(298 days)
Dornier Lithotripter S
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No
The summary describes a traditional lithotripsy system with imaging guidance (fluoroscopy and ultrasound) and does not mention any AI/ML components or capabilities.
Yes
The device is intended for the fragmentation of urinary tract stones, which is a therapeutic intervention aimed at treating a medical condition.
No.
The device is primarily designed for fragmentation of urinary tract stones (therapeutic), and facilitates urological and diagnostic procedures, rather than being solely a diagnostic device itself.
No
The device description clearly outlines hardware components such as a patient table, C-arm with X-ray tube, image intensifier, and shockwave system, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LITHOSKOP is a "urologic procedures system primarily designed for the fragmentation of urinary tract stones... by extracorporeal shock wave lithotripsy (ESWL)." It also facilitates "urological and diagnostic procedures." This describes a device used on the patient for treatment and imaging, not a device used to examine specimens from the patient.
- Device Description: The description details a system with a patient table, C-arm with X-ray and image intensifier, and a shockwave system. These are components of a medical device used for imaging and treatment within the body, not for analyzing biological samples.
- Anatomical Site: The anatomical sites mentioned (urinary tract, renal calyx, renal pelvis, ureteral) are locations within the patient's body where the device is used directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the LITHOSKOP is a therapeutic and diagnostic imaging device used directly on the patient, not a device used to perform tests on samples outside of the body, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
LITHOSKOP is a urologic procedures system primarily designed for the fragmentation of urinary tract stones, such as renal calyx stones and renal pelvis stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
Product codes
LNS
Device Description
Siemens LITHOSKOP is a new 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 a 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 use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy and ultrasound imaging
Anatomical Site
urinary tract, renal calyx, renal pelvis, ureteral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
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 LITHOSKOP is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dornier Lithotripter S
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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K070665 5
510 (k) Summary
Submitter's information
Name
Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway, MS E50 Malvern, PA 19355
JAN - 4 2008
Contact Person:
| Name: | Kim Rendon |
|---|---|
| Title: | Regulatory Affairs Specialist |
| Phone: | (610) 448-1773 |
| Fax: | (610) 448-1787 |
| E-mail: | Kimberly.rendon@siemens.com |
Date summary prepared 11/08/2007
Device names
Trade Name: LITHOSKOP
Common or Classification Name: Extracorporeal shockwave lithotripter
Legally marketed device to which the device is substantially equivalent
Dornier Lithotripter S
Description of device
Siemens LITHOSKOP is a new 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 a 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 use.
Indications for Use
LITHOSKOP is a urologic procedures system primarily designed for the fragmentation of urinary tract stones, such as renal calyx stones and renal pelvis stones and for upper, middle and lower ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
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Contraindications
Do not use the LITHOSKOP 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 posttreatment. 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 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.
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. 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 iniury: .
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 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
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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°C) is occasionally reported after lithotripsy, and may be . secondary to infection.
- . Nausea/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