Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical function and do not mention any AI/ML components or capabilities.

Therapeutic

No
This device controls functions of an endoscope during a GI procedure; it does not directly treat or diagnose a disease.

Diagnostic

No

The device is described as controlling air/water and suction functions on an endoscope during a GI procedure. Its purpose is operational control of the endoscope, not to provide diagnostic information about a patient's condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components (snap cap, stem, gaskets, spring, valve base) and describes them as sterile, single-use, disposable devices. This indicates a hardware-based medical device, not a software-only one.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to control air/water and suction functions on an endoscope during a GI endoscopic procedure. This is a functional control of a medical device used in vivo (within the body), not for testing samples in vitro (outside the body).
Device Description: The description details mechanical components (snap cap, stem, gaskets, spring, valve base) that control the flow of air, water, and suction. It does not describe any components or processes related to analyzing biological samples.
Performance Studies: The performance studies described are focused on the mechanical function and durability of the valves (torque testing, functional cycling). There are no studies related to the accuracy or performance of a diagnostic test.
Key Metrics: The absence of key metrics like sensitivity, specificity, PPV, or NPV further indicates that this is not a diagnostic device. These metrics are crucial for evaluating the performance of IVDs.

In summary, the BioGuard Air/Water Valve and BioGuard Suction Valve are accessories used to facilitate an endoscopic procedure, which is a medical procedure performed on a patient. They do not perform any diagnostic testing on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 on an endoscope during a GI endoscopic procedure.

Product codes (comma separated list FDA assigned to the subject device)

ODC, FDF

Device Description

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

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 released) of the air/water valve. This simulates actual use testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192059

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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 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

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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/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)

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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

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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 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).

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.

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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 and
Suction Valves K192059 –
Predicate Device | Modified Device | Comparison |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended 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. | 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. | Identical |
| Construction | Air/Water Valve
Stem, gaskets, spring and
valve base (skirt and endcap)

of gaskets: 4 | Air/Water Valve

Stem, gaskets, spring and
valve base (skirt and
endcap)

of gaskets: 4 | Identical |

Table 1. Technological Characteristics Comparison Table

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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.