WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR

K091516 · Well Lead Medical Co., Ltd. · EZL · Oct 16, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K091516
• Device Name: WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
• Applicant: Well Lead Medical Co., Ltd.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Oct 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The Well Lead all Silicone Foley Catheters with Temperature Sensor are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.

Device Story

Two-way Foley catheter; silicone construction; integrates temperature sensor for core body temperature monitoring; used for urinary drainage/collection. Operated by clinicians in surgical or post-surgical settings. Provides continuous temperature data to external monitoring equipment; assists clinical decision-making regarding patient thermal status during and after surgery.

Clinical Evidence

No clinical data. Performance and biocompatibility testing were conducted and submitted as part of the 510(k) process.

Technological Characteristics

All-silicone Foley catheter; two-way design; integrated temperature sensor. Materials are identical to previously cleared predicate devices (K082815).

Indications for Use

Indicated for patients requiring urinary bladder drainage/collection and simultaneous core body temperature monitoring during surgical or post-surgical intervals.

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

• Smiths Foley Catheter Temperature Sensor (K873448)
• Well Lead Silicone and Latex Foley Catheters (K082815)

Submission Summary (Full Text)

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### 510(k) SUMMARY - K091516 (as required by 807.92(c))

.

:

# OCT】62009

| Regulatory Correspondent: | Regulatory and Marketing Services, Inc<br>962 Allegro Lane<br>Apollo Beach, FL 33572<br>Arthur Ward<br>[e-mail]<br>813-645-2855<br>813-645-2856 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | Well Lead Medical Device Instruments Ltd.<br>A4-1# Jinhu Industrial Estate<br>Hualong, Panyu<br>Guangzhou City, China 511434<br>Han Guang Yuan<br>[e-mail] |
| Date of Summary: | 5/18/09 |
| Trade/Proprietary Name: | Well Lead all Silicone Foley Catheter with<br>Temperature Sensor |
| Classification Name: | Urological Catheter and Accessories |
| Product Code: | EZL |
| Intended Use: | The Well Lead all Silicone Foley Catheters with<br>Temperature Sensor are intended for use in the<br>drainage/collection of urine from the urinary<br>bladder and simultaneous monitoring of the body<br>core temperature during surgical or post-surgical<br>intervals. |
| Device Description: | The Well Lead all Silicone Foley Catheters with<br>Temperature are two-way Foley Catheters which<br>are used in the drainage/collection of urine from the<br>urinary bladder and simultaneous monitoring of the<br>body core temperature during surgical or post-<br>surgical intervals. |

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K873448 -- Smiths Foley Catheter Temperature Predicate Device: Sensor K082815 - Well Lead Silicone and Latex Foley Catheters Well Lead Medical Instruments claims the proposed Substantial Equivalence: devices to be substantially equivalent to the devices previously cleared by FDA in K873448 and K082815. Well Lead Medical Products claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principals and physical operational specifications as compared to the predicate devices. The similarities and differences between the proposed and predicate device has been identified and explained on the comparison chart which has been included in section 9 of this submission. All of the appropriate testing for the Foley Catheters Performance Testing: was completed and submitted in the previously cleared submission K082815 all the materials are the same as the Foley Catheters in this submission. The testing for the Temperature Sensor can be found in Section 11 the Performance Testing section and in Section 14 Biocompatibility Testing.

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Image /page/2/Picture/0 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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Well Lead Medical Co., Ltd. % Mr. Arthur Ward President Regulatory and Marketing Services, Inc. 962 Allegro Lane APOLLO BEACH FL 33572

## OCT 1 6 2009

Re: K091516

Trade/Device Name: Well Lead All Silicone Foley Catheters with Temperature Sensor Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: September 1, 2009 Received: September 11, 2009

Dear Mr. Ward:

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 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

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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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kog15/6

### Indications for Use

091516 510(k) Number (if known):

Device Name: Well Lead All Silicone Foley Catheters With Temperature Sensor

Indication for use:

The Well Lead All Silicone Foley Catheters With Temperature Sensor are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.

x Over-The-Counter Use Prescription Use AND/OR (21CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Hulda Ruma

(Division Sign Off) (Division Sign-On)
Division of Reproductive, Abdominal, Division ological Devices 510(k) Number_

Traditional 510(k) for Well Lead All Silicone Foley Catheter With Temperature Sensor