LTFS230

K021775 · Healthtronics, Inc. · LNS · Dec 23, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021775
• Device Name: LTFS230
• Applicant: Healthtronics, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.

Device Story

Extracorporeal shock wave lithotripter; used for fragmentation of kidney and ureteral calculi. Device utilizes shock waves to break down stones. Includes integrated x-ray imaging system for stone localization. Operated by clinical staff in a medical setting. Output consists of shock wave therapy guided by imaging. Benefits patients by providing non-invasive treatment for renal and ureteral calculi.

Clinical Evidence

Bench testing only. Data provided in accordance with FDA guidance for extracorporeal shock wave lithotripters, including shock wave characteristics and safety data. Initial report on the x-ray imaging system provided.

Technological Characteristics

Extracorporeal shock wave lithotripter; includes x-ray imaging system. Class II device (21 CFR 876.5990).

Indications for Use

Indicated for patients with renal and upper ureteral calculi sized 4mm to 20mm.

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

• LithoTron (P970019)

Submission Summary (Full Text)

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### PREMARKET NOTIFICATION 510(K) SUMMARY

| Applicant: | HealthTronics Surgical Services, Inc.<br>1841 West Oak Parkway<br>Marietta, Georgia 30062<br>Telephone: [phone]<br>Facsimile: 770-419-9490 | DEC 23 2002 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Manufacturer: | HMT High Medical Technologies, AG<br>Lengwil, Switzerland | |
| Official Contact: | Peter Weiman<br>Manager of Clinical Programs<br>HealthTronics Surgical Services, Inc. | |

The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4m and 20mm in size.

This device is substantially equivalent to the predicate device, the LithoTron (P970019), also manufactured by HMT. The primary difference in the devices is that the LithoDiamond has a new imaging system.

The equivalence argument in the 510(k) was supported by bench data (as outlined in FDA's "Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi." (August 9, 2000)). Detailed shock wave characteristics as well as safety data were presented in the 510(k). An initial report on the imaging system (x-ray component) is also on file at FDA.

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## DEPARTMENT OF HEALTH & HUMAN SERVICE

### Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Re: K021775

Mr. Peter Weiman Manager of Clinical Programs HealthTronics, Inc. 1841 West Oak Parkway MARIETTA GA 30062

Trade/Device Name: HealthTronics LithoDiamond (ESWI Lithotripter (LTF0230) Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: September 25, 2002 Received: September 27, 2002

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 (OS) 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 i 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/dsmarnain.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 USI

510(k) Number (if known): K021775

Device Name: LithoDiamond

Indications for Use:

The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.

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

PrescriptionDevice/

David h. Wegman
(Division Sign-Off)

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

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