KSEA UROPUMP

K981615 · KARL STORZ Endoscopy-America, Inc. · LJH · Jul 8, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981615
• Device Name: KSEA UROPUMP
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: LJH · Gastroenterology, Urology
• Decision Date: Jul 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These instruments are intended for use by qualified surgeons and are used for the infusion of sterile irrigation solution into the ureter and upper urinary tract, or used as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor.

Device Story

Karl Storz Uropump is a roller-type irrigation/aspiration pump. It provides infusion of sterile irrigation solution into the ureter and upper urinary tract or functions as a suction pump when used with the Calcuson Ultrasonic Lithotriptor. The device features user-adjustable irrigation flow rate, irrigation pressure, and aspiration suction flow rate. It is intended for use by qualified surgeons in a clinical setting. The device assists in urological procedures by managing fluid dynamics during irrigation and lithotripsy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Roller-type irrigation/aspiration pump. Features user-adjustable controls for irrigation flow rate, irrigation pressure, and aspiration suction flow rate. Mechanical operation.

Indications for Use

Indicated for use by qualified surgeons for infusion of sterile irrigation solution into the ureter and upper urinary tract, or as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor.

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).

Reference Devices

• Calcuson Ultrasonic Lithotriptor

Submission Summary (Full Text)

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K981615

## JUL - 8 1998

P 1 All

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc. |
|------------|--------------------------------------|
| | 600 Corporate Pointe Drive |
| | Culver City, CA 90230 |
| | [phone] |
| Contact: | Kevin Kennan |

Senior Regulatory Affairs Specialist

Device Identification:

Common Name: Suction/irrigation Pump

Trade Name: (optional) Karl Storz Uropump

The Karl Storz Uropump system is intended for use by qualified surgeons and is used Indication: for the infusion of sterile irrigation solution into the ureter and upper urinary tract, or used as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor ..

Device Description: The Karl Storz Uropump and accessories is a roller type irrigation/aspiration pump with user adjustable irrigation flow rate, irrigation pressure, and aspiration suction flow rate.

The Karl Storz Uropump system is substantially equivalent to the Substantial Equivalence: predicate devices since the basic features and intended uses are the same. The minor differences between the Karl Storz Uropump and the predicate devices raise no new jssues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:

Kevin Kennan

Regulatory Affairs Specialist

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 1998

Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600

Re: K981615

Uropump Irrigation/Suction System Dated: May 1, 1998 Received: May 6, 1998 Unclassified/Procode: 78 LJH

Dear Mr. Kennan:

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 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 Feceral 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 801 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/dsmaldsmam.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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510(k) Number (if known): Not yet assigned

## Device Name: Uropump

Indications for Use: These instruments are intended for use by qualified surgeons and are used for the infusion of sterile irrigation solution into the ureter and upper urinary tract, or used as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Rater D. Stalling/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K961611

Prescription Use:
(Per 21 CFR 801.109) OR Over-The-Counter Use:

(Optional Format 1-2-96)

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