READYCATH CATHETER

K973120 · Medical Technologies of Georgia · GBM · Feb 25, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973120
• Device Name: READYCATH CATHETER
• Applicant: Medical Technologies of Georgia
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Feb 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MMG InstantCath Pre-lubricated Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

Device Story

The InstantCath is a pre-lubricated urinary catheter designed for bladder drainage. It is used by patients or clinicians to manage urinary incontinence. The device facilitates the removal of urine from the bladder through a simple mechanical insertion process. It is a single-use, pre-lubricated device intended to simplify the catheterization process for the user.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pre-lubricated urinary catheter; mechanical drainage device; no electronic or software components.

Indications for Use

Indicated for patients requiring urinary bladder drainage due to incontinence.

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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FEB 2 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

YOMASA

Re: K973120

Mr. Richard Starke Vice President Medical Technologies of Georgia 5335 Dividend Drive Decatur, GA 30035

INSTANTCATH (Readycath) Catheter Dated: January 27, 1998 Received: February 3, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 GMB

Dear Mr. Starke:

We have reviewed your Section 510(k) notifiestion of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 marked 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 and additionally 809.10 for in yitzo diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrf/dsmamain.hitml".

Sincerely vours.

Willian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INTENDED USE

The MMG InstantCath Pre-lubricated Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

Richard Starke

Vice President, Medical Technologies of Georgia

Robert R Satling/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K973120 510(k) Number_

Prescription Use
(Per 21 CFR 801.109)

(Per 21 CFR 801.109)

Over-the-Counter Use_

## ATTACHMENT #5

Dated 1/28/98