K Number

Device Name

Disposable Ureteral Access Sheath

Manufacturer

YouCare Technology Co., Ltd. (Wuhan)

Date Cleared

2023-08-02

(138 days)

Product Code

FED

Regulation Number

876.1500

Intended Use

The Disposable 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 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. There is no guide wire. The product is sterilized by EO, it should be sterile and only for single use.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K151084

Reference Devices

No reference devices were used in this submission

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and mechanical properties of a disposable ureteral access sheath, with no mention of AI or ML capabilities.

Therapeutic

This device is designed to facilitate endoscopic procedures by providing a conduit for instruments, not to directly treat a disease or condition.

Diagnostic

Explanation: The device, a Disposable Ureteral Access Sheath, is used to facilitate the passage of endoscopes and instruments, not to diagnose medical conditions. Its function is to establish a conduit during urological procedures.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components (sheath tube, dilator, bases, interfaces, valves, etc.) and mentions physical performance testing, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract." This describes a surgical or procedural device used in vivo (within the body) to aid in a medical procedure.
Device Description: The description details a physical device (sheath tube, dilator, bases, interfaces, valves) designed for insertion into the urinary tract. It does not mention any components or functions related to testing samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostics.
Performance Studies: The performance studies focus on physical and mechanical properties, biocompatibility, sterilization, and shelf life – all relevant to a medical device used in a procedure, but not to the analytical performance of an IVD.

In summary, the Disposable Ureteral Access Sheath is a medical device used to facilitate a surgical procedure within the body, not a device used to perform tests on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Disposable 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.

Product codes

FED

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

urinary tract

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-clinical Tests Performed: A series of preclinical tests were performed to assess the safety and performance of the Disposable Ureteral Access Sheath including biocompatibility physical and mechanical performance.

Biocompatibility tests conducted:

Cytotoxicity Test: ISO10993-5
Sensitization: ISO 10993-10
Intracutaneous reactivity: 1SO10993-10
Material mediated pyrogenicity: ISO10993-11
Acute systemic toxicity: ISO10993-11

Ethylene Oxide Sterilization Validation:

ISO 11135:2014
ISO 11737-1:2018
ISO11737-2:2019
ISO 10993-7: 2008

Shelf life and Package Validation:

ASTM F1980-2016
ASTM D3078-02-2021
ASTMF 1929-15
ASTM F88/F88M-15

Performance testing conducted:

Bending resistance
Coefficients of Friction
Determining the Dimensions
Flow test
Patency
Connection
Peak tensile force
Luer taper

No clinical study is included in this submission.

Key Metrics

Not Found

Predicate Device(s)

K151084

Reference Device(s)

No reference devices were used in this submission

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

August 2, 2023

YouCare Technology Co., Ltd. (Wuhan) Bing Hu Manager Tangxunhu North Street Wuhan, Hubei 430000 China

Re: K230748

Trade/Device Name: Disposable Ureteral Access Sheath Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated: July 5, 2023 Received: July 5, 2023

Dear Bing Hu:

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 (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 located 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.

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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 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

Indications for Use

510(k) Number (if known) K230748

Device Name Disposable Ureteral Access Sheath

Indications for Use (Describe)

The Disposable 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

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."

Section 5 - 510(k) Summary

Date of Summary Preparation: 07/16/2023

1. Submitter's Identifications

Submitter's Name: YouCare Technology Co., Ltd.(Wuhan). Address: Great Wall Science and Technology Park, Tangxunhu North Street, East Lake Development Zone Wuhan, 430223 Hubei P.R. China. Contact Person: Bing Hu Contact Email: hb@youcaretech.com Telephone: +86-27-87926396-830

2. Correspondent's Identifications

Correspondent's Name: YouCare Technology Co., Ltd.(Wuhan). Address: Great Wall Science and Technology Park, Tangxunhu North Street, East Lake Development Zone Wuhan, 430223 Hubei P.R. China. Contact Person: Bing Hu Contact Email: hb@youcaretech.com Telephone: +86-27-87926396-830

3. Name of the Device

Product Name: Disposable Ureteral Access Sheath Trade Name: Disposable Ureteral Access Sheath Model: YC-Videoaid-sheath-A YC-Videoaid-sheath-B Classification Name: Endoscope and accessories Regulation Number: 21 CFR§ 876.1500 Product Code: FED Device Classification: Class II

4. The Predicate Devices

K151084

Well Lead Ureteral Access Sheath

This predicate has not been subject to a design-related recall. No reference devices were used in this submission

5. Device Description

1 / 6

single use.

6. Indications for use

The Disposable 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.

7. Operating instructions

Substantial Equivalence
Check the package, it is forbidden to use when sterile barrier is damaged.
Open the package, and make sure that the product structure is complete without missing of product structure, and it is firmly connected between two-way water valve and irrigation channel, obturator and fiber image channel, needle free joint and equipment channel
Insert the guide wire (diameter no more than 0.035 inch or 0.89mm) into ureter to the predetermined length, and then build the channel.
The endoscope is inserted through the obturator into the fiber image channel until the objective lens of endoscope reaches the end of the dilator. Connect the negative pressure aspirator to irrigation channel.
After flushing and lubricating the sheath tube with normal saline, take away the needle free joint, insert the guide wire into the channel (marked with a notch) on the top of dilator which until it extends out of the equipment channel interface E, then reinstall the needle free joint after threading guide wire out of the needle free joint ..
Push the dilator/sheath along guide wire, open the two-way water valve and water irrigation system to ensure the view of the endoscope is clear. Confirm the position of dilator/sheath through the endoscope.
Fix the sheath in place, at the same time, loosen the joint and remove the dilator.
Import the required endoscope or other surgical instruments.

	New device	Predicate device	Comparison
"K"NUMBERS	/	K151084	/
Manufacturer	YouCare Technology Co.,
Ltd.(Wuhan).	Well Lead Medical Co. Ltd	/
Regulation #	876.1500	876.1500	Same
Product Code	FED	FED	Same
Classification
name	Endoscope and accessories	Endoscope and accessories	Same
Intended use	It is intended to establish a
channel during urologic surgical
procedures, facilitating the
passage of endoscopes and other
instruments into the urinary
tract.	The Well Lead 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.	Same
Regulatory Class	Class II	Class II	Same
Sterility	Yes	Yes	Same
Sterilization
Method	EO	EO	Same
Single Use	Yes	Yes	Same
Sheath ID	12Fr	10Fr, 12Fr, 14Fr	Different 1
Sheath length	45cm, 35cm	13cm, 20cm, 28cm, 35cm, 45cm,
55cm	Different 2
Primary
structure	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.	The Well Lead Ureteral Access
Sheath is comprised of three
components: sheath, dilator and
connector. The outer surface of
the sheath has a hydrophilic
coating.	Different 3
Materials	sheath tube: Pebax6333 SA01
MED, SUS 304, PTFE, PAM
sheath tube base: ABS, PC
(backwater interface: PC)
dilator: LDPE	Sheath Tube: PTFE, Nylon (PA),
stainless steel
Outer surface: Nylon (PA)
Inner surface: PTFE
Dilator: Polyethylene (PE)	Different 4
	center base of dilator
	upper cover of the dilator base:
ABS
	lower cover of the dilator base:
ABS
	fiber image channel interface F:
PC
	irrigation channel interface I: PC
equipment channel interface E:
PC
	obturator: PC, silica gel
	two-way water valve: PC, POM
	needle-free joint: PC, silica gel
Package	Single-use EO sterilized pouch with
one device per pouch	Single-use EO sterilized pouch with
one device per pouch	Same
Biocompatible	Yes	Yes	Same
Shelf Life	3 years	3 years	Same
Bending
Resistance	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.	Bending any section of the
dilator, sheath tube or the
assembly of sheath tube and
dilator into a ring with a radius
of 5cm for 1min, there should
be no crease, crack or other
undesirable phenomena.	Same
Coefficients of
Friction	When the sheath tube is tested
for friction, the friction
coefficient shall not exceed 0.03.	When the sheath tube is tested
for friction, the friction
coefficient shall not exceed
0.03.	Same
Peak tensile
force	The peak tensile force of the
sheath tube and dilator should
not be less than 15N. And the
peak tensile force of the junction
between sheath tube and sheath
tube base, the dilator and center
base of dilator also shall meet
the requirement	The Dilator to Hub Tensile
Strength>15N.	Same

Comparison of technology characteristics

YouCare Technology Co., Ltd.(Wuhan).

9. Substantial equivalence discussion:

Different 1 -sheath ID

This difference is in sheath ID. Different sheath inner diameter device will be selected by physician per patient's condition. Moreover, a small diameter difference has little effect on the product safety performance

Different 2 -Sheath length

This difference is in sheath length. Different sheath length device will be selected by physician per patient's condition, the length difference did not affect the safety and efficacy of the product.

Different 3 - Primary structure

The sheath base of the new device is similar to the connector of the predict product. The New device has three instrument channels --- image channel, irrigation channel and equipment channel, it does not raise different questions of safety and effectiveness for patient, it only increases the operation requirements for doctors.

Different 4 - Materials

The materials of sheath tube and dilator are different. The new device is 304 Stainless Steel and Pebax6333 and Low-Density Polyethylene(LDPE), the materials of predicate device is Stainless Steel、Nylon(PA)and Polyethylene. Pebax6333 is a block polymer composed of nylon and polyether parts, which has the properties of nylon. Although the materials are different, the performance of the product is not affected, and both passed the biological test.

Substantial Equivalence discussion:

The proposed devices and the predicated device have classification information, similar materials, same specifications, same performance effectiveness. The Model of Proposed Device is included in the Model of Predicate device. The Indications for use of proposed device is same as the predicated device. the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.

10. Non-Clinical Tests Performed:

Non-clinical Testing: A series of preclinical tests were performed to assess the safety and performance of the Disposable Ureteral Access Sheath including biocompatibility physical and mechanical performance.

The following biocompatibility and safety tests were conducted in compliance with ISO standards:

Biocompatibility

. Cytotoxicity Test: ISO10993-5
. Sensitization: ISO 10993-10
. Intracutaneous reactivity:1SO10993-10

Material mediated pyrogenicity: ISO10993-11
Acute systemic toxicity: ISO10993-11 ●

Ethylene Oxide Sterilization Validation:

ISO 11135:2014
ISO 11737-1:2018
ISO11737-2:2019
ISO 10993-7: 2008

Shelf life and Package Validation:

ASTM F1980-2016 .
ASTM D3078-02-2021
ASTMF 1929-15
. ASTM F88/F88M-15

11. Performance testing

The following performance testing was conducted:

. Bending resistance
Coefficients of Friction
Determining the Dimensions
Flow test
Patency
. Connection
Peak tensile force
. Luer taper

12. Clinical Test Conclusion

No clinical study is included in this submission.

13. Conclusion:

Comparison to the predicate devices for Intended Use, structure and physical, it shows that our products are as safe, as effective and performs as well as the predicate devices.

--- End of this section ---