1500), product code FEB.

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.