Well Lead Ureteral Access Sheath

K151084 · Well Lead Medical Co., Ltd. · FED · Jan 7, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K151084
• Device Name: Well Lead Ureteral Access Sheath
• Applicant: Well Lead Medical Co., Ltd.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Jan 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

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.

Device Story

Well Lead Ureteral Access Sheath is a single-use, sterile device designed to provide ureteral dilation and a continuous working channel for endoscopic urological procedures. It consists of a sheath, dilator, and connector. The sheath features a hydrophilic coating on its outer surface to facilitate insertion and removal. Available in 10Fr, 12Fr, and 14Fr sizes, with lengths ranging from 13cm to 55cm. Used by physicians in clinical settings to assist in the passage of endoscopes and instruments into the urinary tract, the device simplifies access and reduces friction during navigation.

Clinical Evidence

Bench testing only. Performance testing included attachment security, bending resistance, coefficients of friction, and dimensional verification. Biocompatibility testing was performed per ISO 10993-1 (cytotoxicity, irritation, sensitization). Testing on aged product confirmed the hydrophilic coating does not adversely affect the base material.

Technological Characteristics

Single-use, sterile ureteral access sheath. Components: sheath, dilator, connector. Outer surface features a hydrophilic coating. Available in 10Fr, 12Fr, 14Fr sizes; lengths 13cm to 55cm. Biocompatibility per ISO 10993-1.

Indications for Use

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

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Re-Trace Ureteral Access Sheath (K123675)
• Navigator™ HID Ureteral Access Sheath Set (K140323)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 7, 2016

Well Lead Medical Co. Ltd Huang Gen Regulatory Affairs Manager C-4 Jinhu Industrial Estate Hualong, Panyu Guangzhou. 511434 CN

Re: K151084

> Trade/Device Name: Well Lead Ureteral Access Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FED Dated: November 24, 2015 Received: November 27, 2015

Dear Huang Gen,

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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the FDA logo. The logo is in a light gray color. The letters 'FDA' are in a bold, sans-serif font. The logo is simple and modern.

Jeffrey W. Cooper -S 2016.01.07 16:06:17 -05'00'

For

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K151084

Device Name Well Lead Ureteral Access Sheath

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☑</span></div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div><span style="font-size: 20px;">☐</span></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

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## 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | 2015/04/20 |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | WELL LEAD MEDICAL CO., LTD.<br>Address:C-4 # Jinhu Industrial Estate, Hualong, Panyu,<br>Guangzhou, 511434, P.R. China |
| Contact Person: | Huang Kai gen<br>Regulatory Affairs Manager<br>WELL LEAD MEDICAL CO., LTD.<br>Email: [e-mail]<br>Tel: [phone]<br>Fax:[phone] |
| Device Name:<br>Regulation Number:<br>Classification Name:<br>Product Code:<br>Regulatory Class: | Well Lead Ureteral Access Sheath<br>876.1500<br>Endoscope and accessories<br>FED<br>Class II |
| Device Description: | The Well Lead Ureteral Access Sheath is a single use sterile<br>device, provides ureteral dilation and a continuous working<br>channel for the introduction of endoscopes and instruments<br>during ureteral access procedures. The Ureteral Access<br>Sheath is comprised of three components: sheath, dilator<br>and connector. The outer surface of the sheath has a<br>hydrophilic coating. When activated, the hydrophilic feature<br>allows for easier insertion and removal of the sheath. The<br>sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr,<br>and range in length from 13cm (shortest) to 55cm (longest). |
| Intended Use: | The Well Lead Ureteral Access Sheath is used to establish a<br>conduit during endoscopic urological procedures facilitating<br>the passage of endoscopes and other instruments into the<br>urinary tract. |
| Predicate Device(s): | K123675-Re-Trace Ureteral Access Sheath<br>K140323-Navigator™ HID Ureteral Access Sheath Set |

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- Substantial Equivalence: The Well Lead Ureteral Access Sheath described in this 510(k) have similar technological and performance characteristics to the predicate devices. The proposed device is substantially equivalent in performance, indication for use, design and meterialss to predicate devices. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 12 of this submission. These differences have no effect on safety and effectiveness, or raise different questions of safety and effectiveness.
## Test Data:

The following performance testing was conducted:

- · Attachment security
- · Bending resistance
- Coefficients of Friction
- · Determining the Dimensions

Testing on aged product indicates that application of the coating has no adverse effect on the base material of the Ureteral Access Sheath.

The Well Lead Ureteral Access Sheath passed biocompatibility testing per ISO 10993-1 (Cytotoxicity, Irritation, Sensitization)

Testing datas and results are included in this submission.