(141 days)
Not Found
No
The document describes a standard ultrasonic surgical system for tissue fragmentation and aspiration, with no mention of AI or ML capabilities in the intended use, device description, or performance testing sections.
Yes
The device is described as an "ultrasonic surgical system that fragments, emulsifies, and aspirates soft tissues" for various surgical specialties, indicating its use in treating and modifying the body.
No.
The device's stated intended uses are for fragmentation, emulsification, and aspiration of tissues for aesthetic body contouring and in various surgical specialties, which are all therapeutic or surgical procedures, not diagnostic ones.
No
The device description explicitly states it is an "ultrasonic surgical system" comprised of two primary hardware components: an "Ultrasonic Amplifier" and an "Infiltration and Aspiration Console." It also mentions a "VASER Handpiece and Probe," "infiltration tubing," "handle," and "cannulae," all of which are physical components. While software is mentioned as being tested, the core functionality and components are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the fragmentation, emulsification, and aspiration of subcutaneous fatty and soft tissues for aesthetic body contouring and various surgical procedures. This is a direct surgical intervention on the body.
- Device Description: The description details an ultrasonic surgical system with a handpiece, probe, and aspiration console designed to physically interact with and remove tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical tool used in vivo (within the body) for therapeutic and aesthetic purposes.
N/A
Intended Use / 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 standalone 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.
Product codes
QPB, MUU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous fatty tissues, soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization:
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.
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 and ISO 11137-2: 2006.
Test results indicate that the Sound VASER 2.1 complies with the Standards.
Shelf-Life:
The two (2) year shelf life of the Infiltration and Suction Tubing was validated in accordance with ISO 11607-1: 2006 and ISO 11607-2: 2006.
Test results indicate that the Sound VASER 2.1 complies with the Standards.
Biocompatibility:
The Sound VASER Handpiece and Probes, and VentX Infiltration and Suction Tubing, Handle and Cannulae have patient contact materials and are made from medical grade biocompatible materials.
Test results and analyses indicate that the VASER Handpiece and Probes, and VentX Infiltration and Suction Tubing, Handle and Cannulae materials comply in accordance with ISO 10993-1: 2003.
Software Testing:
The Sound VASER 2.1 contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; and FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02.
Test results indicate that the Sound VASER 2.1 complies with its 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 equipment – Part I: General requirements for basic safety and essential performance.
- UL 60601-1: 2006, Medical electrical equipment, Part 1: Particular requirements for safety.
- IEC 60601-1-1: 2000, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems.
- IEC 60601-1-8: 2006, Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
Test results indicate that the Sound VASER 2.1 complies with the Standards.
Electromagnetic Compatibility Testing:
The Sound VASER 2.1 was tested for EMC in accordance with: IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Test results indicate that the Sound VASER 2.1 complies with the Standard.
Performance Testing - Bench:
The Sound VASER 2.1 was tested for performance in accordance with its predetermined specifications as specified in Section 11, Device Description – Performance Specifications, of this submission.
Test results indicate that the Sound VASER 2.1 complies with its predetermined specification.
Conclusion:
Verification and validation activities were conducted to establish the performance and safety characteristics the Sound VASER 2.1. The results of these activities demonstrate that the Sound VASER 2.1 is safe and effective when used in accordance with its intended use and labeling.
Therefore, the Sound VASER 2.1 is considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.5040 Suction lipoplasty system.
(a)
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 of1/3 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.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
0
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, Cindy.Chowdhury@fda.hhs.gov.
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
1
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
2
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 (800) 638-2041 or (301) 796-7100 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
3
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. |
| 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: Nuerosurgery;Gastrointestinal and affiliated organ surgery;Urological surgery;Plastic and reconstructive surgery;General surgeryGynecological surgery:Thoracic surgery; andLaparoscopic surgery. |
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
4
K110306
1 of 5
510(k) Summary
| JUN 2 3 2011 | |||
|---|---|---|---|
| Submission Date: | 28 January 2011 | ||
| Submitter: | Sound Surgical Technologies LLC | ||
| 357 South McCaslin Boulevard, Suite 100 | |||
| Louisville, CO 80027 | |||
| Submitter and | |||
| Official Contact: | Mr. Stephen C. Smith | ||
| Vice President of RA/QA | |||
| Sound Surgical Technologies LLC | |||
| 357 South McCaslin Boulevard, Suite 100 | |||
| Louisville, CO 80027 | |||
| +1 (720) 240-2970 | |||
| SSmith@soundsurgical.com | |||
| Manufacturing Site: | Sound Surgical Technologies LLC | ||
| 357 South McCaslin Boulevard, Suite 100 | |||
| 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 | |||
| Regulation: | 21 CFR §878.5040 | ||
| Product Code: | MUU | ||
| Substantially | |||
| Equivalent Devices: | Sound Model | Predicate 510(k) | |
| Number | Predicate Manufacturer | ||
| and Model | |||
| Sound VASER 2.1 | |||
| Lipo System | K022051 | Sound Surgical Technologies | |
| LLC / Sound VASER | |||
| System |
..
5
V110306
2 of 5
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.
6
V110306
30f5
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
7
V110306
4 of 5
| Biocompatibility | The Sound VASER 2.1 Consoles have no patient contact materials, and
therefore this section does not apply to the Consoles. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Sound VASER Handpiece and Probes, and VentX Infiltration and
Suction Tubing, Handle and Cannulae have patient contact materials
and are made from medical grade biocompatible materials. |
| | Test results and analyses indicate that the VASER Handpiece and
Probes, and VentX Infiltration and Suction Tubing, Handle and
Cannulae materials comply in accordance with ISO 10993-1: 2003,
Biological evaluation of medical devices - Part 1: Evaluation and
testing. |
| Software Testing | The Sound VASER 2.1 contains MODERATE level of concern
software. Software was designed and developed according to a robust
software development process, and was rigorously verified and
validated. Software information is provided in accordance with: |
| | • FDA guidance: The content of premarket submissions for software
contained in medical devices, 11 May 05; and |
| | • FDA guidance: General principles of software validation; Final
guidance for industry and FDA staff, 11 Jan 02. |
| | Test results indicate that the Sound VASER 2.1 complies with its
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
equipment – Part I: General requirements for basic safety and
essential performance. |
| | • UL 60601-1: 2006, Medical electrical equipment, Part 1:
Particular requirements for safety. |
| | • IEC 60601-1-1: 2000, Medical electrical equipment - Part 1-1:
General requirements for safety - Collateral standard: Safety
requirements for medical electrical systems. |
| | • IEC 60601-1-8: 2006, Medical electrical equipment – Part 1-8:
General requirements for safety – Collateral standard: General
requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems. |
| | Test results indicate that the Sound VASER 2.1 complies with the
Standards. |
| Electromagnetic
Compatibility Testing | The Sound VASER 2.1 was tested for EMC in accordance with:
• IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:
General requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests.
Test results indicate that the Sound VASER 2.1 complies with the
Standard. |
| Performance Testing
- Bench | The Sound VASER 2.1 was tested for performance in accordance with
its predetermined specifications as specified in Section 11, Device
Description – Performance Specifications, of this submission.
Test results indicate that the Sound VASER 2.1 complies with its
predetermined specification. |
| Conclusion | Verification and validation activities were conducted to establish the
performance and safety characteristics the Sound VASER 2.1. The
results of these activities demonstrate that the Sound VASER 2.1 is safe
and effective when used in accordance with its intended use and
labeling.
Therefore, the Sound VASER 2.1 is considered substantially equivalent
to the predicate device. |
8
V110306
5 of 5
in the same of the state of the first of the first of the first of the first of the first of the first for the first for the first for the first for the first for the first f
·
. :
.