PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER

K072538 · United Medical Systems, Inc. · LNS · Jan 30, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072538
• Device Name: PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
• Applicant: United Medical Systems, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Jan 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Device Story

Piezolith 3000 Triple Focus is an extracorporeal shock wave lithotripsy (ESWL) system. It utilizes a shock wave generator with an adjustable therapy head/coupling mechanism to fragment urinary stones. Localization is achieved via an integrated ultrasound imaging system or an optional X-ray system. The system includes a control console (device trolley) and a treatment table. Operated by clinicians in a medical setting, the device allows for precise targeting of stones. By delivering focused shock waves, the system breaks down stones into smaller fragments, facilitating their passage through the urinary tract and providing a non-invasive treatment alternative for urological conditions.

Clinical Evidence

Bench and clinical testing were performed. The device was tested for compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-36, and IEC 61846 standards. Results indicated the device functioned as intended and met expected performance outcomes.

Technological Characteristics

System components: shock wave generator, adjustable therapy head/coupling mechanism, control console, ultrasound imaging system, optional X-ray system, and treatment table. Mounting options include articulating arm or swivel slide on C-arm (LITHOARM). Complies with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-36, and 61846 standards.

Indications for Use

Indicated for fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter) in patients requiring lithotripsy.

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

• Piezolith 3000 Lithotripter (K032958)
• Karl Storz Modulith Lithotripter (K010340, K012482, K011700)
• Direx Systems Corporation Integra (K053640, K062147)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

# K072538 PAGE | VF 2

# United Medical Systems (DE), Inc.'s Piezolith 3000 Triple Focus Extracorporeal Shock Wave Lithotripsy System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

United Medical Systems (DE), Inc. 1500 West Park Drive Suite 390 Westborough, MA 01581 Phone: [phone] Fax: [phone]

Contact Person: Joseph Pelletiere, Director of Operations

Date Prepared: September 6, 2007

#### Name of Device and Name/Address of Sponsor

Piezolith 3000 Triple Focus Extracorporeal Shock Wave Lithotripsy System

United Medical Systems (DE), Inc. 1500 West Park Drive Suite 390 Westborough, MA 01581

## Common or Usual Name/Classification Name

Extracorporeal Shock Wave Lithotripsy System/ Urological Lithotripter

#### Predicate Devices

United Medical Systems (DE), Inc.'s Piezolith 3000 Lithotripter (K032958) Karl Storz Modulith Lithotripter (K010340, K012482, K011700) Direx Systems Corporation Integra (K053640, K062147)

### Intended Use / Indications for Use

The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

#### Technological Characteristics

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The Piezolith 3000 Triple Focus consists of (1) a shock wave generator, which includes an adjustable therapy head/coupling mechanism mounted on an articulating arm or (when X·ray imaging is used) mounted to a swivel slide on C-arm (LITHOARM); (2) a control console (device trolley); (3) ultrasound imaging system for localization; (4) an optional X-ray system for localization; and (5) a treatment table.

## Performance Data

Bench and clinical testing was performed using the Piezolith 3000 Triple Focus. In addition, the modified device was tested according to the following standards: IEC 60601-1 (1988) (including Amendment 1(1991) and Amendment 2 (1995)); IEC 60601-1-1 (2000) with Amendment 1, 1995; IEC 60601-1-2 (2001); IEC 60601-2-36 (1997); IEC 61846 (1998). In all instances, the Piezolith 3000 Triple-Focus functioned as intended and the results observed were as expected.

## Substantial Equivalence

The Piezolith 3000 Triple Focus is as safe and effective as the Piezolith 3000 (K032958), the Karl Storz Modulith Lithotripter (K010340, K012482, K011700), and the Direx Systems Corporation Integra (K053640, K062147). The Piezolith 3000 Triple Focus has the same intended uses/indications for use, and similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the Piezolith 3000 Triple Focus and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Piezolith 3000 Triple-Focus is as safe and effective as the predicate devices. Thus, the Piezolith 3000 Triple Focus is substantially equivalent.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a stylized symbol featuring three abstract human figures connected by flowing lines, representing health and human services.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JAN 30 2008

United Medical Systems, Inc. c/o Mr. Jeffrey K. Shapiro Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W. Suite 1200 WASHINGTON DC 20005

Re: K072538 Trade/Device Name: Piezolith 3000 Triple-Focus Extracorporeal Shock Wave Lithotripsy System Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: January 23, 2008 Received: January 23, 2008

Dear Mr. Shapiro:

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 (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. The logo is surrounded by a dotted border and star shapes.

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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 (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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 Statement

K072538 510(k) Number (if known):

Device Name: Piezolith 3000 Triple Focus Lithotripter

Indications for Use:

The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Prescription Use __ X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 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 C. Braxton

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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K072538