(30 days)
The DEFENDO EUS Air/Water Valve is intended to be used 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 endoscope 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 document is a 510(k) summary for a medical device called "DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS". This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for an extended shelf life. It is not a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device, where terms like "ground truth," "expert consensus," "MRMC study," and "training set" are core to the evaluation.
Therefore, I cannot fulfill all parts of your request based on the provided text. The document describes a biological/mechanical device and its non-clinical performance testing for an extended shelf life, not the performance of an AI/ML algorithm.
However, I can extract the information related to the acceptance criteria and study results that are present for this specific type of device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is present for the non-clinical performance testing of the mechanical device.
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Air/Water Valve | ||
| Leakage | Valve shall not continuously leak water | Pass |
| Insertion | No damage shall occur to either the valve or the endoscope during insertion | Pass |
| Valve - Stationary | Valve shall remain in place on the endoscope after being fully seated | Pass |
| Flow (Air and CO2) | Minimum flows of predetermined levels of each air and CO2 shall be demonstrated | Pass |
| Flow (Water with Air/CO2) | Minimum flow of predetermined rates of water shall be demonstrated during flow of each air and CO2 | Pass |
| Flow (Water to fill balloon) | Minimum flow of predetermined rates of water shall fill the balloon during flow of each air and CO2 | Pass |
| Tensile Strength (Stage 1 compression) | Spring compression force shall fall within predetermined range in Stage 1 compression | Pass |
| Tensile Strength (Stage 2 compression) | Spring compression force shall fall within predetermined range in Stage 2 compression | Pass |
| Cap - Torque | Torque force shall be above a predetermined threshold to ensure no separation of cap from the valve stem occurs. | Pass |
| Suction Valve | ||
| Leakage | Valve shall not continuously leak water | Pass |
| Insertion | No damage shall occur to either the valve or the endoscope during insertion. | Pass |
| Insertion (Incorrect insertion prevention) | The valve must not be able to be inserted incorrectly into EUS scope suction port. | Pass |
| Valve - Stationary | Valve shall remain in place on the endoscope after being fully seated | Pass |
| Tensile Strength (Stage 1 compression) | Spring compression force shall fall within predetermined range in Stage 1 compression | Pass |
| Tensile Strength (Stage 2 compression) | Spring compression force shall fall within predetermined range in Stage 2 compression | Pass |
| Cap - Torque | Torque force shall be above a predetermined threshold to ensure no separation of cap from the valve stem occurs. | Pass |
| Packaging | ||
| Pouch Seal – Tensile Testing | Force to open sealed pouch shall be 0.57 lbs or greater | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states that "Identical testing was conducted on both the predicate (cleared) 1 year version of the device and proposed 3 year shelf life version of the device." It then clarifies, "The three year shelf life summary is below." However, the specific sample size (N) for each test is not provided. The testing is physical/mechanical in nature, not data-driven in the sense of patient data. Therefore, "country of origin of the data" or "retrospective/prospective" are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable as the document describes non-clinical performance testing of a physical medical device, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for the same reason as point 3.
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
This is not applicable as the document is not about an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the document is not about an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of AI/ML. For this mechanical device, the "ground truth" for each test is a direct measurement against a predefined physical, mechanical, or functional standard (e.g., does it leak? does the spring compress within range?).
8. The sample size for the training set
This is not applicable as the document does not describe an AI/ML device with a training set.
9. How the ground truth for the training set was established
This is not applicable as the document does not describe an AI/ML device with a training set or ground truth in that context.
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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.
October 11, 2024
STERIS Corporation Jackie Oliver Sr. Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K242742
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, FDF Dated: September 10, 2024 Received: September 11, 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.
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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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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,
Shanil P. Haugen -S
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
Submission Number (if known)
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 be used 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 endoscope 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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Special 510(K) Summary For the
DEFENDO Single Use Valve Kit AW/S Valves -2pc for OLYMPUS EUS
1. Company Name and Address
1.1 Sponsor
STERIS Corporation 5960 Heisley Rd. Mentor, Ohio 44060
Jackie Oliver Contact: Senior Regulatory Affairs Specialist Telephone: (440) 358-6289 Email: Jackie Oliver@steris.com
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 forOLYMPUS EUS |
|---|---|
| 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
US Endoscopy 5976 Heisley Road Mentor, Ohio 44060 Registration number: 1528319
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4. Device Classification
Class: Classification Number: Classification Panel: FDA Review Product Code: II 21 CFR 876.1500 Gastroenterology/Urology ODC, FDF
ട. Predicate Devices
DEFENDO Single Use Valve Kit AW/S Valves – 2pc OLYMPUS EUS K240098
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 identical in design to the predicate and have the same intended use. The shelf life of the predicate device is 1 year while the subject device has a shelf life of 3 years (see comparison table below).
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| Features | DEFENDO Single Use Valve Kit AW/S Valves – 2-pc for OLYMPUS EUS K240098 (Predicate Device) | DEFENDO Single Use Valve Kit AW/S Valves - 2-pc for OLYMPUS EUS (Proposed Device) | Comparison |
|---|---|---|---|
| Intended Use | 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. | 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 |
| 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), Endcap with Skirt, and Stainless-Steel Collar# of gaskets: 4# of springs: 2 | Stem, Spring Guide, Spring(s), Endcap with Skirt, and Stainless-Steel Collar# of gaskets: 4# of springs: 2 | Identical | |
| 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 | Identical | ||
| Suction Valve | |||
| 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 | Identical | ||
| 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 – SteelCenter Valve stem: Stainless-SteelOffset Valve Stem: Ultem PlasticSpring Guide: PC-ABSGaskets: TPESkirt: TPEEndcap: UltemCap Insert: BrassMetal collar: Stainless-Steel | |||
| DeviceDimensions(lengths/widths) | Air/Water Valve: | Identical | |
| Overall Length: 46 mmEndcap Overmold Diameter: 11.25 mm | |||
| Suction Valve: | Identical | ||
| Overall Length: 33 mmStem Diameter: 3.8 mm | |||
| Overall Length: 46 mmEndcap Overmold Diameter: 11.25 mm | |||
| Overall Length: 33 mmStem Diameter: 3.8 mm | |||
| TargetPopulation | 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 |
| *Shelf Life | 1 year shelf life | 3 year shelf life | Similar:The DEFENDOSingle Use ValveKit AW/S Valves– 2pc OLYMPUSEUS has passed 3year (accelerated)age testing andthe devicefunctions asintended. |
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9. Summary of Non-Clinical Performance Testing
(*Identical testing was conducted on both the predicate (cleared) 1 year version of the device and proposed 3 year shelf life version of the device. The three year shelf life summary is below.)
| Testing | Acceptance Criteria | Results |
|---|---|---|
| Air/Water Valve | ||
| Leakage | Valve shall not continuously leakwater | Pass |
| Insertion | No damage shall occur to either thevalve or the endoscope duringinsertion | Pass |
| Valve - Stationary | Valve shall remain in place on theendoscope after being fully seated | Pass |
| Flow | Minimum flows of predeterminedlevels of each air and CO2 shall bedemonstrated | Pass |
| Flow | Minimum flow of predeterminedrates of water shall be demonstratedduring flow of each air and CO2 | Pass |
| Flow | Minimum flow of predeterminedrates of water shall fill the balloonduring flow of each air and CO2 | Pass |
| Tensile Strength | Spring compression force shall fallwithin predetermined range in Stage1 compression | Pass |
| Tensile Strength | Spring compression force shall fallwithin predetermined range in Stage2 compression | Pass |
| Cap - Torque | Torque force shall be above apredetermined threshold to ensure noseparation of cap from the valve stemoccurs. | Pass |
Non-clinical testing consisted of the following:
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| Testing | Acceptance Criteria | Results |
|---|---|---|
| Suction Valve | ||
| Leakage | Valve shall not continuously leakwater | Pass |
| Insertion | No damage shall occur to either thevalve or the endoscope duringinsertion. | Pass |
| Insertion | The valve must not be able to beinserted incorrectly into EUS scopesuction port. | Pass |
| Valve - Stationary | Valve shall remain in place on theendoscope after being fully seated | Pass |
| Tensile Strength | Spring compression force shall fallwithin predetermined range in Stage1 compression | Pass |
| Tensile Strength | Spring compression force shall fallwithin predetermined range in Stage2 compression | Pass |
| Cap - Torque | Torque force shall be above apredetermined threshold to ensure noseparation of cap from the valve stemoccurs. | Pass |
| Testing | Acceptance Criteria | Results |
|---|---|---|
| Packaging | ||
| Pouch Seal – TensileTesting | Force to open sealed pouch shall be0.57 lbs or greater | Pass |
10. Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, and effective as the predicate. The differences between the proposed and predicate devices include extension of shelf life and additional statements in the Instructions for Use.
The non-clinical testing for the extension in shelf life from one year to three years demonstrates the proposed change is substantially equivalent to the predicate.
The additional statements in the Instructions for Use do not raise any new concerns of safety and effectiveness.
§ 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.