BioGuard Air/Water and Suction Valves

K203630 · Steris Corporations · ODC · Jan 8, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K203630
• Device Name: BioGuard Air/Water and Suction Valves
• Applicant: Steris Corporations
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Jan 8, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

BioGuard Air/Water and Suction Valves are sterile, single-use, disposable accessories for endoscopes. The Air/Water valve controls air/CO2 insufflation and lens-washing water; the Suction valve controls suction through the endoscope's accessory channel. Operated manually by clinicians during GI endoscopic procedures. The subject device introduces Loctite 4011 glue to the Air/Water valve stem to prevent snap cap loosening. The device provides mechanical control of endoscope functions, improving procedural reliability and patient safety by ensuring valve integrity during use.

Clinical Evidence

Bench testing only. Testing included torque (unscrewing) testing to verify glue bond strength and functional testing involving repetitive cycling (push/release) to simulate clinical use.

Technological Characteristics

Manual actuation; sterile, single-use. Materials: ABS plastic, stainless steel, Rabalon gaskets, TPE skirt, PC-ABS endcap. Modification: Loctite 4011 glue added to Air/Water valve stem. Sterilization: EtO (10^-6 SAL). No energy source.

Indications for Use

Indicated for patients undergoing GI endoscopic procedures requiring control of air/water insufflation or suction via endoscope accessory channels.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BioGuard Air/Water and Suction Valves (K192059)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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: [phone] Email: [e-mail]

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:<br>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<br>Suction Valves K192059 –<br>Predicate Device | Modified Device | Comparison |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The BioGuard Air/Water<br>Valve is intended to be used<br>to control the air/water<br>function on an endoscope<br>during a GI endoscopic<br>procedure. The BioGuard<br>Suction Valve is intended to<br>be used to control the suction<br>function on an endoscope<br>during a GI endoscopic<br>procedure. | The BioGuard Air/Water<br>Valve is intended to be used<br>to control the air/water<br>function on an endoscope<br>during a GI endoscopic<br>procedure. The BioGuard<br>Suction Valve is intended to<br>be used to control the<br>suction function on an<br>endoscope during a GI<br>endoscopic procedure. | Identical |
| Construction | Air/Water Valve<br>Stem, gaskets, spring and<br>valve base (skirt and endcap)<br># of gaskets: 4 | Air/Water Valve<br>Stem, gaskets, spring and<br>valve base (skirt and<br>endcap)<br># of gaskets: 4 | Identical |
| Construction | Suction Valve<br>Stem, spring and valve base<br>(skirt and endcap)<br>No ridges at bottom of stem | Suction Valve<br>Stem, spring and valve base<br>(skirt and endcap)<br>No ridges at bottom of stem | Identical |
| Sterile/Non-<br>sterile | Sterile | Sterile | Identical |
| Sterilization<br>Method | EtO | EtO | Identical |
| Sterilization<br>Assurance Level | 10-6 | 10-6 | Identical |
| Usage | Single use | Single use | Identical |
| Materials (by<br>component) | Air/Water Valve<br>Snap Cap: ABS Plastic<br>Spring: Stainless Steel<br>Valve Stem: ABS Plastic<br>Gaskets: Rabalon<br>Skirt: TPE<br>Endcap: ABS plastic or PC-<br>ABS | Air/Water Valve<br>Snap Cap: ABS Plastic<br>Spring: Stainless Steel<br>Valve Stem: ABS Plastic<br>Gaskets: Rabalon<br>Skirt: TPE<br>Endcap: ABS plastic or PC-<br>ABS<br>Addition of glue (4011<br>Loctite) to the valve stem. | Similar |
| Materials (by<br>component) | Suction Valve<br>Suction Stem: ABS Plastic<br>Spring: Stainless Steel<br>Skirt: TPE<br>Endcap: PC-ABS | Suction Valve<br>Suction Stem: ABS Plastic<br>Spring: Stainless Steel<br>Skirt: TPE<br>Endcap: PC-ABS | Identical |
| Features | BioGuard Air/Water and<br>Suction Valves K192059 –<br>Predicate Device | Modified Device | Comparison |
| Device<br>Dimensions<br>(lengths/widths) | Air/Water Valve:<br>Length: 45.9 mm | Air/Water Valve:<br>Length: 45.9 mm | Identical |
| Device<br>Dimensions<br>(lengths/widths) | Suction Valve:<br>Length: 27.4 mm<br>Diameter: 5.6 mm | Suction Valve:<br>Length: 27.4 mm<br>Diameter: 5.6 mm | Identical |
| Operating<br>Principle | Manual actuation | Manual actuation | Identical |
| Target Population | Patients undergoing an<br>endoscopic procedure | Patients undergoing an<br>endoscopic procedure | Identical |
| Energy<br>Used/Delivered | None | None | Identical |
| Method of<br>Application | Manual | Manual | 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.