STORZ SLX-F2 STORM TOUCH

K070579 · KARL STORZ Endoscopy-America, Inc. · LNS · Aug 30, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070579
• Device Name: STORZ SLX-F2 STORM TOUCH
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Aug 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5990
• Device Class: Class 2

Indications for Use

The Storz SLX-F2 Storm Touch® software allows remote control / display communication between Storz Communication Buss® (SCB) network computer and SLX-F2 System® via a graphic user interface with a touch panel LCD screen. The SLX-F2 Storm Touch® interface communication software permits additional remote control and adjustment of the third party device through Storm Touch®.

Device Story

Storm Touch® is optional software installed on an SCB network computer in the OR suite; enables remote control, display, and communication between the SCB system and the SLX-F2 lithotripter system. Uses a graphic user interface with a touch panel LCD screen to display SLX-F2 control panel parameters, including x-ray parameters, during lithotripsy treatment or surgery. Permits remote control/adjustment of connected third-party devices. Original device controls can override SCB control; if remote control is not required, device control remains with the device itself. Does not add new clinical functions to the SLX-F2 or third-party devices; supports physician workflow by centralizing control/display.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Software-based interface for SCB network computer; utilizes touch panel LCD screen for GUI; connects to SLX-F2 system via specific Buss Connectors and designated cables; operates within OR suite environment.

Regulatory Classification

Identification

An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.

Special Controls

*Classification.* Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)

Submission Summary (Full Text)

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K070579

# AUG 3 0 2007

## 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: | Paul S. Lee<br>Senior Regulatory Affairs Specialist<br>Telephone [phone]<br>Telecopier [phone]<br>E-mail: [e-mail] |
| Device Identification: | Common Name: Extracorporeal Shock Wave Lithotripter<br>Trade Name: Storz SLX-F2 Storm Touch® |
| Indication: | The Storz SLX-F2 Storm Touch® software allows remote<br>control / display communication between Storz Communication<br>Buss® (SCB) network computer and SLX-F2 System® via a<br>graphic user interface with a touch panel LCD screen. The<br>SLX-F2 Storm Touch® interface communication software<br>permits additional remote control and adjustment of the third<br>party device through Storm Touch®. |
| Device Description: | The new Storm Touch® software allows remote control /<br>display / communication between the SCB system and SLX-F2<br>System via a graphic user interface with a touch panel LCD<br>screen. The main function of the Storm Touch® graphical user<br>interface is to support the doctor by displaying SLX-F2 control<br>panel System including its x-ray parameters during lithotripsy<br>treatment or surgery. This SCB Storm Touch® communication<br>software does not add any new clinical function to the SLX-F2<br>and third party devices. Storm Touch® has the same graphic<br>user interface principle as our original SCB graphic interface<br>software. |

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Storm Touch® is installed as an optional software in the SCB computer which is located in the OR suite. SLX -F2 connects to the SCB system by a specific Buss Connectors in the SCB computer with a designated cable.

The SCB Storm Touch® interface communication software also permits additional remote control and adjustment of the third party device. All third party devices that are connected to the SCB Storm Touch may still be controlled by the original device overwriting the SCB control. In case the additional remote control is not required, control of the device still remains with the device itself. The SCB Storm Touch® software allows additional optional control / communication of the third party device with the SCB.

Substantial Equivalence: The Storz Medical SLX-F2 Storm Touch is substantially equivalent to predicate devices since the basic technology and design are similar. The intended usage is similar to predicate devices and raise no new issues of safety and effectiveness. The minor differences between the Storz Medical Storz SLX-F2 Storm Touch® and predicate devices have no effect on the performance, function or intended use of the devices.

Signature:***_*****_**

Paul Lee Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 3 0 2007

Mr. Paul S. Lee Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive CULVER CITY CA 90230

Re: K070579

> Trade/Device Name: Storz SLX-F2 Storm Touch® Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: July 27, 2007 Received: July 31, 2007

Dear Mr. Lee:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Protecting and Promoting Public Health

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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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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K070579

## INDICATIONS FOR USE

510(k) Number (if known):

K070579

Device Name:

Storz SLX-F2 Storm Touch®

### Indications for Use:

SLX-F2 Storm Touch® software allows remote control / display The Storz communication between Storz Communication Buss® (SCB) network computer and SLX-F2 System® via a graphic user interface with a touch panel LCD screen. The SLX-F2 Storm Touch® interface communication software permits additional remote control and adjustment of the third party device through Storm Touch®

Prescription Use: (Per 21 CFR 801.Subpart D) OR Over-The-Counter Use: (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number