WELL LEAD SILICONE AND LATEX FOLEY CATHETERS

K082815 · Well Lead Medical Instruments · EZL · Oct 8, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082815
• Device Name: WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
• Applicant: Well Lead Medical Instruments
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Oct 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Two-Way Catheter - Urethral catheterization for bladder drainage for Urological use only Three Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only

Device Story

Well Lead Foley catheters are two-way or three-way retention catheters inserted into the bladder via the urethra. The device facilitates urine drainage into an external collection bag; three-way variants additionally allow for bladder irrigation. Used in clinical settings by healthcare professionals. The device functions as a passive conduit for fluid management. Benefits include effective bladder drainage and irrigation for urological patients.

Clinical Evidence

Bench testing only. The device conforms to ASTM F 623-99 standards for dimensions, design, sterility, and packaging.

Technological Characteristics

Materials: Silicone and Latex. Design conforms to ASTM F 623-99. Retention-type balloon catheter. Passive drainage/irrigation mechanism. Non-powered.

Indications for Use

Indicated for urethral catheterization for bladder drainage (two-way) or bladder drainage and irrigation (three-way) in patients requiring urological intervention.

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

• Rochester Medical all Silicone Foley Catheter (K981612)
• Bard I.C (K040658)

Submission Summary (Full Text)

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# 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | Well Lead Medical Instruments<br>A4-1# Jinhu Industrial Estate<br>Hualong, Pan Yu<br>Guangdong, China 511434 |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Han Guang Yuan |
| Date of Summary: | 5/09/07 |
| Trade/Proprietary Name: | Well Lead All Silicone Foley Catheters<br>Well Lead Latex Foley Catheters |
| Classification Name: | Silicone - Catheter, Retention Type, Balloon<br>Latex - Urological catheter and accessories |
| Product Code: | Silicone - EZL<br>Latex - MJC |

Intended Use:

Two-Way Catheter - Urethral catheterization for bladder drainage for Urological use only

Three Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only

#### Device Description:

The Well Lead Latex and Silicone Foley catheters are two-way Foley catheters which are placed in the bladder throught the urethra. The urine drains out through the catheter into a collection device attached to the catheter.

## Device Performance:

The dimensions, design, sterility and packaging of the Well Lead Foley Catheters (silicone and latex) conform to ASTM F 623-99.

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#### Predicate Device:

Silicone - K981612 - Rochester Medical all Silicone Foley Catheter Latex - K040658 - Bard I.C

#### Substantial Equivalence:

Well Lead Medical Instruments claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K981612 and K040658. Well Lead Medical Products claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principles, and physical, operational specifications as compared to the 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 9 of this submission. Additionally, this matrix is included as an attachment to the 510(k) Summary. These differences have no effect on safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 8 2008

Well Lead Medical Instruments Co. % Mr. Jay Y. Kogoma Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087

Re: K082815

Trade/Device Name: Well Lead Silicone and Latex Foley Catheters Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: September 24, 2008 Received: September 25, 2008

Dear Mr. Kogoma:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

loque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): Ko82815

Device Name: Well Lead Silicone and Latex Foley Catheters

Indications for Use:

Two - Way Catheters - Urethral catheterization for bladder drainage for urological use only.

Three - Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Heidi Heitner

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number

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