ULTRASOUND LOCALIZATION SYSTEM ULS 0142

K040741 · Hmt High Medical Technologies AG · LNS · Aug 19, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040741
• Device Name: ULTRASOUND LOCALIZATION SYSTEM ULS 0142
• Applicant: Hmt High Medical Technologies AG
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Aug 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2

Indications for Use

The ULS0142 accessory is indicated for localization of a target stone prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230. The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.

Device Story

ULS 0142 is an accessory ultrasound localization system for the LithoDiamond LTFS230 extracorporeal shock wave lithotripter. Device provides ultrasound imaging to locate target stones prior to lithotripsy procedures. Used in clinical settings by trained personnel; not intended for stand-alone diagnostic ultrasound. Output assists clinicians in targeting stones for shock wave therapy, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasound localization system designed as an accessory to the LithoDiamond LTFS230 lithotripter. Operates as a non-diagnostic imaging tool for stone targeting. Technical specifications and materials are consistent with the predicate LithoTron ULS 0132.

Indications for Use

Indicated for ultrasound localization of target stones in patients undergoing extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230. Not for use as a stand-alone diagnostic ultrasound 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

• LithoTron ULS 0132

Reference Devices

• LithoDiamond LTFS230

Submission Summary (Full Text)

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AUG 1 9 2004

#### PREMARKET NOTIFICATION 510(K) SUMMARY

| Sponsor: | HMT High Medical Technologies AG<br>Kreuzlingerstrasse 5<br>CH-8574 Lengwil<br>Switzerland<br>Telephone: [phone]<br>Fax: [phone]<br>Contact: Karl Ensslen, PhD |
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## HMT High Medical Technologies AG Manufacturer: Kreuzlingerstrasse 5 CH-8574 Lengwil Switzerland Telephone: [phone] Fax: [phone] Contact: Karl Ensslen, PhD

### Establishment Registration Number: 9614425

| Contact Person: | Patricia Landry<br>M Squared Associates, Inc.<br>719 A Street, NE<br>Washington DC 20002<br>Telephone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name of Device: | Ultrasound Localization System ULS 0142 |
| Common Name: | Accessory to Extracorporeal Shock Wave Lithotripter |
| Classification name: | Lithotripter, Extracorporeal Shock-Wave, Urological |

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Product Code:

Regulation Class: Class II (Special Controls)

K040741

Caye K2

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K140741

Page 2 of 2

Regulation Number : 8876,5990

The ULSUL42 accessory is an adjunct ultrasound localization system for Device Description: use prior to extracorporcal shock wave lithotripsy with the LithoDiamond LTFS230.

The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.

The ULS 0142 accessory is indicated for ultrasound localization of a Indications for Use: target stone prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230.

The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.

The LithoDiamond ULS 0142 is substantially equivalent Basis for Substantial Equivalence to the LithoTron ULS 0132.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2004

HMT High Medical Technologies AG c/o Ms. Trish Landry Senior Consultant M Squared Associates, Inc. 719 A Street, N.E. WASHINGTON DC 20002

Re: K040741

Trade/Device Name: HMT Ultrasound Localization System ULS 0142 Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: August 6, 2004 Received: August 6, 2004

Dear Ms. Landry:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are card in 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 docs not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a dolly regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing Comply with an the 110 110 110 Part 801); good manufacturing practice requirements as sct (2) CFR Part 801), advening (21 cegulation (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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#### Page 2

This letter will allow you to begin marketing your device as described in your Section 100(k) This letter will allow you to begin marcemi, your outstance of your device to a legally premarket nothication. The PDA midn't in actassification 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 CIFR Part 801), please
rs the see latest of the many and in the comment of the seculation If you desire specific advice for your decles on of the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the promotion of the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by reference to prematics notification (DTCPA) in the Act may be obtained from the Division of Strail information on your responsionities ander are Assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free with Manufacturers, International and Octoballion of Seasonner of Seathern of Separamain.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

510(k) Number (if known):

040741

Device Name: Ultrasound Localization System ULS 0142

Device Name. Gtt 250276
Indications For Use: The ULS0142 accessory is indicated for localization of a target stone prior to Indications I or 'Use. "The "See" "The "LithoDiamond LTFS230.
extracorporeal shock wave litthotripsy with the LithoDiamond LTFS230.

The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.

Prescription Use X Presempelour Subpart D) AND/OR

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 Fivaluation (ODE)

Nancy Enogdor

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(Division Sign-Off)

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

Page 1 of

March 22, 2004

CONFIDENTIAL

Appendices