Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.

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. These fluid volumes are defined by the endoscope manufacturer. Scope Buddy Plus 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 an endoscope manufacturer specified volume of fluid to the endoscope channels. 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 is a 510(k) Summary for the "Scope Buddy Plus Endoscope Flushing Aid" and details its equivalence to a predicate device, not its acceptance criteria or a study proving it meets such criteria in the traditional sense of a clinical trial for diagnostic performance.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Fluid Pump CP-3, K914524) rather than establishing novel safety and effectiveness through a clinical performance study with acceptance criteria like sensitivity, specificity, or accuracy. Therefore, many of the requested points below are not directly applicable or available in this type of submission.

However, I can extract information related to the device's functional performance testing which serves as a form of "acceptance criteria" for its intended mechanical function.

Here's an attempt to answer your questions based on the provided document:

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

Since this is a mechanical flushing aid, the "acceptance criteria" from the document revolve around its ability to deliver fluids according to manufacturer specifications and meet safety standards.

Acceptance Criteria (Functional Performance)	Reported Device Performance
Detergent Dosing Capability: Ability to dose a set volume of detergent.	Demonstrated the ability of the subject device to dose a set volume of detergent. (Specific volumes/tolerances are not detailed in this summary, but the general capability was affirmed.)
Fluid Delivery Flow Rate Performance: Meet or exceed the endoscope manufacturer's requirements for fluid delivery through endoscope channels during manual cleaning.	Determined the flushing times required by the subject device to meet endoscope manufacturers' requirements for fluid volumes delivered to endoscope channels during manual cleaning. (Specific flow rates/tolerances are not detailed, but compliance with requirements was affirmed.)
Electrical Safety: Compliance with IEC 61010-1.	Compliance demonstrated.
Electromagnetic Compatibility (EMC): Compliance with IEC 61326-1.	Compliance demonstrated.
Software Validation: Compliance with FDA's guidance for software in medical devices.	Software Validation conducted as recommended per FDA's guidance. (Specific validation results are not detailed.)
Human Factors/Usability: Safe and effective use by users per IEC 62366-1 and FDA guidance.	Human Factors/Usability Evaluation conducted to validate that users can safely and effectively use the subject device. (Specific evaluation results are not detailed.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify sample sizes for any of the functional or safety tests. These types of tests typically involve a set number of devices or iterations to demonstrate performance and compliance, but the exact numbers are not provided in this summary.
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given that Medivators Inc. is a US-based company and the submission is to the US FDA, the testing was likely conducted in the US and prospectively as part of the device development and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device. The "ground truth" for a mechanical flushing aid is its ability to perform its specified function (e.g., deliver a certain volume of fluid, meet safety standards). This is assessed through engineering and performance testing, not via expert interpretation of diagnostic images or patient outcomes.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing medical images). For engineering and functional tests, results are typically objective measurements against a predefined specification, not subjective interpretations 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

This question is not applicable. The Scope Buddy Plus Endoscope Flushing Aid is a mechanical device, not an AI-powered diagnostic tool involving human readers or interpretation of cases. No MRMC study was conducted.

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

This question is not applicable. The device is not an algorithm, but a mechanical flushing aid. While it has software, its "standalone" performance refers to its ability to pump fluids, which is what the functional performance testing assessed.

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

The "ground truth" for this device's performance is objective measurement against engineering specifications and regulatory standards. For example:
- Detergent Dosing/Fluid Delivery: Measured volumes and flow rates compared to pre-defined manufacturer requirements.
- Electrical Safety/EMC: Compliance with specified international standards (IEC 61010-1, IEC 61326-1) based on test measurements.
- Software Validation: Adherence to software development lifecycle processes and functional requirements.
- Human Factors/Usability: Observation and assessment of user interaction against usability goals and safety criteria.

8. The sample size for the training set

This question is not applicable. The Scope Buddy Plus Endoscope Flushing Aid is a hardware device with software controls, not a machine learning or AI algorithm that requires a "training set" in the context of data-driven model training.

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

This question is not applicable, as there is no "training set" for this type of device.

Summary

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

December 21, 2016

Medivators Inc. Kristin Padilla Regulatory Affairs Associate 14605 28th Ave. North Minneapolis, Minnesota 55447

Re: K162128

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: November 23, 2016 Received: November 28, 2016

Dear Kristin Padilla:

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,

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) K162128

Device Name Scope Buddy Plus Endoscope Flushing Aid

Indications for Use (Describe)

Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.

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

Date Prepared:	December 12, 2016
Manufacturer:	Medivators Inc., a Cantel Medical Company
Address:	14605 28th Avenue NorthMinneapolis, MN 55447(800) 328-3345
Official Contact:	Kristin Bergeson PadillaRegulatory Affairs Associate, Medivators Inc.
Trade Name:	Scope Buddy Plus Endoscope Flushing Aid
Common Name:	Accessories, Cleaning, For Endoscope
Classification Name:	Endoscope and accessories
Product Code:	FEB
Device Class:	II
Regulation No:	876.1500

Medivators Inc. has supplied the following information to the US Food and Drug Administration to support substantial equivalence of Scope Buddy Plus to other endoscope flushing aid devices currently cleared for sale in the United States of America.

1. Intended Use

Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.

2. Device Description

3. Comparison to Other Devices in Commercial Distribution Within the United States

Scope Buddy Plus is equivalent in intended use, function and fundamental technology to its predicate device, Fluid Pump CP-3 cleared under 510(k) K914524.

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Image /page/4/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, sans-serif font. Below the company name, the text "A Cantel Medical Company" is written in a smaller, blue, sans-serif font. The overall design is clean and corporate, reflecting the company's medical focus.

Similarities Between Subject and Predicate Devices

Scope Buddy Plus and its predicate device, Fluid Pump CP-3, have the same intended use, fundamental technology and performance. Both the subject device and the predicate device are similar in that the intended use replicates the mechanical means of fluid delivery to endoscope channels in the same manner as a manual syringe would be used. Both devices are used during the manual cleaning phase of endoscope reprocessing to deliver fluid volumes to the endoscope channels according to the endoscope manufacturer's instructions. Both devices are similar in fundamental technology and general performance.

Differences Between Subject and Predicate Devices

The main notable differences between the subject device, Scope Buddy Plus, and the predicate, Fluid Pump CP-3, are the connection tubing and software. Scope Buddy Plus utilizes an external peristaltic pump with 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) while the predicate device utilizes internal fluid pumps with reusable tubing set connections. The subject device utilizes a software controlled user interface while the predicate device utilizes analog circuitry control. In addition, the subject device does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing while the predicate device bears cleaning and disinfection efficacy claims.

A device comparison table which supports substantial equivalence of the subject device to the predicate device is provided below:

Device Parameters	Subject Device – Scope Buddy PlusEndoscope Flushing Aid	Predicate Device – Fluid Pump CP-3(K914524)
Trade Name	Scope Buddy Plus Endoscope Flushing Aid	Fluid Pump CP-3
Regulation Number	876.1500	876.1500
Device Class	Class II	Class II
Certification Panel	Gastroenterology/Urology	Gastroenterology/Urology
Product Code	FEB	FEB
Intended Use	To pump fluids through the channelsof flexible, immersible endoscopes	To pump fluids through the channels offlexible, immersible endoscopes
Type of MachineFunction	Electro-mechanical	Electro-mechanical
Connection Tubing	24 hour multi-use connection tubing	Reusable tubing set connections
Software ControlledUser Interface	Yes	No
Fluid Delivery FlowRate Performance	Meet or exceed the endoscopemanufacturer's requirements for fluiddelivery through endoscope channels	Meet or exceed the endoscopemanufacturer's requirements for fluiddelivery through endoscope channels
Mechanism of Action	External peristaltic fluid pump withbuilt-in timer	Internal fluid pump with built-in timer
Schematic Flow	Flushing liquids are placed into a	Flushing liquids are placed into a

Table 1 - Device Comparison Table

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	container, pre-cleaning basin or sink.A tubing set pulls fluid from thecontainer, basin or sink via action fromthe external peristaltic pump. The fluidcontinues to flow through the tubingset which is connected to theendoscope channels. The fluid is thenpumped through the endoscopechannels.	medical washing tray. An intake tubingset pulls fluid from the washing tray andinto and through two internal fluidpumps. The fluid is then expelled fromthe pumps through discharge tubing setswhich are connected to the endoscopechannels. The fluid is then pumpedthrough the endoscope channels.
Amount of CleaningLiquid	Amount sufficient to meet or exceedthe endoscope manufacturer'srequirements for volume of fluiddelivery through endoscope channels.	Amount sufficient to meet or exceed theendoscope manufacturer's requirementsfor volume of fluid delivery throughendoscope channels.
Time for CleaningLiquid Circulation	Variable, the length of the cleaningliquid circulation time is sufficient todeliver cleaning liquid volumes thatmeet or exceed the endoscopemanufacturer's requirements.	Variable, the length of the cleaningliquid circulation time is determined bysetting a timer.

4. Summary of Non-Clinical Performance Data

Medivators has conducted the following testing to demonstrate the substantial equivalence of Scope Buddy Plus:

Functional Performance Testing
- Detergent Dosing to demonstrate the ability of the subject device to dose a set volume of O detergent.
- Fluid Delivery Flow Rate to determine the flushing times required by the subject device o to meet endoscope manufacturers' requirements for fluid volumes delivered to endoscope channels during manual cleaning.
. Electrical Safety and Electromagnetic Compatibility in accordance with IEC 61010-1 and IEC 61326-1. respectively.
Software Validation as recommended per FDA's guidance for the Content of Premarket ● Submissions for Software Contained in Medical Devices.
Human Factors/Usability Evaluation to validate that users can safely and effectively use the ● subject device per IEC 62366-1 and FDA's guidance for Applying Human Factors and Usability Engineering to Medical Devices.

5. Conclusion

Scope Buddy Plus is substantially equivalent to predicate device Fluid Pump CP-3 cleared under 510(k) K914524. Based on the intended use, fundamental technology and performance data, the subject device Scope Buddy Plus is substantially equivalent to and is as safe and as effective as the legally marketed predicate device.

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.