WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER

K133615 · Well Lead Medical Co., Ltd. · EZD · Feb 24, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133615
• Device Name: WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
• Applicant: Well Lead Medical Co., Ltd.
• Product Code: EZD · Gastroenterology, Urology
• Decision Date: Feb 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

Device Story

Well Lead PVC Hydrophilic Urethral Catheter is a single-use, flexible, tubular urinary catheter designed for clean intermittent catheterization (CIC) to drain the bladder. Device consists of medical-grade polyvinyl chloride (PVC) shaft coated with hydrophilic polymer (polyvinyl pyrrolidone). Prior to use, catheter is immersed in water for 30 seconds to activate coating, creating a slippery surface to reduce friction against urethral mucosa during insertion. Device is used by patients with chronic urine retention to empty the bladder. Available in various sizes for pediatric, male, and female patients. Device is non-powered and manually operated.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including flow rate analysis, catheter strength, connector security, and coefficient of friction testing per EN 1616:1997/A1:1999. Biocompatibility testing performed per ISO 10993 standards, including in vitro cytotoxicity, delayed contact sensitization, and penile irritation.

Technological Characteristics

Materials: Medical grade PVC coated with polyvinyl pyrrolidone. Design: Single lumen shaft, multi-port adaptor, 1 cuff. Sizes: 6Fr-24Fr. Energy: None (manual). Sterilization: Ethylene oxide (EO) per ISO 11135-1. Packaging: Peel pack compliant with ISO 11607-1/2. Shelf life: 5 years (accelerated aging).

Indications for Use

Indicated for patients with chronic urine retention requiring clean intermittent catheterization (CIC). Suitable for pediatric patients (ages 2 to <12 years, sizes 6Fr-10Fr) and patients 12 years and older (sizes 12Fr-24Fr).

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

• Hi-Slip Single Use Hydrophilic Urinary Catheter (K062444)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) SUMMARY (as required by 807.92)

FEB 2 4 2014

| Regulatory Correspondent: | AJW Technology Consultants, Inc.<br>445 Apollo Beach Blvd.<br>Apollo Beach, FL 33572 USA<br>John O'Brien<br>Email: [e-mail] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | WELL LEAD MEDICAL CO. LTD<br>C-4 JINHU INDUSTRIAL ESTATE, HUALONG,<br>PAN YU<br>GUANGZHOU, 511434, CHINA<br>Han Guang Yuan<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date of Summary: | 10/18/2013 |
| Trade/Proprietary Name: | Well Lead PVC Hydrophilic Urethral Catheter |
| Common/Usual Name: | Catheter, Straight |
| Classification Name: | Class II |
| Product Code: | EZD |

### Intended Use:

The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

{1}------------------------------------------------

#### Device Description:

The Well Lead PVC Hydrophilic Urethral Catheter is a flexible tubular single use urinary catheter that is inserted through the urethra to allow drainage of the bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds it becomes slippery and ready to use.

The catheters come in sizes from 12Fr-24Fr for Male, 12Fr-24Fr for Female and 6Fr-10Fr for Pediatric.

Sizes 6Fr - 10Fr are for Children ages 2 years old to less than 12 years old, Sizes 12Fr -24Fr are for 12 years old and over.

| Predicate Device: | K062444 – Hi-Slip Single Use Hydrophilic Urinary<br>Catheter. |
|-------------------|---------------------------------------------------------------|
|-------------------|---------------------------------------------------------------|

#### Substantial Equivalence:

The Well Lead PVC Hydrophilic Urethral Catheters are substantially equivalent in intended use and technological characteristics to the HI-Slop Single Use Hydrophilic Urethral Catheters. Any difference that exists between the Well Lead PVC Hydrophilic Urethral Catheters and the predicate device do not affect safety or effectiveness, or raise different questions of safety and effectiveness.

| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Comparison<br>Elements | Applicant Device | Predicate Device |
| 510k Number | | K062444 |
| Device Name | Well Lead PVC Hydrophilic Urethral<br>Catheters | Hi-Slip Single Use<br>Hydrophilic Urinary Catheter |
| Technical Data | | |
| Device Composition | Polyvinyl Chloride catheter coated with<br>polyvinyl pyrrolidone | Polyvinyl Chloride catheter<br>coated with polyvinyl<br>pyrrolidone |
| Sizes | Male (12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr,<br>24Fr) | Male 40cm, CH08-24 |
| | Female (12Fr, 14Fr. 16Fr. 18Fr. 20Fr, 22Fr.<br>24Fr) | Female 20cm, CH08-18 |
| | Pediatric (6Fr, 8Fr, 10Fr) | Boys/Pediatric 30cm, CH06-<br>10 |
| | Tiemann (6Fr-24Fr) | Girls/Pediatric 20cm, CH06-<br>10<br>Tiemann 40cm, CH10-18 |
| Design Features | Single lumen shaft, multi-port adaptor, 1<br>cuff | Double lumen shaft, multi-<br>port adaptor, 1 cuff |
| Function of the Device | Intermittent Catheterization | Intermittent Catheterization |
| Features of the device | Hydrophilic Coated, slippery surface. Low<br>friction between catheter and urethral<br>mucosa | Hydrophilic Coated, slippery<br>surface. Low friction between<br>catheter and urethral mucosa |
| Sterility | EO | EO |
| Packaging | Peel Pack | Peel Pack |

{2}------------------------------------------------

### Sterilization and Shelf-Life

Sterilization was completed using the ethylene oxide process. The validation was completed according to ISO 11135-1. The sterility assurance level is SAL 106. Ethylene oxide residual is validated according to EN ISO 10993 part 7 for Limited Exposure Devices of 4mg/day for ETO and 9mg/day for ECH.

The packaging material complies with requirements of ISO 11607-1. sealing validation per ISO 11607-2 and GHTF-SG3-N99-10:2004. Accelerated aging was completed to validate a shelf life of 5 years.

| Packaging Testing | | | |
|-----------------------------------------------------------------|--------------------|----------|--|
| Test Performed | Standard Tested to | Result | |
| Tensile Seal Strength Test | ISO 11607 | Complies | |
| Impermeability and Continuity of<br>Seals formed by fusion test | ISO 11607 | Complies | |
| Vacuum Leak Test | ISO 11607 | Complies | |
| Agar contact-attack test | ISO 11607 | Complies | |

## Performance /Non-Clinical Testing:

| Non-Clinical Testing | | |
|-----------------------------------------|---------------------|----------|
| Test Performed | Standard Tested to | Result |
| Analysis of Flow Rate | EN1616:1997/A1:1999 | Complies |
| Analysis of Strength of the<br>Catheter | EN1616:1997/A1:1999 | Complies |
| Analysis of Connector Security | EN1616:1997/A1:1999 | Complies |
| Analysis of Coefficients of<br>Friction | EN1616:1997/A1:1999 | Complies |

Testing was completed on 3 different size catheters, 8Fr (pediatric size), 14Fr and 24Fr, based on the data generated from the testing on it can be concluded that the Well Lead PVC Hydrophilic Urethral Catheters are substantially equivalent to the Hi-Slip Single Use Hydrophilic Urinary Catheters.

#### Biocompatibility Testing:

Based on ISO 10993-1:2009 Annex A Table A.I - Well Lead PVC Hydrophilic Urethrai Catheters Category is considered a Surface Device that comes in contact with the Mucosal Membrane at for limited exposure. The following tests were performed:

In Vitro Cytotoxicity - ISO 10993-5:2009 and ISO 10993-12:2012 Delayed Contact Sensitization Study - ISO 10993-10:2010 and ISO 10993-12:2012 Penile Irritation Test -- ISO 10993-10:2010 and ISO 10993-12:2012

{3}------------------------------------------------

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

February 24, 2014

Well Lead Medical CO., LTD. % John O'Brien Consultant Level I AJW Technology Consultants, Inc. 445 Apollo Beach Blvd. Apollo Beach, FL 33572

Re: K133615

> Trade/Device Name: Well Lead PVC Hydrophilic Urethral Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: January 27, 2014 Received: January 31, 2014

Dear John O'Brien,

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.

{4}------------------------------------------------

Page 2 - John O'Brien

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

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

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known): K133615

Device Name: Well Lead PVC Hydrophilic Urethral Catheter

Indications for use:

The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization -ClC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | |
|-----------------------|--|
| (21CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S

2014.02.24 14:52:33 -05'00'

Page 1 Of 1

K 133615 - PVC Hydrophilic Urethral Catheter - Supplementary Response 1