The BioGuard EUS Air/Water Valve and the BioGuard EUS Suction Valve are accessories to an echoendoscope. The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope.

The EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.

Both devices are single use devices, supplied sterile.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (BioGuard EUS Air/Water and Suction Valves). It describes the device's technical characteristics, intended use, and comparison with a predicate device to demonstrate substantial equivalence. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-based device.

The document discusses functional bench and simulated use testing for the physical valves to ensure they control air/CO2 and water supply/evacuation. This is standard for mechanical devices but is not related to the acceptance criteria or study methodologies typically used for AI/ML-driven medical devices (e.g., performance metrics like sensitivity, specificity, AUC).

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance: The document does not define such criteria or report AI/ML performance metrics.
Sample size for test set and data provenance: Not applicable as no AI/ML study is mentioned.
Number of experts used to establish ground truth and qualifications: Not applicable.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not applicable.
Sample size for training set: Not applicable.
How ground truth for training set was established: Not applicable.

The document's conclusion states that "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device." This refers to mechanical and functional performance, not AI/ML performance.

In summary, the provided text describes the regulatory clearance process for mechanical medical valves and does not contain the information requested regarding AI/ML device acceptance criteria or performance studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 13, 2021

Steris Corporation Carroll Martin Regulatory Affairs Director 5976 Heislev Road Mentor, OH 44060

Re: K202104

Trade/Device Name: BioGuard EUS Air/Water and Suction Valves Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC, FDF Dated: December 4, 2020 Received: December 7, 2020

Dear Carroll Martin:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K202104

Device Name

BioGuard EUS Air/Water and Suction Valves

Indications for Use (Describe)

The BioGuard EUS Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The BioGuard EUS 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K202104 Page 1 of 4

Image /page/3/Picture/1 description: The image shows the STERIS logo. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.

510(k) Summary For the BioGuard EUS Air/Water and Suction Valves

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact: Carroll Martin Regulatory Affairs Director Tel: 440-358-6259 Email: carroll_martin@steris.com

January 4, 2021 Summary Date:

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

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STERIS Traditional 510(k) PREMARKET NOTIFICATION BioGuard EUS Air/Water and Suction Valves

1. Device Name

Device Name:	BioGuard EUS Air/Water and Suction Valves, P/N 00711780
Common Name:	Air/Water and Suction Valves
Regulation Name:	Endoscopic Channel Accessory

Device Classification 2.

Regulatory Class:	II
Regulation Number:	21 CFR 876.1500
Device Panel:	Gastroenterology/Urology
Product Code:	ODC and FDF
Product Code Name:	Endoscope Channel Accessory (ODC)Colonoscope and Accessories, Flexible, Rigid(FDF)

3. Predicate Device

K192059 BioGuard Air/Water Valve, BioGuard Suction Valve

4. Description of Device

The EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.

Both devices are single use devices, supplied sterile.

5. Intended Use

The BioGuard EUS Air/Water Valve is intended to be used to control the air/water function of an endoscope during a GI endoscopic procedure.

The BioGuard EUS Suction Valve is intended to be used to control the suction function of an endoscope during a GI endoscopic procedure.

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6. Technological Characteristic Comparison Table

The BioGuard EUS Air/Water and Suction valves are similar in design to the predicate and have exactly the same intended use. The differences between the proposed and predicate devices are the design of the valves and the particular type of endoscope on which the devices are used. The design is different than the predicate (see table below) because the BioGuard EUS Air/Water and Suction valves are used on echoendoscopes that have different dimensions than the endoscopes that are used with the predicate device. The echoendoscopes also have a balloon channel to allow the inflation and deflation of a balloon with water. These differences do not raise any new concerns of safety and effectiveness when compared to the predicate device.

Table 1 summarizes the similarities/differences between the proposed device and the predicate.

Feature	BioGuard EUS Air/Water andSuction Valve(Proposed)	BioGuard Air/Water andSuction Valve(Predicate K192059)	Comparison
Intended use	The BioGuard EUS Air/WaterValve is intended to be used tocontrol the air/water function onan endoscope during a GIendoscopic procedure. TheBioGuard EUS Suction Valve isintended to be used to controlthe suction function on anendoscope during a GIendoscopic procedure.	The BioGuard Air/WaterValve is intended to be usedto control the air/waterfunction on an endoscopeduring a GI endoscopicprocedure. The BioGuardSuction Valve is intended tobe used to control thesuction function on anendoscope during a GIendoscopic procedure.	Same
Construction	Air/Water Valve:Stem, gaskets, spring guide,spring(s) and endcap with skirt	Air/Water Valve:Stem, gaskets, spring andvalve base (skirt andendcap)	Similar
	Suction Valve:Stem, spring guide, spring(s)and endcap with skirt	Suction Valve:Stem, spring and valve base(skirt and endcap)
Sterile/Non-sterile	Sterile	Sterile	Same
SterilizationMethod	EtO	EtO	Same
SterilizationAssurance Level	10-6	10-6	Same
Usage	Single use	Single use	Same

Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table

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Feature	BioGuard EUS Air/Water andSuction Valve(Proposed)	BioGuard Air/Water andSuction Valve(Predicate K192059)	Comparison
Materials	Air/Water Valve:	Air/Water Valve:
	PC-ABS, Stainless Steel, TPE	ABS Plastic, Stainless Steel,Thermoplastic styrene(Rabalon), TPE	Similar
	Suction Valve:	Suction Valve:
	PC-ABS, Stainless Steel, UltemPlastic, TPE, Brass	ABS Plastic, Stainless Steel,TPE, PC-ABS	Similar
DeviceDimensions(lengths/widths)	Air/Water Valve:Length: 46 mmDiameter: 11 mm	Air/Water Valve:Length: 45.9 mmDiameter: 10 mm	Similar
	Suction Valve:Length: 33 mmDiameter: 3.8 mm	Suction Valve:Length: 27.4 mmDiameter: 5.6 mm	Similar
TargetPopulation	Patients undergoing anendoscopic procedure	Patients undergoing anendoscopic procedure	Same
EnergyUsed/Delivered	None	None	Same
Method ofApplication	Manual actuation	Manual actuation	Same
CompatibleEndoscopes	Olympus endoscope with aballoon channel	Olympus endoscope withouta balloon channel	Similar
Packaging	Sealed thermoform tray	Sealed thermoform tray	Same

STERIS Traditional 510(k) PREMARKET NOTIFICATION BioGuard EUS Air/Water and Suction Valves

7. Description of Safety and Substantial Equivalence

Functional testing assessing the air/water valves ability to control the supply of air/CO2 and water to an endoscope was conducted via bench and simulated use testing. Functional testing assessing the suction valves ability to control the evacuation of air/CO2 and water through the endoscope was conducted via bench and simulated use testing.

8. Conclusion

The proposed device, the BioGuard EUS Air/Water and Suction Valves, is substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed 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.