EM-9000

K101482 · Elite Medical, Inc. · LNS · Mar 31, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K101482
• Device Name: EM-9000
• Applicant: Elite Medical, Inc.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Mar 31, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EM-9000 Lithotripsy system is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Device Story

EM-9000 is an extracorporeal shock-wave lithotripter used to fragment urinary stones. System comprises a therapy unit (shock wave generator, patient table, optional ultrasound localization) and control interface (remote, table control, foot pedal). Operation involves high-voltage discharge through an electromagnetic coil to repel a membrane, creating shock waves focused via an acoustical lens and water cushion. Stones are positioned at the focal point using a 3-axis motorized table; localization is achieved via external mobile fluoroscopic X-ray. Used in clinical settings by trained personnel. Output is focused acoustic energy for stone fragmentation, facilitating non-invasive treatment of urolithiasis.

Clinical Evidence

Confirmatory clinical study conducted to support safety and effectiveness. Study design justified by similarity in mechanism of action and shock wave characteristics to predicate devices. Results indicated the device is safe and effective for extracorporeal fragmentation of urinary stones in the kidney and ureter.

Technological Characteristics

Electromagnetic shock wave generator; high voltage power supply; closed-circuit water system; acoustical lens; rubber membrane water cushion. 3-axis motorized patient table. Optional ultrasound localization. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-36, IEC 60601-2-46, and IEC 61846. Measurements performed using PVDF film hydrophones.

Indications for Use

Indicated for fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

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

• Modulith SLX-F2 (K040476)
• Modularis Variostar (K070799)
• Compact Sigma (P840008)

Submission Summary (Full Text)

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K101482

# 510(k) SUMMARY

### ELITE's EM-9000

MAR 3 1 2011

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant 1.

ELITE Medical, Inc.

4343 Shallowford Road Suite H-4B Marietta,

GA 30062 USA

| Phone | :(+1) [phone] |
|-------|-----------------------|
| Fax | : (+1) [phone] |

Contact Person: Steven J. De Brock, President

| Prepared Date | : 05/06/2010 |
|---------------|--------------|
|---------------|--------------|

#### 2. Device Identification

| Proprietary Device Name | : EM-9000 |
|----------------------------|-------------------------------------------------------|
| Common/Generic Device Name | : Extracorporeal Shock-wave Lithotripter |
| Classification Name | : Lithotripter, extracorporeal shock-wave, urological |
| Product Code | : LNS |
| Regulatory Class | : Class II |
| Regulation Number | : 21 CFR §876.5990 |

#### 3. Predicate Devices

The EM-9000 Extracorporeal Shock Wave Lithotripter is substantially equivalent to the following currently marketed devices:

- K040476, Modulith SLX-F2, Karl Storz Endoscopy America Inc.
- K070799, Modularis Variostar, Siemens Medical Solutions, Inc.

- P840008, Compact Sigma, Dornier Medtech America Inc.

#### 4. Description of Device / Technological Characteristics

The EM-9000 consists of: (1) a Therapy Unit; and (2) a Control Interface Master. The Therapy Unit consists of the following sub-modules: (a) shock wave generator with therapy head; (b) patient table (c) optional Ultrasound Localization System ("ULS"); and (d) accessories. The Electronics Module is mounted within the EM-9000's Housing. Since all of the assembly parts are collected on the main body of the unit, it is a self-contained unit for providing the lithotripsy application. The Control Interface Master consists of the following

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sub-modules: Hand Held Remote Control Box, Hand Held Table Control Box and Foot Pedal (Optional)

The shock wave generator has a high voltage power supply, a closed circuit water supply system with a tank, an electromagnetic coil, a membrane, an acoustical lens for focusing and a water cushion (rubber membrane) for the acoustic conductivity of the shock waves to the patient. The shock waves are generated by the high voltage discharge through the electromagnetic coil which repels the membrane creating a shockwave. The shockwave is then focused to the focal point. The stones to be fragmented are positioned at this focal point by moving the motorized patient table in 3 axis. The localization is performed with a separate and commercially available mobile fluoroscopic x-ray unit.

#### 5. Intended Use / Indications for Use

The EM-9000 Lithotripsy system is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

#### Performance Data 6.

In accordance with FDA's Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Uretal Calculi (August 9, 2000), ELITE conducted the following types of performance testing: Shock Wave Characteristics; Localization Accuracy; Road Testing; and Clinical Performance Testing. In all instances, the EM-9000 met its specifications and functioned as intended. The laboratory and clinical data provide reasonable assurance of the safety and effectiveness of the EM-9000 for the extracorporeal fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The shock wave characteristics are reported below in Table-1 by taking the described in the consensus standard IEC 61846 "Ultrasonics - Pressure pulse lithotripters - Characteristics of fields" (1998) into consideration. PVDF film type hydrophones are used in the measurements. The details of the measurements/calculations are given in relevant part of 510(k) application. The results are found similar to the predicate device characteristics.

Pressure at focus is:

| EM-9000 | Modulith SLX-F2 | Modularis variostar | Compact sigma |
|---------|---------------------|---------------------|---------------|
| 630 bar | 210-1500 (1000) bar | 627 bar | 510 bar |

(see section XII Substantially equivalent chart, for detailed comparison )

| Parameter | Min<br>10 kV | Typical<br>15 kV | Max<br>20 kV |
|---------------------------------------|--------------|------------------|--------------|
| Peak-positive acoustic pressure (Mpa) | 48 | 53 | 62 |
| Peak-negative acoustic pressure (Mpa) | -5.8 | -6.6 | -7.2 |
| Rise time (ns) | 137 | 128 | 116 |
| Pressure pulse duration (ns) | 511 | 523 | 537 |
| Maximum focal width (mm) (x-y plane) | 7.6 | 8.1 | 7.8 |
| Orthogonal focal width (mm) | 8.7 | 7.9 | 7.0 |

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| Parameter | Min<br>10 kV | Typical<br>15 kV | Max<br>20 kV |
|-----------------------------------------------------------------|--------------|------------------|--------------|
| Focal extent Fz(mm) | 58 | 68 | 75 |
| Focal volume (cm3) | 2.00 | 2.27 | 2.14 |
| Distance between the focus and target<br>location (mm) (z axis) | 3.6 | 3.6 | 3.6 |
| Derived focal acoustic pulse energy E+ (-6dB)<br>(mJ) | 18.3 | 32.5 | 32.1 |

Table-1 Shock Wave Characteristics

# Standards

The EM-9000 is designed in accordance with the national and international product safety and performance requirements established in the following standards given in below,

- 1) IEC 60601-1, Medical Electrical Equipment - Part 1 General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-1. Medical Electrical Equipment-Part 1 General Requirements for Safety" 2) with Amendment 1 and 2
- IEC 60601-1-2, Medical Electrical Equipment Part 1 General Requirements for Basic 3) Safety and Essential Performance - Collateral Standard : Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-4, Medical Electrical Equipment 1-4: General Requirements for safety -4) Collateral standard. Programmable electrical systems.
- IEC 60601-2-36, Particular Requirements for safety of equipment for extracorporeally 2) induced lithotripsy
- IEC 60601-2-46, Medical Electrical Equipment, Safety for Operating Table ()
- IEC 61846, Ultrasonics- Pressure pulse lithotripters Characteristics of fields (1998) 7)

Results of performance and compliance testing conducted at manufacturing facility and independent test organizations on EM-9000, indicates conformance to all applicable performance standards.

Comparative performance testing demonstrated the EM-9000 to be substantially equivalent to the predicate devices.

#### 7. Clinical Performance Data

The confirmatory clinical study suggests that treatment of urinary tract stones with the EM-9000 is safe and effective.

In accordance with the Lithotripter Guidance, ELITE Medical conducted clinical performance testing in the form of a confirmatory clinical study. A confirmatory clinical study was appropriate because the EM-9000: (1) employs a similar mechanism of action for the generation of shock waves as compared to predicate extracorporeal shock wave lithotripters; and (2) has shock wave characteristics that are within the range of predicate systems.

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The clinical data provides reasonable assurance of the safety and effectiveness of the EM-9000 Electromagnetic Lithotripter for the extracorporeal fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

(see section XX Performance Testing - Clinical, for detailed explanations )

### 8. Conclusion

Based on the comparison to other devices in technological characteristics and intended use, the EM-9000 is substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

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

Mr. Steven J. De Brock President Elite Medical, Inc. 4343 Shallowford Rd., Suite H-4B MARIETTA GA 30062 ·

MAR 3 1 201

. Re: K101482 Trade/Device Name: EM-9000 · Regulation Number: 21 CFR 8876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: March 25, 2011 Received: March 28, 2011

Dear Mr. De Brock:

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 of medical device-related

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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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Hubert Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K101482

Device Name: EM-9000

Indications for Use:

The EM-9000 Lithotripsy system is intended to fragment urinary stones in the kidney (renal · pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Prescription Use X (Part 21 CFR 801 Subpard D) AND/OR

Over The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hormi Kothary

(Division Sign Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101482

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