(90 days)
The STORZ MEDICAL Lithotripter Model Modulith SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
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.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided document is a 510(k) Summary for a medical device called the "Storz Modulith SLK," which is an extracorporeal shock-wave lithotriptor. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the way a novel AI algorithm might.
Therefore, the requested information elements related to AI algorithm performance (such as sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for training) are not applicable to this type of submission. This document describes a modification to an existing, cleared device, and the focus is on physical and technical equivalence.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this conventional medical device submission are primarily based on demonstrating that the modified device has substantially equivalent technological characteristics and performance to its predicate device, and that the modifications do not raise new issues of safety or effectiveness.
Here's the table of core technological characteristics and performance parameters, comparing the subject device to its predicate:
Table 1: Acceptance Criteria and Reported Device Performance (Technological Characteristics)
| Characteristic | Acceptance Criterion (Predicate Device Performance) | Reported Device Performance (Subject Device) |
|---|---|---|
| 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 -6dB focal volume | 4.2 – 10 mm | identical |
| Shockwave source positioning Principle | Freely articulated arm for over table positioning of the therapy head. | Movable arm for under and over the table position of the therapy head. |
| Type (PCCU) | PCCU (Pulse current and charging unit) | PCCU (Pulse current and charging unit) |
| High voltage switch | Thyratron | Thyristor |
| X-Ray Localization Type | External C-arm | identical |
| Alignment control of C-arm | Optical coupling (Lithotrack) | Manual aiming process in central opening of therapy head |
| 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 | Separate table (e.g. TRUMPF MARS endouro) | Integrated table |
| Max. Patient weight | 225 kg for Trumpf MARS endouro | 225 kg for integrated table |
| Control panel lithotripsy | Foil keyboard with dot-matrix character display (shock wave counter or menu display) and 7 segment displays (for energy level, frequency, cushion level) | Touch screen display. Shock wave parameters and controls are all time visible. |
| Table controls | Separated control panel | Integrated in touch screen of the MODULITH SLK |
| Emergency halt | Not available | Emergency halt for table motions, shock wave release and cushion inflation |
In addition to technological characteristics, specific shock wave acoustic parameters were measured:
Table 2: Acceptance Criteria and Reported Device Performance (Shock Wave Acoustic Parameters)
| Parameter | Min (Acceptance Criterion) | Typical (Reported) | Max (Acceptance Criterion) |
|---|---|---|---|
| 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 |
The document states: "The results are found similar to the predicate device characteristics," implying that these measured values meet the "acceptance criteria" of being comparable to the predicate.
The Study that Proves the Device Meets Acceptance Criteria
The study described is a non-clinical performance and safety testing focused on demonstrating substantial equivalence.
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Sample size used for the test set and the data provenance: Not applicable. This is not a study involving patient data or images to test an algorithm. It's bench testing of a physical device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance (e.g., pressure measurements) is established by calibrated instruments and engineering standards, not expert radiologists.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical characteristics and acoustic parameters: Measurement against established engineering standards and specifications. The shock wave characteristics 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 for measurements.
- For safety: Compliance with recognized safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36, and IEC61846).
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The sample size for the training set: Not applicable. This is not an AI device (no training set).
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How the ground truth for the training set was established: Not applicable.
In summary, the study described is a comprehensive bench testing and safety evaluation, rather than a clinical trial or an AI performance study. The "acceptance criteria" are the established performance parameters of the predicate device and relevant industry standards for safety and acoustic measurements. The "study" consisted of performing these measurements and tests on the modified device to confirm its equivalence and adherence to safety requirements.
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. 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 AG2151 E. Grand AvenueEl Segundo, CA 90245 |
|---|---|
| Contact: | Leigh SpottenRegulatory Affairs ManagerPhone: (424) 218-8738 |
| Device Identification: | Trade Name:Storz Modulith SLKCommon Name:Extracorporeal Shock-Wave LithotriptorClassification 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 isindicated for use in the noninvasive fragmentation of urinary calculiin the kidney and upper ureter. |
| Device Description: | The Storz Modulith SLK is a modification of the previouslycleared Storz Modulith SLK, K011700. The device consists of aShockwave Generator, an operator interface/touch panel, and acoupling cushion. Shock waves are generated when a rapidcurrent pulse changes the diameter of a cylindrical shaped body.The shock waves are focused by a parabolic reflector. A watercircuit is used to for generating the required coupling pressure. |
| The Modulith SLK has been modified to include an integratedpatient table, the Lithotrack optical coupling C-Arm alignmentmechanism was replaced with the crosshair manual aimingmechanism used in the Modulith SLX-F2 device (K072788),and an updated user interface that includes patient tablemovement control. It is intended to be used properly by trainedand qualified medical personnel for use in noninvasivefragmentation of urinary calculi in the kidney and the upperureter. The modifications incorporated do not alter the intendeduse or the fundamental technology and also does not raise anyissues of safety and effectiveness. |
K120769 10f3
JUN 1 9 2012
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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 fragmentationof urinary calculi in thekidney 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) and10 to 90 (increments of 5) | identical |
| Positive peak pressure | 17 – 92 MPa | identical |
| Axial dimension of the -6dB focalvolume | 88 – 54 mm | identical |
| Lateral dimension of the-6bD focalvolume | 4.2 – 10 mm | identical |
| Shockwave source positioningPrinciple | Movable arm for under andover the table position of thetherapy head. | Freely articulated arm forover table positioning of thetherapy head. |
| Type | PCCU (Pulse current andcharging unit) | PCCU (Pulse current andcharging unit) |
| High voltage switch | Thyristor | Thyratron |
| X-Ray Localization Type | External C-arm | identical |
| Alignment control of C-arm | Manual aiming process incentral opening of therapyhead | Optical coupling (Lithotrack) |
| Ultrasound Localization Type | External ultrasound device | identical |
| Localization principle | In-line (in the centralopening of the coil) | identical |
| Transducer | Aloka UST-9102U-3.5 | identical |
| Movements of transducer | Rotation manual, liftmotorized | identical |
| Patient table | Integrated table | Separate table (e.g. TRUMPFMARS endouro) |
| Max. Patient weight | 225 kg for integrated table | 225 kg for Trumpf MARSendouro |
| Control panel lithotripsy | Touch screen display. Shockwave parameters andcontrols are all time visible. | Foil keyboard with dot-matrixcharacter display (shock wavecounter or menu display) and7 segment displays (for |
| energy level, frequency,cushion level) | ||
| Table controls | Integrated in touch screen ofthe MODULITH SLK | Separated control panel |
| Emergency halt | Emergency halt for tablemotions, shock wave releaseand cushion inflation | Not available |
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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 targetlocation (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 PerformanceData: | The STORZ MEDICAL Lithotripter Model Modulith SLK hasundergone bench testing for its functions and performance, includingverification of aiming accuracy, peak positive pressure and energylevel of the shockwaves, software validation. Safety testing hasbeen performed per FDA recognized standards IEC 60601-1, IEC60601-1-2, IEC 60601-2-36 and IEC61846. |
|---|---|
| Conclusion: | The STORZ MEDICAL Lithotripter Model Modulith SLK issubstantially equivalent to its predicate devices and the non-clinicaltesting demonstrates that the device is as safe, as effective, andperforms as well as or better than the legally marketed devices. |
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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
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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
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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
§ 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.”)