PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000

K032958 · United Medical Systems, Inc. · LNS · Feb 17, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K032958
• Device Name: PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
• Applicant: United Medical Systems, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Feb 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Piezolith 3000 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 is an extracorporeal shock wave lithotripter used to fragment urinary stones. System inputs include X-ray and ultrasound imaging for stone localization. Device utilizes a shock wave generator with an adjustable therapy head/coupling mechanism mounted on an articulating arm or C-arm swivel slide. Operated by clinicians in a medical setting, the system includes a control console and treatment table. The device transforms electrical energy into focused shock waves to disintegrate calculi. Healthcare providers use imaging to guide the therapy head, targeting stones for fragmentation to facilitate passage. Benefits include non-invasive stone treatment.

Clinical Evidence

Clinical data demonstrated substantial equivalence to predicate devices. Bench testing included shock wave characterization, localization accuracy, and road testing. The device conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, CISPR 11, IEC 60601-2-36, and IEC 61846 standards.

Technological Characteristics

System components: shock wave generator, adjustable therapy head/coupling mechanism, control console, X-ray, ultrasound imaging system, and treatment table. Operates via extracorporeal shock wave generation. Conforms to IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-36, CISPR 11, and IEC 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

• Richard Wolf Piezolith E.P.L. Lithotripter (Model 2300)
• Dornier Compact S
• Dornier Compact Delta
• Siemens Modularis Litho
• Storz Modulith SLX
• Storz Modulith SLK

Submission Summary (Full Text)

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# 510(k) SUMMARY

## UMS's Piezolith 3000 Lithotripter

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

United Medical Systems One Technology Drive, Third Floor Westborough, MA 01581 Tel: [phone] Fax: [phone] Registration Number: 1226692

Contact Person: Jorgen Madsen

Date Prepared: September 17, 2003

## Name of Device and Name/Address of Sponsor

Piezolith 3000 Lithotripter

United Medical Systems One Technology Drive, Third Floor Westborough, MA 01581

## Common or Usual Name

Extracorporeal Shock Wave Lithotripter

#### Classification Name

Extracorporeal Shock Wave Lithotripter

#### Predicate Devices

Richard Wolf Piezolith E.P.L. Lithotripter, Model 2300 Dornier Compact S Dornier Compact Delta Siemens Modularis Litho Storz Modulith SLX Storz Modulith SLK

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## Intended Use / Indications for Use

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

### Technological Characteristics

The Piezolith 3000 is comprised of the following principal components: (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; (2) a control console; (3) an X-ray; (4) ultrasound imaging system for localization; and (5) a treatment table.

## Substantial Equivalence

The Piezolith 3000 is substantially equivalent to the other currently marketed lithotripters which are referenced above. The Piezolith 3000 and its predicate devices are all extracorporeal shock wave lithotripters. Thus, the Piezolith 3000 raises no new issues of safety or effectiveness.

## Performance Data

The company performed shock wave characterization measurements, localization accuracy measurements, and road testing. In addition, the Piezolith 3000 system was tested according to and conforms with the following voluntary consensus standards: (1) IEC 60601-1: 1988 with Amdt 1, 1991 and Amdt 2, 1995 "Medical electrical equipment," (2) IEC 60601-1-1: 1992 with Amdt 1, 1995 "Medical electrical equipment; Part 1: General requirements for safety," (3) IEC 60601-1-2: 1993 "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests; 62A/336/FDIS", (4) CISPR 11: 1990 "Limits and Methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment," (5) IEC 60601-2-36: 1997 "Medical electrical equipment: Part 2 Particular requirement for the safety of equipment for extracorporeally induced lithotripsy," and (6) as reference for the measurements: IEC 61846: 1998 "Ultrasonic - Pressure pulse lithotripters -Characteristics of field." In addition, clinical data demonstrated that the device is substantially equivalent to its predicate devices. In all instances, the Piezolith 3000 functioned as intended and performed as expected.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2004

United Medical Systems, Inc. c/o Jeffrey K. Shapiro Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, N.W. WASHINGTON DC 20004-1109

Re: K032958

Trade/Device Name: Piezolith 3000 Lithotripter Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporcal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: December 17, 2003 Received: December 17, 2003

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 (sec 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 (2) 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 Section 510(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notheadon. The PDA miams cassification 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 If you desire specific advice of your do too of the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [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 promote the regulation entitled, "Misbranding Other of Complance at (301) 37 1 185 (21CFR Part 807.97) you may obtain. Other general by relection on your responsibilities under the Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Colless 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

| ్ 10(k) Number (if known): K032958 | |
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United Medical Systems, Inc. Piezolith 3000 Device Name: Lithotripter

The Piezolith 3000 is intended to fragment Indications for Use: urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

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

Over-The-Counter Use (Part 21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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