VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR

K092033 · Elmed USA · FFK · Apr 30, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K092033
• Device Name: VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
• Applicant: Elmed USA
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Apr 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This unit is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

Device Story

Vibrolith and Vibrolith Plus are intracorporeal lithotriptors for fragmenting urinary tract calculi. Vibrolith Plus integrates pneumatic and ultrasonic modalities; Vibrolith provides pneumatic lithotripsy only. Pneumatic mode uses compressed air to accelerate a projectile within a handpiece, delivering ballistic impact energy to stones via a probe. Ultrasonic mode uses piezo-ceramic crystals to generate 15-28 kHz longitudinal vibrations transmitted via a steel probe. Both modalities support simultaneous aspiration through hollow probes. Operated by physicians in clinical settings under general or spinal anesthesia, the device is positioned via endoscope under direct observation. Energy delivery is controlled by a two-pedal footswitch. Combined pneumatic-ultrasonic operation is available for hard stones. The device enables minimally invasive stone fragmentation, potentially benefiting patients by reducing the need for more invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

System consists of pneumatic and ultrasonic handpieces. Pneumatic: compressed air-driven projectile. Ultrasonic: piezo-ceramic transducer (15-28 kHz). Probes: various lengths/diameters, hollow for aspiration. Energy source: external compressed air and electrical generator. Operation: two-pedal footswitch. Sterilization: compatible with endoscopic procedures.

Indications for Use

Indicated for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder in patients requiring lithotripsy.

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 Lithocast Master (K012445)
• EMS Swiss Lithocast 2 (K963285)

Submission Summary (Full Text)

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K092033
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## 510(k) SUMMARY (as required by 807.92(c))

### APR 3 0 2010

Regulatory Correspondent: Jon Ward AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33527 USA [e-mail] 813-645-2855 813-645-2856

Submitter of 510(k):

ELMED USA 11310 South OBT. Suite 138 Orlando, FL 32837 USA Axel Lopez

Electrohydrolic Lithotriptor

Date of Summary:

June 26, 2009

Trade/Proprietary Name:

Vibrolith and Vibrolith PLUS Intracorporeal Lithotriptor

Classification Name:

Product Code:

78 FFK

Regulation Number: 876.4480

This unit is intended to be used for the fragmentation of Intended Use: urinary tract calculi in the kidney, ureter and bladder.

Device Description: The ELMED Vibrolith Plus® is intracorporeal lithotripter which joint together the ultrasonic lithotripter with aspiration system with the high efficiancy of the electro-pneumatic lithotripter. Three possible modes of operation are available using Vibrolith Plus such as; (1) pneumatic lithotripsy alone; (2) ultrasonic lithotripsy alone; (3) and combined pneumatic and ultrasonic lithotripsy.

The system consists of two independent operating units in one housing, which allows for independent operation of the two modalities. Delivery of energy is controlled using a common two-pedal footswitch.

The pneumatic part of the system works under the principle of collision of a bullet, accelerated by a medical compressed air supply from either a compressor or a central hospital supply. The compressed air provides the pressure pulse that drives the projectile

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K092033
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within pneumatic handpiece toward the proximal end of the probe. This probe transmits the impact energy to the stone, resulting in fragmentation. By this electro-pneumatic ballistic energy, only the calculi is disintegrated, there is no effect on tissue.

The pneumatic part can also be used in combination with aspiration system. The pneumatic probes can be inserted through the suction tube for simultaneous lithotripsy and suction.

The ultrasonic lithotriptor works under the principle of vibration in the ultrasonic area by the piezo-ceramic crystals and transmites these vibrations to the stone with a steel probe inserted into the body by endoscopy.

The endoscope is used to position the Vibrolith Plus® handpiece in the urethra under direct observation.

The ultrasonic handpiece consists of an ultrasound transducer containing the piezoelectric elements, which are driven by a generator operating between 15-28 kHz. The resulting longitudinal waves are propagated along the ultrasound probe to the target stone. The ultrasound transducer and the probes are hollow, permitting simultaneous suction.

Combined operation of the pneumatic and ultrasonic parts is desirable for certain hard kidney and bladder stones. In order to use the combined energy, the pneumatic and ultrasonic handpieces must be mounted together. In a combined operation, the probes must be length-adjusted so that the tip of the pneumatic probe is flush with the tip of the ultrasonic probe.

The Vibrolith Plus® is designed to be used with general or spinal anesthesia. This design, together with the clinical data, offers a particular advantage for using Vibrolith Plus® in patients with renal, ureteral and bladder stones. This advantage may be most significant in patients who wish to remain physically active and for those who are in higher risk categories where serious side effects present a significant threat to their health and well being.

For the application, probes with various lengths and in various diameters are available, which permits adaptation to the stone size as well as to the available lumen of the working channel.

The ELMED Vibrolith is very similar to the Vibrolith Plus with the exception that the Vibrolith is only available with pneumatic lithotripsy.

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K092033
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Predicate Device:

Substantial Equivalence:

EMS Swiss Lithocast Master -- K012445 EMS Swiss Lithocast 2 - K963285

The Vibrolith Plus is substantially equivalent to the Swiss Lithocast Master, which has been cleared for both pneumatic and ultrasonic lithotripsy and the Vibrolith is substantially equivalent to the Swiss Lithocast 2 which has been cleared for pneumatic lithotripsy. The proposed devices have the same intended use and similar technological characteristics as compared to the predicate device.

Vibrolith and Vibrolith Plus Intracorporeal Lithotriptor - Supplemental 1 Response

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

# APR 3 0 2010

Elmed USA % Mr. Jonathan Ward Vice-President AJW Technology Consultants, Inc. 962 Allegro Lane APOLLO BEACH FL 33572

Re: K092033

Trade/Device Name: Vibrolith and Vibrolith Plus Intracorporeal Lithotriptor Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: II Product Code: FFK Dated: March 16, 2010 Received: March 18, 2010

Dear Mr. Ward:

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 (PMA), it may be subject to 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.

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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting 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): K092033

Device Name: Vibrolith and Vibrolith Plus Intracorporeal Lithotriptor

This unit is intended to be used for the fragmentation of urinary Indications for Use: tract calculi in the kidney, ureter and bladder.

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 807 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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

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Vibrolith and Vibrolith Plus Intracorporeal Lithotriptor - Supplemental 1 Response

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