(223 days)
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No
The document describes a lithotripter device that uses fluoroscopy and ultrasound for imaging and positioning. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
Yes
The device is a lithotripter designed to treat urolithiasis with extracorporeal shock wave lithotripsy (ESWL), which fits the description of a therapeutic device as it directly treats a medical condition.
No
Explanation: The device is described as a lithotripter designed to treat urolithiasis with extracorporeal shock wave lithotripsy (ESWL), which is a therapeutic procedure involving the fragmentation of stones. While it uses imaging for positioning, its primary function is treatment, not diagnosis.
No
The device description explicitly states it includes hardware components such as a lithotripter, patient table, ECG device, C-arm, X-ray tube assembly, image intensifier, and shockwave system.
Based on the provided information, the MODULARIS Variostar is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- MODULARIS Variostar Function: The MODULARIS Variostar is a lithotripter. Its function is to treat kidney and ureteral stones using extracorporeal shock wave lithotripsy (ESWL). It uses imaging (fluoroscopy and ultrasound) to locate the stones and then delivers shock waves to break them up within the body.
The device operates directly on the patient's body to treat a condition, rather than analyzing samples taken from the body. Therefore, it falls under the category of a therapeutic medical device, not an IVD.
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Intended 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.
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.
Product codes
LNS
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
fluoroscopy, ultrasound imaging, mobile C-arm, ultrasound system
Anatomical Site
urinary tract stones, renal calyceal stones, renal pelvis stones, ureteral stones, kidney, upper ureteral stones
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The confirmatory clinical study suggests that treatment of urinary tract stones with the MODULARIS Variostar is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LITHOSTAR Modularis
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
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.(b)
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.”)
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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: (610) 448-1773 Fax: (610) 448-1787 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.
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. 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 ( 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