(60 days)
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI/ML terms or image processing.
No
The device is described as a water container used with endoscopes for gas insufflation and water feeding, which are supportive functions for the endoscope, not therapeutic actions themselves.
No
Explanation: The device is described as a water container designed for gas insufflation and water feeding through endoscopes, and its performance studies focus on physical attributes like flow rate and durability, not on diagnosing medical conditions. It is an accessory for an existing medical procedure, not a diagnostic tool itself.
No
The device description explicitly states that the device is comprised of physical components (Lid, Container, O-ring, Container Protector, gas tube connector).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being used with endoscopes for gas insufflation and water feeding. This is a function related to the endoscopic procedure itself, not the analysis of biological samples.
- Device Description: The description details components like a lid, container, O-ring, and container protector, all related to holding and delivering fluids/gas during endoscopy. There is no mention of components or functions related to analyzing samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on flow rate, durability, biocompatibility, reprocessing, and human factors – all relevant to the mechanical and functional performance of a device used in a procedure, not the analytical performance of an IVD.
- Predicate Device: The predicate device (Endo SmartCap) is also a device used in conjunction with endoscopes, further supporting the conclusion that this is not an IVD.
In summary, the function of the MAJ-901 and MAJ-902 is to facilitate the endoscopic procedure by providing water and gas, not to perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The water container MAJ-901 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.
Do not use this instrument for any purpose other than its intended use.
The water container MAJ-902 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.
Do not use this instrument for any purpose other than its intended use.
Product codes
OCX
Device Description
The MAJ-901 and MAJ-902 have been designed to be used with Olympus light sources and endoscopes to allow gas insufflation and water feeding from the endoscope.
MAJ-901 and MAJ-902 are both comprised of a Lid, Container, O-ring, and Container Protector. Other than Lid, the devices are the same.
MAJ-902 also includes a "gas tube connector" in the lid for carbon dioxide gas delivery. Additionally, MAJ-902 includes a Caution tag that the MAJ-901 does not.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing - Bench
Bench testing as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
• Flow Rate
- Durability (GA)
- · Durability (AC)
- · Biocompatibility
- Reprocessing
- Human Factors
All testing demonstrated that the subject devices met design specifications and performed as intended.
No clinical testing was submitted in this 510(k) application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
October 7, 2024
Olympus Medical Systems Corporation % Teffany Hutto Regulatory Affairs Program Manager Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K242357
Trade/Device Name: Water Container (MAJ-901); Water Container (MAJ-902) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX Dated: August 8, 2024 Received: August 8, 2024
Dear Teffany Hutto:
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"
1
(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 OS 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 Rue"). 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-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-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).
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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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Water Container (MAJ-901) Water Container (MAJ-902)
Indications for Use (Describe)
The water container MAJ-901 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.
Do not use this instrument for any purpose other than its intended use.
The water container MAJ-902 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.
Do not use this instrument for any purpose other than its intended use.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours be response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| K242357 Page 1 of 2 | |||||
|---|---|---|---|---|---|
| 510(k) #: | 510(k) Summary | Prepared on: 2024-08-12 | |||
| Contact Details | |||||
| 21 CFR 807.92(a)(1) | |||||
| Applicant Name | Olympus Medical Systems Corporation | ||||
| Applicant Address | 2951 Ishikawa-cho Hachioji-shi Tokyo 192-8507 Japan | ||||
| Applicant Contact Telephone | +81 42-642-269 | ||||
| Applicant Contact | Mr. Shinichiro Kawachi | ||||
| Applicant Contact Email | Shinichiro.Kawachi@olympus.com | ||||
| Correspondent Name | Olympus Corporation of the Americas | ||||
| Correspondent Address | 800 West Park Drive Westborough MA 01581 United States | ||||
| Correspondent Contact Telephone | 5125086550 | ||||
| Correspondent Contact | Mrs. Teffany Hutto | ||||
| Correspondent Contact Email | teffany.hutto@olympus.com | ||||
| Device Name | |||||
| 21 CFR 807.92(a)(2) | |||||
| Device Trade Name | Water Container (MAJ-901); | ||||
| Water Container (MAJ-902) | |||||
| Common Name | Endoscopes and Accessories | ||||
| Classification Name | Endoscope and accessories | ||||
| Regulation Number | 876.1500 | ||||
| Product Code(s) | OCX | ||||
| Legally Marketed Predicate Devices | |||||
| 21 CFR 807.92(a)(3) | |||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K093665 | Endo SmartCap [Model: 100145] | FAJ | |||
| Device Description Summary | |||||
| 21 CFR 807.92(a)(4) | |||||
| The MAJ-901 and MAJ-902 have been designed to be used with Olympus light sources and endoscopes to allow gas insufflation and | |||||
| water feeding from the endoscope. | |||||
| MAJ-901 and MAJ-902 are both comprised of a Lid, Container, O-ring, and Container Protector. Other than Lid, the devices are the same. | |||||
| MAJ-902 also includes a "gas tube connector" in the lid for carbon dioxide gas delivery. Additionally, MAJ-902 includes a Caution tag that | |||||
| the MAJ-901 does not. |
5
Intended Use/Indications for Use
The water container MAJ-901 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.
Do not use this instrument for any purpose other than its intended use.
The water container MAJ-902 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.
Do not use this instrument for any purpose other than its intended use.
Indications for Use Comparison
The Water Containers MAJ-902 have been designed to be used with Olympus light sources and endoscopes to allow gas insufflation and water feeding from the endoscope. The Indications for the predicate Endo SmartCap is not identical to the predicate device as it is also intended to provide air; however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device to the predicate. Both the subject and predicate devices have the same intended use for insufflation and water feeding to the endoscope.
Technological Comparison
• Principle of Operation
Both subject devices and predicate device have the same principles of operation, providing pressurized gas or air into the container/ bottle by the endoscope's processor/light source and the water, air (MAJ-902) is fed into the endoscope through the tube.
· Both Subject Devices and Predicate Device are compatible with Olympus endoscopes
• Patient Contact Duration
Both subject devices and predicate device have indirect contact with the patient.
Differences
· The Subject Devices are reusable, and the Predicate Device is single use.
· The Subject Devices and the Predicate Device utilize different materials.
The subject devices have undergone comparative performance testing, biocompatibility testing, and reprocessing validations to demonstrate the differences do not raise new questions of safety or effectiveness, and therefore, is substantially equivalent to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance testing - Bench
Bench testing as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
• Flow Rate
- Durability (GA)
- · Durability (AC)
- · Biocompatibility
- Reprocessing
- Human Factors
All testing demonstrated that the subject devices met design specifications and performed as intended.
No clinical testing was submitted in this 510(k) application.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)