(57 days)
Not Found
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on electronic control of mechanical motion.
Yes
The device is intended for "removal of tissues or fluids from the body" and "suction lipoplasty for the purpose of aesthetic body contouring," which are therapeutic interventions.
No
The PowerX Lipo System is described as being used for the "removal of tissues or fluids from the body," specifically for "suction lipoplasty for the purpose of aesthetic body contouring." This is a therapeutic or surgical function, not a diagnostic one. There is no mention of the device analyzing or providing information about a patient's medical condition.
No
The device description explicitly states that the system consists of three components: an electronic controller with software, a handpiece, and a cannula. This indicates the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "removal of tissues or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a system for physically removing tissue and fluid using a handpiece, cannula, and aspiration source. This is a surgical tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Using reagents or assays
The PowerX Lipo System is a surgical device used for aesthetic body contouring.
N/A
Intended Use / Indications for Use
The PowerX Lipo System is intended for the removal of tissues or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
Product codes
QPB, MUU
Device Description
The PowerX Lipo System consists of three components: electronic controller with software, handpiece, and cannula. The handpiece is connected to the controller and to an independent aspiration source. The controller sends electronic signals to the handpiece and thereby controls the motion of the cannula that is fitted to the distal end of the handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Safety tests of the 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
- 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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 Jersev 08807
Re: K190555
Trade/Device Name: PowerX Lipo 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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & 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.
May 1, 2019
Solta Medical % Ms. Marci Halevi Senior Director Regulatory Affairs, Surgical Equipment & Devices 400 Somerset Corporate Boulevard Bridgewater, New Jersey 08807
Re: K190555
Trade/Device Name: PowerX Lipo 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/cfpmr/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 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
2
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,
Joseph A Nielsen
igitally signed by Joseph A. Nielse J: cn=Joseph A. Nielsen, o=FDA -iosenh nielsen@fda hhs go te: 2019.05.01 07:26:32 -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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K190555
Device Name PowerX Lipo System
Indications for Use (Describe)
The PowerX Lipo System is intended for the removal of tissues or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
| 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 K190555
- General Information Submitter:
Solta Medical Inc. 11720 North Creek Pkwy N., Suite 100 Bothell, WA 98011 Tel: 510-259-5299
Contact Person: Marci Halevi Director, Regulatory Affairs 400 Somerset Corporate Boulevard Bridgewater, New Jersey 08807 Phone: 908-541-8695 Marci.Halevi@bauschhealth.com
Preparation Date: 2. Names
Classification Name
Common Name: CFR References:
Product Codes:
Device Name
PowerX Lipo System System, Suction, Lipoplasty Suction lipoplasty system 21 CFR 878.5040 MUU No performance standards for this device.
April 26, 2019
-
- Predicate Device
Performance Standards:
- Predicate Device
K110255 PowerX Lipo System
-
- Product Description
The subject of this Special 510(k) submission is for the PowerX Lipo System which is substantially equivalent to the predicate PowerX Lipo System.
- Product Description
The PowerX Lipo System consists of three components: electronic controller with software, handpiece, and cannula.
The handpiece is connected to the controller and to an independent aspiration source. The controller sends electronic signals to the handpiece and thereby controls the motion of the cannula that is fitted to the distal end of the handpiece.
-
- Indications for Use
The PowerX Lipo System is intended for the removal of tissues or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
- Indications for Use
-
- Summary of Technological Characteristics
5
| Characteristic | Subject Device
PowerX Lipo
System | Predicate
K110255 |
|-------------------------|------------------------------------------------|-------------------------------------------|
| Intended Use | Removal of tissue
or fluid from the
body | Identical to
subject device |
| Operating
Frequency | 36kHz Nominal | Identical to
subject device |
| Suction Vacuum
(max) | 20 inHg at 5,000 ft | Identical to subject device |
| Cannula
dimensions | 1-6 mm diameter
7-40 cm length | 2.4 -4.6 mm diameter
17 – 34 cm length |
The technological characteristics of the PowerX Lipo System are substantially equivalent to those of the predicate device.
-
- Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates the PowerX Lipo System is substantially equivalent to the predicate device.
- Safety and Effectiveness Information
-
- Brief Summary of Nonclinical Tests and Results
Safety tests of the 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 |
9. Conclusion
The PowerX Lipo System shares the same indications for use, design features, and functional features, and thus is substantially equivalent to, the predicate device.
Non-clinical test results demonstrate that the PowerX Lipo System is substantially equivalent to the predicate device and no new issues of safety or effectiveness have been raised.