TWINTRODE ELC 134 ELECTRODE

K012785 · Healthtronics Surgical Services, Inc. · LNS · Nov 16, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012785
• Device Name: TWINTRODE ELC 134 ELECTRODE
• Applicant: Healthtronics Surgical Services, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TwinTrode® ELC 134 Electrode, is intended for multiple patient use during lithotripsy procedures as a replacement electrode to be used with the LithoTron Lithotripsy System.

Device Story

TwinTrode ELC 134 Electrode is a component for the LithoTron electrohydraulic extracorporeal shock wave lithotripter. Device functions as a replacement electrode for multiple patient use. Primary operational difference from predicate is increased longevity, providing up to 2.5 times greater total usable shocks. Used in clinical lithotripsy settings by trained personnel. Output is the generation of shock waves for lithotripsy; clinical benefit is the fragmentation of calculi.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing verifying increased total usable shocks compared to the predicate device.

Technological Characteristics

Electrohydraulic electrode for extracorporeal shock wave lithotripsy. Multiple patient use. Designed for compatibility with LithoTron Lithotripsy System. Primary technical improvement is increased longevity (2.5x increase in usable shocks).

Indications for Use

Indicated for use as a replacement electrode in patients undergoing lithotripsy procedures using the LithoTron Lithotripsy System.

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

• NewTrode® ELC 124 (part of HealthTronics LithoTron Lithotripsy System)

Submission Summary (Full Text)

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## PREMARKET NOTIFICATION 510(K) SUMMARY 8.0

| Applicant: | HealthTronics, Inc.<br>1841 West Oak Parkway<br>Marietta, Georgia 30062<br>Telephone: [phone]<br>Facsimile: 77-419-9490 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | NOV 1 6 2001 |
| Manufacturer: | HMT High Medical Technologies, AG<br>Lengwil, Switzerland |
| Official Correspondent: | Peter Weiman<br>Manager, Clinical Programs<br>HealthTronics, Inc. |

The TwinTrode® ELC 134 Electrode is a multiple patient use electrode for electrohydraulic extracorporeal shock wave lithotripter. It is substantially equivalent to the NewTrode® ELC 124 Both electrodes are components of the HealthTronics LithoTron Electrode (predicate device). Lithotripsy System.

The TwinTrode and NewTrode devices are very similar and are utilized as part of the LithoTron The TwinTrode differs from the NewTrode in that the longevity of the system identically. TwinTrode is up to 2.5 times greater than the longevity of the NewTrode. Performance testing verifying this increase in total useable shocks has been provided in the 510(k). Clinical data were not required to demonstrate substantial equivalence.

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Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Mr. Peter Weiman Manager of Clinical Programs HealthTronics Surgical Services, Inc. 1841 West Oak Parkway, Suite A MARIETTA GA 30062-9923

Re: K012785

Trade/Device Name: Twin Trode® ELC 134 Electrode Regulatory Number: 21 CFR 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: August 15, 2001 Received: August 20, 2001

Dear Mr. Weiman:

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); 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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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INDICATIONS FOR USE

## NOV 1 6 2001

Page 1 of 1

510(k) Number (if known): K012785

Device Name: TwinTrode® ELC 134 Electrode

Indications for Use:

The TwinTrode® ELC 134 Electrode, is intended for multiple patient use during lithotripsy procedures as a replacement electrode to be used with the LithoTron Lithotripsy System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Navy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012785

Prescription Use