STORZ MODULITH LITHOTRIPTER SLX-F2-F180

K072788 · KARL STORZ Endoscopy-America, Inc. · LNS · Dec 26, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072788
• Device Name: STORZ MODULITH LITHOTRIPTER SLX-F2-F180
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Dec 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Storz MODULITH® Lithotripter SLX-F2 F180 is intended for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

Device Story

The Storz MODULITH® Lithotripter SLX-F2 F180 is an extracorporeal shock wave lithotripter used for the noninvasive fragmentation of urinary calculi. The device generates shock waves via an electromagnetic membrane source; these waves are focused onto kidney or upper ureteral stones using a parabolic reflector dish. The shock waves are transmitted to the patient's body through a water-filled rubber cushion. By fragmenting stones into smaller pieces, the device facilitates their passage through the patient's urine. It is intended for clinical use by trained medical professionals. The device is a modification of the predicate MODULITH SLX-F2, featuring a different treatment depth (180 mm) and focal size specifications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and bench testing of performance parameters (focal size, peak-positive pressure, focal energy).

Technological Characteristics

Electromagnetic shock wave generator; parabolic reflector dish for focusing; water-filled rubber cushion for coupling. Treatment depth: 180 mm. Focal size: F1 (2 x 24 mm), F2 (4.7 x 39 mm). 26 energy levels. Class II device.

Indications for Use

Indicated for noninvasive fragmentation of urinary calculi in the kidney and upper ureter in patients requiring lithotripsy.

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.”)

Predicate Devices

• Storz MODULITH Lithotripter SLX-F2 (K040476)
• Medispec Econolith EM1000 (K063504)

Submission Summary (Full Text)

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KD72188
pg 1 of 2

DEC 2 6 2007

## 510(k) SUMMARY

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:

| Sponsor/Submitter: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe<br>Culver City, CA 90230-7600<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Crystal Dizol<br>Regulatory Affairs Associate<br>Email: [e-mail] |
| Date of Submission: | September 24, 2007 |
| Device Trade Name: | Storz MODULITH® Lithotripter SLX-F2 F180 |
| Common Name: | Extracorporeal Shock Wave Lithotripter |
| Classification Name: | Lithotripter, Extracorporeal Shock-Wave, Urological |
| Regulation Number: | 21 CFR 876.5990 |
| Product Code: | LNS |
| Predicate Device(s): | Storz MODULITH Lithotripter SLX-F2 (K040476)<br>Medispec Econolith EM1000 (K063504) |
| Device Description: | The Storz MODULITH® Lithotripter SLX-F2 F180 is an Extracorporeal<br>Shock Wave Lithotripter Device. It generates shock waves that are<br>focused onto a kidney or ureteral stone so that the stone fragments can<br>be passed with the patient's urine. |
| Indications for Use: | The Storz MODULITH® Lithotripter SLX-F2 F180 is indicated for use in<br>the noninvasive fragmentation of urinary calculi in the kidney and upper<br>ureter. |
| Technological<br>Characteristics: | The Storz MODULITH® Lithotripter SLX-F2 F180 and its predicate<br>devices generate shock waves using electromagnetically repelled<br>membranes. The shock waves are focused onto the stone by a<br>parabolic reflector dish, and are transferred to the patient's body via<br>contact with a water-filled rubber cushion. |
| Summary of<br>Substantial<br>Equivalence: | The Storz MODULITH® Lithotripter SLX-F2 F180 is substantially<br>equivalent to the predicate devices since the intended uses and<br>technological characteristics are similar. The minor differences between<br>the Storz MODULITH® Lithotripter SLX-F2 and the predicate devices<br>raise no new issues of safety and effectiveness, as these design<br>differences have no affect on the performance, function or intended use<br>of the devices. |

Att: Substantial Equivalence Table for Storz MODULITH® Lithotripter SLX-F2 F180

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:

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RE STORZ ENDOSCOP 0

## JBSTANTIAL EQUIVALENCE TABLE FOR STORZ MODULITH® SLX-F2 F1

| Manufacturer | Storz Medical AG<br>MODULITH® SLX-F2 F180 | Storz Medical AG<br>MODULITH® SLX-F2 | Medispec, Ltd.<br>Econolith™ EM1000 |
|------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Proprietary Name | | | |
| 510(k) Number | Not Yet Assigned | K040476 | K063504 |
| Shock wave generator | Electromagnetic | Electromagnetic | Electromagnetic |
| Diameter of source | 300 mm | 300 mm | Unavailable |
| Treatment depth | 180 mm | 165 mm | 145-175 mm |
| Focal size (typical) | F1: 2 x 24 mm<br>F2: 4.7 x 39 mm | F1: 2 x 20 mm<br>F2: 4.8 x 36 mm | 11 x 175 mm |
| Peak-positive pressure,<br>Min/Max (MPa) | F1: 18 - 107<br>F2: 15 - 36 | F1: 18 - 107<br>F2: 16 - 44 | 9.8 - 41.6 |
| Focal energy,<br>Min/Max (MPa) | F1: 1.9 - 2.1<br>F2: 3.8 - 4.0 | F1: 2.2 - 2.5<br>F2: 4.3 - 5.5 | Unavailable |
| Number of Energy Levels | 26 | 26 | Unavailable |
| Intended Use | For use in the noninvasive<br>fragmentation of urinary<br>calculi in the kidney and<br>upper ureter. | For use in the noninvasive<br>fragmentation of urinary<br>calculi in the kidney and<br>upper ureter. | For use in non-invasive<br>fragmentation of upper<br>urinary tract stones, to<br>include urinary stones<br>located in the kidney (renal<br>pelvis and renal calyces) and<br>upper ureter. |

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K072758
pg. 2 of 2

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 6 2007

Crystal Dizol Regulatory Affairs Associate Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe 5th Floor Culver City, CA 90230-7600

K072788 Re:

> Trade/Device Name: Storz MODULITH® Lithotripter SLX-F2 F180 Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: Class II Product Code: LNS Dated: September 24, 2007 Received: October 1, 2007

Dear Ms. Dizol:

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, 1796, 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 (PMA), 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): K072788

Storz MODULITH® Lithotripter SLX-F2 F180 Device Name:

Indications for Use: The Storz MODULITH® Lithotripter SLX-F2 F180 is intended for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

Prescription Use: (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Leuner
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _