MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS

K041058 · Misonix, Inc. · QPB · May 17, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041058
• Device Name: MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
• Applicant: Misonix, Inc.
• Product Code: QPB · General, Plastic Surgery
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LYSONIX 2000/3000 Systems are indicated for the liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery Applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

Device Story

Ultrasonic surgical aspirator system; utilizes generator to feed 22.5 kHz electrical signal to piezoelectric crystals in handheld handpiece; crystals vibrate at 22.5 kHz; titanium tip amplifies vibration to liquefy soft tissue; integrated irrigation/aspiration unit introduces solution and removes fragmented material/waste; used by surgeons in clinical settings; output allows for precise tissue removal and body contouring; benefits include efficient tissue aspiration.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and operating parameter comparisons to predicate devices and adherence to voluntary safety standards (UL 2601-1, EN 60601-1, EN 60601-1-2, FCC Part 18).

Technological Characteristics

System includes generator, handheld handpiece with piezoelectric crystals, and titanium tip. Operates at 22.5 kHz. Includes irrigation/aspiration unit. Complies with UL 2601-1, EN 60601-1, EN 60601-1-2, and FCC Part 18 standards.

Indications for Use

Indicated for liquefaction and aspiration of soft tissues in general, plastic, reconstructive, and gynecological surgery, and for aesthetic body contouring via aspiration of localized subcutaneous fatty deposits.

Regulatory Classification

Identification

A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Predicate Devices

• Mentor Contour Genesis Ultrasound Assisted Tissue Removal System (K004005)
• SoundVaser System, Sound Surgical Technologies Inc. (K022051)

Submission Summary (Full Text)

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June 8, 2021

Misonix, Inc. Ronald Manna VP, Regulatory Affairs 1938 New Highway Farmingdale, New York 11735

Re: K041058

Trade/Device Name: Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Ronald Manna:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 17, 2004. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, [e-mail].

Sincerely,

# Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2004

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

Re: K041058

Trade/Device Name: Misonix Inc. LYSONIX 2000/3000 Ultrasonic Surgical Aspirator System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: April 15, 2004 Received: April 23, 2004

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 gencral 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electromic product radiation control provisions (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

(d 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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K04/1058

#### Exhibit C Indications for Use Statement

Device Name: Misonix Inc. L YSONIX 2000/3000 Ultrasonic Surgical Aspirator System

L YSONIX 2000/3000 Systems are indicated for the liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery Applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

Prescription Use
(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)

Miriam C. Provost

Page 1 of

(Division Division of General, Restorative. and Neurological Devices

**510(k) Number** K641058

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## MAY 1 7 2004

K04/058
P.1/2

### 510(k) SUMMARY - Misonix Inc. LYSONIX 2000/3000Ultrasonic Exhibit E Aspirator Systems

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

#### 】. 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: | April 1, 2004 |

#### 2. Name of Device

| Proprietary Name: | Misonix Inc. LYSONIX 2000/3000 Ultrasonic<br>Surgical Aspirator Systems |
|----------------------|-------------------------------------------------------------------------|
| Common/Usual Name: | Ultrasonic Surgical System<br>Ultrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |

#### 3. Predicate Device Information

Mentor Contour Genesis Ultrasound Assisted Predicate Devices Tissue Removal System K004005 SoundVaser System, Sound Surgical Technologies Inc. K022051 LYSONIX 2000/3000 Ultrasonic Surgical System 4. Device Description is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation / aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.

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K04/058
P2/2

| 5. | Intended Use: | LYSONIX 2000/3000 System is indicated<br>for the liquefaction and aspiration of soft<br>tissues in General Surgery, Plastic and<br>Reconstructive Surgery and Gynecological<br>Surgery Applications. It is also indicated for<br>the liquefaction and aspiration of localized<br>subcutaneous fatty deposits for the purposes<br>of aesthetic body contouring. |
|----|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. | Comparison to Predicate Device | LYSONIX 2000/3000 Systems is similar in<br>design, material and operating parameters to<br>the SoundVaser Ultrasonic Aspirator. The<br>Sound Vaser is an Ultrasonic Aspirator<br>System that features Pulsed Output<br>Technology. It has an Ultrasonic Lipoplasty<br>Indication for Use as well. In addition,<br>LYSONIX 2000/3000 Systems are<br>substantially equivalent to the Mentor<br>Contour Genesis System in terms of Theory<br>of Operation, Indications and Operating<br>Specifications with the exception that the<br>Mentor Contour Genesis System (K004005)<br>does not incorporate Pulsed Output<br>Technology. |

## 7. Safety and Performance Data

The Misonix Inc. LYSONIX 2000/3000 SYSTEMS have been designed and tested to pass the following Voluntary 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 60601-1-2:1993 Electromagnetic Compatibility (LySonix 2000) EN 60601-1-2:2001 Electromagnetic Compatibility (LySonix 3000) FCC Part 18 EMC Requirements

- This device docs not contain software. 7. Software Validation
- Validation reports are contained in Exhibit J. 8. Sterilization Validations