(120 days)
No.
The device description and performance studies do not mention any AI, machine learning, or deep neural network components. The device is a physical instrument for medical procedures, not a software-based or AI-driven system.
Yes
The device is described as facilitating the passage of endoscopes and other instruments into the urinary tract for "the treatment of urinary stones or other urinary diseases during the endoscopic procedures," which indicates a therapeutic purpose.
No
The device is described as an access sheath to facilitate the passage of instruments during endoscopic urological procedures, rather than for diagnosing a condition. Its function is to establish a conduit for treatment, not to identify or characterize a disease.
No
The device is a physical ureteral access sheath, which is a hardware medical device. The description details its physical characteristics (e.g., diameters, lengths, materials, and connection points) and refers to bench testing, sterilization validation, packaging, and biocompatibility studies that are typical of a tangible product, not a software application. There is no mention of software anywhere in the summary.
No
The device is a physical instrument used during endoscopic urological procedures to facilitate access to the urinary tract. It does not perform tests on samples taken from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The LumenaTM Ureteral Access Sheath is indicated to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
Product codes
FED
Device Description
The LumenaTM Ureteral Access Sheaths are designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The sheaths are available with both a bendable tip with a Y-shape joint on the proximal end and a straight tip with the outside diameters ranging from 11 to 15 French and lengths ranging from 35 to 45 centimeters. These devices are available in a single lumen configuration and include a sheath tube and a dilator. The bendable-tip sheath is intended to be connected to a negative pressure aspirator for the collection of stones or foreign bodies during the endoscopic procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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
Bench testing was performed to establish substantial equivalence to the predicates and to demonstrate that the subject device will perform as intended. All the testing results meet the defined acceptance criteria. Detailed testing conducted are as follows:
- Tensile Performance Test
- Hydrophilic Coating Performance Test
- Luer Connector Performance Test
- Compatibility Performance Test
- Bending-Resistance Test
- Negative Pressure Suction Test
- Adhesion performance of marks Test
- Radiopacity Test
Sterilization validation of LumenaTM Ureteral Access Sheath was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Packaging & Shelf-life testing was conducted based on an accelerated aging test in accordance with: - ASTM D4169-23 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 11607-1:2019: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes.
Accelerated aging test was performed to demonstrate the device's stability during its claimed shelf life.
Biocompatibility evaluation for the LumenaTM Ureteral Access Sheath was conducted in accordance with FDA Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (September 8, 2023), the following tests were conducted:
a) Cytotoxicity
b) Sensitization
c) Irritation
d) Acute System Toxicity
e) Pyrogen
No clinical study is included in this submission.
Key Metrics
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.
FDA 510(k) Clearance Letter - LumenaTM Ureteral Access Sheath
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 27, 2025
CatheGenix (Xiamen) Co., Ltd.
Deyuan Zheng
Management Representative
Room 605-2A, No.37 Banshang, Building 2,
Torch Hi-Tech Zone, P.R.
Xiamen, Fujian 361000
CHINA
Re: K250585
Trade/Device Name: LumenaTM Ureteral Access Sheath
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FED
Dated: May 28, 2025
Received: May 28, 2025
Dear Deyuan Zheng:
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"
Page 2
K250585 - Deyuan Zheng Page 2
(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
Page 3
K250585 - Deyuan Zheng Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,
Mark R. Kreitz -S
for 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
| Submission Number (if known) |
|---|
| K250585 |
| Device Name |
|---|
| LumenaTM Ureteral Access Sheath |
Indications for Use (Describe)
The LumenaTM Ureteral Access Sheath is indicated to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
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 per 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."
Page 5
The 510(k) Submission contains confidential trade secret and proprietary information pursuant to 21 CFR 20.61, CatheGenix requests that it be treated as such by FDA (per 21 CFR 807.95).
K250585
Page 1 of 5
510(k) Summary
1. Submitter's Information
Sponsor: CatheGenix (Xiamen) Co., Ltd.
Room 605-2A, No.37 Banshang, Building 2, Torch Hi-Tech Zone, Xiamen 361000, P.R. China
Contact: Deyuan Zheng
CatheGenix (Xiamen) Co., Ltd.
Management representative
86+15201818268
Date Prepared: February 21, 2025
2. Identification of Proposed Device
Trade Name: LumenaTM Ureteral Access Sheath
Common Name: Ureteral Access Sheath
Classification Name: Endoscopic access overtube
Classification Regulation: 21 CFR 876.1500
Product Code: FED
Device Class: 2
3. Identification of Predicate Devices
Disposable Ureteral Guide Sheath cleared under K241181.
4. Intended Use/Indications for Use
The ureteral access sheath is indicated to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
5. Device Description
The LumenaTM Ureteral Access Sheaths are designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The sheaths are available with both a bendable tip with a Y-shape joint on the proximal end and a straight tip with the outside diameters ranging from 11 to 15 French and lengths ranging from 35 to 45 centimeters. These devices are available in a single lumen configuration and include a sheath tube and a dilator. The bendable-tip sheath is intended to be connected to a negative pressure aspirator for the collection of stones or foreign bodies during the endoscopic procedure.
6. Comparison to Predicate Devices
The subject device is substantially equivalent to the predicate devices as they share the same indications for use and similar technological characteristics. Technological
Page 6
The 510(k) Submission contains confidential trade secret and proprietary information pursuant to 21 CFR 20.61, CatheGenix requests that it be treated as such by FDA (per 21 CFR 807.95).
K250585
Page 2 of 5
characteristics of the subject device compared to each predicate is shown in the following table.
Table 1. General Comparison
| Technological Characteristics | Proposed Device | Predicate Device Disposable Ureteral Guide Sheath[K241181] |
|---|---|---|
| Manufacturer | CatheGenix (Xiamen) Co., Ltd. | Dongguan ZSR Biomedical Technology Company Limited |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code | FED | FED |
| Classification Name | Endoscope and accessories | Endoscope and accessories |
| Classification | Class 2 | Class 2 |
| Intended Use/Indications for Use | The ureteral access sheath is indicated to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. | The Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. |
| Sterility | Yes, 10-6 | Yes, 10-6 |
| Sterilization method | Eto sterilized | Eto sterilized |
| Single Use | Yes | Yes |
| Sheath ID | 9.5Fr, 11Fr, 12Fr, 13Fr | 10Fr, 11Fr, 12Fr, 13Fr, 14Fr, 15Fr, 16Fr, |
| Sheath length | 9.5Fr, 11Fr, 12Fr, 13Fr: 35cm, 40cm, 45cm | 10Fr, 11Fr, 12Fr, 13Fr, 14Fr:35cm, 40cm, 45cm 15Fr, 16Fr:40cm, 45cm |
| Primary structure | The device is composed of sheath and dilator. The sheath consists of sheath tube and connector (straight, Y-shaped). | The device is composed of guide sheath and dilator. The guide sheath consists of guide sheath tube and connector (straight, Y-shaped, W-shaped and cross-shaped). |
Page 7
The 510(k) Submission contains confidential trade secret and proprietary information pursuant to 21 CFR 20.61, CatheGenix requests that it be treated as such by FDA (per 21 CFR 807.95).
K250585
Page 3 of 5
| Technological Characteristics | Proposed Device | Predicate Device Disposable Ureteral Guide Sheath[K241181] |
|---|---|---|
| Materials | Sheath tube: PEBAX, SUS304, PTFE Sheath connector: Polycarbonate (PC), Silicone Dilator connector: polypropylene (PP) Dilator tube: Polyethylene (PE) Hydrophilic coating: Polyvinylpyrrolidone (PVP) | Sheath tube: Pebax, SUS304, PTFE Connector: Polyamide (PA), silica gel Dilator connector: polypropylene (PP) Dilator tube: Polyethylene (PE) Hydrophilic coating: Polyvinylpyrrolidone (PVP) |
| Package | Single-use EO sterilized pouch with one device per pouch | Single-use EO sterilized pouch with one device per pouch |
| Biocompatible | Yes | Yes |
Page 8
The 510(k) Submission contains confidential trade secret and proprietary information pursuant to 21 CFR 20.61, Beneeon requests that it be treated as such by FDA (per 21 CFR 807.95).
K250585
Page 4 of 5
7. Summary of Non-Clinical Performance Data
Bench testing was performed to establish substantial equivalence to the predicates and to demonstrate that the subject device will perform as intended. All the testing results meet the defined acceptance criteria. Detailed testing conducted are as follows:
- Tensile Performance Test
- Hydrophilic Coating Performance Test
- Luer Connector Performance Test
- Compatibility Performance Test
- Bending-Resistance Test
- Negative Pressure Suction Test
- Adhesion performance of marks Test
- Radiopacity Test
Sterilization validation of LumenaTM Ureteral Access Sheath was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Packaging & Shelf-life testing was conducted based on an accelerated aging test in accordance with:
- ASTM D4169-23 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 11607-1:2019: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes.
Accelerated aging test was performed to demonstrate the device's stability during its claimed shelf life.
Biocompatibility evaluation for the LumenaTM Ureteral Access Sheath was conducted in accordance with FDA Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (September 8, 2023), the following tests were conducted:
a) Cytotoxicity
b) Sensitization
c) Irritation
d) Acute System Toxicity
e) Pyrogen
8. Summary of Clinical Test
No clinical study is included in this submission.
Page 9
The 510(k) Submission contains confidential trade secret and proprietary information pursuant to 21 CFR 20.61, Beneeon requests that it be treated as such by FDA (per 21 CFR 807.95).
K250585
Page 5 of 5
9. Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the LumenaTM Ureteral Access Sheath has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate devices:
(1) Disposable Ureteral Guide Sheath cleared under K241181;