Who is the manufacturer of Disposable Ureteral Guide Sheath?

Dongguan Zsr Biomedical Technology Company Limited filed the 510(k) submission for Disposable Ureteral Guide Sheath (K241181).

What is the FDA product code for Disposable Ureteral Guide Sheath?

FED. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Disposable Ureteral Guide Sheath?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Disposable Ureteral Guide Sheath?

Disposable Ureteral Access Sheath (K230748).

Who can help prepare an FDA 510(k) submission like Disposable Ureteral Guide Sheath?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Disposable Ureteral Guide Sheath

K241181 · Dongguan Zsr Biomedical Technology Company Limited · FED · Aug 2, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K241181
Device Name	Disposable Ureteral Guide Sheath
Applicant	Dongguan Zsr Biomedical Technology Company Limited
Product Code	FED · Gastroenterology, Urology
Decision Date	Aug 2, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

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

Device Story

Disposable Ureteral Guide Sheath establishes conduit in urinary tract during endoscopic urological procedures; facilitates passage of endoscopes and instruments. Device comprises guide sheath tube and connector (straight, Y, W, or cross-shaped) plus dilator. Used by physicians in clinical settings. Sheath tube materials include Pebax, SUS304, PTFE; connector uses polyamide and silica gel; dilator uses polyethylene and polypropylene. Hydrophilic PVP coating reduces friction. Device supplied sterile (EO gas) for single use. Physician selects appropriate sheath ID (10Fr-16Fr) and length (35cm-55cm) based on patient condition. Provides stable access path for urological instrumentation.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included EN 1618 compliance, biocompatibility (cytotoxicity, sensitization, irritation, acute systemic, pyrogenicity), and sterility/shelf-life validation (ISO 11135, ISO 11737, ASTM F1980, ASTM D3078, ASTM F1929, ASTM F88).

Technological Characteristics

Materials: Pebax, SUS304, PTFE (sheath tube); polyamide, silica gel (connector); polypropylene (dilator connector); polyethylene (dilator tube). Hydrophilic PVP coating. Dimensions: 10-16Fr ID; 35-55cm length. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Shelf life: 3 years. Standards: EN 1618, ISO 10993-1, ISO 11135, ISO 11737, ASTM F1980, ASTM D3078, ASTM F1929, ASTM F88.

Indications for Use

Indicated for patients undergoing endoscopic urological procedures requiring a conduit for the passage of endoscopes and other instruments into the urinary tract.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Disposable Ureteral Access Sheath (K230748)

Related Devices

K243710 — Disposable ureteral access sheath · Shenzhen Trious Medical Technology Co., Ltd. · Apr 11, 2025
K203165 — Disposable Ureteral Access Sheath · Suzhou Beyo Medical Technology Co., Ltd. · Apr 30, 2021
K151084 — Well Lead Ureteral Access Sheath · Well Lead Medical Co., Ltd. · Jan 7, 2016
K051593 — UROPASS URETERAL ACCESS SHEATH, MODEL 61224 · Acmi Corporation · Sep 2, 2005
K250695 — Single-use Ureteral Access Sheath · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Jul 8, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 2, 2024 Dongguan ZSR Biomedical technology Company Limited % Kyra Kang Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza West Guangzhong Road 555, Jingan District Shanghai, 200072 CHINA Re: K241181 > Trade/Device Name: Disposable Ureteral Guide Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FED Received: July 15, 2024 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. 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}------------------------------------------------ # K241181 - Kyra Kang (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. 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 {2}------------------------------------------------ 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). Sincerely, Mark R. 2024.08.02 13:46:16 Kreitz -S -04'00' 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241181 Device Name Disposable Ureteral Guide Sheath Indications for Use (Describe) 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 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." {4}------------------------------------------------ # 510(k) Summary ### l. Submitter Dongguan ZSR Biomedical technology Company Limited Unit 448, Qingfeng Road, Taihu Village, Sanzhong Village Committee, Qingxi Town, 523651 Dongguan City, Guangdong Province,PEOPLE'S REPUBLIC OF CHINA Date of Preparation: July 25, 2024 Contact person: Mrs. Wen Xiuyun Position: Management Representative Tel.: +86-13728363586 E-mail: Sharon@zsrbiomedical.com # 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 Guide Sheath | |----------------------|----------------------------------| | Common name: | Endoscope and accessories | | Classification Name: | Endoscopic access overtube | | Regulation Number: | 21 CFR 876.1500 | | Regulatory Class: | Class II | | Product code: Review | FED | | Panel: | Gastroenterology/Urology | | III. Predicate Devices | K230748 | |------------------------|--------------------------------------| | 510(k) Number: Trade | Disposable Ureteral Access Sheath | | name: Common | Endoscope and accessories | | name: Classification: | Class II | | Product Code: | FED | | Manufacturer | YouCare Technology Co., Ltd.(Wuhan). | {5}------------------------------------------------ # IV. Device description The propose device, 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. This device is divided into 4 types: - Straight type (ZSR-UA) - Y type (ZSR-UAY) - W type (ZSR-UAW) - Cross type (ZSR-UAC) 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). 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. Indication for use 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 # VI. Comparison of technological characteristics with the predicate devices | Character istics | Proposed device | Predicate device (K230748) | Discussio n | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Manufactu rer | Dongguan ZSR Biomedical technology Company Limited | YouCare Technology Co., Ltd.(Wuhan) | / | | Regulation # | 876.1500 | 876.1500 | Same | | Product code | FED | FED | Same | | Classificati on name | Endoscope and accessories | Endoscope and accessories | Same | | Intended use | The Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures | The Disposable Ureteral Access Sheath is used to establish a conduit during endoscopic urological | Same | | | facilitating the passage of endoscopes and other instruments into the urinary tract | procedures facilitating the passage of endoscopes and other instruments into the urinary tract | | | Regulatory Class | Class II | Class II | Same | | Sterility | Yes | Yes | Same | | Sterilizatio n Method | EO | EO | Same | | Single Use | Yes | Yes | Same | | Sheath ID | 10Fr, 11Fr, 12Fr, 13Fr, 14Fr, 15Fr, 16Fr | 12Fr | Different 1 | | Sheath length | 10Fr, 11Fr, 12Fr, 13Fr, 14Fr:35cm, 40cm, 45cm, 50cm, 55cm 15Fr, 16Fr:40cm, 45cm | 45cm, 35cm | Different 2 | | Primary structure | 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). | 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. | Different 3 | | Materials | Sheath tube: Pebax,SUS304,PTFE Connector: polyamide (PA) , silica gel Dilator connector: polypropylene (PP) Dilator tube: polyethylene (PE) | 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 | Different 4 | | | Hydrophilic coating: Polyvinylpyrrolidone (PVP) | 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 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 | | Biocompat ible | Yes | Yes | Same | | Shelf Life | 3 years | 3 years | Same | | Bending Resistanc e | The guiding sheath tube and the dilating tube were bent 90 ° in both directions by grasping the head and the tail. After 20 times of repetition, the tube body was free of cracks, creases, cracks and fractures, the coating was free of falling off, and the steel wire was not separated from the inner and outer rubber layers. | 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. | Similar 1 | | Coefficient s of Friction | After being dipped in water, the surface is smooth, and the friction force is not more than 0.5 N; The average dynamic friction force of 25 repeated tests shall not be greater than 0.5 N | When the sheath tube is tested for friction, the friction coefficient shall not exceed 0.03. | Similar 2 | | Peak tensile force | The joint between the guiding sheath tube and the tube body of the dilating tube and the connector shall be able to bear a force of $\[0.3em] ">=$ 20 N and shall not break for 15 s; | 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 | Similar 3 | | The fracture force test shall be carried out when the guiding sheath tube connector and the expansion tube connector are locked. The minimum fracture force shall be ≥ 15N and shall not break for 15 s. | requirement. | | | Table 1 General Comparison of Disposable Ureteral Guide Sheath {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # 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 any issues in 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 any issues in safety and effectiveness. # Different 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 any issues in safety and effectiveness. # Different 4 - Materials Biocompatibility of the Disposable Ureteral Guide Sheath was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1", this difference will not raise any issues in safety and effectiveness. # Similar 1&2&3 – Performance The subject device has similar performance to the predicate device. All performance of the subject device has been tested according to relevant standards and meets the requirements of the standards,this difference will not raise any issues in safety and effectiveness. # VII. Non-Clinical Testing The device described in this summary Disposable Ureteral Guide Sheath, were {9}------------------------------------------------ tested and demonstrated to be in conformance with the following standards: #### Performance testing: - A EN 1618 Catheters otherthan intravascular catheters - Test methods for commonproperties # 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: - 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 safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.