(57 days)
Not Found
No
The document describes a mechanical ultrasonic surgical system and does not mention any AI or ML components or functionalities.
Yes
The intended use and indications for use clearly state that the system is used for "fragmentation of subcutaneous fatty tissues for aesthetic body contouring" and "fragmentation, emulsification and aspiration of soft tissues" in various surgical specialties, which are therapeutic medical procedures.
No
The VASERlipo System is described as an ultrasonic surgical system intended for the fragmentation, emulsification, and aspiration of soft tissues for aesthetic body contouring and in various surgical specialties. Its functionality is to perform procedures, not to diagnose conditions.
No
The device description explicitly states it is comprised of two hardware components: the VASER Ultrasonic Amplifier and the VentX Infiltration and Aspiration Console, which include physical parts like handpieces, probes, tubing, handles, and cannulas.
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 soft tissues within the body during surgical procedures. IVDs are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical system with handpieces, probes, tubing, handles, and cannulas designed for direct interaction with tissues during surgery. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
The device is a surgical tool used for tissue manipulation during procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The VASERlipo System is intended for the fragmentation of subcutaneous fatty tissues for aesthetic body contouring. The VentX console is intended for the suction of fluids and tissue during surgical procedures. The VentX console is designed to operate with the VASERlipo System or as a stand-alone system. The VASERlipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring. The VASERlipo 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
Product codes
QPB, MUU
Device Description
The VASERlipo System is an ultrasonic surgical system that fragments, emulsifies, and aspirates soft tissues. The VASERlipo System is comprised of two components: the VASER Ultrasonic Amplifier and the VentX Infiltration and Aspiration Console. Both components are designed to operate independently, and may be sold or used separately/together, or as a system. The Amplifier uses an ultrasonic surgical handpiece and probe to fragment and emulsify the soft tissue. The Console uses sterile tubing, a handle, and cannula to infiltrate the tissue with fluids and aspirate the fluids/soft tissue.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Subcutaneous fatty tissues, soft tissues (various surgical specialties including Neurosurgery, Gastrointestinal, Urological, Plastic and reconstructive, General, Orthopedic, Gynecological, Thoracic, and Laparoscopic surgery).
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety tests of the VASERlipo System have demonstrated its compliance with applicable requirements of the following electrical standards: IEC 60601-1:2005/AM1:2012 (Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance), ISO 10079-1:2015 (Medical suction equipment -- Part 1: Electrically powered suction equipment). Other tests include Cannula deformation resistance ($20°±5°$ and straightening without the shaft exhibiting any fractures, sharp edges, or loss of suction performance), Suction Vacuum (max) 20 inHg at 5,000 ft, and Infiltration Rates (50-550 ml/min). Non-clinical test results demonstrate that the VASERlipo System is substantially equivalent to the predicate device and no new issues of safety or effectiveness have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2021
Solta Medical % Manal Morcos Senior Director Regulatory Affairs, Surgical Equipment & Devices Manal Morcos, MS BME, MBA 400 Somerset Corporate Boulevard Bridgewater, New Jersey 08807
Re: K190551
Trade/Device Name: VASERlipo System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Manal Morcos:
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 1, 2019. 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 1, 2019
Solta Medical % Ms. Marci Halevi Senior Director Regulatory Affairs, Surgical Equipment & Devices 400 Somerset Corporate Boulevard Bridgewater, New Jersey 08807
Re: K190551
Trade/Device Name: VASERlipo System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: March 5, 2019 Received: March 5, 2019
Dear Ms. Halevi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
2
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/5 description: The image shows the name "Joseph A. Nielsen" in large, bold font on the left side. On the right side, there is a digital signature block that includes information such as the signer's name, organization (FDA), email address, and date. The date of the signature is May 1, 2019, at 08:49:14 -04'00'.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Indications for Use
510(k) Number (if known)
K190551
Device Name
VASERlipo System
Indications for Use (Describe)
The VASERlipo System is intended for the fragmentation of subcutaneous fatty tissues for aesthetic body contouring.
The VentX console is intended for the suction of fluids and tissue during surgical procedures. The VentX console is designed to operate with the VASERlipo System or as a stand-alone system.
The VASERlipo System is intended for the fragmentation, emulsification of subcutaneous fatty tissue for the purpose of aesthetic body contouring.
The VASERlipo 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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
4
510(k) SUMMARY K190551
1. General Information Submitter:
Contact Person:
| Solta Medical Inc. | Marci Halevi |
|---|---|
| 11720 North Creek Pkwy N., | Director, Regulatory Affairs |
| Suite 100 | 400 Somerset Corporate Boulevard |
| Bothell, WA 98011 | Bridgewater, New Jersey 08807 |
| Tel: 510-259-5299 | Phone: 908 952 5174 |
| Marci.Halevi@bauschhealth.com |
Preparation Date:
25 April 2019
-
- Names
| Device Name | VASERlipo System |
|---|---|
| Classification Name | System, Suction, Lipoplasty |
| Common Name: | Suction lipoplasty system |
| CFR References: | 21 CFR 878.5040 |
| Product Codes: | MUU |
| Performance Standards: | No performance standards for this device. |
-
- Predicate Device
K110306 VASERlipo System
- Predicate Device
4. Product Description
The subject of this Special 510(k) submission is for the VASERlipo System which is substantially equivalent to the predicate VASERlipo System.
The VASERlipo System is an ultrasonic surgical system that fragments, emulsifies, and aspirates soft tissues.
The VASERlipo System is comprised of two components: the VASER Ultrasonic Amplifier and the VentX Infiltration and Aspiration Console. Both components are designed to operate independently, and may be sold or used separately/together, or as a system.
The Amplifier uses an ultrasonic surgical handpiece and probe to fragment and emulsify the soft tissue. The Console uses sterile tubing, a handle, and cannula to infiltrate the tissue with fluids and aspirate the fluids/soft tissue.
5
-
- Indications for Use
The VASERlipo System is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring.
- Indications for Use
The VentX console is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX console is designed to operate with the VASERlipo System or as a stand-alone system.
The VASERlipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.
The VASERlipo 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
-
- Summary of Technological Characteristics
The technological characteristics of the VASERlipo System are substantially equivalent to those of the predicate device.
| Characteristic | Subject Device
VASERlipo System | Predicate
K110306 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use | Intended for the fragmentation and
emulsification of subcutaneous fatty tissues
for aesthetic body contouring | Identical to subject device |
| Operating
Frequency | 36kHz Nominal | Identical to subject device |
| Infiltration
Rates | 50-550 ml/min | Identical to subject device |
| Suction
Vacuum (max) | 20 inHg at 5,000 ft | Identical to subject device |
| Cannula | 1-6 mm diameter
7-40 cm length | 2.4-4.6 mm diameter
17-34 cm length |
6
-
- Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates the VASERlipo System is substantially equivalent to the predicate device.
- Safety and Effectiveness Information
-
- Brief Summary of Nonclinical Tests and Results
Safety tests of the VASERlipo System have demonstrated its compliance with applicable requirements of the following electrical standards:
- Brief Summary of Nonclinical Tests and Results
| IEC 60601-1:2005/AM1:2012 | Medical Electrical Equipment - Part 1: General
Requirements For Basic Safety And Essential
Performance |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| ISO 10079-1:2015 | Medical suction equipment -- Part 1: Electrically
powered suction equipment |
| Cannula deformation resistance | $20°±5°$ and straightening without the shaft exhibiting
any fractures, sharp edges, or loss of suction
performance |
| Suction Vacuum (max) 20 inHg at
5,000 ft | 20 inHg at 5,000 ft |
| Infiltration Rates | 50-550 ml/min |
-
- Conclusion
The VASERlipo System shares the same indications for use, design features, and functional features, and thus is substantially equivalent to the predicate device.
- Conclusion
Non-clinical test results demonstrate that the VASERlipo System is substantially equivalent to the predicate device and no new issues of safety or effectiveness have been raised.