ENDO FMS UROLOGY

K980808 · Future Medical Systems, Inc. · LJH · May 8, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980808
• Device Name: ENDO FMS UROLOGY
• Applicant: Future Medical Systems, Inc.
• Product Code: LJH · Gastroenterology, Urology
• Decision Date: May 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The ENDO FMS® UROLOGY is a fluid management system used to maintain adequate irrigation pressure and flow in endoscopic Urology procedures, including all endoscopic procedures in the Kidney, Ureter/Urethra , Bladder and Prostate.

Device Story

ENDO FMS® UROLOGY is a fluid management system designed for endoscopic urological procedures. It maintains irrigation pressure and flow during surgeries involving the kidney, ureter, urethra, bladder, and prostate. Operated by clinicians in a surgical setting, the device manages fluid delivery to ensure clear visualization and stable pressure within the operative site. By regulating irrigation, it assists the surgeon in maintaining a controlled environment, potentially reducing procedural complications related to fluid imbalance or poor visibility. The system functions as an electromechanical pump/controller assembly.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Fluid management system for irrigation pressure and flow control. Electromechanical operation. Intended for endoscopic urology applications. Class II device under 21 CFR 876.1500.

Indications for Use

Indicated for patients undergoing endoscopic urological procedures, including procedures involving the kidney, ureter, urethra, bladder, and prostate, requiring irrigation pressure and flow management.

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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8 1000 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Patrick Janin General Manager Future Medical Systems, Inc. 504 McCormick Drive, Suite T Glen Burnie, MD 21061

Re: K980808 ENDO FMS® UROLOGY (Fluid Management System) Dated: March 30, 1998 Received: April 1, 1998 Unclassified/Procode: 78 LJE Regulatory Class: II 21 CFR \$876.1500/Procode: 78 FDC

Dear Mr. Janin:

We have reviewed your Section 510/k) notification 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 requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product 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 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 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/cdrh/dsmaldsmamain.html".

Sincerely yours,

Lillian 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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K980808

510(k) Number (if known):

ENDO FMS®UROLOGY

Device Name:

Indications For Use:

The ENDO FMS® UROLOGY is a fluid management system used to maintain adequate irrigation pressure and flow in endoscopic Urology procedures, including all endoscopic procedures in the Kidney, Ureter/Urethra , Bladder and Prostate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Sitting/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K980808

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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