SOUND SURGICAL VASER 2.1 LIPO SYSTEM

K110306 · Sound Surgical Technologies, LLC · QPB · Jun 23, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110306
• Device Name: SOUND SURGICAL VASER 2.1 LIPO SYSTEM
• Applicant: Sound Surgical Technologies, LLC
• Product Code: QPB · General, Plastic Surgery
• Decision Date: Jun 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. The Sound Surgical VentX 2.1 is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX 2.1 is designed to operate with the Sound Surgical VASER 2.1 or as a stand-alone system. The Sound Surgical VASER 2.1 Lipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring. The Sound Surgical VASER 2.1 Lipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues: Neurosurgery; Gastrointestinal and affiliated organ surgery; Urological surgery; Plastic and reconstructive surgery; General surgery; Gynecological surgery; Thoracic surgery; and Laparoscopic surgery.

Device Story

Ultrasonic surgical system; fragments, emulsifies, and aspirates soft tissues. Comprised of VASER 2.1 Ultrasonic Amplifier and VentX 2.1 Infiltration/Aspiration Console. Operates via ultrasonic handpiece and probe for tissue fragmentation; console uses sterile tubing, handles, and cannulae for fluid infiltration and suction. Used in OR settings by surgeons. Provides mechanical tissue disruption via ultrasound; facilitates body contouring and soft tissue removal. Benefits include precise tissue emulsification; reduced trauma to surrounding structures. Healthcare providers use system to perform lipoplasty and various surgical procedures; output is physical removal of tissue/fluids.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified against predetermined specifications, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1).

Technological Characteristics

Ultrasonic surgical system; components include VASER 2.1 Amplifier and VentX 2.1 Console. Materials: medical grade biocompatible materials (ISO 10993-1). Sterilization: moist heat (ISO 17665-1) for handpieces/cannulae; radiation (ISO 11137-1/2) for tubing. Electrical safety: IEC 60601-1, UL 60601-1, IEC 60601-1-8. EMC: IEC 60601-1-2. Software: Moderate level of concern.

Indications for Use

Indicated for patients requiring fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for aesthetic body contouring, or soft tissue fragmentation/aspiration in neurosurgery, GI, urological, plastic/reconstructive, general, gynecological, thoracic, and laparoscopic surgical specialties.

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

• Sound VASER System (K022051)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Sound Surgical Technologies LLC. Stephen Smith Vice President Of RA / Qa 357 S. Mccaslin Blvd. #100 Louisville, Colorado 80027

June 9, 2021

Re: K110306

Trade/Device Name: Sound Surgical Vaser 2.1 Lipo System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Stephen Smith:

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 June 23, 2011. 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

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

Sound Surgical Technologies, LLC' % Mr. Stephen C. Smith VP of RAQA 357 McCaslin Boulevard, Suite 100 Louisville. Colorado 80027

JUN 2 3 2011

Re: K110306

Trade/Device Name: Sound Surgical Technologies LLC VASER 2.1 Lip System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: June 20, 2011 Received: June 21, 2011

Dear Mr. Smith:

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

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Page 2 - Mr. Stephen C. Smith

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

E. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

| 510(k) Number (if known): | K110306 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Sound Surgical Technologies LLC VASER 2.1 Lipo System |
| Indications for Use: | The Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring.<br>The Sound Surgical VentX 2.1 is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX 2.1 is designed to operate with the Sound Surgical VASER 2.1 or as a stand-alone system.<br>The Sound Surgical VASER 2.1 Lipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.<br>The Sound Surgical VASER 2.1 Lipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues: <ul><li>Nuerosurgery;</li><li>Gastrointestinal and affiliated organ surgery;</li><li>Urological surgery;</li><li>Plastic and reconstructive surgery;</li><li>General surgery</li><li>Gynecological surgery:</li><li>Thoracic surgery; and</li><li>Laparoscopic surgery.</li></ul> |

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_

Daniel Krane for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110306

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# 510(k) Summary

| | JUN 2 3 2011 | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------|
| Submission Date: | 28 January 2011 | | |
| Submitter: | Sound Surgical Technologies LLC<br>357 South McCaslin Boulevard, Suite 100<br>Louisville, CO 80027 | | |
| Submitter and<br>Official Contact: | Mr. Stephen C. Smith<br>Vice President of RA/QA<br>Sound Surgical Technologies LLC<br>357 South McCaslin Boulevard, Suite 100<br>Louisville, CO 80027<br>[phone]<br>[e-mail] | | |
| Manufacturing Site: | Sound Surgical Technologies LLC<br>357 South McCaslin Boulevard, Suite 100<br>Louisville, CO 80027 | | |
| Trade Name: | Sound Surgical Technologies LLC VASER 2.1 Lipo System | | |
| Common Name: | Suction lipoplasty system | | |
| Classification Name: | System, Suction, Lipoplasty | | |
| Classification<br>Regulation: | 21 CFR §878.5040 | | |
| Product Code: | MUU | | |
| Substantially<br>Equivalent Devices: | Sound Model | Predicate 510(k)<br>Number | Predicate Manufacturer<br>and Model |
| | Sound VASER 2.1<br>Lipo System | K022051 | Sound Surgical Technologies<br>LLC / Sound VASER<br>System |

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#### Device Description:

The Sound Surgical Technologies LLC (Sound) VASER 2.1 Lipo System (VASER 2.1) is an ultrasonic surgical system that fragments, emulsifies, and aspirates soft tissues.

The Sound VASER 2.1 is comprised of two (2) primary components: (1) the Sound VASER 2.1 Ultrasonic Amplifier; and (2) the VentX 2.1 Infiltration and Aspiration Console. Both the Sound VASER 2.1 Ultrasonic Amplifier and the Sound VentX 2.1 Infiltration and Aspiration Console are designed to operate independently, and may be sold or used separately, or together, as a system.

The VASER 2.1 Amplifier utilizes an ultrasonic surgical VASER Handpiece and Probe to fragment and emulsify the soft tissue. The VentX 2.1 Console utilizes sterile infiltration tubing, a handle and cannulae to infiltrate the tissue with fluids, and sterile suction tubing, a handle and cannulae to aspirate fluids and soft tissue.

### Intended Use:

The Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring.

The Sound Surgical VentX 2.1 is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX 2.1 is designed to operate with theSound Surgical VASER 2.1 or as a standalone system.

The Sound Surgical VASER 2.1 Lipo System is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring.

The Sound Surgical VASER 2.1 Lipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification, and aspiration of soft tissues:

- . Neurosurgery:
- Gastrointestinal and affiliated organ surgery; .
- Urological surgery; ●
- Plastic and reconstructive surgery; .
- General surgery; .
- Orthopedic surgery: �
- Gynecological surgery; .
- Thoracic surgery; and .
- Laparoscopic surgery. .

Technology Comparison: The Sound VASER 2.1 Lipo System employs the same technological characteristics as the predicate device.

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### Performance Testing:

Sterilization

The Sound VASER 2.1 Consoles are not sterilized or sterilizable, and therefore this section does not apply to the Consoles.

The Sound VASER Handpiece and Probes, and VentX Handle and Cannulae are not provided sterile, but are sterilized by the user prior to use. The sterilization of the Handpiece and Cannulae will be validated prior to commercial distribution in accordance with ISO 17665-1: 2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.

The Sound VentX Infiltration and Suction Tubing are provided sterile. The sterilization of the Infiltration and Suction Tubing was validated in accordance with:

- . ISO 11137-1: 2006. Sterilization of health care products -Radiation, Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; and
- ISO 11137-2: 2006, Sterilization of health care products -. Radiation -- Part 2: Establishing the sterilization dose.

Test results indicate that the Sound VASER 2.1 complies with the Standards.

The Sound VASER 2.1 Consoles, Sound VASER Handpiece and Probes, and VentX Handle and Cannulae are not provided sterile, and therefore this section does not apply.

> The Sound Ventx Infiltration and Suction Tubing are provided sterile. The two (2) year shelf life of the Infiltration and Suction Tubing was validated in accordance with:

- ISO 11607-1: 2006. Packaging for terminally sterilized medical . devices - Part 1: Requirements for materials, sterile barrier systems and packages systems; and
- ISO 11607-2: 2006, Packaging for terminally sterilized medical . devices - Part 2: Validation requirements for forming, sealing and assembly processes.

Test results indicate that the Sound VASER 2.1 complies with the Standards.

Shelf-Life

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| Biocompatibility | The Sound VASER 2.1 Consoles have no patient contact materials, and<br>therefore this section does not apply to the Consoles. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Sound VASER Handpiece and Probes, and VentX Infiltration and<br>Suction Tubing, Handle and Cannulae have patient contact materials<br>and are made from medical grade biocompatible materials. |
| | Test results and analyses indicate that the VASER Handpiece and<br>Probes, and VentX Infiltration and Suction Tubing, Handle and<br>Cannulae materials comply in accordance with ISO 10993-1: 2003,<br>Biological evaluation of medical devices - Part 1: Evaluation and<br>testing. |
| Software Testing | The Sound VASER 2.1 contains MODERATE level of concern<br>software. Software was designed and developed according to a robust<br>software development process, and was rigorously verified and<br>validated. Software information is provided in accordance with: |
| | • FDA guidance: The content of premarket submissions for software<br>contained in medical devices, 11 May 05; and |
| | • FDA guidance: General principles of software validation; Final<br>guidance for industry and FDA staff, 11 Jan 02. |
| | Test results indicate that the Sound VASER 2.1 complies with its<br>predetermined specification. |
| Electrical Safety | The Sound VASER 2.1 was tested for patient safety in accordance with: |
| | • IEC 60601-1:1988, Am1: 1991, Am2: 1995, Medical electrical<br>equipment – Part I: General requirements for basic safety and<br>essential performance. |
| | • UL 60601-1: 2006, Medical electrical equipment, Part 1:<br>Particular requirements for safety. |
| | • IEC 60601-1-1: 2000, Medical electrical equipment - Part 1-1:<br>General requirements for safety - Collateral standard: Safety<br>requirements for medical electrical systems. |
| | • IEC 60601-1-8: 2006, Medical electrical equipment – Part 1-8:<br>General requirements for safety – Collateral standard: General<br>requirements, tests and guidance for alarm systems in medical<br>electrical equipment and medical electrical systems. |
| | Test results indicate that the Sound VASER 2.1 complies with the<br>Standards. |
| Electromagnetic<br>Compatibility Testing | The Sound VASER 2.1 was tested for EMC in accordance with:<br>• IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:<br>General requirements for safety - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests.<br><br>Test results indicate that the Sound VASER 2.1 complies with the<br>Standard. |
| Performance Testing<br>- Bench | The Sound VASER 2.1 was tested for performance in accordance with<br>its predetermined specifications as specified in Section 11, Device<br>Description – Performance Specifications, of this submission.<br><br>Test results indicate that the Sound VASER 2.1 complies with its<br>predetermined specification. |
| Conclusion | Verification and validation activities were conducted to establish the<br>performance and safety characteristics the Sound VASER 2.1. The<br>results of these activities demonstrate that the Sound VASER 2.1 is safe<br>and effective when used in accordance with its intended use and<br>labeling.<br><br>Therefore, the Sound VASER 2.1 is considered substantially equivalent<br>to the predicate device. |

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