MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM

K032690 · Misonix, Inc. · LFL · Dec 9, 2003 · SU

Device Facts

• Record ID: K032690
• Device Name: MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Applicant: Misonix, Inc.
• Product Code: LFL · SU
• Decision Date: Dec 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of soft tissue in the following surgical specialties: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery The system may also be combined with electrosurgery using optional RF Surgery interface components.

Device Story

System comprises generator, handpiece, and irrigation/aspiration unit. Generator feeds 23 kHz electrical signal to piezoelectric crystals in handpiece; crystals vibrate at same frequency. Titanium tip amplifies vibration to fragment soft tissue. Irrigation/aspiration unit delivers solution and removes fragmented material/liquids. Optional RF interface allows integration with standard electrosurgery generators for tissue cauterization, with or without ultrasound energy. Used in OR by surgeons across multiple specialties (neurosurgery, general, etc.). Output provides mechanical fragmentation and aspiration; RF output provides cautery. Surgeon controls device via handpiece; visual/tactile feedback from tissue interaction guides clinical decision-making. Benefits include efficient soft tissue removal and integrated hemostasis.

Clinical Evidence

No clinical data. Substantial equivalence determined via non-clinical bench testing, including output frequency, power, tip displacement, irrigation/vacuum flow rates, life testing, and electrical safety/EMC/dielectric testing per UL 2601-1, EN 60601-1, EN 60601-2-2, and FCC Part 18 standards.

Technological Characteristics

System uses 23 kHz piezoelectric transducer; titanium fragmentation tip. Includes irrigation/aspiration pump. Interfaces with external electrosurgery generators for RF cautery. Tested to UL 2601-1, EN 60601-1, EN 60601-2-2, EN 60601-1-2, and FCC Part 18. Software-controlled.

Indications for Use

Indicated for fragmentation, emulsification, and aspiration of soft tissue during neurosurgery, GI, urological, plastic/reconstructive, general, orthopedic, gynecological, thoracic, laparoscopic, and thoracoscopic surgeries. May be combined with electrosurgery.

Predicate Devices

• ValleyLab CUSA® EXCEL Ultrasonic Surgical Aspirator
• Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator

Submission Summary (Full Text)

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# DEC - 9 2003

# K032690 (e3 1of 3)

# 510(k) SUMMARY - Misonix Inc. FS 1000 RF Ultrasonic Aspirator System

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

### 1. Submitter's Identification

| 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 15, 2003 |

### 2. Name of Device

4

| Proprietary Name: | Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator<br>System |
|----------------------|-----------------------------------------------------------------|
| Common/Usual Name: | Ultrasonic Surgical System<br>Ultrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |

### 3. Predicate Device Information

| Predicate Devices | ValleyLab CUSA® EXCEL Ultrasonic Surgical Aspirator<br>Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Device Description | The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System<br>is comprised of a generator that feeds a 23 kHz electrical<br>signal to piezoelectric crystals mounted in a hand-held<br>Handpiece. The crystals then vibrate at the same frequency.<br>The vibration is amplified by a titanium Tip attached to the<br>Handpiece. Fragmentation of unwanted tissue occurs at the<br>end of the Tip. An Irrigation/Aspiration unit is provided to<br>introduce irrigation solution and remove fragmented<br>material and waste liquids. The system incorporates<br>features that allow it to interface with standard<br>electrosurgery generators (modules). By activating the<br>output of the electrosurgery generators, RF voltage is<br>available at the distal end of the ultrasonic cannula. This<br>feature allows the surgeon to cauterize tissue with or<br>without the simultaneous application of ultrasound energy. |

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# KO32690 leg 2 of 3

# 510(k) SUMMARY - Misonix Inc. FS 1000 RF Ultrasonic Aspirator System

- The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System ર . Intended Use: is indicated for use in the fragmentation, emulsification and aspiration of soft tissue in the following surgical specialties: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery
General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery

Laparoscopic Surgery Thoracoscopic Surgery

The system may also be combined with electrosurgery using optional RF Surgery interface components.

- The Misonix Inc. FS 1000 RF Ultrasonic Aspirator Q. Comparison to Predicate Device Systemis similar in design, material and operating parameters to the CUSA® EXCEL Ultrasonic Surgical Aspirator. Although the CUSA® has a magneto-strictive transducer and the Misonix Inc. FS 1000 RF Ultrasonic Aspirator System has a piezoelectric transducer, the FDA has determined in past that the piezoelectric handpiece is the substantially equivalent to the magnetostrictive handpiece technology.
- The Misonix Inc. FS 1000 RF has been designed 7. · Safety and Performance Data to pass the following Voluntary and tested Standards:

UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-2-2 Medical Electrical Equipment, Part 2: Particular Requirements for Safety of High Frequency Surgical Equipment EN 60601-1-2:2001 Electromagnetic Compatibility FCC Part 18 EMC Requirements

- Software Validation 7.
This device contains software. The software has been validated. The validation protocol considered failure and effects analysis.

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# 510(k) SUMMARY - Misonix Inc. FS 1000 RF Ultrasonic Aspirator System

- Non-Clinical Tests Performed for Determination of Substantial Equivalence are as 8. follows:
Output Frequency Measurements Output Power Measurements (No Load to Maximum Load) Tip Displacement Measurements I Ip Displacement Measurements
Irrigation Flowrate Measurements (Ultrasound On and Flush Mode) Life Tests Vacuum Flowrate and Pressure Measurements Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Dicient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits RF Cautery Life Tests Dielectric Tests with RF Cautery Unit Attached RF Cautery Unit Ouput Power Tests

## Discussions of Clinical Tests Performed 9.

N/A

#### Conclusions 9.

Based upon an analysis of the operating characteristic specifications, Based upon an anarysis of the operating and Voluntary Consensus Output of Engineering Tests, Hazard I Enc. has concluded that the Misonix Inc. Standard Investigations, Institution System is substantially equivalent to the CUSA EXCEL system.

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DEC - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032690

R022070
Trade/Device Name: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: August 27, 2003 Received: September 11, 2003

Dear Mr. Manna:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases 976, the enactment date of the Medical Device Amendments, or to connices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees that have been room 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 I ou may, merenter, mains 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 cither class II (Special Controls) or class III (PMA), it If your device is elashined (overols. Existing major regulations affecting your device can may be subject to such actively a subtions, 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 docs not mean I lease be advised that i Drivination that your device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must or any I edetar statuted and requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, adoning (Dr OS) regulation (21 CFR Part 820); and if applicable, the electronic fordline the quarty by overse (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Ronald R. Manna

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" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement Exhibit C

510(k) Number (if known): K032690

Device Name: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System

- Indications For Use: The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of soft tissue in the following surgical specialties:
Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery

The system may also be combined with electrosurgery using optional RF Surgery interface components.

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

Over-The-Counter Use --------(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

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510(k) Number K032690