(260 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a mechanical device (a sheath and dilator) and do not mention any computational or analytical capabilities that would involve AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device facilitates surgical procedures by providing access and a working channel, but it does not directly treat a disease or condition.
No
The device is described as facilitating the passage of endoscopes and instruments, and providing a working channel during procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical, single-use sterile device comprised of a sheath, dilator, and connector, with a hydrophilic coating. It is used to establish a conduit during endoscopic procedures, which is a physical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a medical procedure (endoscopic urological procedures) to facilitate the passage of instruments into the body. This is an in vivo application, meaning it interacts with the living body.
- Device Description: The description details a physical device (sheath, dilator, connector) with a hydrophilic coating for insertion into the urinary tract. This is consistent with a surgical or procedural device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in samples.
- Providing diagnostic information based on sample analysis.
- Reagents or assays.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and procedural.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FED
Device Description
The Well Lead Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of three components: sheath, dilator and connector. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in length from 13cm (shortest) to 55cm (longest).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| ☑Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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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. |
| Address:C-4 # Jinhu Industrial Estate, Hualong, Panyu, | |
| Guangzhou, 511434, P.R. China | |
| Contact Person: | Huang Kai gen |
| Regulatory Affairs Manager | |
| WELL LEAD MEDICAL CO., LTD. | |
| Email: huangkg@welllead.com.cn | |
| Tel: +86-20-84758878 | |
| Fax:+86-20-84758224 | |
| Device Name: | |
| Regulation Number: | |
| Classification Name: | |
| Product Code: | |
| Regulatory Class: | Well Lead Ureteral Access Sheath |
| 876.1500 | |
| Endoscope and accessories | |
| FED | |
| Class II | |
| Device Description: | The Well Lead Ureteral Access Sheath is a single use sterile |
| device, provides ureteral dilation and a continuous working | |
| channel for the introduction of endoscopes and instruments | |
| during ureteral access procedures. The Ureteral Access | |
| Sheath is comprised of three components: sheath, dilator | |
| and connector. The outer surface of the sheath has a | |
| hydrophilic coating. When activated, the hydrophilic feature | |
| allows for easier insertion and removal of the sheath. The | |
| sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, | |
| and range in length from 13cm (shortest) to 55cm (longest). | |
| Intended 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. | |
| Predicate Device(s): | K123675-Re-Trace Ureteral Access Sheath |
| K140323-Navigator™ HID Ureteral Access Sheath Set |
4
- 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.