LITHOGOLD

K062081 · Tissue Regeneration Technologies, Inc. · LNS · Nov 2, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062081
• Device Name: LITHOGOLD
• Applicant: Tissue Regeneration Technologies, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).

Device Story

LithoGold is an extracorporeal shock wave lithotripsy (ESWL) system for non-invasive fragmentation of urinary stones. Device utilizes electrohydraulic shock wave generation; features ECG gating and fixed frequency capabilities. System integrates with third-party components: Siemens Modularis Uro Plus or Arcadis Varic/Siremobil Compact L C-arms for imaging; Draeger Infinity Gamma for ECG monitoring. Operated by clinicians in urological settings. Shock waves target calculi to facilitate stone clearance; ECG gating synchronizes delivery with cardiac cycle to minimize potential cardiac effects. Clinical benefit includes non-invasive stone treatment.

Clinical Evidence

Confirmatory clinical study conducted to evaluate safety and effectiveness for renal and ureteral calculi treatment. Results indicate outcomes are substantially equivalent to predicate lithotripsy devices.

Technological Characteristics

Electrohydraulic shock wave generator; ECG gating and fixed frequency modes. Acoustic characteristics measured per IEC 61846 (1998). Integrated with external C-arm imaging and ECG monitoring systems. Conforms to electrical and EMC consensus standards.

Indications for Use

Indicated for patients requiring fragmentation of urinary stones located in the renal pelvis, renal calyces, or upper, middle, and lower ureter.

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

• HealthTronics LithoTron (P970019)

Submission Summary (Full Text)

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## Section 5: 510(k) Summary

Tissue Regeneration Technologies Sponsor: 110 Arnold Mill Park. Suite 400 Woodstock, Georgia 30188

Manufacturer: MTS Europe GmbH Robert-Bosch-Str. 18 D-78467 Konstanz, Germany

- Contact: Cherita James M Squared Associates, Inc 719 A Street. NE Washington, DC 20002 Ph: 202-546-1262 Ext 257 Fax: [phone]
Date of submission: July 21, 2006

Proprietary Name: LithoGold

Common name: Extracorporeal shock wave lithotriptor

Recommended classification regulation: 876.5990

Class: Il

Panel: Gastroenterology/Urology Devices

Product Code: LNS

Intended Use: The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).

Predicate device: HealthTronics LithoTron (P970019)

Device description: The LithoGold is an extracorporeal shock wave therapy device designed for the non-invasive fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle and lower ureter). The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities.

The LithoGold unit will be combined with the Modularis Uro Plus (table) and Arcadis

NUW -- 2 2005

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Varic (C-arm) or Siremobil Compact L (C-arm), all products manufactured by Siemens Medical Solutions, Inc .; and the ECG Monitor Infinity Gamma (ECG) manufactured by Draeger Medical systems, Inc. These components have each been cleared for distribution in the U.S.

Summary of non-clinical testing: Testing in accordance with "Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotribters Indicated for the Fragmentation of Kidney and Ureteral Calculi (2000)" has been successfully completed. The LithoGold acoustic qualities have been measured using the methodology described in the consensus standard IEC 61846 "Ultrasonics - Pressure pulse lithotripters - Characteristics of fields" (1998). Additionally, the device has been found to conform to recognized consensus standards for electrical and EMC testing.

## Summary of clinical testing:

The confirmatory clinical study showed that the LithoGold ESWL system is expected to treat patients with renal or ureteral calculi with safety and effectiveness outcomes substantially equivalent to those for predicate lithotripsy devices.

Basis for Substantial Equivalence: Both the LithoGold and the predicate device have similar technical design features and indications for use. Bench testing and clinical testing confirm the substantial equivalence of the LithoGold to the LithoTron extracorporeal shock wave delivery system.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Tissue Regeneration Technologies, Inc. c/o Ms. Cherita James Regulatory Consultant M Squared Associates, Inc. 719 A Street, N.E. WASHINGTON DC 20002

NOV - 2 2006

Re: K062081

Trade/Device Name: LithoGold Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: September 12, 2006 Received: September 13, 2006

Dear Ms. James:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encready to regary and of the Medical Device Amendments, or to devices that prov to May 20, 1770, the onecations and the provisions of the Federal Food, Drug, and Cosmetic tiale occh roolabilited in are approval of a premarket approval application (PMA). You may, Act (free) market the device, subject to the general controls provisions of the Act. The general therefore, mance the det include requirements for annual registration, listing of devices, good controls provisions or allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is olashiba (500 acorry) and controls. Existing major regulations affecting your Apployal), it thay be sabject to Jack aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA ate roo bat of rither announcements concerning your device in the Federal Register.

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moting Public J

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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 (\$1 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 Hodgon

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

Finclosure

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## Indications for Use

X062081

510(k) Number (if known): not yet assigned

Device Name: LithoGold

Indications For Use: The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).

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

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062081

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