EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER

K130729 · Dornier Medtech Systems · LNS · May 14, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130729
• Device Name: EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
• Applicant: Dornier Medtech Systems
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: May 14, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gemini FPD is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Device Story

Gemini FPD is a modular urological workstation for extracorporeal shock wave lithotripsy (ESWL) and diagnostic/therapeutic urological procedures. System components include a basic unit with integrated X-ray C-arm and therapy arm, patient table, and control desk. Device utilizes an electromagnetic shock wave emitter (EMSE) to generate shock waves for stone fragmentation. Imaging is provided by an integrated X-ray unit featuring a flat panel detector (FPD) and high-resolution camera chain. Operated by clinicians in a clinical setting, the system allows for positioning of the stone in the shock wave focus via longitudinal, lateral, and vertical table movement. The image processing system supports DICOM 3 and PACS connectivity for image handling and X-ray control. Output consists of fluoroscopic anatomical images used by the physician to guide stone fragmentation, facilitating non-invasive treatment of urinary calculi.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, design specifications, and compliance with recognized international standards (IEC 60601 series, ISO 13485, IEC 61846).

Technological Characteristics

Modular urological workstation; electromagnetic shock wave emitter (EMSE); fluoroscopic X-ray system with flat panel detector (FPD); DICOM 3 connectivity. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-36, IEC 60601-2-32, ISO 13485, and IEC 61846.

Indications for Use

Indicated for fragmentation of urinary tract stones, including renal calyceal, renal pelvic, and upper ureteral stones 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

• Dornier Gemini Lithotripter (K121656)
• Dornier Genesis (K122768)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 510(k) SUMMARY Gemini FPD Lithotripter

# MAY 1 4 2013

## Submitter's Name. Address, Telephone Number. Contact Person and Date Prepared

Dornier MedTech America Phone: [phone] Roberts Blvd. 770-514-6291 -Fax: Date Prepared: April 9, 2013 Kennesaw, GA 30144

Contact Person: John Hoffer

Phone: [phone]

# Name of Device and Name/Address of Sponsor Gemini FPD 1155 Roberts Blvd.

Kennesaw. GA 30144

Common or Usual Name Shock Wave Lithotripter

#### Classification Name

According to 21 C.F.R. § 876.5990, FDA has classified extracorporeal shock wave lithotripters as Class II devices with special controls. The Product Code for these lithotripters is LNS.

#### Predicate Devices

Dornier Gemini Lithotripter (K121656) Dornier Genesis (K 122768) FPD system

#### Purpose of the Special 510(k) Notice

The Gemini FPD is a modification to Dornier's Gemini Lithotripter (K121656).

#### Intended Use

The Gemini FPD is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

#### Device Description

The Gemini FPD is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology.

The Gemini FPD is composed of the following modules:

- Basic Unit with integrated X-ray C-arm and Therapy Arm for Shockwave Treatment: .
- Patient Table: .
- Control Desk User Interface; and .

The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.

The therapy and X-Ray C-arm house the shock wave source (*EMSE'') and the complete X-ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube. the FPD image receptor module, and a high resolution camera imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures.

The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.

{1}------------------------------------------------

The Gemini FPD's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures. It is the same as in the predicate device.

The image processing system with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.

#### Standards

The Gemini FPD device as well as the predicate device complies to all the standards (non-clinical) listed below:

| IEC 60601-1:2005 | Electrical safety of medical devices |
|------------------------|-----------------------------------------------------------------------|
| IEC60601-1-2:2007 | Electromagnetic compatibility |
| IEC 60601-1-3:2008 | Radiation Protection |
| IEC 60601-1-6:2006 | Usability |
| IEC 60601-2-7:1998 | Safety of High-Voltage Generators of Diagnostic x-ray Generator |
| IEC 60601-2-28:1993 | Particular Requirements for the Safety of X-ray Source Assemblies and |
| | X-ray Tube Assemblies for Medical Diagnosis |
| IEC 60601-2-36:1997 | Extracorporeally induced Lithotripsy |
| IEC 60601-2-32:1994 | Safety of x-ray equipment |
| ISO 13485:2003+AC:2007 | Quality Management System |
| IEC 61846 | Ultrasonics - Pressure pulse lithotripters characteristic of fields |

Thev also comply with all of the requirements described in FDA's Guidance for the Content of Premarket Notifications (510k's) for Extracorporeal Shock Wave Lithoripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.

#### Substantial Equivalence

The Gemini FPD has similar technological characteristics as the predicate FDA-cleared Gemini Lithotripter (K121656), to which it is a modification. The Gemini are extracorporeal shock wave lithotripters used for fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones. The technology to perform this function involves use of an electromagnetic shock wave emitter ("EMSE"). In the case of the subject device and the cleared product. the identical shock wave source is used as well as all supporting electronics. The other elements of the

Gemini FPD, i.e., the patient table and the X-ray unit, are the same as that of the Gemini (K121656). They perform the same function and operate in the same manner during the procedures involved in the fragmenting of urological stones.

The subject and predicate devices utilize fluoroscopic X-ray systems. Specifically, the Genini uses a solid state Image Intensifier to capture the X-ray image while the Gemini FPD uses a flat panel detector to receive X-ray radiation beams in order to produce anatomical images of adequate resolution for diagnostic/treatment purposes. The flat panel detector used in the subject device is identical to the system used in the cleared Dornier Genesis (K122768). The X-ray source for the Gemini FPD is unchanged from the cleared predicate device.

From a clinical perspective and comparing design specifications, the Gemini FPD and the predicate devices are substantially equivalent and have the same intended use.

Dornier MedTech America, Inc. believes the minor differences do not raise any concerns regarding the overall safety or effectiveness. Thus, the Gemini FPD is substantially equivalent to its predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 14, 2013

Dornier MedTech Systems % Mr. John S. Hoffer VP Quality, Regulatory, Clinical Dornier MedTech America, Inc. 1155 Roberts Blvd. KENNESAW GA 30144

Re: K130729

Trade/Device Name: Gemini FPD Regulation Number: 21 CFR& 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: April 9, 2013 Received: April 16, 2013

# Dear Mr. Hoffer:

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.

{3}------------------------------------------------

Page 2 - Mr. John S. Hoffer

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 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/ReportalProblem/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

HerbertPLerner-S

for

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

{4}------------------------------------------------

### Indications for Use Statement

K130729 510(k) Number (if known):

Device Name: Gemini FPD

Indications for Use:

The Gemini FPD is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Prescription Use × (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Herbert Posterner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number _ K130729