MODULTH SLK

K120769 · KARL STORZ Endoscopy-America, Inc. · LNS · Jun 12, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120769
• Device Name: MODULTH SLK
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Jun 12, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Storz Modulith SLK is an extracorporeal shock-wave lithotriptor for noninvasive fragmentation of urinary calculi in kidney and upper ureter. Device comprises shockwave generator, operator touch panel, coupling cushion, and integrated patient table. Shock waves generated via rapid current pulse changing diameter of cylindrical body; focused by parabolic reflector; water circuit provides coupling pressure. Operated by trained medical personnel in clinical setting. Modifications from predicate include integrated patient table, manual crosshair aiming mechanism (from Modulith SLX-F2), and updated user interface with table controls. Healthcare providers use integrated X-ray (external C-arm) and ultrasound (external transducer) for stone localization. Output is focused acoustic shock waves; clinical benefit is noninvasive stone fragmentation, reducing need for invasive surgery.

Clinical Evidence

Bench testing only. Performance verified per IEC 61846 for acoustic field characteristics (peak positive pressure 17-92 MPa, focal volume 0.5-4.6 mm3). Safety testing performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36. No clinical data presented.

Technological Characteristics

Shockwave generation via electromagnetic pulse (PCCU). Focal depth 150 mm. Energy levels 1-90. Localization via external C-arm (X-ray) and Aloka UST-9102U-3.5 ultrasound transducer. Integrated patient table (max 225 kg). Touch screen interface. Emergency halt for table, shock wave, and cushion. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36, IEC 61846.

Indications for Use

Indicated for noninvasive fragmentation of urinary calculi in the kidney and upper ureter in patients requiring lithotripsy.

Regulatory Classification

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.

Special Controls

*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.”)

Predicate Devices

• Storz Modulith SLK (K011700)

Reference Devices

• Modulith SLX-F2 (K072788)
• TRUMPF MARS endouro

Submission Summary (Full Text)

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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 AG<br>2151 E. Grand Avenue<br>El Segundo, CA 90245 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leigh Spotten<br>Regulatory Affairs Manager<br>Phone: [phone] |
| Device Identification: | Trade Name:<br>Storz Modulith SLK<br>Common Name:<br>Extracorporeal Shock-Wave Lithotriptor<br>Classification Name:<br>Lithotriptor, Extracorporeal Shock-Wave, Urological |
| Date of Preparation | June 7, 2012 |
| Regulation: | 21 CFR 876.5990 |
| Product Code: | LNS |
| Predicate Devices: | Storz Modulith SLK<br>(K011700, cleared 08/16/2002) |
| Indication: | The STORZ MEDICAL Lithotripter Model Modulith SLK is<br>indicated for use in the noninvasive fragmentation of urinary calculi<br>in the kidney and upper ureter. |
| Device Description: | The Storz Modulith SLK is a modification of the previously<br>cleared Storz Modulith SLK, K011700. The device consists of a<br>Shockwave Generator, an operator interface/touch panel, and a<br>coupling cushion. Shock waves are generated when a rapid<br>current pulse changes the diameter of a cylindrical shaped body.<br>The shock waves are focused by a parabolic reflector. A water<br>circuit is used to for generating the required coupling pressure. |
| | The Modulith SLK has been modified to include an integrated<br>patient table, the Lithotrack optical coupling C-Arm alignment<br>mechanism was replaced with the crosshair manual aiming<br>mechanism used in the Modulith SLX-F2 device (K072788),<br>and an updated user interface that includes patient table<br>movement control. It is intended to be used properly by trained<br>and qualified medical personnel for use in noninvasive<br>fragmentation of urinary calculi in the kidney and the upper<br>ureter. The modifications incorporated do not alter the intended<br>use or the fundamental technology and also does not raise any<br>issues of safety and effectiveness. |

K120769 10f3

JUN 1 9 2012

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## Technological Characteristics:

| Device Name | Storz Modulith SLK<br>(Subject Device) | Storz Modulith SLK<br>(Predicate Device ) |
|----------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Not yet assigned | K011700 |
| Intended Use | non-invasive fragmentation<br>of urinary calculi in the<br>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<br>10 to 90 (increments of 5) | identical |
| Positive peak pressure | 17 – 92 MPa | identical |
| Axial dimension of the -6dB focal<br>volume | 88 – 54 mm | identical |
| Lateral dimension of the-6bD focal<br>volume | 4.2 – 10 mm | identical |
| Shockwave source positioning<br>Principle | Movable arm for under and<br>over the table position of the<br>therapy head. | Freely articulated arm for<br>over table positioning of the<br>therapy head. |
| Type | PCCU (Pulse current and<br>charging unit) | PCCU (Pulse current and<br>charging unit) |
| High voltage switch | Thyristor | Thyratron |
| X-Ray Localization Type | External C-arm | identical |
| Alignment control of C-arm | Manual aiming process in<br>central opening of therapy<br>head | Optical coupling (Lithotrack) |
| Ultrasound Localization Type | External ultrasound device | identical |
| Localization principle | In-line (in the central<br>opening of the coil) | identical |
| Transducer | Aloka UST-9102U-3.5 | identical |
| Movements of transducer | Rotation manual, lift<br>motorized | identical |
| Patient table | Integrated table | Separate table (e.g. TRUMPF<br>MARS endouro) |
| Max. Patient weight | 225 kg for integrated table | 225 kg for Trumpf MARS<br>endouro |
| Control panel lithotripsy | Touch screen display. Shock<br>wave parameters and<br>controls are all time visible. | Foil keyboard with dot-matrix<br>character display (shock wave<br>counter or menu display) and<br>7 segment displays (for |
| | | energy level, frequency,<br>cushion level) |
| Table controls | Integrated in touch screen of<br>the MODULITH SLK | Separated control panel |
| Emergency halt | Emergency halt for table<br>motions, shock wave release<br>and 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 target<br>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<br>Data: | The STORZ MEDICAL Lithotripter Model Modulith SLK has<br>undergone bench testing for its functions and performance, including<br>verification of aiming accuracy, peak positive pressure and energy<br>level of the shockwaves, software validation. Safety testing has<br>been performed per FDA recognized standards IEC 60601-1, IEC<br>60601-1-2, IEC 60601-2-36 and IEC61846. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The STORZ MEDICAL Lithotripter Model Modulith SLK is<br>substantially equivalent to its predicate devices and the non-clinical<br>testing demonstrates that the device is as safe, as effective, and<br>performs 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 [phone] or [phone] 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