Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical function and control of air, water, and suction, with no mention of AI or ML.

Therapeutic

No
The device controls functions of an endoscope (air/water, suction) but does not directly achieve a therapeutic effect on the patient. Its role is purely operational for the endoscope.

Diagnostic

No

The device is described as controlling air/water and suction functions of an endoscope, which are operational functions during a procedure, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the devices are "accessories to an echoendoscope" and describes physical components like "valves" that control air, water, and suction. It also mentions being "single-use devices, supplied sterile," which are characteristics of physical medical devices, not software. The performance studies also describe physical testing like "Leakage Testing," "Insertion," and "Strength of Suction Valve."

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 clearly states that the devices are "intended to control the air/water function of an endoscope" and "intended to be used to control the suction function of an endoscope during a GI Endoscopic procedure." This describes a device used during a medical procedure to manipulate the endoscope, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
Device Description: The description reinforces this by explaining how the valves control air, water, and suction through the endoscope's channels. This is a functional accessory for the endoscope itself.
Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.

IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The DEFENDO EUS Air/Water Valve is intended to control the air/water function of an endoscope during an GI Endoscopic procedure.

The DEFENDO EUS Suction Valve is intended to be used to control the suction function of an endosocpe during a GI Endoscopic procedure.

Product codes

ODC

Device Description

The DEFENDO EUS Air/Water Valve and the DEFENDO 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 DEFENDO 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

GI (Gastrointestinal)

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)

Non-clinical testing consisted of the following:

Air/Water Valve:
Leakage Testing - The EUS Air/Water Valve shall not leak. Results: Pass
Insertion - The valves shall stay seated on the air/water port once placed. Results: Pass

Suction Valve:
Strength of Suction Valve - The valve shall maintain suction capability and strength. Results: Pass
Insertion - The valve must not be able to be inserted incorrectly into EUS scope's suction port. Results: Pass
Valve actuation - The Suction Valve shall withstand repeated actuation. Results: Pass
Valve usage without sticking - The Suction Valve shall be used without any sticking. Results: Pass

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

Not Found

Predicate Device(s)

K202104

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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.

February 9, 2024

Steris Corporation Jackie Oliver Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K240098

Trade/Device Name: DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: January 12, 2024 Received: January 12, 2024

Dear Jackie Oliver:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Sivakami Venkatachalam -S

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

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Indications for Use

510(k) Number (if known) K240098

Device Name

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

Indications for Use (Describe)

The DEFENDO EUS Air/Water Valve is intended to control the air/water function of an endoscope during an GI Endoscopic procedure.

The DEFENDO EUS Suction Valve is intended to be used to control the suction function of an endosocpe 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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510(k) Summary for the

DEFENDO Single Use Valve Kit AW/S Valves -2pc for OLYMPUS EUS

Company Name and Address 1.

1.1 Sponsor

STERIS Corporation 5960 Heisley Rd. Mentor, Ohio 44060

Contact: Jackie Oliver Senior Regulatory Affairs Specialist Telephone: (440) 358-6289 Jackie Oliver@steris.com Email:

1.2 Manufacturing Facility

US Endoscopy 5976 Heisley Road Mentor, Ohio 44060

2. Device Name

| Proprietary Name: | DEFENDO Single Use Valve Kit AW/S Valves – 2pc
for OLYMPUS EUS (00711900) |
|----------------------|------------------------------------------------------------------------------|
| Common Usual Name: | Endoscope channel accessory |
| Classification Name: | Endoscopic and accessories |

3. Establishment Registration Number

STERIS Corporation 5960 Heisley Rd. Mentor, Ohio 44060 Registration number: 1527821

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US Endoscopy 5976 Heisley Road Mentor, Ohio 44060 Registration number: 1528319

Device Classification 4.

Class: II Classification Number: Classification Panel: FDA Review Product Code: ODC

21 CFR 876.1500 Gastroenterology/Urology

5. Predicate Devices

BioGuard EUS Air/Water and Suction Valves K202104

6. Device Description

The DEFENDO EUS Air/Water Valve and the DEFENDO 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 DEFENDO 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.

7. Intended Use/Indications for Use

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

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

8. Device Comparison Table

The DEFENDO Single Use Valve Kit AW/S Valves – 2pc for OLYMPUS EUS are similar in design to the predicate and have the same intended use. The differences between the proposed and predicate devices are summarized in the table below.

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Table 1. Device Comparison Table for the DEFENDO Single Use Valve Kit AW/S Valves – 2pc for OLYMPUS EUS and predicate device.

| Features | BioShield Air/Water
Suction Valves EUS
K202104 (Predicate
Device) | DEFENDO Single Use
Valve Kit AW/S Valves –
2-pc for OLYMPUS EUS
(Proposed Device) | Comparison |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 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. | The DEFENDO EUS
Air/Water Valve is
intended to be used to
control the air/water
function on an endoscope
during a GI endoscopic
procedure.

The DEFENDO EUS
Suction Valve is intended
to be used to control the
suction function on an
endoscope during a GI
endoscopic procedure. | Identical
(Only a name
change) |
| Construction: | Air/Water Valve
Stem, Gaskets, Spring
Guide, Spring(s), and
Endcap with Skirt

of Gaskets: 9

of Springs: 2 | Stem, Gaskets, Spring

Guide, Spring(s), and
Endcap with Skirt

of Gaskets: 9

of Springs: 2 | Identical |

| | Suction Valve
Stem, Spring Guide,
Spring(s), and Endcap
with Skirt

of gaskets: 4

of springs: 2 | Stem, Spring Guide,

Spring(s), Endcap with
Skirt, and Stainless-Steel
Collar

of gaskets: 4

of springs: 2 | Similar |

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9. Summary of Non-Clinical Performance Testing

Non-clinical testing consisted of the following:

10. Conclusion

Based on the Construction and materials and non-clinical performance data, the subject device is shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use.