(28 days)
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.
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.
The provided text describes a 510(k) premarket notification for the DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS. It concludes that the device is substantially equivalent to a predicate device based on its construction, materials, and non-clinical performance data.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance |
|---|---|
| Air/Water Valve | |
| The EUS Air/Water Valve shall not leak. | Pass |
| The valves shall stay seated on the air/water port once placed. | Pass |
| Suction Valve | |
| The valve shall maintain suction capability and strength. | Pass |
| The valve must not be able to be inserted incorrectly into EUS scope's suction port. | Pass |
| The Suction Valve shall withstand repeated actuation. | Pass |
| The Suction Valve shall be used without any sticking. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of devices tested) for each of the non-clinical performance tests. It also does not explicitly state the data provenance in terms of country of origin or whether the data was retrospective or prospective. Given that this is a premarket notification for a new device, the testing would generally be prospective, conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The non-clinical performance tests for this device (valves for an endoscope) appear to be functional engineering tests rather than studies requiring expert interpretation of medical images or patient outcomes. Therefore, "ground truth" in the clinical sense, established by medical experts, is not applicable to these types of tests.
4. Adjudication method for the test set
This information is not applicable for the reported non-clinical performance testing. The tests described are objective functional assessments (e.g., leakage, proper seating, strength, resistance to sticking, correct insertion) which would typically have predefined pass/fail criteria, not requiring adjudication by multiple readers or decision-makers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is typically performed for AI-powered diagnostic or assistive devices that impact human clinical decision-making. The DEFENDO Single Use Valve Kit is a mechanical device for controlling functions of an endoscope, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone (algorithm only) performance study. This is not an AI device, so such a study would not be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" would be established by engineering specifications and predefined pass/fail criteria for each functional test (e.g., no measurable leakage, successful actuation, correct fit). It is not based on expert consensus, pathology, or outcomes data, as these are functional tests of a mechanical device.
8. The sample size for the training set
This information is not applicable. This device is a mechanical accessory, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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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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2
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 – 2pcfor 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/WaterSuction Valves EUSK202104 (PredicateDevice) | DEFENDO Single UseValve Kit AW/S Valves –2-pc for OLYMPUS EUS(Proposed Device) | Comparison |
|---|---|---|---|
| Intended Use | The BioGuard EUSAir/Water Valve isintended to be used tocontrol the air/waterfunction of anendoscope during a GIendoscopic procedure.The BioGuard EUSSuction Valve isintended to be used tocontrol the suctionfunction of anendoscope during a GIendoscopic procedure. | The DEFENDO EUSAir/Water Valve isintended to be used tocontrol the air/waterfunction on an endoscopeduring a GI endoscopicprocedure.The DEFENDO EUSSuction Valve is intendedto be used to control thesuction function on anendoscope during a GIendoscopic procedure. | Identical(Only a namechange) |
| Construction: | Air/Water ValveStem, Gaskets, SpringGuide, Spring(s), andEndcap with Skirt# of Gaskets: 9# of Springs: 2 | Stem, Gaskets, SpringGuide, Spring(s), andEndcap with Skirt# of Gaskets: 9# of Springs: 2 | Identical |
| Suction ValveStem, Spring Guide,Spring(s), and Endcapwith Skirt# of gaskets: 4# of springs: 2 | Stem, Spring Guide,Spring(s), Endcap withSkirt, and Stainless-SteelCollar# of gaskets: 4# of springs: 2 | Similar | |
| Sterile/ Non-sterile | Sterile | Sterile | Identical |
| Sterilization Method | EtO | EtO | Identical |
| Sterilization Assurance Level | 10-6 | 10-6 | Identical |
| Usage | Single-Use | Single-Use | Identical |
| Materials: | Air/Water Valve | ||
| Cap: PC-ABSSpring(s): Stainless-SteelValve Stem: Top Half - Stainless-Steel / Bottom Half - PC-ABSSpring Guide: PC-ABSGaskets: TPESkirt: TPEEndcap: PC-ABS | Cap: PC-ABSSpring(s): Stainless-SteelValve Stem: Top Half - Stainless-Steel / Bottom Half - PC-ABSSpring Guide: PC-ABSGaskets: TPESkirt: TPEEndcap: PC-ABS | Identical | |
| Suction Valve | |||
| Cap: PC-ABSSpring(s): Stainless-SteelCenter Valve Stem: Stainless-SteelOffset Valve Stem: Ultem PlasticSpring Guide: PC-ABSGaskets: TPESkirt: TPEEndcap: PC-ABS Cap Insert: Brass | Cap: PC-ABSSpring(s): Stainless - SteelCenter Valve stem: Stainless-SteelOffset Valve Stem: Ultem PlasticSpring Guide: PC-ABSGaskets: TPESkirt: TPEEndcap: UltemCap Insert: BrassMetal collar: Stainless-Steel | Similar | |
| Device Dimensions (lengths/widths) | Air/Water Valve: | Air/Water Valve: | Similar |
| Overall Length: 46 mmEndcap Overmold Diameter: 11 mm | Overall Length: 46 mmEndcap Overmold Diameter: 11.25 mm | ||
| Suction Valve: | Suction Valve: | Identical | |
| Overall Length: 33 mmStem Diameter: 3.8 mm | Overall Length: 33 mmStem Diameter: 3.8 | ||
| Target Population | Patients undergoing an endoscopic procedure | Patients undergoing an endoscopic procedure | Identical |
| Energy Used/Delivered | None | None | Identical |
| Compatible Endoscopes | Olympus endoscope with a balloon channel | Olympus endoscope with a balloon channel | Identical |
| Packaging | Sealed thermoform tray | Sealed thermoform tray | Identical |
| Testing | Acceptance Criteria | Results | |
| Air/Water Valve | |||
| Leakage Testing | The EUS Air/Water Valve shall not leak. | Pass | |
| Insertion | The valves shall stay seated on the air/water port once placed. | Pass | |
| Suction Valve | |||
| Strength of SuctionValve | The valve shall maintain suction capability and strength. | Pass | |
| Insertion | The valve must not be able to be inserted incorrectly into EUS scope's suction port. | Pass | |
| Valve actuation | The Suction Valve shall withstand repeated actuation. | Pass | |
| Valve usage withoutsticking | The Suction Valve shall be used without any sticking. | Pass |
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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.
§ 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.