The 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. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

Device Description

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 provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. Ureteral Access Sheath comes in two models: Tip-unbendable Ureteral Access Sheath and Tip-bendable Ureteral Access Sheath with suction. The Tip-unbendable Ureteral Access Sheath is offered in French size ranging from 10Fr to 14Fr and length 28cm to 45cm. The Tip-bendable Ureteral Access Sheath with Suction is offered in French size ranging from 10Fr to 13Fr and length 33cm to 50cm.

AI/ML Overview

The Seplou (Zhuhai) Co., Ltd. Ureteral Access Sheath (K243025) is a medical device used to create a conduit in the urinary tract for endoscopic urological procedures. The device's acceptance criteria and proven performance are outlined through various tests detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria/Standard	Reported Device Performance/Compliance
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-21:2021, ISO 10993-11:2017, and USP 151. (Ensures the device is not harmful when in contact with and within the body).	Tested and Compliant:
	Cytotoxicity	Meets ISO 10993-5:2009 standards.
	Intracutaneous Irritation	Meets ISO 10993-10:2021 standards.
	Sensitization	Meets ISO 10993-21:2021 standards.
	Acute Systemic Toxicity	Meets ISO 10993-11:2017 standards.
	Material Mediated Pyrogenicity	Meets ISO 10993-11:2017 and USP 151 standards.
Performance Testing	Satisfactory performance in key functional aspects. (Ensures the device functions as intended during use).	Tested and Compliant:
	Dimension	Performance data indicates compliance with specified dimensional requirements for sheaths ranging from 10Fr to 14Fr and lengths from 28cm to 50cm. (Specific values or ranges are not provided in the summary but are implied as meeting expectations).
	Compatibility	Performance data indicates compatibility for endoscopic urological procedures, facilitating the passage of endoscopes and other instruments. (Specific compatibility parameters are not detailed but are implied as satisfactory).
	Fracture Force	Performance data indicates the device can withstand expected forces without fracture. (Specific force thresholds are not provided but are implied as meeting safety and functional requirements).
	Bending Resistance	Performance data indicates appropriate bending resistance for intended use in the urinary tract, including both tip-unbendable and tip-bendable models. (Specific resistance values are not provided but are implied as meeting functional requirements).
	Liquid Leakage	Performance data indicates the device is free from liquid leakage, which is crucial for maintaining a sterile and functional conduit. (Specific leakage thresholds are not provided but are implied as meeting functional requirements).
	Surface Friction Coefficient	Performance data indicates an acceptable surface friction coefficient, important for smooth insertion and removal and minimizing tissue trauma. (Specific coefficient ranges are not provided but are implied as meeting functional requirements).
Sterilization Validation	Compliance with ISO 11135:2014, ISO 11737-1:2018, ISO 11737-2:2019, ISO 10993-7:2008. (Ensures the device is sterile and free from harmful residual sterilant).	Tested and Compliant: Validated for Ethylene Oxide (EO) sterilization, ensuring the device is sterile for use and that EO residuals are within safe limits.
Shelf Life and Package Validation	Compliance with ISO 11607-1:2019, DIN 58953-6, ASTM F2096-11, ASTM F88/F88M-15, ASTM F1886/F1886M-16, ASTM F1929-15, ASTM D4169-22. (Ensures the sterility and integrity of the device over its shelf life and during transport).	Tested and Compliant: Validated to maintain sterility and device integrity throughout its claimed shelf life, with packaging designed to protect the device and indicate damage. (Specific shelf life duration not mentioned, but validation confirms it meets criteria).

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not explicitly state the sample sizes used for each specific performance test (biocompatibility, general performance, sterilization, shelf life). It notes that various tests were conducted.

The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. However, given that it is a 510(k) submission for a device manufactured by a Chinese company (SEPLOU (ZHUHAI) CO., LTD.), it is highly probable that the testing was performed in laboratories affiliated with or contracted by the manufacturer, potentially in China or other authorized testing facilities globally.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device submission. The device is a Ureteral Access Sheath, which is a physical instrument. The "ground truth" for its performance relies on objective measurements against engineering specifications and international standards, not on expert interpretations of data like in an AI/imaging study.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or studies involving subjective human interpretation (e.g., imaging reviews), which is not the case for the premarket testing of this physical medical device. The tests performed are objective, laboratory-based evaluations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable. The device is a physical Ureteral Access Sheath, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical Ureteral Access Sheath, not an algorithm or software.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the Ureteral Access Sheath is established through:

Compliance with International Standards: ISO (International Organization for Standardization) standards for biocompatibility and sterilization, and ASTM/DIN standards for packaging and shelf-life.
Engineering Specifications: The manufacturer's own design specifications for dimensions, material properties, mechanical strength (fracture force, bending resistance), and functional aspects (liquid leakage, surface friction).
Predicate Device Equivalence: The ultimate purpose of the 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device (ClearPetra Suction-Evacuation Sheath K161110) in terms of safety and effectiveness, meaning the subject device performs similarly or better than a device already proven safe and effective.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" for a physical medical device like a Ureteral Access Sheath. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this device.

Summary

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January 30, 2025

Seplou (zhuhai) Co., Ltd. Vince Zeng Regulatory Affairs Manager 5th Floor, Building 1, No. 8, Keji 10th Road Tangjiawan Town Zhuhai, Guangddong 519086 CHINA

Re: K243025

Trade/Device Name: Ureteral Access Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Received: January 3, 2025

Dear Vince Zeng:

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"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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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. 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

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Indications for Use

Submission Number (if known)

K243025

Device Name

Ureteral Access Sheath (SPAS1028, SPAS1035, SPAS1045, SPAS1135, SPAS1145, SPAS1235, SPAS1245, SPAS1335, SPAS1345, SPAS1435, SPAS1445); Ureteral Access Sheath with Suction Collection (SPAS1033S, SPAS1040S, SPAS1050S, SPAS1140S, SPAS1150S, SPAS1240S, SPAS1250S, SPAS1340S, SPAS1350S)

Indications for Use (Describe)

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)

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510k Summary

510(k) Premarket Notification

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510k Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: 2025/01/03

1. Submitter (Owner) of 510k

Name: SEPLOU (ZHUHAI) CO., LTD.

Address: 5th Floor, Building 1, No. 8, Keji 10th Road, Tangjiawan Town, High-tech Zone, 519085 Zhuhai, Guangdong, People's Republic of China

2. Contact person

Vince Zeng Regulatory Affairs Manager Tel: +86 13650966940 Email: Vince@seplou.com

3. Subject device information

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

4. Predicate device

No	Device name	K number	Manufacturer
1	ClearPetra Suction-Evacuation Sheath	K161110	WELL LEAD MEDICAL CO.,LTD.

5. Device Description

Ureteral Access Sheath comes in two models: Tip-unbendable Ureteral Access Sheath and Tip-bendable Ureteral Access Sheath with suction.

The Tip-unbendable Ureteral Access Sheath is offered in French size ranging from 10Fr to 14Fr and length 28cm to 45cm.

The Tip-bendable Ureteral Access Sheath with Suction is offered in French size ranging from 10Fr

510(k) Premarket Notification

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to 13Fr and length 33cm to 50cm.

6. Intended use & Indication for use

7. Comparison to the predicate device

The following tabulation indicates the detailed differences between the subject devices and the predicate devices.

Features	Subject Device	Pridicate Device	Remark
Product Name	Ureteral Access Sheath	ClearPetra Suction-Evacuation Sheath	/
Model Name	Ureteral Access Sheath	ClearPetra Ureteral Access Sheath	/
510k Number	Applying	K161110	/
Applicant	SEPLOU (ZHUHAI) CO., LTD.	WELL LEAD MEDICAL CO., LTD.	/
Product Code	FED	FED	Same
Regulation Number	21 CFR 876.1500	21 CFR 876.1500	Same
Regulatory Class	Class II	Class II	Same
Review Pannel	Gastroenterology/Urology	Gastroenterology/Urology	Same
Indications for Use	The 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. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.	It is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.	Same
Patient Population	Patients undergoing endoscopic procedures, through percutaneous passages	Patients undergoing endoscopic procedures, through percutaneous passages	Same
Material	SheathTube:PTFE+PEBAX+304Stainless steelOuter surface:PEBAXInner surface:PTFEDilator: LDPE	Sheath Tube:PTFE+PA+Stainless steelOuter surface: PAInner surface: PTFEDilator: PE	Different 1
Coating	The outer surface of the sheathhas a hydrophilic coating.	The outer surface of the sheathhas a hydrophilic coating.	Same
SterilizationMethod	EO	EO	Same
Sheath ID	10Fr to 14Fr	10Fr to 14Fr	Same
Sheath Length	28cm to 50cm	13cm to 55cm	Different 2
Structure	1) The Tip-Unbendable UreteralAccess Sheath is comprised ofDilator, Sheath, DilatorConnector and Sheath ConnectorImage: drawing of a medical device2) The Tip-Bendable UreteralAccess Sheath with suction iscomprised of Dilator, Sheath,Dilator Connector and WConnector, Straightway valve,Silicone Cap, Protective CapImage: drawing of a medical device	The Ureteral AccessSheath is comprised of Sheath,Obturator, Luer Connector, YConnector, Rubber CapImage: drawing of a medical device	Different 3
Single Use	Yes	Yes	Same
Biocompatibility	Cytotoxicity, Irritation,Sensitization, Acute SystemToxicity, Material mediatedpyrogencity	Cytotoxicity, Irritation,Sensitization, Acute SystemToxicity, Material mediatedpyrogencity	Same

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K243025 Page 4 of 6

SEPLOU (ZHUHAI) CO., LTD.

The subject device and predicate device have the same classification information, similar materials, same specifications, and same performance outcomes. Any differences in characteristics (material, sheath length, structure) have been supported through testing (i.e., biocompatibility testing, performance testing, and shelf-life testing). These differences do not raise different questions of safety and effectiveness.

8. Performance Data

The following performance data were provided in support of the substantial equivalence 510(k) Premarket Notification Page 4 of 6 Ureteral Access Sheath

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K243025 Page 5 of 6 SEPLOU (ZHUHAI) CO., LTD.

determination.

Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

Cytotoxicity as per ISO 10993-5:2009
Intracutaneous Irritation as per ISO 10993-10:2021
Sensitization as per ISO 10993-21:2021
Acute Systemic Toxicity as per ISO 10993-11:2017
Material Mediated Pyrogenicity per ISO 10993-11:2017 and <USP 151>

Performance testing

General performance testing including:

Dimension
Compatibility
Fracture Force
Bending Resistance
Liquid Leakage
Surface friction coefficient

Ethylene Oxide Sterilization Validation

ISO 11135:2014
ISO 11737-1:2018
ISO 11737-2:2019
ISO 10993-7: 2008

Shelf life and Package Validation

ISO 11607-1:2019
DIN 58953-6
ASTM F2096-11
ASTM F88/F88M-15
ASTM F1886/F1886M-16 ●

510(k) Premarket Notification

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K243025 Page 6 of 6 SEPLOU (ZHUHAI) CO., LTD.

ASTM F1929-15
ASTM D4169-22

Clinical study

No clinical study is included in this submission.

9. Conclusion

According to the 510(k) submission, the subject device and the predicate device have the same intended use, and the difference in technological features of the proposed devices and the predicate devices do not raise different questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed device models are substantially equivalent to the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.

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.