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 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a medical device called the "Disposable Ureteral Guide Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing. The document does not detail a study proving the device meets acceptance criteria related to AI/algorithm performance or human reader improvement.

Therefore, I cannot provide information on acceptance criteria for AI performance, sample sizes for AI test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI. These sections are not relevant to the provided text.

However, I can extract information regarding the non-clinical performance testing acceptance criteria and results as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For non-clinical performance testing, the document refers to compliance with standards. The 'Discussion' section under 'Comparison of technological characteristics with the predicate devices' (Table 1) provides some insight into the performance aspects considered, although explicit numerical acceptance criteria are not always stated, rather the outcome of testing.

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria (Implicit from discussion)	Reported Device Performance (Implicit from discussion)
Performance - Bending Resistance	Guiding sheath tube and dilating tube bending (90° in both directions, 20 repetitions)	Tube body free of cracks, creases, and fractures; coating free of falling off; steel wire not separated from inner/outer rubber layers.	"The guiding sheath tube and the dilating tube were bent 90 ° in both directions... 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." (Meets criteria)
Performance - Coefficient of Friction (Hydrophilic)	After dipping in water, friction force	Not more than 0.5 N for static friction; average dynamic friction force of 25 repeated tests not greater than 0.5 N.	"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." (Meets criteria)
Performance - Peak Tensile Force	Joint between guiding sheath tube/dilating tube and connector	Able to bear a force of ≥ 20 N for 15s without breaking.	"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 ≥ 20 N and shall not break for 15 s;" (Meets criteria)
Performance - Fracture Force (Locked connector)	Guiding sheath tube connector and expansion tube connector locked	Minimum fracture force ≥ 15N for 15s without breaking.	"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." (Meets criteria)
Biocompatibility	Cytotoxicity, Sensitization, Irritation, Acute Systemic, Pyrogenicity	Compliance with ISO 10993-1.	"Biocompatibility of the Disposable Ureteral Guide Sheath was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1"" and lists the specific tests. Implies successful completion ("this difference will not raise any issues in safety and effectiveness").
Sterility & Shelf-life	Sterility Assurance Level (SAL), Packaging Integrity	SAL of 10-6 upon sterilization; maintenance of sterility for 3 years shelf life.	"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." (Meets criteria)
General Performance	Overall performance for all physical characteristics not explicitly detailed above	Meets requirements of relevant standards (e.g., EN 1618 for catheters).	"All performance of the subject device has been tested according to relevant standards and meets the requirements of the standards..."

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

This document describes non-clinical engineering and bench testing, not a clinical study involving a "test set" of patient data in the way an AI/ML device would.

Sample Size: Not explicitly stated as a grand total for testing. For specific tests like "Coefficient of Friction," it mentions "25 repeated tests." For "Bending Resistance," it mentions "20 times of repetition."
Data Provenance: This is bench test data, not patient data. The country of origin for the manufacturing company is Dongguan ZSR Biomedical technology Company Limited, China. The testing would have been conducted as part of their device development and validation process. It is neither retrospective nor prospective in the context of patient data studies; it's product validation testing.

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

Not applicable. This is not a study involving expert readers establishing ground truth for diagnostic accuracy, but rather bench testing against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not pertain to an AI-assisted diagnostic device, nor does it describe an MRMC study.

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

No. This document does not pertain to an algorithm, AI, or software device. It is for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described would be the engineering specifications and industry standards (e.g., specific force values for tensile strength, visual inspection for defects after bending, a defined Sterility Assurance Level). For biocompatibility, the 'ground truth' is compliance with the ISO 10993 series of standards.

8. The Sample Size for the Training Set

Not applicable. This is for a physical device, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device.

Summary

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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"

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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

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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

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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)

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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).

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IV. Device description

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

Characteristics	Proposed device	Predicate device(K230748)	Discussion
Manufacturer	Dongguan ZSR Biomedicaltechnology Company Limited	YouCare Technology Co.,Ltd.(Wuhan)	/
Regulation#	876.1500	876.1500	Same
Productcode	FED	FED	Same
Classificationname	Endoscope and accessories	Endoscope and accessories	Same
Intendeduse	The Disposable Ureteral GuideSheath is used to establish aconduit during endoscopicurological procedures	The Disposable UreteralAccess Sheath is used toestablish a conduit duringendoscopic urological	Same
	facilitating the passage ofendoscopes and otherinstruments into the urinarytract	procedures facilitating thepassage of endoscopes andother instruments into theurinary tract
RegulatoryClass	Class II	Class II	Same
Sterility	Yes	Yes	Same
SterilizationMethod	EO	EO	Same
Single Use	Yes	Yes	Same
Sheath ID	10Fr, 11Fr, 12Fr, 13Fr, 14Fr,15Fr, 16Fr	12Fr	Different 1
Sheathlength	10Fr, 11Fr, 12Fr, 13Fr,14Fr:35cm, 40cm, 45cm,50cm, 55cm15Fr, 16Fr:40cm, 45cm	45cm, 35cm	Different 2
Primarystructure	The device is composed ofguide sheath and dilator. Theguide sheath consists of guidesheath tube and connector(straight, Y-shaped, W-shapedand cross-shaped).	The product is composed ofsheath tube, sheath tubebase, dilator and center baseof dilator. The sheath tubebase contains a backwaterinterface. The center base ofdilator consists of uppercover of dilator base, lowercover of dilator base , fiberimage channel interface F,irrigation channel interface I,equipment channel interfaceE, obturator, two-way watervalve, needle free joint.	Different 3
Materials	Sheath tube:Pebax,SUS304,PTFEConnector: polyamide (PA) ,silica gelDilator connector:polypropylene (PP)Dilator tube: polyethylene(PE)	sheath tube: Pebax6333SA01MED, SUS 304、PTFE、PAMsheath tube base: ABS, PC(backwater interface: PC)dilator: LDPEcenter base of dilatorupper cover of the dilator	Different 4
	Hydrophilic coating:Polyvinylpyrrolidone (PVP)	base: ABSlower cover of the dilatorbase: ABSfiber image channelinterface F: PCirrigation channel interfaceI: PCequipment channelinterface E: PCobturator: PC, silica geltwo-way water valve: PC,POMneedle-free joint: PC, silicagel
Package	Single-use EO sterilized pouchwith one device per pouch	Single-use EO sterilizedpouch with one device perpouch	Same
Biocompatible	Yes	Yes	Same
Shelf Life	3 years	3 years	Same
BendingResistance	The guiding sheath tube andthe dilating tube were bent90 ° in both directions bygrasping the head and the tail.After 20 times of repetition, thetube body was free of cracks,creases, cracks and fractures,the coating was free of fallingoff, and the steel wire was notseparated from the inner andouter rubber layers.	Bending any section of thedilator, sheath tube or theassembly of sheath tube anddilator into a ring with aradius of 5cm for 1min, thereshould be no crease, crack orother undesirablephenomena.	Similar 1
Coefficients ofFriction	After being dipped in water,the surface is smooth, and thefriction force is not more than0.5 N;The average dynamic frictionforce of 25 repeated tests shallnot be greater than 0.5 N	When the sheath tube istested for friction, the frictioncoefficient shall not exceed0.03.	Similar 2
Peaktensileforce	The joint between the guidingsheath tube and the tube bodyof the dilating tube and theconnector shall be able to beara force of $[0.3em] ">=$ 20 N and shall notbreak for 15 s;	The peak tensile force of thesheath tube and dilatorshould not be less than 15N.And the peak tensile force ofthe junction between sheathtube and sheath tube base,the dilator and center base ofdilator 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

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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

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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.

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.