(266 days)
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI or ML.
No.
The device is a Luer-Split adapter designed to attach to an endoscope for irrigation and to allow the use of EndoTherapy accessories; it does not directly treat a condition or disease.
No
The device description clearly states its purpose: to be attached to endoscopes for irrigation and access of endoscopy accessories. It facilitates procedures rather than performing any diagnostic function itself. The performance studies focus on physical properties and reprocessing, not on diagnostic accuracy.
No
The device description clearly describes a physical, reusable device (Luer-Split MAJ-2092) that attaches to an endoscope and facilitates irrigation and accessory use. The performance studies also focus on physical characteristics like flow rate, durability, and reprocessing, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be attached to endoscopes to facilitate irrigation and the use of endoscopy accessories. This is a mechanical function related to the delivery of fluids and instruments during an endoscopic procedure.
- Device Description: The description details a physical device that connects to an endoscope and has ports for irrigation and accessory insertion. It's a reusable accessory for an endoscopic system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with patient specimens in this manner. It's used during a procedure on the patient, not for analyzing samples from the patient.
- Performance Studies: The performance studies focus on mechanical aspects like flow rate, durability, human factors, and reprocessing, which are typical for medical devices used in procedures, not for IVD performance metrics like sensitivity, specificity, etc.
Therefore, the Luer-Split MAJ-2092 is a medical device used in conjunction with an endoscope, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Luer-Split MAJ-2092 has been designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of EndoTherapy accessories.
Product codes
ODC
Device Description
The Luer-Split MAJ-2092 ("Luer-Split") has been designed to be attached to the instrument channel port of endoscopes to allow both irrigation and the use of endoscopy accessories. The Luer-Split is a reusable device after appropriate cleaning and disinfection/ reprocessing as stated in the instruction manual accompanied with device. The Luer-Split is provided as a single model (MAJ-2092) and packed as a single unit.
The Luer-Split is mounted on the instrument channel port of endoscope and the sealing accessory (i.e., single use biopsy valve) is attached on the proximal end of the Luer-Split. The side arm/T-Pipe of the Luer-Split, also referred to as the irrigation port, is connected to the irrigation tube and irrigation equipment. EndoTherapy devices are inserted via attached sealing accessory to perform procedures.
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)
The following verification and validation testing activities were conduction in support of the substantial equivalence determination between the subject device and predicate device.
- Performance Testing - Bench
- Flow Rate
- Composite Durability
- Human Factors Validation
- Reprocessing Validation
- Biocompatibility Evaluation
Clinical testing is not applicable.
The verification and validation testing activities demonstrate that the technological differences between nd predicate device do not adversely affect device performance and the substantially equivalent to the predicate device.
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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March 14, 2025
Olympus Medical Systems Corporation % Rebecca Walker Program Manager, Regulatory Affairs Olympus Surgical Technologies of America 800 West Park Drive Westborough, Massachusetts 01581
Re: K241842
Trade/Device Name: Luer-Split MAJ-2092 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: June 21, 2024 Received: June 26, 2024
Dear Rebecca Walker:
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-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 medical devices and radiation-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
2
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,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology 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
Luer-Split MAJ-2092
Indications for Use (Describe)
The Luer-Split MAJ-2092 has been designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of EndoTherapy accessories.
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.
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| 510(k) #: | K241842 Page 1 of 2 | Prepared on: 2025-02-14 | ||
|---|---|---|---|---|
| ----------- | --------------------- | -- | -- | ------------------------- |
| 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 |
| Device Name | 21 CFR 807.92(a)(2) | |||
|---|---|---|---|---|
| Device Trade Name | Luer-Split MAJ-2092 | |||
| Common Name | Endoscope and accessories | |||
| Classification Name | Endoscope Channel Accessory | |||
| Regulation Number | 876.1500 | |||
| Product Code(s) | ODC |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
|---|---|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K173105 | Side-Arm Adapter (G14732) | ODC |
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
|---|---|---|---|---|
| ---------------------------- | -- | -- | -- | --------------------- |
The Luer-Split MAJ-2092 ("Luer-Split") has been designed to be attached to the instrument channel port of endoscopes to allow both
irrigation and the use of endoscopy accessories. The Luer-Split is a reusable device after appropriate cleaning and disinfection/
reprocessing as stated in the instruction manual accompanied with device. The Luer-Split is provided as a single model (MAJ-2092) and
packed as a single unit.
The Luer-Split is mounted on the instrument channel port of endoscope and the sealing accessory (i.e., single use biopsy valve) is
attached on the proximal end of the Luer-Split. The side arm/T-Pipe of the Luer-Split, also referred to as the irrigation port, is connected
to the irrigation tube and irrigation equipment. EndoTherapy devices are inserted via attached sealing accessory to perform procedures.
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |||
|---|---|---|---|---|
| ---------------------------------- | -- | -- | -- | --------------------- |
The Luer-Split MAJ-2092 has been designed to be attached to the instrument channel port of Olympus endoscopes to allow both
irrigation and the use of EndoTherapy accessories.
Indications for Use Comparison
There are differences in the specific wording in the indications for use between the subject device and the predicate device; however, the fundamental intended use is the same. Both devices are intended to gain access to the working channel of endoscopes. The subject device is connected to a sealing accessory (biopsy valve) to resist backflow. This difference in wording does not describe a new disease, condition or patient population that the device is intended to treat, diagnose, prevent, cure or mitigate.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
5
The Luer-Split has similar technological characteristics and principles of operation as the precicated of ce. The subject device is a reusable, mutli-patient device, whereas the predicate is single use. The subject device is designed to connect to a biopsy valve to resist backflow, while the predicate device does not utilize a separate valve. Additionally, the subject device has the following differences in technological characteristics:
· Compatible instrument diameter range
· Shape of the arm on the adapter body
The differences above have been verified by completion of performance bench testing which demonstrate the technological differences do not raise any new issues of safety or effectiveness of the subject device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following verification and validation testing activities were conduction in support of the substantial equivalence determination between the subject device and predicate device.
· Performance Testing - Bench
o Flow Rate
o Composite Durability
• Human Factors Validation
• Reprocessing Validation
- Biocompatibility Evaluation
Clinical testing is not applicable.
The verification and validation testing activities demonstrate that the technological differences between nd predicate device do not adversely affect device performance and the substantially equivalent to the predicate device.