(130 days)
Not Found
No
The device description and performance studies do not mention any AI, machine learning, or deep learning components. The device is a physical medical instrument used for facilitating endoscopic procedures.
No.
The device facilitates instrument passage during urological endoscopy, but it does not directly treat a disease or condition.
No
Explanation: The device is described as a "Ureteral Access Sheath" used for establishing a continuous conduit for instruments during urological endoscopic procedures. Its function is to facilitate the passage of endoscopes and other instruments, not to diagnose a condition.
No
The device is a physical medical instrument (ureteral access sheath and dilator tube) made of various materials (nylon, stainless steel, PTFE, PC, ABS, silicone, PE), sterilized, and used in surgical procedures. It is clearly a hardware device, not software.
No.
The device is an access sheath used during urological endoscopic procedures to facilitate the passage of endoscopes and instruments into the urinary tract. It is a surgical tool, not a device used to perform tests on specimens derived from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.
Product codes
FED
Device Description
The proposed device, Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.
This device is divided into five types:
- Z type Straight joint access sheath
- Y type negative suction Y joint access sheath
- W type negative suction Y joint access sheath
- T type Straight joint access sheath
- C type negative suction W joint access sheath
This product consists of access sheath and dilator tube. The access sheath tube consists of access sheath tube body and access sheath joint. The surface of access sheath tube is coated with polyvidone (PVP). The dilator tube consists of dilator tube body and dilator tube connector. The access sheath tube body is made from nylon (PA), stainless steel and polytetrafluoroethylene (PTFE). The access sheath joint is made from polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS) and silicone. The dilator tube body and dilator tube connector are made from PE.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing: A series of performance tests were conducted on the device.
Key Results:
Whole device: Appearance, Dimension
Access sheath tube: Liquid leakage, Peak tensile force, Friction coefficient, Toughness, Resistance To Flattening
Dilator tube: Strength of union of the dilator tube connector and dilator tube, Resistance to flexing, Compatibility, Trafficability
Dilator tube connector: Not specified beyond the header.
Biocompatibility testing: Evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1".
Testing conducted: Cytotoxicity, Sensitization, Irritation, Acute Systemic, Pyrogenicity
Sterility and Shelf-life: Conformance with ISO 11135:2014, ISO 11737-1:2018, ISO11737-2:2019, ISO 10993-7: 2008, ASTM F1980-2016, ASTM D3078-02-2021, ASTMF 1929-15, ASTM F88/F88M-15.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
March 26, 2025
Shenzhen Trious Medical Technology Co., Ltd
℅ Kyra Kang
Director
Landlink Healthcare Technology (Shanghai) Co., Ltd
Room 1308, Baohua International Plaza, West Guangzhong Road
Shanghai, Jingan District
CHINA
Re: K243710
Trade/Device Name: Disposable ureteral access sheath
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FED
Dated: December 2, 2024
Received: March 12, 2025
Dear Kyra Kang:
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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K243710 - Kyra Kang Page 2
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
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K243710 - Kyra Kang Page 3
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-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 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
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)
K243710
Device Name
Disposable Ureteral Access Sheath
Indications for Use (Describe)
The Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out 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."
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K243710
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510(k) Summary
I. Submitter
Shenzhen Trious Medical Technology Co., Ltd
Rm 102-2, Longtian Tongfuyu Ind Estate #11-3, and Rm 401 & 402, Bldg D3, YingZhan S&T Estate, Longtian Tongfuyu Rd #8; Longtian Com, Longtian St, Pingshan, Shenzhen, GD, China
Contact person: Yi Yingfang
Position: Registration Specialist
Tel.: 0086-13424218407
E-mail: trsyl@trious.cn
Preparation date: March 25, 2025
Submission Correspondent
Ms. Kyra Kang
Landlink Healthcare Technology (Shanghai) Co., Ltd.
E-mail: kyra.kang@landlink-health.com
II. Proposed Device
Device Trade Name: Disposable Ureteral Access Sheath
Common name: Endoscopic Access Overtube
Classification Name: Endoscope and accessories (21 CFR 876.1500)
Regulatory Class: Class II
Product code: FED
Review Panel: Gastroenterology/Urology
III. Predicate Devices
510(k) Number: K230748
Trade name: Disposable Ureteral Access Sheath
Common name: Endoscopic Access Overtube
Regulatory Class: Class II
Product Code: FED
Manufacturer YouCare Technology Co., Ltd. (Wuhan).
This predicate has not been subject to a design-related recall.
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IV. Device description
The proposed device, Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.
This device is divided into five types:
- Z type Straight joint access sheath
- Y type negative suction Y joint access sheath
- W type negative suction Y joint access sheath
- T type Straight joint access sheath
- C type negative suction W joint access sheath
This product consists of access sheath and dilator tube. The access sheath tube consists of access sheath tube body and access sheath joint. The surface of access sheath tube is coated with polyvidone (PVP). The dilator tube consists of dilator tube body and dilator tube connector. The access sheath tube body is made from nylon (PA), stainless steel and polytetrafluoroethylene (PTFE). The access sheath joint is made from polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS) and silicone. The dilator tube body and dilator tube connector are made from PE.
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
V. Indications for use
The Disposable Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.
VI. Comparison of technological characteristics with the predicate devices
Table 1 General Comparison of Disposable Ureteral Access Sheath
| Characteristics | Proposed device | Predicate device (K230748) | Discussion |
|---|---|---|---|
| Manufacturer | Shenzhen Trious Medical Technology Co. Ltd | YouCare Technology Co., Ltd. (Wuhan) | / |
| Regulation # | 876.1500 | 876.1500 | Same |
| Product code | FED | FED | Same |
| Classification name | Endoscope and accessories | Endoscope and accessories | Same |
| Intended use | The Disposable Ureteral Access Sheath is used to | The Disposable Ureteral Access Sheath is used to establish a conduit during | Same |
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| establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract. | endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract | ||
|---|---|---|---|
| Regulatory Class | Class II | Class II | Same |
| Sterility | Yes | Yes | Same |
| Sterilization Method | EO | EO | Same |
| Single Use | Yes | Yes | Same |
| Sheath ID | 10Fr, 11Fr, 12Fr, 13Fr, 14Fr | 12Fr | Different 1 |
| Sheath length | 35cm, 40cm, 45cm, 50cm | 45cm，35cm | Different 2 |
| Primary structure | This product consists of access sheath and dilator tube. Z-type access sheath and T-type access sheath consist of tube body and straight joint; Y-type access sheath and W-type access sheath consist of tube body, Y-type joint and end cap; C type access sheath consists of tube body, W-type joint and end cap; the dilator tube consists of tube body and joint. | The product is composed of sheath tube, sheath tube base, dilator and center base of dilator. The sheath tube base contains a backwater interface. The center base of dilator consists of upper cover of dilator base, lower cover of dilator base, fiber image channel interface F, irrigation channel interface I, equipment channel interface E, obturator, two-way water valve, needle free joint. | Similar 3 |
| Materials | Access sheath Tube body：PEBAX 6333 SA 01 MED, SUS 304, PTFE Access sheath joint: ABS, PC (Pressure valve: ABS) Silicone cap: silicone Access sheath Tube body Coating: PVP Dilator tube body: LDPE Dilator tube connector: HDPE | sheath tube: Pebax6333 SA01 MED, SUS 304, PTFE, PAM sheath tube base: ABS, PC (backwater interface: PC) dilator: LDPE center base of dilator upper cover of the dilator base: ABS lower cover of the dilator base: ABS fiber image channel interface F: PC irrigation channel interface I: PC equipment channel interface E: PC | Similar 4 |
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| obturator: PC, silica gel two-way water valve: PC, POM needle-free joint: PC, silica gel | |||
|---|---|---|---|
| Package | Single-use EO sterilized pouch with one device per pouch | Single-use EO sterilized pouch with one device per pouch | Same |
| Biocompatible | Yes | Yes | Same |
| Shelf Life | 3 years | 3 years | Same |
| Bending Resistance | Fix the head end of the access sheath tube, dilator tube on a cylinder former with a radius of 5cm.wind the access sheath around the cylinder former for one circle ring and keep it for l min. Then release the wound access sheath tube. The tube body of the access sheath should remain intact without any deformations, cracks, folding, or other defective phenomena. | Bending any section of the dilator, sheath tube or the assembly of sheath tube and dilator into a ring with a radius of 5cm for 1min, there should be no crease, crack or other undesirable phenomena. | Same |
| Coefficients of Friction | When the sheath tube is tested for friction, the friction coefficient shall not exceed 0.03. | When the sheath tube is tested for friction, the friction coefficient shall not exceed 0.03. | Same |
| Peak tensile force | The minimum peak tensile force at the access sheath tube body, and at union of the access sheath tube body and the access sheath tube joint shall not be less than 15 N. | The peak tensile force of the sheath tube and dilator should not be less than 15N. And the peak tensile force of the junction between sheath tube and sheath tube base, the dilator and center base of dilator also shall meet the requirement. | Same |
Different 1 – Sheath ID
This difference is in sheath ID. Different sheath inner diameter device will be selected by physician per patient's condition, this difference will not raise new questions of safety and effectiveness.
Different 2 – Sheath length
Different sheath length device will be selected by physician per patient's condition, this difference will not raise new questions of safety and effectiveness.
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Similar 3 – Primary structure
The predicate device has three instrument channels--- image channel, irrigation channel and equipment channel, it only increases the operation requirements for doctors. All the performance of the proposed device was tested, and the results met the standard requirements, this difference will not raise new questions of safety and effectiveness.
Similar 4 – Materials
Biocompatibility of the Disposable Ureteral Access Sheath was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1", this difference will not new questions of safety and effectiveness.
VII. Non-Clinical Testing
The device described in this summary Disposable Ureteral Access Sheath, were tested and demonstrated to be in conformance with the following standards:
Performance testing：
A series of performance tests were conducted on the device.
| Items |
|---|
| Whole device |
| Appearance |
| Dimension |
| Access sheath tube |
| Liquid leakage |
| Peak tensile force |
| Friction coefficient |
| Toughness |
| Resistance To Flattening |
| Dilator tube |
| Strength of union of the dilator tube connector and dilator tube |
| Resistance to flexing |
| Compatibility |
| Trafficability |
| Dilator tube connector |
Biocompatibility testing
Biocompatibility of the Disposable Ureteral Guide Sheath was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1" The following testing was conducted:
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- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic
- Pyrogenicity
Sterility and Shelf -life
- ISO 11135:2014
- ISO 11737-1:2018
- ISO11737-2:2019
- ISO 10993-7: 2008
- ASTM F1980-2016
- ASTM D3078-02-2021
- ASTMF 1929-15
- ASTM F88/F88M-15
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is as safe and effective as the predicate device. Accordingly, the proposed device is substantially equivalent to the predicate device.