MODULARIS Variostar 510(k) K070799

Siemens Medical Solutions USA, Inc.

510 (k) Summary

Submitter's information
Name
Siemens Medical Solutions, Inc. USA
51 Valley Stream Parkway, MS E50
Malvern, PA 19355
Contact Person:
Name: Kim Rend'n
Title: Regulatory Affairs
Phone: (610) 4484773
Fax: (610) 448-1787
E-mail: [email protected]

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 C-
arm 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

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 Chs, a patient table, and an ECG device.
MODULARIS Variostar 510(k) K070799
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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
MODULARIS Variostar 510(k) K070799
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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 I 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
MODULARIS Variostar 510(k) K070799
Siemens Medical Solutions USA, Inc. i.

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 Hrematuria
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
MODULARIS Variostar 510(k) K070799
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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 - 70% 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
pyelonephritis 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 0C) 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/intrarenal) - 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-temi 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.
S44 DEPARTMENT OFHEALTH &HLUMAN SERVICES Public Health Service

Food and Drug Administration

9200 Corporate Boulevard
Rockville MD 20850
NOV - I 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 Ill (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.
Page 2

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 (800) 638-2041 or
(240) 276-3150 or at its Internet address http://ww.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon
Director, Division of Reproductive,
Abdominal, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure
MOI'ULARIS Variostar 510(k) K070799
Siemens Medical Solutions USA, Inc.

Indications for Use Statement

510(k) Number (if known): K070799

Device Name: MODULARIS Variostar

Indicrations for Use:

MODULARIS Variostar is a lithotripter device designed to treat urolithiasis with extracorporeal

shocLk; wave lithotripsy (ESWL) when used as part of the modular platform, MODULARIS.

Thedevice may be used in two separate configurations. Both configurations are designed to support
urolcgic procedures within the scope of urolitlhiasis and may be used in a mobile-use environment.

Each configuration includes: the lithotripter MODULARIS Variostar with shockwave head Cplus, a
pati,.:nt 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
stores, 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 AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (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)

(Di ion Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices ,-,©Page _ of
510(k) Number