MODULARIS VARIOSTAR

K070799 · Siemens Medical Solutions USA, Inc. · LNS · Nov 1, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070799
• Device Name: MODULARIS VARIOSTAR
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Nov 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MODULARIS Variostar is a lithotripter device designed to treat urolithiasis with extracorporeal shock wave lithotripsy (ESWL) when used as part of the modular platform, MODULARIS. The device may be used in two separate configurations. Both configurations are designed to support urologic procedures within the scope of urolithiasis and may be used in a mobile-use environment. Each configuration includes: the lithotripter MODULARIS Variostar with shockwave head, a patient table, and an ECG device. One configuration would include a mobile C-arm to provide the imaging and positioning of the shockwave focus to the urinary tract stones. This configuration may be used to treat renal calyceal stones, renal pelvis stones, and ureteral stones. A second configuration would include an ultrasound system to provide the imaging and positioning of the shockwave focus to the urinary tract stones. For this configuration, the indication for use is limited to the fragmentation of kidney and upper ureteral stones only.

Device Story

MODULARIS Variostar is an extracorporeal shockwave lithotripter for urolithiasis treatment; utilizes modular platform including patient table, shockwave head, and ECG device. Operates via two configurations: 1) mobile C-arm for fluoroscopic imaging/positioning; 2) ultrasound system for imaging/positioning. Physician operates system to focus shockwaves on urinary tract stones; ECG gating available to synchronize shockwave delivery with cardiac cycle to prevent arrhythmias. Used in stationary or mobile clinical environments. Output is fragmentation of kidney/ureteral stones; clinical benefit is non-invasive stone removal. Healthcare providers use imaging to guide focus; monitor patient cardiac status during procedure. System requires prophylactic antibiotics for specific patient populations (e.g., cardiac disease, immunosuppression, diabetes).

Clinical Evidence

Confirmatory clinical study suggests the device is safe and effective for treating urinary tract stones. No specific sample size or statistical metrics provided in the summary.

Technological Characteristics

Extracorporeal shockwave lithotripter; modular design with patient table, shockwave head, and ECG device. Imaging via mobile C-arm (fluoroscopy) or ultrasound. Shockwave parameters compliant with K033337 guidance. Features ECG-gated shockwave delivery mode for cardiac safety.

Indications for Use

Indicated for patients with urolithiasis requiring extracorporeal shock wave lithotripsy (ESWL). Configurations support treatment of renal calyceal, renal pelvis, and ureteral stones. Contraindicated in pregnancy, coagulation abnormalities, patients on anticoagulants, arterial calcification/aneurysm in shockwave path, distal urinary tract obstruction, or anatomy precluding focus (e.g., severe obesity, spinal curvature).

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

• LITHOSTAR Modularis

Submission Summary (Full Text)

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# MODULARIS Variostar 510(k) Siemens Medical Solutions USA, Inc.

### K070799

PG / ti- 5

## 510 (k) Summary

### Submitter's information

Name

Siemens Medical Solutions, Inc. USA 51 Vallev Stream Parkway, MS E50 Malvern, PA 19355 Contact Person: Kim Rendon Name: Title: Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: Kimberley.rendon(@siemens.com

Date summary prepared 10/30/2007

### Device names

Trade Name: MODULARIS Variostar

Common or Classification Name: Extracorporeal shockwave lithotripter

# Legally marketed device to which the device is substantially equivalent

LITHOSTAR Modularis

### Description of device

Siemens MODULARIS Variostar is a modified lithotripter featuring a patient table, a Carm with X-ray tube assembly attached to one end, an image intensifier to the other end and a shockwave system adjacent to the x-ray tube. The shockwave system can be coupled with the patient in various positions providing a high flexibility. For positioning of the shockwave focus there will be fluoroscopy and ultrasound imaging provided. The system is intended for stationary and trans-mobile use.

### Indications for Use

MODUL ARIS Variostar is a lithotripter device designed to treat urolithiasis with extracorporeal shock wave lithotripsy (ESWL) when used as part of the modular platform, MODULARIS.

The device may be used in two separate configurations. Both configurations are designed to support urologic procedures within the scope of urolithiasis and may be used in a mobile-use environment.

Each configuration includes: the lithotripter MODULARIS Variostar with shockwave head Colus, a patient table, and an ECG device.

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One configuration would include a mobile C-arm to provide the imaging and positioning of the shockwave focus to the urinary tract stones. This configuration may be used to treat renal calyceal stones, renal pelvis stones, and ureteral stones.

A second configuration would include an ultrasound system to provide the imaging and positioning of the shockwave focus to the urinary tract stones. For this configuration, the indication for use is limited to the fragmentation of kidney and upper ureteral stones only.

# Contraindications

Do not use the MODULARIS Variostar in patients with:

- Confirmed or suspected pregnancy. .
- Coagulation abnormalities (as indicated by abnormal prothrombin time, partial . thromboplastin time, or bleeding time) or those currently receiving anticoagulants (including aspirin).
- . Arterial calcification or vascular aneurysm in the lithotripter's shockwave path,
- Urinary tract obstruction distal to the stone. ◆
- Anatomy which precludes focusing the device at the target stone, such as severe . obesity or excessive spinal curvature.

# Warnings, Precautions, Adverse Events

## Warnings

#### . Anticoagulants:

Patients receiving anticoagulants (including aspirin) should temporarily discontinue such medication prior to extracorporeal shock wave lithotripsy to prevent severe hemorrhage.

- . Cardiac monitoring:
Always perform cardiac monitoring during lithotripsy treatment, since the use of extracorporeal shock wave lithotripsy has been reported to cause ventricular cardiac arrhythmias in some individuals.

This warning is especially important for patients who may be at risk of cardiac arrhythmia due to a history of cardiac irregularities or heart failure.

#### . Pacemaker or implantable defibrillator:

To reduce the incidence of malfunction to a pacemaker or implantable defibrillator, the pulse generator should be programmed to a single chamber, non-rate responsive mode (pacemakers) or an inactive mode (implantable defibrillators) prior to lithotripsy, and evaluated for proper function post-treatment. Do not focus the lithotripter's shock wave through or near the pulse generator.

- . Infected stones: Prophylactic antibiotics should be administered prior to treatment whenever the possibility of stone infection exists. Extracorporeal shock wave lithotripsy treatment of pathogen-harboring calculi could result in systemic infection.
- . Cardiac disease, immunosuppression, and diabetes mellitus: Prophylactic antibiotics should be administered prior to extracorporeal shock

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wave lithotripsy treatment to patients with cardiac disease (including valvular disease), immunosuppression, and diabetes mellitus, to prevent bacterial and/ or subacute endocarditis.

- . Bilateral stones:
Do not perform bilateral treatment of kidney stones in a single treatment session, because either bilateral renal injury or total urinary tract obstruction by stone fragments may result. Patients with bilateral kidney stones should be treated using a separate treatment session for each side. In the event of total urinary obstruction, corrective procedures may be needed to assure drainage of urine from the kidney.

#### . Air-filled interfaces in shock wave path:

Do not apply shock waves to air-filled areas of the body, i.e., intestines or lungs. Shock waves are rapidly dispersed by passage through an air-filled interface, which can cause bleeding and other harmful side effects.

#### Cardiac arrhythmia during treatment: .

If a patient experiences cardiac arrhythmia during treatment at a fixed shock wave repetition rate, shock wave delivery should either be terminated or switched to an ECG-gated mode (i.e., delivery of the shock wave during the refractory period of the patient's cardiac cycle). As a general practice, patients with a history of cardiac arrhythmia should be treated in the ECG-gated mode.

# Precautions

#### . Impacted or embedded stones:

The effectiveness of extracorporeal shock wave lithotripsy may be limited in patients with impacted or embedded stones. Alternative procedures are recommended for these patients.

- . Staghorn stones:
The effectiveness of extracorporeal shock wave lithotripsy may be limited in patients with either staghorn or large (> 20 mm in largest dimension) stones. Alternative procedures are recommended for these patients.

- . Small ureteral stones:
Small middle and lower ureteral stones, 4 to 6 mm in largest dimension, are likely to pass spontaneously. Therefore, the risks and benefits of extracorporeal shock wave lithotripsy should be carefully assessed in this patient population.

- . Renal injury:
To reduce the risk of injury to the kidney and surrounding tissues, it is recommended that:

the number of shock waves administered during each treatment session be minimized:

retreatment to the same kidney/anatomical site occur no sooner than 1 month after the initial treatment;

each kidney/anatomical site be limited to a total of three treatment sessions.

#### . Use of fluoroscopy:

While fluoroscopy must be used during the procedure, caution should be used to minimize the exposure.

#### . Electromagnetic interference:

If electromagnetic interference between the extracorporeal shock wave lithotripter

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and nearby electronic equipment is suspected (as evidenced by erratic behavior with either device), it is recommended that their distance be increased until proper operation resumes. If it is necessary to operate an electronic device in close proximity to the lithotripsy system during treatment, the device and the lithotripter should be tested for proper simultaneous operation prior to clinical use.

#### . Radiographic follow-up:

All patients should be followed radiographically after treatment until stone-free or there are no remaining stone fragments which are likely to cause silent obstruction and loss of renal function.

Electrical shock hazard. .

> Never remove any of the cabinet covers to the system's electronics. The high voltage power supply circuits utilized by extracorporeal shock wave lithotripters use voltages that are capable of causing serious injury or death from electric shock.

### Adverse Events

Potential adverse events associated with the use of extracorporeal shock wave lithotripsy include those listed below, categorized by frequency and individually described:

Commonly reported (> 20% of patients)

o Hematuria

o Pain/renal colic

o Skin redness at shock wave entry side

Occasionally reported (1 - 20% of patients)

o Cardiac arrhythmia

- o Urinary tract infection
o Urinary obstruction/steinstrasse

o Skin bruising at shock wave entry side

o Fever (> 38°C)

o Nausea/vomiting

Infrequently reported (< 1% of patients)

o Hematoma (perirenal/intrarenal)

o Renal injury

Hematuria occurs following most treatments, is believed to be secondary to trauma to the renal parenchyma, and usually resolves spontaneously within 24 to 48 hours of treatment.

Pain/renal colic commonly occurs during and immediately after treatment, and typically resolves spontaneously. Temporary pain/renal colic may also occur secondary to the passage of stone fragments, and can be managed with medication.

Skin redness at shockwave entry site commonly occurs during and immediately after treatment, and typically resolves spontaneously.

Cardiac arrhythmia, most commonly premature ventricular contractions, are generally reported during extracorporeal shock wave lithotripsy at fixed shock wave delivery in 2 to 20% of patients. These cardiac disturbances rarely pose a serious risk to the healthy

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patient, and typically resolve spontaneously upon synchronizing the shock waves with the refractory period of the ventricular cycle (i.e., ECG gating) or terminating treatment. Urinary tract infection Urinary tract infection (UTI) occurs in 1 - 7% of patients following extracorporeal shock wave lithotripsy as a result of the release of bacteria from the fragmentation of infected calculi, and infrequently results in pvelonephritis or sepsis.

The risk of infectious complications secondary to extracorporeal shock wave lithotripsy can be minimized through the use of prophylactic antibiotics in patients with UTI and infection stones.

Urinary obstruction/steinstrasse occurs in up to 6% of patients following lithotripsy due to stone fragments becoming lodged in the ureter, and may be the result of either a single stone fragment or the accumulation of multiple small stone particles (i.e., steinstrasse). Patients with urinary obstruction typically present with persistent pain, and may be at risk of developing hydronephrosis with subsequent renal failure if the obstruction is not promptly treated. Intervention is necessary if the obstructing fragments do not pass spontaneously.

Skin bruising at shock wave entry site occasionally occurs after treatment, and typically resolves spontaneously.

Fever (> 38℃) is occasionally reported after lithotripsy, and may be secondary to infection.

Nausea/vomiting - Transient nausea and vomiting are occasionally reported immediately after lithotripsy, and may be associated with either pain or the administration of sedatives or analgesia.

Hematoma (perirenal/intrarena}} - Clinically significant intrarenal or perirenal hematomas occur in < 1% of lithotripsy treatments. These patients typically present with severe, chronic flank pain. Although clinically significant hematomas often resolve with conservative management, severe hemorrhage and death have been reported. Management of severe renal hemorrhage includes the administration of blood transfusions, percutaneous drainage, or surgical intervention.

Renal injury - Extracorporeal shock wave lithotripsy procedures have been known to cause damage to the treated kidney. The potential for injury, its long-term significance, and its duration are unknown.

- A. Technological characteristics
The modification has not altered the fundamental technology of the predicate device.

- B. Assessment of non-clinical performance data
Device shockwave parameters were measured and documented according to Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shockwave Lithotripters in K033337. MODULARIS Variostar features the same shockwave head and generator as the predicate device LITHOSTAR Modularis.

- C. Assessment of clinical performance data
The confirmatory clinical study suggests that treatment of urinary tract stones with the MODULARIS Variostar is safe and effective.

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Image /page/5/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 that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2007

Ms. Kim Rendon Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K070799

Trade/Device Name: MODULARIS Variostar Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: September 27, 2007 Received: September 28, 2007

## Dear Ms. Rendon:

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 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.

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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/cdrh/industry/support/index.html.

Sincerely yours.

Nancy 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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MOINULARIS Variostar 510(k) Siemens Medical Solutions USA, Inc.

# Indications for Use Statement

510(k) Number (if known): K070799

Device Name: MODULARIS Variostar

Indications for Use:

MO!DULARIS Variostar is a lithotripter device designed to treat urolithiasis with extracorporeal shock wave lithotripsy (ESWL) when used as part of the modular platform, MODULARIS.

The device may be used in two separate configurations. Both configurations are designed to support urologic procedures within the scope of urolithiasis and may be used in a mobile-use environment.

Each configuration includes: the lithotripter MODULARIS Variostar with shockwave head Cynass a pationt table, and an ECG device.

One configuration would include a mobile C-arm to provide the imaging and positioning of the shockwave focus to the urinary tract stones. This configuration may be used to treat renal calyccal stones, renal pelvis stones, and ureteral stones.

A second configuration would include an ultrasound system to provide the imaging and positioning of the shockwave focus to the urinary tract stones. For this configuration, the indication for use is limited to the fragmentation of kidney and upper ureteral stones only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lmmhthy
(Division Sign-Off)

n Sian-Of Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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