The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Device Description

The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 12Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and four lengths: 35cm, 45cm, 50cm, 55cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.

AI/ML Overview

The provided 510(k) clearance letter is for a "Single-Use Ureteral Access Sheath" (K251599), which is a physical medical device and not an AI or software-based device.

Therefore, many of the requested points related to AI/software performance, such as:

MRMC comparative effectiveness study
Standalone (algorithm only) performance
Sample size and ground truth for training set
Number of experts and their qualifications for ground truth establishment
Adjudication method for test set

do not apply to this device and its associated performance data.

The performance data provided in the 510(k) summary focuses entirely on non-clinical performance data for a physical device, including:

Biocompatibility Testing
Sterility Testing
Functional and Mechanical Performance Testing (e.g., appearance, size, patency, breaking force, friction, etc.)

Based on the information provided in the 510(k) clearance letter for the Single-Use Ureteral Access Sheath (K251599), here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document lists various performance tests conducted but does not explicitly state the quantitative acceptance criteria for each test or the specific numerical results obtained. It generally states that "All evaluation acceptance criteria were met" for biocompatibility and implies successful results for performance testing by concluding substantial equivalence.

Performance Attribute/Test Category	Acceptance Criteria (Implicit from document)	Reported Device Performance (Implicit from document)
Biocompatibility	Met ISO 10993-1:2018 recommendations for "breached or compromised surface," "Limited (<24 hours)" contact duration.	"All evaluation acceptance criteria were met" for Cytotoxicity, Irritation, Sensitization, Pyrogenicity, and Acute systemic toxicity.
Sterility	Met ISO 11607 for sterile barrier systems; Sterilization process validated per ISO 11135.	Validated sterilization process and evaluated sterile barrier systems were successful.
Functional & Mechanical Performance	Demonstrated safety and effectiveness comparable to predicate device.	• Appearance: Met internal specifications• Mark: Met internal specifications• Size: Met internal specifications• Luer fitting: Functioned as intended• Patency: Confirmed• Freedom from leakage: Confirmed• Resistance to deformation: Confirmed• Breaking force: Met internal specifications• Connection firmness: Confirmed• Toughness: Confirmed• Flexural properties: Confirmed• Anti-twisting force: Confirmed• Compression Resistance: Confirmed• Compatibility: With 0.038" guidewire, endoscopes, and other urological instruments of compatible OD.• Air pressure Regulation Function: Confirmed• Negative Pressure Suction Function: Confirmed• Bending Reliability: Confirmed• Corrosion resistance: Confirmed• Friction: Within acceptable limits for smooth deployment• Coating Uniformity: Confirmed• Firmness: Confirmed• Chemical Property: Met internal specifications

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the non-clinical performance and mechanical testing. It also doesn't mention data provenance in terms of country of origin or retrospective/prospective for this type of testing, as it's laboratory-based physical device testing, not clinical data or real-world usage data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept (experts establishing ground truth) is not applicable to the non-clinical, physical device testing described. The "ground truth" for physical device performance is established by standardized test methods and engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable to non-clinical, physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device, not an AI or imaging diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" or reference standards are:

Biocompatibility: ISO 10993-1:2018 (international standard for biological evaluation of medical devices).
Sterilization: ISO 11607 (packaging for terminally sterilized medical devices) and ISO 11135 (ethylene oxide sterilization for medical devices).
Functional/Mechanical Performance: Internal engineering specifications and established test methods for physical characteristics, likely derived from industry standards and predicate device performance.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model requiring a "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

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

July 3, 2025

Hunan Vathin Medical Instrument Co., Ltd.
c/o Ya Tang
RA Affairs
1/F, Building 12, Innovation Entrepreneurship Service Center
No.9 Chuanqi West Road, Jiuhua Economic Development Zone
Xiangtan, Hunan 411100
CHINA

Re: K251599
Trade/Device Name: Single-Use Ureteral Access Sheath
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FED
Dated: June 3, 2025
Received: June 3, 2025

Dear Ya Tang:

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.

July 3, 2025

Dear Ya Tang:

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251599 - Ya Tang 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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K251599 - Ya Tang 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.

510(k) Number (if known)
K251599

Device Name
Single-use Ureteral Access Sheath

Indications for Use (Describe)
The Single-use Ureteral Access 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."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

510(k) Summary

I. SUBMITTER INFORMATION

Applicant: Hunan Vathin Medical Instrument Co., Ltd.

Address: 1/F, Building 12, Innovation and Entrepreneurship Service Center, No 9 Chuanqi west road, Jiuhua Economic Development Zone, 411100 Xiangtan, Hunan, China

Contact Person: Lily Fei
Title: Quality Manager
Phone Number: +86-18017856052
E-mail: lily@zothin.com

Date Prepared: June 3, 2025

II. SUBJECT DEVICE

Trade Name: Single-use Ureteral Access Sheath
Common Name: Ureteral Access Sheath
Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology
Regulatory Class: II
Product Code: FED
Regulation Number: 21 CFR 876.1500
Review Panel: Gastroenterology/Urology

III. PREDICATE DEVICE

	Primary predicate	Secondary predicate
Trade Name:	Single-use Ureteral Access Sheath	Disposable Ureteral Access Sheath
510(k) Number:	K240167	K203165
Manufacturer:	Hunan Vathin Medical Instrument Co., Ltd.	Suzhou Beyo Medical Technology Co., Ltd.

This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges.

K251599
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Page 6

Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma.

The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit.

To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process.

The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 12Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath.

The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and four lengths: 35cm, 45cm, 50cm, 55cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.

The subject device components are made of the following materials:

K251599
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Page 7

Table 1. Subject Device Materials

Device Components	Contact Method	Tissue-contacting device component
		Material Full Name
inner layer		Austenitic stainless steel
Sheath	outer layer	Direct contact

Sheath hub	hub	Indirect contact
	Suction nozzle
Sheath cap		Indirect contact
Sealing sleeve		Indirect contact
Vent push button		Indirect contact
Dilator		Direct contact
Dilator hub	hub	Indirect contact
	locking clip

V. INDICATIONS FOR USE

The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.

K251599
Page 3 of 6

Page 8

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Single-use Ureteral Access Sheath (K240167) is the legally marketed device to which the subject device in this 510k submission claims substantial equivalence, and Disposable Ureteral Access Sheath (K203165) is referred to as secondary predicate device to support the inclusion of longer device models. The subject and predicate devices have the same indications for use, similar technological characteristics. See the following table for comparison information in details.

Table 2. Comparison of Technological Characteristics

Description	Subject Device	Primary Predicate (Vathin, K240167)	Secondary Predicate Device (Beyo, K203165)
Trade Name	Single-use Ureteral Access Sheath	Single-use Ureteral Access Sheath	Disposable Ureteral Access Sheath
Regulation Number	876.1500	876.1500	876.1500
Regulatory Class	II	II	II
Product Code	FED	FED	FED
Indications for Use	The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.	The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.	The Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.
Delivered Sterile	Yes	Yes	Yes
Sterilization Method	EO	EO	EO
Single Use	Yes	Yes	Yes
Sheath ID	10Fr, 11Fr, 12Fr, 13Fr, 14Fr	10Fr, 11Fr, 12Fr, 13Fr, 14Fr	10Fr, 12Fr, 14Fr
Sheath Length	35cm, 45cm, 50cm, 55cm	35cm, 45cm	25cm, 35cm, 40cm, 45cm, 55cm
Guidewire Compatibility	0.038" (0.97mm) guidewire can smoothly enter and exit the inner lumen of the dilator.	0.038" (0.97mm) guidewire can smoothly enter and exit the inner lumen of the dilator.	0.038" (0.97mm) guidewire can smoothly enter and exit the inner cavity of the dilator.
Materials	Sheath: TPU, LDPE, PET, SUS304Dilator: LDPEHydrophilic coating: PVP	Sheath: TPU, LDPE, PET, SUS304Dilator: LDPEHydrophilic coating: PVP	Sheath: PEBAX, SUS304, PTFEDilator: LDPEHydrophilic coating: PAM
Biocompatibility	No CytotoxicityNo Irritation to SkinNo significant evidence of sensitization	No CytotoxicityNo Irritation to SkinNo significant evidence of sensitization	No CytotoxicityNo Irritation to SkinNo significant evidence of sensitization
Package	Single-use EO sterilized blister box with one device per box	Single-use EO sterilized blister box with one device per box	Single-use EO sterilized pouch with one device per pouch

K251599
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Page 9

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Non-Clinical Performance Data

Biocompatibility Testing

Biocompatibility of the Single-use Ureteral Access Sheath was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "breached or compromised surface" with a contact duration of "Limited (<24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Pyrogenicity and Acute systemic toxicity. All evaluation acceptance criteria were met.

Sterility Testing

Sterile barrier systems were evaluated in accordance with ISO 11607.

Sterilization Process has been validated accordance with ISO 11135.

Performance Testing

The following functional and mechanical performance testing were conducted on the Single-use Ureteral Access Sheath:

Appearance
Mark
Size
Luer fitting
Patency
Freedom from leakage
Resistance to deformation
Breaking force
Connection firmness
Toughness
Flexural properties
Anti-twisting force
Compression Resistance
Compatibility
Air pressure Regulation Function
Negative Pressure Suction Function
Bending Reliability
Corrosion resistance
Friction
Coating Uniformity
Firmness

K251599
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Page 10

Chemical Property

VIII. CONCLUSION

The results of the performance testing described above demonstrate the Single-use Ureteral Access Sheath is as safe and effective as the predicate device and supports a determination of substantial equivalence.

K251599
Page 6 of 6

Regulation Number and Section

§ 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.