The BioGuard Air/Water Valve and the BioGuard Suction Valve are accessories to an endoscope. The Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel and also controls water used to wash the lens of the endoscope. The Suction valve allows the user to control suction through the scope's accessory channel. The valves are sterile, single-use, disposable devices.

The Air/Water valve consists of a snap cap, stem, gaskets, spring and valve base (skirt and endcap).

The Suction valve consists of a stem, spring and valve base (skirt and endcap).

AI/ML Overview

This document, K203630, is a 510(k) premarket notification for a modification to the STERIS BioGuard Air/Water and Suction Valves. It's a "Special 510(k)" because the modification (adding glue to a component of the air/water valve) is minor and doesn't significantly alter the device's fundamental technology or indications for use.

Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria (especially regarding AI/human interaction, ground truth establishment, training sets, etc.) is not applicable to this type of medical device submission. This submission is for physical, disposable valves, not a diagnostic or AI-driven system.

The study presented here is a pre-clinical performance test, specifically to confirm the safety and effectiveness of the modification to the device (adding glue) and ensure it doesn't negatively impact the device's intended function.

Here's a breakdown of the relevant information provided in the document concerning the device's technical performance:

Acceptance Criteria and Device Performance (for the modification):

The document describes non-clinical performance testing conducted to ensure the safety and effectiveness of adding glue to the air/water valve stem.

Acceptance Criteria	Reported Device Performance
Torque (unscrewing) testing of the air/water valve cap to ensure the glue bond meets a set strength. (Specific strength value not provided in this summary, but implies a quantitative target was met.)	The testing was performed and supports the conclusion that the device is "as safe, as effective and performs as well or better than the legally marketed predicate device." Failure to meet the set strength would have required further investigation or redesign.
Functional testing that involved repetitive cycling (pushed down and released) of the air/water valve. This simulates actual use testing. (Specific number of cycles or performance metrics not provided, but implies the valve maintained functionality throughout the simulated use.)	This testing ensures the glue bond and the overall valve integrity can withstand repeated action during typical use without compromising function. The successful completion of this test indicates the device performs adequately.

Study That Proves the Device Meets Acceptance Criteria:

This was a non-clinical performance test focused on the specific design change.

Sample Size: Not explicitly stated for each test, but standard engineering validation would involve a statistically relevant number of samples for torque and cycling tests.
Data Provenance: This is internal company testing, likely conducted at STERIS's facilities. The location (Mentor, OH, USA) is provided for the company.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is mechanical/physical testing, not an interpretative diagnostic study requiring expert consensus for ground truth. The "ground truth" here is the physical performance of the valve against engineering specifications.
Adjudication method: Not applicable. These are quantitative mechanical tests, not subjective interpretations.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an algorithm.
The type of ground truth used: Engineering specifications and performance standards for mechanical durability and functionality (e.g., specific torque values, successful completion of cycle tests).
The sample size for the training set: Not applicable. This is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary of the document's relevance:

The document describes a Special 510(k) for a physical medical device (endoscope valves), where the primary evidence of safety and effectiveness for a minor modification is through non-clinical bench testing to ensure mechanical integrity and functionality. It does not involve complex clinical studies, AI algorithms, or human reader performance assessments. The "acceptance criteria" are therefore engineering and performance specifications pertinent to the device's mechanical function.

Summary

{0}------------------------------------------------

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 8, 2021

STERIS Corporations Carroll Martin Regulatory Affairs Director 5976 Heislev Road Mentor, OH 44060

Re: K203630

Trade/Device Name: BioGuard 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 9, 2020 Received: December 11, 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

{1}------------------------------------------------

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/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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K203630

Device Name

BioGuard Air/Water and Suction Valves

Indications for Use (Describe)

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

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol next to it. Below the word is a graphic of several horizontal, wavy lines. At the top right of the image, the text "K203630 Page 1 of 4" is visible.

510(k) Summary For BioGuard 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

Submission Date: December 10, 2020

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

{4}------------------------------------------------

1. Device Name

Trade Name:	BioGuard Air/Water and Suction Valves
Device Class:	Class II
Regulation Name:	Endoscope and Accessories
Common/usual Name:Valves	Endoscope Air/Water and Suction
Regulation Number:	21 CFR 876.1500
Product Code:	ODC, FDF

2. Predicate Device

BioGuard Air/Water and Suction Valves, K192059

3. Device Description

The Air/Water valve consists of a snap cap, stem, gaskets, spring and valve base (skirt and endcap).

The Suction valve consists of a stem, spring and valve base (skirt and endcap).

4. Indications for Use

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

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

{5}------------------------------------------------

5. Technological Characteristics Comparison Table

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

Features	BioGuard Air/Water andSuction Valves K192059 –Predicate Device	Modified Device	Comparison
Intended Use	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 the suctionfunction on an endoscopeduring a GI endoscopicprocedure.	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.	Identical
Construction	Air/Water ValveStem, gaskets, spring andvalve base (skirt and endcap)# of gaskets: 4	Air/Water ValveStem, gaskets, spring andvalve base (skirt andendcap)# of gaskets: 4	Identical
Construction	Suction ValveStem, spring and valve base(skirt and endcap)No ridges at bottom of stem	Suction ValveStem, spring and valve base(skirt and endcap)No ridges at bottom of stem	Identical
Sterile/Non-sterile	Sterile	Sterile	Identical
SterilizationMethod	EtO	EtO	Identical
SterilizationAssurance Level	10-6	10-6	Identical
Usage	Single use	Single use	Identical
Materials (bycomponent)	Air/Water ValveSnap Cap: ABS PlasticSpring: Stainless SteelValve Stem: ABS PlasticGaskets: RabalonSkirt: TPEEndcap: ABS plastic or PC-ABS	Air/Water ValveSnap Cap: ABS PlasticSpring: Stainless SteelValve Stem: ABS PlasticGaskets: RabalonSkirt: TPEEndcap: ABS plastic or PC-ABSAddition of glue (4011Loctite) to the valve stem.	Similar
Materials (bycomponent)	Suction ValveSuction Stem: ABS PlasticSpring: Stainless SteelSkirt: TPEEndcap: PC-ABS	Suction ValveSuction Stem: ABS PlasticSpring: Stainless SteelSkirt: TPEEndcap: PC-ABS	Identical
Features	BioGuard Air/Water andSuction Valves K192059 –Predicate Device	Modified Device	Comparison
DeviceDimensions(lengths/widths)	Air/Water Valve:Length: 45.9 mm	Air/Water Valve:Length: 45.9 mm	Identical
DeviceDimensions(lengths/widths)	Suction Valve:Length: 27.4 mmDiameter: 5.6 mm	Suction Valve:Length: 27.4 mmDiameter: 5.6 mm	Identical
OperatingPrinciple	Manual actuation	Manual actuation	Identical
Target Population	Patients undergoing anendoscopic procedure	Patients undergoing anendoscopic procedure	Identical
EnergyUsed/Delivered	None	None	Identical
Method ofApplication	Manual	Manual	Identical

Table 1. Technological Characteristics Comparison Table

{6}------------------------------------------------

6. Summary of Non-Clinical Performance Testing

The purpose of this Special 510(k) is apply glue (4011 Loctite) to the valve stem of the air/water valve. This change is intended to mitigate loosening of the snap cap from the valve during use. The non-clinical testing involved the following:

o Torque (unscrewing) testing of the air/water valve cap to ensure the glue bond meets a set strength.
Functional testing that involved repetitive cycling (pushed down and o released) of the air/water valve. This simulates actual use testing.

7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K192059), Class II (21 CFR 876.1500), product code ODC and FDF.

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.