MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM

K042096 · Misonix, Inc. · NTB · Jan 26, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K042096
• Device Name: MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM
• Applicant: Misonix, Inc.
• Product Code: NTB · General, Plastic Surgery
• Decision Date: Jan 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.

Device Story

The Sonatherm 600 is an ultrasonic surgical system used in laparoscopic or intraoperative settings by surgeons. It consists of a generator and a handheld transducer containing piezoelectric crystals. The generator delivers a 3-5 MHz electrical signal to the crystals, causing them to vibrate. A coupling fluid recirculation system, contained by a flexible membrane, stabilizes the temperature and couples the acoustic waves to the target organ tissue. The waves converge at a focal point, concentrating energy to heat and necrose tissue. The surgeon moves the treatment head to ablate a preselected volume of tissue from the focal point back to the surface. The ablated tissue is either removed surgically or left for natural absorption. The device provides controlled energy input for tissue ablation, offering a therapeutic alternative to other energy-based surgical ablation systems.

Clinical Evidence

No clinical data. Evidence is based on bench testing, including output frequency and power measurements, focal length accuracy (Schlieren photography), life tests, EMI/dielectric testing, sterilization validation, and computer modeling of lesion creation versus time and focal depth.

Technological Characteristics

System comprises a generator and handheld transducer with piezoelectric crystals. Operates at 3-5 MHz. Includes a coupling fluid recirculation system with a flexible membrane. Bench testing includes UL 2601-1, EN 60601-1, EN 60601-1-2:2001, and FCC Part 18 compliance. No software is associated with this device.

Indications for Use

Indicated for laparoscopic or intraoperative ablation of soft tissue in general surgery.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Rita Medical Systems Model 500 (K983214)
• Rita Medical Systems 1500 RF (K993944)
• AFx Inc. Microwave Surgical System and Accessories (K003978)
• Endocare Cryocare Surgical System (K011074)
• Radionics RFG-3C RF Lesion Generator (K901540)

Submission Summary (Full Text)

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### JAN 2 6 2006

### 510(k) SUMMARY - Misonix Inc Sonatherm 600 Ultrasonic Lesion C Exhibit E

is summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

K 042096

#### Submitter's Identification 1 .

| Submitter's Name: | MISONIX INCORPORATED |
|-------------------|-----------------------------------------|
| Address: | 1938 New Highway, Farmingdale, NY 11735 |
| Telephone Number: | 516-694-9555 |
| Contact Person: | Ronald R. Manna |
| Date Prepared: | July 14, 2004 |
| Date Revised: | October 28, 2005 |

#### 2. Name of Device

| Proprietary Name: | Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System |
|----------------------|----------------------------------------------------------------|
| Common/Usual Name: | Ultrasonic Surgical System |
| Classification Name: | Instrument. Ultrasonic Surgical |

## Predicate Device Information

Rita Medical Systems Model 500 (K983214) and 1500 RF (K993944) Generator Systems and Accessories AFx Inc. Microwave Surgical System and Accessories (K003978) Endocare Cryocare Surgical System (K011074). Radionics RFG-3C RF Lesion Generator (K901540)

### Sonatherm 600 Ultrasonic Lesion Generating System is comprised of a न Device Description generator, which feeds a 3 to 5 MHz electrical signal to one or more piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. A Coupling Fluid Recirculation System is provided to provide a temperature stabilized coupling/coolant fluid surrounding the Transducer crystal(s). The tluid is contained by a Hexible membrane surrounding the transducer head. A user interface provides Input Controls and Output Readouts for Operator.

In operation, the Transducer Membrane is placed against the organ to be treated. When the unit is engaged, the transducer will vibrate, create

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K 042096

acoustic waves in the coupling fluid that then couples to the organ tissue and propagates into it. The waves converge to a focal point that concentrates the energy within a finite tissue volume. As the temperature of the tissue rises above the ablation point, the tissue necroses. The treatment head is moved under Operator control to treat a preselected volume of tissue from the focal point back to the surface of the organ.

- The Sonatherm is indicated for the laparoscopic or intraoperative ablation 5. Intended Use: of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.
# 6. Comparison to Predicate Device

Sonatherm 600 Ultrasonic Lesion Generating System is similar in clinical use, safety and outcome to the Rita Medical Systems Model 500 (K983214) and 1500 RF (K993944) Generator Systems and Accessories, the AFx Inc. Microwave Surgical System and Accessories (K003978), the Endocare Cryocare Surgical System (K011074) and the Radionics RFG-3C RF Lesion Generator and accessories (K901540B). Although housed differently, all of the aforementioned devices allow the surgeon to target selected tissue for ablation in either laparoscopic or intraoperative modes and provide controlled energy input to the organ to facilitate said ablation. In the case of the Sonatherm 600, this volume is located from the focal point back to the surface of the organ. Ablated tissue may then be removed surgically or left intact for absorption and removal by the bodies normal cleansing mechanisms. Such treatment has been shown to be safe and efficacious over many decades of clinical use.

### 7 Safety and Performance Data

The Sonatherm 600 Ultrasonic Lesion Generating System has been designed to and will be tested to pass the following Voluntary Standards:

UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety F.N 60601-1 Medical Electrical Equipment, Part 1 : General Requirements for Safety EN 60601-1-2:2001 Electromagnetic Compatibility FCC Part 18 EMC Requirements

There is no software associated with this product. 8. Software Validation

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K O 4 2 O 9 6

### Validation statements are contained in Exhibit J. 9. Sterilization Validations

# 10. Non-Clinical Tests for Determination of Substantial Equivalence:

Output Frequency Measurements Output Power Measurements Focal Length Accuracy Measurements (Schlieren Photos) Life Tests Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits Sterilization or Disinfection Protocol Validation for all Reusable Components In Vitro Targeting Accuracy Measurements Computer Modeling of Lesion Creaton vs Time and Focal Depth

# 11. Conclusions

Based upon an analysis of the operating characteristic specifications, Output of Engineering Tests, FMEA Analysis and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System is substantially equivalent to the Rita Medical Systems Model 500 (K983214) and 1500 RF (K993944) Generator Systems and Accessories, the AEx Inc. Microwave Surgical System and Accessories (K003978), the Endocare Surgical System (K011074) and the Radionics RFG-3C RF Lesion Generator and accessories.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three lines forming its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2006

Mr. Ronald R. Manna Vice President, Regulatory Affairs Misonix, Inc. 1938 New Highway Farmingdale, New York 11735

Re: K042096

Trade/Device Name: Sonatherm 600 Ultrasonic Lesion Generating System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NTB Dated: November 17, 2005 Received: November 17, 2005

Dear Mr. Manna:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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## Page 2 - Mr. Manna

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

fabare Brechin

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Exhibit C

# 510(k) Number (if known): K042096

# Device Name: Sonatherm 600 Ultrasonic Lesion Generating System

Indications for Use:

The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.

Prescription Use __ ど (Part 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 OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Barbara Bush for Nixon

Division of General, Restorative, and Neurological Devices

**510(k) Number** K042096