(90 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical and electrical components for shockwave generation and aiming.
Yes
The device is indicated for the "noninvasive fragmentation of urinary calculi," which is a treatment for a medical condition.
No
Explanation: The device is a lithotripter, used for the noninvasive fragmentation of urinary calculi. This describes a therapeutic, not a diagnostic, function. While it uses imaging (X-Ray, Ultrasound) for aiming, its primary purpose is treatment, not diagnosis.
No
The device description clearly outlines hardware components such as a Shockwave Generator, operator interface/touch panel, coupling cushion, integrated patient table, and mechanisms for aiming. While there is mention of software validation, the device is fundamentally a physical lithotripter system.
Based on the provided information, the STORZ MEDICAL Lithotripter Model Modulith SLK is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is the "noninvasive fragmentation of urinary calculi in the kidney and upper ureter." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a device that generates and focuses shock waves to break up stones within the body. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on biological samples.
Therefore, the STORZ MEDICAL Lithotripter Model Modulith SLK is a therapeutic medical device used for lithotripsy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STORZ MEDICAL Lithotripter Model Modulith SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
Product codes (comma separated list FDA assigned to the subject device)
LNS
Device Description
The Storz Modulith SLK is a modification of the previously cleared Storz Modulith SLK, K011700. The device consists of a Shockwave Generator, an operator interface/touch panel, and a coupling cushion. Shock waves are generated when a rapid current pulse changes the diameter of a cylindrical shaped body. The shock waves are focused by a parabolic reflector. A water circuit is used to for generating the required coupling pressure.
The Modulith SLK has been modified to include an integrated patient table, the Lithotrack optical coupling C-Arm alignment mechanism was replaced with the crosshair manual aiming mechanism used in the Modulith SLX-F2 device (K072788), and an updated user interface that includes patient table movement control. It is intended to be used properly by trained and qualified medical personnel for use in noninvasive fragmentation of urinary calculi in the kidney and the upper ureter. The modifications incorporated do not alter the intended use or the fundamental technology and also does not raise any issues of safety and effectiveness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray, Ultrasound
Anatomical Site
kidney and upper ureter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and qualified medical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Non-Clinical Performance Data: The STORZ MEDICAL Lithotripter Model Modulith SLK has undergone bench testing for its functions and performance, including verification of aiming accuracy, peak positive pressure and energy level of the shockwaves, software validation. Safety testing has been performed per FDA recognized standards IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36 and IEC61846.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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).
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.”)
0
. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Storz Medical AG
2151 E. Grand Avenue
El Segundo, CA 90245 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leigh Spotten
Regulatory Affairs Manager
Phone: (424) 218-8738 |
| Device Identification: | Trade Name:
Storz Modulith SLK
Common Name:
Extracorporeal Shock-Wave Lithotriptor
Classification Name:
Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Date of Preparation | June 7, 2012 |
| Regulation: | 21 CFR 876.5990 |
| Product Code: | LNS |
| Predicate Devices: | Storz Modulith SLK
(K011700, cleared 08/16/2002) |
| Indication: | The STORZ MEDICAL Lithotripter Model Modulith SLK is
indicated for use in the noninvasive fragmentation of urinary calculi
in the kidney and upper ureter. |
| Device Description: | The Storz Modulith SLK is a modification of the previously
cleared Storz Modulith SLK, K011700. The device consists of a
Shockwave Generator, an operator interface/touch panel, and a
coupling cushion. Shock waves are generated when a rapid
current pulse changes the diameter of a cylindrical shaped body.
The shock waves are focused by a parabolic reflector. A water
circuit is used to for generating the required coupling pressure. |
| | The Modulith SLK has been modified to include an integrated
patient table, the Lithotrack optical coupling C-Arm alignment
mechanism was replaced with the crosshair manual aiming
mechanism used in the Modulith SLX-F2 device (K072788),
and an updated user interface that includes patient table
movement control. It is intended to be used properly by trained
and qualified medical personnel for use in noninvasive
fragmentation of urinary calculi in the kidney and the upper
ureter. The modifications incorporated do not alter the intended
use or the fundamental technology and also does not raise any
issues of safety and effectiveness. |
K120769 10f3
JUN 1 9 2012
1
Technological Characteristics:
| Device Name | Storz Modulith SLK
(Subject Device) | Storz Modulith SLK
(Predicate Device ) |
|----------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Not yet assigned | K011700 |
| Intended Use | non-invasive fragmentation
of urinary calculi in the
kidney and upper ureter | identical |
| Transport concept | Wheel based concept | identical |
| Penetration depth | 150 mm | identical |
| Diameter of therapy source | 178 mm | identical |
| Energy levels | 1 to 9 (increments of 1) and
10 to 90 (increments of 5) | identical |
| Positive peak pressure | 17 – 92 MPa | identical |
| Axial dimension of the -6dB focal
volume | 88 – 54 mm | identical |
| Lateral dimension of the-6bD focal
volume | 4.2 – 10 mm | identical |
| Shockwave source positioning
Principle | Movable arm for under and
over the table position of the
therapy head. | Freely articulated arm for
over table positioning of the
therapy head. |
| Type | PCCU (Pulse current and
charging unit) | PCCU (Pulse current and
charging unit) |
| High voltage switch | Thyristor | Thyratron |
| X-Ray Localization Type | External C-arm | identical |
| Alignment control of C-arm | Manual aiming process in
central opening of therapy
head | Optical coupling (Lithotrack) |
| Ultrasound Localization Type | External ultrasound device | identical |
| Localization principle | In-line (in the central
opening of the coil) | identical |
| Transducer | Aloka UST-9102U-3.5 | identical |
| Movements of transducer | Rotation manual, lift
motorized | identical |
| Patient table | Integrated table | Separate table (e.g. TRUMPF
MARS endouro) |
| Max. Patient weight | 225 kg for integrated table | 225 kg for Trumpf MARS
endouro |
| Control panel lithotripsy | Touch screen display. Shock
wave parameters and
controls are all time visible. | Foil keyboard with dot-matrix
character display (shock wave
counter or menu display) and
7 segment displays (for |
| | | energy level, frequency,
cushion level) |
| Table controls | Integrated in touch screen of
the MODULITH SLK | Separated control panel |
| Emergency halt | Emergency halt for table
motions, shock wave release
and cushion inflation | Not available |
2
The shock wave characteristics reported below were measured according to the guideline described in the consensus standard IEC 61846 "Ultrasonics- Pressure pulse lithotriptcrs- Characteristics of fields" (1998). A glass fiber hydrophone was used in the measurements. The results are found similar to the predicate device characteristics
| Parameter | Min | Typical | Max |
|---|---|---|---|
| Peak-positive acoustic pressure (MPa) | 17 | 44 | 92 |
| Peak-negative acoustic pressure (MPa) | 9 | 16 | 20 |
| Rise time (ns) | 700 | 200 | 40 |
| Compressional pulse duration (ns) | 1200 | 670 | 250 |
| Maximum focal width (mm) | 10 | 6.3 | 4.2 |
| Orthogonal focal width (mm) | 10 | 6.3 | 4.2 |
| Focal extent (mm) | 88 | 62 | 54 |
| Focal volume (mm3) | 4.6 | 1.3 | 0.5 |
| Distance between the focus and target | |||
| location (mm) | ≤2.5 | ≤2.5 | ≤2.5 |
| Derived focal acoustic pulse energy (mJ) | 20 | 23 | 23 |
| Derived acoustic pulse energy (mJ) | 5 | 16 | 30 |
| Non-Clinical Performance
Data: | The STORZ MEDICAL Lithotripter Model Modulith SLK has
undergone bench testing for its functions and performance, including
verification of aiming accuracy, peak positive pressure and energy
level of the shockwaves, software validation. Safety testing has
been performed per FDA recognized standards IEC 60601-1, IEC
60601-1-2, IEC 60601-2-36 and IEC61846. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The STORZ MEDICAL Lithotripter Model Modulith SLK is
substantially equivalent to its predicate devices and the non-clinical
testing demonstrates that the device is as safe, as effective, and
performs as well as or better than the legally marketed devices. |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Leigh Spotten Regulatory Affairs Manager Karl Storz Endoscopy - America, Inc. 2151 E. Grand Avenue EL ESGUNDO CA 90245
JUN 1 2 2012
K120769 Re: Trade/Device Name: Modulith SLK Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: May 11, 2012 Received: May 14, 2012
Dear Ms. Spotten:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see 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); medical device reporting (reporting of medical
4
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerély wours.
Benjamin K. Evanko
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for use
K120769
510(k) Number (if known): Not assigned yet
Device Name: Modulith SLK
Indications for use: The STORZ MEDICAL Lithotripter Model Modulith SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
Prescription Use ____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Beulah Kitch 12 June 2012
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
(Urological Devices
510(k) Number K120769