3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS

K022287 · 3t Medical Systems, LLC · EZL · Sep 23, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022287
• Device Name: 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
• Applicant: 3t Medical Systems, LLC
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Sep 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three-Way catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization. Temperature Sensing Catheter: Urethral catheterization for bladder drainage and or irrigation with simultaneous temperature monitoring.

Device Story

3T/Sewoon Temperature Sensing Foley Balloon Catheters are urological devices used for bladder drainage and irrigation. The temperature-sensing variant incorporates a thermistor to provide continuous bladder temperature monitoring during catheterization. Used in clinical settings by healthcare professionals. The device facilitates patient management by allowing simultaneous drainage and temperature tracking, aiding in clinical decision-making regarding patient thermoregulation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Urological Foley balloon catheter; includes thermistor for temperature sensing; available in two-way and three-way configurations; radiopaque options available. Materials and sterilization methods are consistent with standard urological catheter requirements.

Indications for Use

Indicated for patients requiring urethral catheterization for bladder drainage, irrigation, radiographic visualization, or simultaneous bladder drainage/irrigation and temperature monitoring.

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).

Submission Summary (Full Text)

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## Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sewoon Medical Co., Inc. c/o Mr. Robert P. Eaton Manager of Regulatory Affairs 3T Medical Systems, LLC 12553 South Wamblee Valley Road

## Re: K022287

SEP 23 2002

Trade/Device Name: 3T/Sewoon™ Temperature Sensing Foley Balloon Catheters Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: September 4, 2002 Received: September 9, 2002

Dear Mr. Eaton:

CONIFER CO 80433

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); 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.

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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy Chogden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3T Medical Systems, LLC (Regulatory Office) 12553 South Wamblee Valley Road Conifer, Colorado 80433

## INDICATIONS FOR USE STATEMENT

Special 510 (k) Device Modification: K O222267

Device Name: 3T/Sewoon™ Temperature Sensing Foley Balloon Catheters (various sizes)

INDICATIONS FOR USE: For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three-Way catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization. Temperature Sensing Catheter: Urethral catheterization for bladder drainage and or irrigation with simultaneous temperature monitoring.

*Prescription Use*

Daniel A. Lyman

ision Sian-O inn of Ronroducti