(110 days)
The AIR/WATER VALVE MAJ-1444 and SUCTION VALVE MAJ-1443 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract, as follows.
Air/Water Valve (MAJ-1444)
- To feed air to remove any fluids or debris adhering to the objective lens.
- To feed water for lens washing.
- To fill the balloon with sterile water.
Suction Valve (MAJ-1443)
- To remove any fluids, debris, or air from the patient.
- To remove the water from the balloon.
The Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract. The subject devices are reusable. The subject devices are compatible with Olympus endoscopes GF-UCT180 and GF-UE160-AL5.
The Suction Valve MAJ-1443 is attached to the suction cylinder of a compatible endoscope to remove any fluids, debris, or air from the patient and to remove water from the balloon. Suction Valve MAJ-1443 has no patient-contacting components and is a reusable device.
The Air/Water Valve MAJ-1444 is attached to the air/water cylinder of a compatible endoscope to feed air to remove any fluid or debris adhering to the objective lens, to feed water for lens washing, and to fill the balloon with sterile water. MAJ-1444 has indirect patient-contacting components and is a reusable device.
The subject device has the same technological characteristics and similar design as the applicable predicate device.
The provided text is an FDA 510(k) clearance letter for two medical device accessories: the Suction Valve (MAJ-1443) and the Air/Water Valve (MAJ-1444). These devices are classified as endoscopic accessories.
Based on the information provided, the study conducted to prove the device meets acceptance criteria focused on bench testing to demonstrate the functionality of reusable accessories, rather than a clinical study involving human patients, AI integration, or multi-reader multi-case (MRMC) studies.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document states: "The following performance bench tests were conducted. All test samples passed pre-defined acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the quantitative reported performance for each test. It only lists the types of tests performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Suction Valve MAJ-1443 | All test samples passed pre-defined acceptance criteria. |
| - Endoscope compatibility | (Specific criteria and performance not detailed) |
| - Suction rate | (Specific criteria and performance not detailed) |
| - Balloon suction rate | (Specific criteria and performance not detailed) |
| - Leakage | (Specific criteria and performance not detailed) |
| - Depression Force | (Specific criteria and performance not detailed) |
| - Composite Durability | (Specific criteria and performance not detailed) |
| Air/Water Valve MAJ-1444 | All test samples passed pre-defined acceptance criteria. |
| - Endoscope compatibility | (Specific criteria and performance not detailed) |
| - Air flow rate | (Specific criteria and performance not detailed) |
| - Water flow rate | (Specific criteria and performance not detailed) |
| - Balloon water rate | (Specific criteria and performance not detailed) |
| - Leakage | (Specific criteria and performance not detailed) |
| - Depression Force | (Specific criteria and performance not detailed) |
| - Composite Durability | (Specific criteria and performance not detailed) |
| - Microbiological Evaluation of Backflow Prevention | (Specific criteria and performance not detailed) |
Therefore, while the document confirms that acceptance criteria were predefined and met, the specific details of these criteria and the quantitative performance results are not included in this FDA clearance letter. This information would typically be found in the full 510(k) submission.
Regarding the other points of your request, much of the requested information (especially concerning AI, human readers, ground truth establishment for AI models, and large-scale clinical studies) is not applicable to this particular device and its clearance.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document simply states "Test samples were final, finished devices." It does not specify the number of samples tested for each performance bench test.
- Data Provenance: The tests were "bench testing" performed by Olympus. The data provenance is laboratory/bench data generated internally for regulatory submission. It is not patient data, and therefore, concepts like "country of origin of the data" or "retrospective/prospective" study design in a clinical sense do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a device like an endoscope valve, the "ground truth" for its performance is typically established through engineering specifications, material science, and functional testing as defined by recognized standards and internal quality control. This does not involve expert readers establishing ground truth on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for studies where human interpretation of data (e.g., medical images) is involved and consensus is needed. For bench testing of mechanical or functional properties, the "adjudication" is based on objective measurements against engineering specifications.
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:
- No. This was not an AI-enabled device. The document describes a traditional medical device accessory (valves for endoscopes). MRMC studies are specific to evaluating diagnostic performance, often of AI algorithms assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is not an algorithm. It's a physical accessory; therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For these devices, the "ground truth" is defined by engineering specifications and functional requirements (e.g., specific flow rates, suction pressures, resistance to leakage, durability under repeated use, compatibility with specified endoscopes). Successful performance means meeting these pre-defined technical criteria. There is no biological "ground truth" like pathology for these mechanical accessories.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, no ground truth was established for it.
In summary: The provided FDA 510(k) clearance letter pertains to reusable endoscope valves. The clearance was based on bench testing demonstrating the functional performance and durability of the devices. It is a traditional medical device clearance and does not involve AI, clinical efficacy studies with human participants, or complex ground truth establishment methods typical for AI or diagnostic imaging devices. The specific quantitative acceptance criteria and detailed performance results from these bench tests are not present in this summary document but would be part of the full 510(k) submission.
FDA 510(k) Clearance Letter - K250949
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 16, 2025
Olympus Medical Systems Corporation
℅ Susan Lewandowski
Program Manager, Regulatory Affairs
Olympus Corporation of the Americas
3500 Corporate Parkway
Center Valley, Pennsylvania 18034
Re: K250949
Trade/Device Name: Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: Class II
Product Code: ODC
Dated: March 28, 2025
Received: March 28, 2025
Dear Susan Lewandowski:
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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K250949 - Susan Lewandowski
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250949 - Susan Lewandowski
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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,
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
Enclosure
Page 4
Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250949 |
|---|---|
| Please provide the device trade name(s). |
Suction Valve (MAJ-1443);
Air/Water Valve (MAJ-1444)
| Please provide your Indications for Use below. |
|---|
The AIR/WATER VALVE MAJ-1444 and SUCTION VALVE MAJ-1443 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract, as follows.
Air/Water Valve (MAJ-1444)
- To feed air to remove any fluids or debris adhering to the objective lens.
- To feed water for lens washing.
- To fill the balloon with sterile water.
Suction Valve (MAJ-1443)
- To remove any fluids, debris, or air from the patient.
- To remove the water from the balloon.
| Please select the types of uses (select one or both, as applicable). | ☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
Suction Valve
Page 9 of 35
Page 5
Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444
510(k) Summary
1. General Information
Date Prepared: March 28, 2025
510(K) submitter: Olympus Medical Systems Corporation
2951 Ishikawa-cho, Hachioji-shi, Tokyo Japan 192-8507
Contact: Osamu Tamada
Product RA Lead GI Endoscope, OMSC
Correspondent: Olympus Surgical Technologies of America
800 West Park Drive, Westborough, MA 01581
Primary Contact: Susan Lewandowski
Email: susan.lewandowski@olympus.com
2. Device Information
Device Name: Suction Valve MAJ-1443, Air/Water Valve MAJ-1444
Common Name: Endoscope channel accessory
Classification: 876.1500 – Endoscope and accessories
Regulatory Class: II
Product Code: ODC (endoscope channel accessory)
Device Panel: Gastroenterology & Urology
3. Predicate Device Information
BioGuard EUS Air/Water and Suction Valves K202104
4. Device Description
The Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract. The subject devices are reusable. The subject devices are compatible with Olympus endoscopes GF-UCT180 and GF-UE160-AL5.
The Suction Valve MAJ-1443 is attached to the suction cylinder of a compatible endoscope to remove any fluids, debris, or air from the patient and to remove water from the balloon. Suction Valve MAJ-1443 has no patient-contacting components and is a reusable device.
The Air/Water Valve MAJ-1444 is attached to the air/water cylinder of a compatible endoscope to feed air to remove any fluid or debris adhering to the objective lens, to feed water for lens
K250949
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Page 6
Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444
washing, and to fill the balloon with sterile water. MAJ-1444 has indirect patient-contacting components and is a reusable device.
The subject device has the same technological characteristics and similar design as the applicable predicate device.
5. Indications for Use
The Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract, as follows:
Suction Valve MAJ-1443
• To remove any fluids, debris, or air from the patient
• To remove the water from the balloon
Air/Water Valve MAJ-1444
• To feed air to remove any fluid or debris adhering to the objective lens
• To feed water for lens washing
• To fill the balloon with sterile water
6. Predicate Comparison
| Description | Subject Device (SD)Suction Valve MAJ-1443Air/Water Valve MAJ-1444 | Predicate Device (PD)BioGuard EUS Air/Water and Suction ValvesK202104 | Comparison |
|---|---|---|---|
| Product Code | ODC | ODC, FDF | SAMEThe predicate device additionally has the assigned FDA product code FDF (colonoscope and accessories, flexible/rigid) which the subject device does not have. |
| Classification | II | II | SAME |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | SAME |
| Common Name | Endoscope channel accessory | Endoscope channel accessory | SAME |
| Regulation Name | Endoscope and accessories | Endoscope and accessories | SAME |
| Review Panel | Gastroenterology and Urology | Gastroenterology and Urology | SAME |
| Indications for Use | The Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444 have been designed for use with an Olympus ultrasound endoscope for the gastrointestinal (GI) tract, as follows: | The BioGuard EUS Suction Valve is intended to be used to control the suction function of an endoscope during a GI endoscopic procedure. | SAMEThe SD and PD have the same intended use/indications for use but are phrased differently. The SD indications statement specifically details the |
K250949
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Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444
| Description | Subject Device (SD)Suction Valve MAJ-1443Air/Water Valve MAJ-1444 | Predicate Device (PD)BioGuard EUS Air/Water and Suction ValvesK202104 | Comparison |
|---|---|---|---|
| Suction Valve MAJ-1443• To remove any fluids, debris, or air from the patient• To remove the water from the balloonAir/Water Valve MAJ-1444• To feed air to remove any fluid or debris adhering to the objective lens• To feed water for lens washing• To fill the balloon with sterile water | 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. | expected use/function of the valves. | |
| Compatible Endoscopes | Olympus GI ultrasound endoscope (with a balloon channel) | Olympus GI ultrasound endoscope (with a balloon channel) | SAMEThe PD has been designed to be used with an Olympus GI ultrasound endoscope (with a balloon channel) |
| Single Use | No | Yes | DIFFERENTPerformance testing was conducted to demonstrate that this difference in technology does not impact the safety or effectiveness of the SD. |
| Function | Suction valve• remove any fluids, debris, or air from the patient.• remove the water from the balloon.Air/water valve• feed air to remove any fluid or debris adhering to the objective lens.• feed water for lens washing.• fill the balloon with sterile water. | Suction valve• remove any fluid or debris adhering to the objective lens.• remove the water from the balloon.Air/water valve• feed air to remove any fluid or debris adhering to the objective lens.• feed water for lens washing.• fill the balloon with sterile water. | SAME |
| Reprocessing Method | - Manual cleaning- Manual disinfection- Autoclaving | Not applicable as the PD is single use | DIFFERENTPerformance testing was conducted to demonstrate |
K250949
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Suction Valve MAJ-1443 and Air/Water Valve MAJ-1444
| Description | Subject Device (SD)Suction Valve MAJ-1443Air/Water Valve MAJ-1444 | Predicate Device (PD)BioGuard EUS Air/Water and Suction ValvesK202104 | Comparison |
|---|---|---|---|
| that this difference in technology does not impact the safety or effectiveness of the SD. | |||
| Method of application | Manual actuation | Manual actuation | SAME |
7. Non-Clinical/Clinical Tests Summary and Conclusion
Olympus performed bench testing to demonstrate the functionality of the Suction Valve MAJ-1443 and the Air/Water Valve MAJ-1444. Test samples were final, finished devices subjected to the full manufacturing process.
The following performance bench tests were conducted. All test samples passed pre-defined acceptance criteria.
Suction Valve MAJ-1443 - Endoscope compatibility, Suction rate, Balloon suction rate, Leakage, Depression Force, and Composite Durability
Air/Water Valve MAJ-1444 - Endoscope compatibility, Air flow rate, Water flow rate, Balloon water rate, Leakage, Depression Force, Composite Durability, and Microbiological Evaluation of Backflow Prevention
8. Conclusion
Based on the comparison to the predicate device, intended use, technological characteristics, and performance testing, the Suction Valve MAJ-1443 and the Air/Water Valve MAJ-1444 raise no new issues of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.
K250949
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§ 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.