Well Lead PVC Urethral Catheter

K142563 · Well Lead Medical Co., Ltd. · EZD · Oct 28, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K142563
• Device Name: Well Lead PVC Urethral Catheter
• Applicant: Well Lead Medical Co., Ltd.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Oct 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Well Lead PVC Urethral Catheter is launched for clean intermittent catheterization(CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract.

Device Story

Well Lead PVC Urethral Catheter is a sterile, single-patient-use urinary drainage device. Constructed from PVC; available in French sizes 6-24. Inserted through urethra by clinician or patient for clean intermittent catheterization (CIC) to drain fluid from urinary tract. Device functions as passive conduit for fluid drainage. Benefits include relief of urinary retention or bladder management. No active components, software, or algorithms.

Clinical Evidence

Bench testing only. Performance testing included dimensions, flow rate, catheter strength, and connector security per ASTM F623-99 and EN1616:1997. Biocompatibility testing conducted per ISO 10993-1 (cytotoxicity, irritation, sensitization).

Technological Characteristics

Material: PVC. Sizes: 6Fr-24Fr. Principle: Passive fluid drainage. Standards: ASTM F623-99 (test methods), EN1616:1997, ISO 10993-1 (biocompatibility). Sterile, single-use.

Indications for Use

Indicated for clean intermittent catheterization (CIC) for fluid drainage from the urinary tract in male, female, and pediatric patients (ages 2-12 years).

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Medline PVC Urethral Catheter (K100302)
• Well Lead PVC Hydrophilic Urethral Catheter (K133615)

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

October 28, 2014

Well Lead Medical Co., Ltd. Han Guang Yuan General Manager C-4# Jinhu Industrial Estate Hualong, Panyu Guangzhou, 511434 P.R. China

Re: K142563

> Trade/Device Name: Well Lead PVC Urethral Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD Dated: September 10, 2014 Received: September 11, 2014

Dear Han Guang Yuan,

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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

Enclosure

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510(k) Number (if known): K142563

Device Name: Well Lead PVC Urethral Catheter

Indications for Use:

The Well Lead PVC Urethral Catheter is launched for clean intermittent catheterization(CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract.

Prescription Use × (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary

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

| Date: | 2014/09/10 |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | WELL LEAD MEDICAL CO., LTD.<br>Address:C-4 # Jinhu Industrial Estate, Hualong,<br>Panyu,<br>Guangzhou, 511434, P.R. China |
| Contact Person: | Han Guang Yuan<br>General 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 PVC Urethral Catheter<br>876.5130<br>Urological catheter and accessories<br>EZD<br>Class II |
| Device Description: | The Well Lead PVC Urethral Catheter is sterile, single<br>patient use, urinary drainage catheter that is made from<br>PVC. The Catheter is inserted through the urethra and used<br>to pass fluids from the urinary tract.<br>The Catheter is supplied in French size ranging from 6 to 24.<br>The Catheters come in sizes from 12Fr-24Fr for Male,<br>12Fr-24Fr for Female and 6Fr-10Fr for Pediatric 2-12 years<br>old. |
| Intended Use: | The Well Lead PVC Urethral Catheter is launched for clean<br>intermittent catheterization(CIC) treatment. It is intended for<br>use in the drainage of fluid from the urinary tract. |
| Predicate Device(s): | K100302- Medline PVC Urethral Catheter<br>K133615- Well Lead PVC Hydrophilic Urethral Catheter |
| Substantial Equivalence: | The Well Lead PVC Urethral Catheters described in this<br>510(k) have similar technological and performance<br>characteristics to the predicate devices. The proposed device<br>is manufactured from PVC. The predicate devices are<br>manufactured from similar materials such as PVC. The<br>similarities and differences between the proposed and<br>predicate devices have been identified and explained in the |

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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 Well Lead PVC Urethral Catheters meet the following performance requirements per testing conducted according to ASTM F623-99 & EN1616:1997, when appropriate, and/or Well Lead testing/ acceptance criteria:

> NOTE: ASTM F623-99 is applicable only to 2-way foley catheter, however, the test methods described therein will be utilized to test 1-way urethral catheter.

- · Dimensions
- Flow Rate
- Strength of the Catheter
- · Connector Security

Lead The Well PVC Urethral Catheter passed biocompatibility testing per ISO 10993-1 (Cytotoxicity, Irritation, Sensitization)

Testing datas and results are included in this submission.