GEMINI LITHOTRIPTER

K121656 · Dornier Medtech America, Inc. · LNS · Sep 24, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K121656
• Device Name: GEMINI LITHOTRIPTER
• Applicant: Dornier Medtech America, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Sep 24, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Gemini is a modular urological workstation for extracorporeal shock wave lithotripsy (ESWL) and diagnostic/therapeutic urological procedures. System modules include a basic unit with integrated X-ray C-arm and therapy arm, patient table, control desk, and ultrasound unit. Device uses an electromagnetic shock wave emitter (EMSE) to fragment stones. Clinicians operate the system via the control desk, utilizing integrated X-ray and ultrasound for stone localization. The system aligns the shock wave focus area with the stone to perform fragmentation. Modifications from predicate devices include updated patient table specifications (weight limit, travel, speed), optional larger X-ray image intensifier, alternate X-ray generator, alternate ultrasound unit, and alternate image storage. Benefits include non-invasive stone fragmentation. Used in clinical settings by urologists.

Clinical Evidence

Bench testing only. Compliance 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. Design verification confirmed anti-collision system performance and accuracy of stone localization at the shock wave focus area.

Technological Characteristics

Modular urological workstation. Electromagnetic shock wave emitter (EMSE) 140f. Integrated X-ray C-arm, patient table, control desk, and ultrasound unit. Standards: IEC 60601 series (safety, EMC, radiation, usability), ISO 13485 (quality management), IEC 61846 (ultrasonics). Connectivity includes image storage system. Software-controlled for system operation and stone localization.

Indications for Use

Indicated for fragmentation of urinary tract stones, including renal calyceal, renal pelvic, and upper ureteral stones in adult patients.

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 Lithotripter (Doli) (P840008, S062)
• Dornier Lithotripter 140 (Doli 140) (K011773)

Reference Devices

• Dornier Compact Alpha (K002929)
• Dornier Compact Delta (P840008, S066)

Submission Summary (Full Text)

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2121656 PE. I DF

# 510(k) SUMMARY

#### Gemini Lithotripter

SEP 24 2012

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

Dornier MedTech America 1155 Roberts Blvd. Kennesaw, GA 30144 Phone: [phone] Fax: [phone]

Contact Person: John Hoffer

Date Prepared: September 4, 2012

#### Device Trade Name

Gemini Lithotripter

# Classification Name

Extracorporeal Shock Wave Lithotripters (21 C.F.R. § 876.5990)

### Predicate Devices

Dornier Lithotripter (Doli) {P840008, S062)

Dornier Lithotripter 140 (Doli 140) (K011773)

#### Intended Use / Indications for Use

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

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

The Gemini is a modification to Dornier's Lithotripter (P840008, S062) and the Doli 140 (K011773). Specifically, the Gemini is the same device as the cleared predicate Doli products with the exception of the modifications outlined below:

- Minor changes to the patient table, including weight limit, travel range and speed; o
- Minor changes to the X-ray system to include an optional larger Image Intensifier and 0 use of an alternate X-ray generator;
- O Use of an alternate ultrasound unit; and
- Use of an alternate image storage system. O

# Technological Characteristics/Principles of Operation

The Gemini is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in Urology. The Gemini is composed of the following modules: (1) basic unit with integrated X-ray C-arm and

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therapy arm for shockwave treatment; (2) patient table; (3) control desk – user interface; and (4) ultrasound unit.

As indicate above, the Gemini is an extracorporeal shock wave lithotripter 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 predicate devices, the identical shock wave source is used. This source, the 140f EMSE, has a well-established record of performance and also is utilized in other Lithotripers that have been cleared by FDA (e.g., Dornier Compact Alpha (K002929) and Dornier Compact Delta (P840008, S066)).

The other elements of the Gemini, i.e., the patient table and the X-ray unit, are also are similar to that of other cleared stationary Lithotripters, the Doli 140 (K011773) and the Dornier Lithotriper (P840008, S062). They perform the same function and operate in the same manner during the procedures involved in the fragmenting of urological stones.

#### Performance Data

The company has complied with all of the requirements described in FDA's Guidance for the Content of Premarket Notifications (510k's) for Extracorporeal Shock Wave Lithotrioters Indicated for the Fragmentation of Kidney and Ureteral Calculi.

Device testing was performed to confirm compliance with the following standards:

| o IEC 60601-1:2007 | Electrical safety of medical devices |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------|
| o IEC60601-1-2:2007 | Electromagnetic compatibility |
| o IEC 60601-1-3:2008 | Radiation protection |
| o IEC 60601-1-6:2008 | Usability |
| o IEC 60601-2-7 | Safety of high-voltage generators of diagnostic X-ray<br>generator |
| o IEC 60601-2-28 | Particular requirements for the safety of X-ray<br>source assemblies and X-ray tube assemblies for<br>medical diagnosis |
| o IEC 60601-2-36:1997 | Extracorporeally induced Lithotripsy |
| o IEC 60601-2-32:1995 | Safety of X-ray equipment |
| o ISO 13485:2003+AC:2007 | Quality management system |
| o IEC 61846 | Ultrasonics - Pressure pulse lithotripters<br>characteristic of fields |

In all instances, the Gemini Lithotripter functioned as intended and results observed were as expected.

In addition, the system and its software was tested and validated during the company's design control process and the system met all acceptance criteria. The anti-collision system of the subject device was verified to perform as designed to mitigate the risk of injury. The methodology for accurately locating the stone was tested during the design verification testing and the assessment demonstrated that the system is capable of locating the shock wave focus area with sufficient accuracy. Lastly, the device manual was reviewed and approved as part of the design control process. It contains all necessary warnings, cautions and instructions to mitigate potential injuries.

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K121656 PG.3 VF- 3

# Substantial Equivalence

The Gemini Lithotripter is as safe and effective as the identified predicate devices listed above. The Gemini Lithotripter has the same intended uses / indications for use, technological characteristics, and principles of operation as its predicate devices. Performance data demonstrate that the Gemini Lithotripter is as safe and effective as the predicate devices. Thus, the Gemini Lithotripter is substantially equivalent.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the side. The design is simple and monochromatic.

#### Public Health Service

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

SEP 24 2012

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

Re: K121656

Trade/Device Name: Gemini Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: September 4, 2012 Received: September 5, 2012

Dear Mr. Hoffer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3.10(t) premier on substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard management date of the Medical Device Amendments, or to commerce prior to May 26, 1776, the enaounters with the provisions of the Federal Food, Drug, devices that have been reclassinou in access approval of a premarket approval application (PMA). and Cosmelle Act (Act) that do not require apple of the general controls provisions of the Act. The You may, dielefore, market the device, basics to the ments for annual registration, listing of general controls provisions of the rict labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease note: ODICT acce how care labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into othing major regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affe It may be subject to additional conseiler. This 21, Parts 800 to 898. In addition, FDA may found in the Code of I cacal resguing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a backer with other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a decemination that your accessed by other Federal agencies. You must of ally Federal statutes and roganatelle , including, but not limited to: registration and listing comply with an the Act 3 requirements, mondaing, Frinately, Frances
(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 device-related adverse events) (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (QD) rogalications (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 IT you desire specific advice for your do need on the corress.
go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/com/15809.html/sear go to million.rwww.ida.gov/rtloudio.org/w/index.php?tice of Compliance. Also, please the Concertion Borroos and Ramorogious of reference to premarket notification" (21CFR Patt note the regulation onlined, "informating 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 I ou thay 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.

Sincerely yours,

Sincerely yours,

Benjamin K. Twitchell

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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# Indications for Use Statement

K121656 510(k) Number (if known):

Device Name: Gemini

Indications for Use:

The Gemini 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)

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(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121656