SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.

Device Description

The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.

AI/ML Overview

The provided text describes the acceptance criteria and a summary of performance data for the SCOPE BUDDY PLUS Endoscope Flushing Aid.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
Fluid Delivery Flow Rate Verification	Meet manufacturers minimum requirements for individual channel flushing volumes.	PASS
Tubing Durability Verification	The 24-hour tubing shall withstand at least 40 full automatic cycles without leaking.	PASS
Software Verification	Verification steps outlined in procedure must be met for acceptance of the protocol.	PASS

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Performance testing to demonstrate substantial equivalence to the predicate has been completed."

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 (Fluid Delivery Flow Rate, Tubing Durability, Software Verification) appear to be engineering/performance tests rather than tests requiring expert human interpretation or ground truth establishment based on clinical observations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided as the tests described are technical performance verifications and do not involve human adjudication for ground truth.

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

An MRMC comparative effectiveness study was not done. The device is an electro-mechanical flushing aid for endoscopes, not an AI or diagnostic tool that assists human readers.

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

This concept is not applicable to this device. It is an electro-mechanical device with software control, not an algorithm performing a standalone diagnostic or interpretative function. The software verification confirms the software's functionality within the device.

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

The "ground truth" for the tests appears to be engineering specifications and defined performance metrics.

For Fluid Delivery Flow Rate, the ground truth is the "manufacturers minimum requirements for individual channel flushing volumes."
For Tubing Durability, the ground truth is the specified requirement to "withstand at least 40 full automatic cycles without leaking."
For Software Verification, the ground truth is the "verification steps outlined in procedure."

These are objective, measurable criteria rather than clinical ground truth established by experts.

8. The sample size for the training set

The document does not mention a "training set" as this device is not a machine learning or AI model.

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

This question is not applicable as there is no mention of a training set.

Summary

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January 14, 2022

Medivators Inc Mark Arnold Principal Regulatory Affairs Specialist 14605 28th Ave North Minneapolis, Minnesota 55447

Re: K213833

Trade/Device Name: SCOPE BUDDY PLUS Endoscope Flushing Aid Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: December 7, 2021 Received: December 9, 2021

Dear Mark Arnold:

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 (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213833

Device Name SCOPE BUDDY PLUS Endoscope Flushing Aid

Indications for Use (Describe)

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

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 SCOPE BUDDY PLUS Endoscope Flushing Aid

Medivators Inc 14605 28th Avenue North Minneapolis, MN 55447

Contact: Mark Arnold Principal Regulatory Affairs Specialist Tel: 844-348-5636 Fax: 844-348-5637
Summary Date: January 13, 2022

Medivators Inc = 14605 28th Avenue North ▪ Minneapolis, MN 55447 USA ▪ 800-328-3345

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1. Device Name

Trade Name:	SCOPE BUDDY PLUS Endoscope Flushing Aid
Device Class:	II
Common/Generic Name:	Circulating Pump
Classification Name:	Accessories, Cleaning, For Endoscope
Classification Number:	21 CFR 276.1500
Product Code:	FEB

2. Predicate Device

SCOPE BUDDY PLUS Endoscope Flushing Aid, cleared under K162128

3. Description of Device

Indications for Use 4.

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5. Summary of Technical Characteristics

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

Feature	Subject Device – SCOPEBUDDY PLUS EndoscopeFlushing Aid	Predicate Device – SCOPEBUDDY PLUS EndoscopeFlushing Aid (K162128)	Comparison
Indications for Use	SCOPE BUDDY PLUSEndoscope Flushing Aid is anelectro-mechanical deviceintended to pump fluids throughthe channels of flexible,immersible endoscopes duringthe manual cleaning process ofendoscope reprocessing.	SCOPE BUDDY PLUSEndoscope Flushing Aid isan electro-mechanical deviceintended to pump fluidsthrough channels of flexible,immersible endoscopesduring the endoscope manualcleaning process.	Same
Type of Machine Function	Electro-mechanical	Electro-mechanical	Same
Connection Tubing	24-hour connection tubing	24-hour connection tubing	Same
Air Purge	Yes	Yes	Same
Cleans orReprocesses theExterior ofEndoscopes	No	No	Same
Performs Leak Test	No	No	Same
AutomaticDetergentDosing	Yes	Yes	Same
TemperatureMonitoring	Yes	Yes	Same
SoftwareControlled UserInterface	Yes	Yes	Same
Fluid DeliveryFlow RatePerformance	Meet or exceed the endoscopemanufacturer's requirements forfluid delivery through endoscopechannels	Meet or exceed theendoscope manufacturer'srequirements for fluiddelivery through endoscopechannels	Same
Mechanism ofAction	External peristaltic fluid pumpwith built-in timer	External peristaltic fluidpump with built-in timer	Same
Feature	Subject Device – SCOPEBUDDY PLUS EndoscopeFlushing Aid	Predicate Device – SCOPEBUDDY PLUS EndoscopeFlushing Aid (K162128)	Comparison
Schematic Flow	Flushing liquids are placed into acontainer, pre-cleaning basin orsink. A tubing set pulls fluidfrom the container, basin or sinkvia action from the externalperistaltic pump. The fluidcontinues to flow through thetubing set which is connected tothe endoscope channels. Thefluid is then pumped through theendoscope channels.	Flushing liquids are placedinto a container, pre-cleaningbasin or sink. A tubing setpulls fluid from thecontainer, basin or sink viaaction from the externalperistaltic pump. The fluidcontinues to flow through thetubing set which is connectedto the endoscope channels.The fluid is then pumpedthrough the endoscopechannels.	Same
Amount ofCleaning Liquid	Amount sufficient to meet orexceed the endoscopemanufacturer's requirements forvolume of fluid delivery throughendoscope channels.	Amount sufficient to meet orexceed the endoscopemanufacturer's requirementsfor volume of fluid deliverythrough endoscope channels.	Same
Time forCleaning LiquidCirculation	Variable. The length of thecleaning liquid circulation timeis set by an adjustable timer, andthe range is sufficient to delivercleaning liquid volumes thatmeet or exceed the endoscopemanufacturer's requirements	Variable. The length of thecleaning liquid circulationtime is set by an adjustabletimer, and the range issufficient to deliver cleaningliquid volumes that meet orexceed the endoscopemanufacturer's requirements	Same

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MEDIVATORS INC Special 510(k) PREMARKET NOTIFICATION Modification to SCOPE BUDDY PLUS Endoscope Flushing Aid

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

Summary of Non-Clinical Performance Data 6.

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.

Test	Acceptance Criteria	Conclusion
Fluid Delivery Flow RateVerification	Meet manufacturersminimum requirements forindividual channel flushingvolumes.	PASS

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MEDIVATORS INC Special 510(k) PREMARKET NOTIFICATION Modification to SCOPE BUDDY PLUS Endoscope Flushing Aid

Test	Acceptance Criteria	Conclusion
Tubing DurabilityVerification	The 24-hour tubing shallwithstand at least 40 fullautomatic cycles withoutleaking.	PASS
Software Verification	Verification steps outlined inprocedure must be met foracceptance of the protocol.	PASS

Table 5-2: Summary of Non-Clinical Performance Data

7. Conclusion

Based on the conclusions for 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 (K162128), 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.