KSEA CALCUSPLIT

K981233 · KARL STORZ Endoscopy-America, Inc. · FFK · Jun 15, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981233
• Device Name: KSEA CALCUSPLIT
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Jun 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Karl Storz Calcusplit system is intended for use by qualified surgeons and provides for the pneumatic fragmentation of renal and lower ureteral calculi.

Device Story

Pneumatic lithotriptor; uses compressed air to drive mechanical energy for fragmentation of urinary tract stones. Operated by surgeons under direct vision endoscopic control; utilizes rigid probes for direct contact with calculi. Used in clinical settings for percutaneous (renal) or ureteroscopic (lower ureter) procedures. Output is mechanical force; assists in stone disintegration; facilitates stone removal; benefits patient by enabling minimally invasive treatment of urinary calculi.

Clinical Evidence

Unmasked, self-controlled multi-center clinical trial conducted. Evaluated fragmentation of lower ureter and renal stones via ureteroscopic and percutaneous approaches. Results demonstrated safety and effectiveness were no worse than the EMS Swiss Lithoclast Lithotriptor. Bench testing of probe endurance and tissue effects also performed.

Technological Characteristics

Pneumatic lithotriptor; utilizes compressed air to generate mechanical energy; rigid probes for direct contact; endoscopic control; standalone system.

Indications for Use

Indicated for qualified surgeons to perform intracorporeal fragmentation of lower ureter and renal calculi.

Regulatory Classification

Identification

An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”

Predicate Devices

• EMS Swiss Lithoclast Lithotriptor (K951531 and K963285)

Submission Summary (Full Text)

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JUN 1 5 1998

## 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.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan<br>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Pneumatic Lithotriptor |

Trade Name: (optional) Karl Storz Calcusplit

Indication: The Karl Storz Calcusplit system is intended for use by qualified surgeons and provides for the pneumatic fragmentation of renal and lower ureteral calculi.

Predicate: EMS Swiss Lithoclast Lithotriptor

Device Description: The Karl Storz Calcusplit is a pneumatic lithotriptor designed for the pneumatic fragmentation of urinary calculi. The Calcusplit system uses pneumatic energy converted to mechanical energy to disintegrate calculi. The force of the mechanical energy provided by this device is sufficient to fragment calculi of most sizes and composition.

Substantial Equivalence: The Karl Storz Calcusplit is substantially equivalent to the EMS Swiss Lithoclast currently marketed by Boston Scientific Corporation (K951531 and K963285); the Karl Storz Calcusplit has the same intended use as the predicate Swiss Lithoclast and has the same technological characteristics as the predicate Swiss Lithoclast. Both the Calcusplit and the Lithoclast systems use compressed air and direct contact, rigid probes to fragment urinary tract stones under direct vision endoscopic control.

Bench testing of probe endurance and tissue effects was conducted and demonstrated that the safety and effectiveness of the Calcusplit system was no worse than the safety and efficacy for the EMS Swiss Lithotriptor. An unmasked and self-controlled multi-center

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clinical trial of the Calcusplit system for fragmentation of lower ureter and renal stones was also conducted. The study demonstrated that the safety and effectiveness of the Calcusplit system in fragmenting lower ureter (ureteroscopic approach) and renal stones (percutaneous approach) was no worse than the safety and efficacy for the EMS Swiss Lithoclast Lithotriptor.

Signed:

Kevin Kennan

Senior Regulatory Affairs Specialist

Date: March 31, 1998

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Image /page/2/Picture/1 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 a stylized human figure or bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 1998

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

Re: K981233

Calcusplit Lithotriptor and Accessories Dated: March 31, 1998 Received: April 3, 1998 Regulatory Class: III 21 CFR 876.4480/Procode: 78 FFK

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 Ouality 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 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: Calcusplit Lithotriptor

Indications for Use: These instruments are intended for use by qualified surgeons and provide for the intracorporeal fragmentation of lower ureter and renal calculi.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daler R. Rolling/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

OR Over-The-Counter Use:

510(k) Number K981233

Prescription Use: (Per 21 CFR 801.109)

(Optional Format 1-2-96)