PowerX Lipo System

K190555 · Solta Medical · QPB · May 1, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190555
• Device Name: PowerX Lipo System
• Applicant: Solta Medical
• Product Code: QPB · General, Plastic Surgery
• Decision Date: May 1, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

PowerX Lipo System is a suction lipoplasty device used in surgical settings by physicians for aesthetic body contouring. The system comprises an electronic controller, a handpiece, and a cannula. The handpiece connects to the controller and an independent aspiration source. The controller sends electronic signals to the handpiece to actuate the motion of the cannula, facilitating the removal of tissue or fluid. The device assists surgeons in body contouring procedures by providing controlled mechanical assistance for suction lipoplasty.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1:2005/AM1:2012 (General safety) and ISO 10079-1:2015 (Electrically powered suction equipment) was demonstrated. Additional testing included cannula deformation resistance and verification of maximum suction vacuum (20 inHg at 5,000 ft).

Technological Characteristics

System consists of an electronic controller, handpiece, and cannula. Operates at 36kHz nominal frequency. Maximum suction vacuum of 20 inHg at 5,000 ft. Cannula dimensions range from 1-6 mm diameter and 7-40 cm length. Complies with IEC 60601-1 and ISO 10079-1 standards.

Indications for Use

Indicated for removal of tissues or fluids from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring.

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

• PowerX Lipo System (K110255)

Submission Summary (Full Text)

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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, [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/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

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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 [phone] 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

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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) | |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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*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
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## 510(k) SUMMARY K190555

1. General Information Submitter:

Solta Medical Inc. 11720 North Creek Pkwy N., Suite 100 Bothell, WA 98011 Tel: [phone]

Contact Person: Marci Halevi Director, Regulatory Affairs 400 Somerset Corporate Boulevard Bridgewater, New Jersey 08807 Phone: [phone] [e-mail]

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

- 3. Predicate Device
Performance Standards:

K110255 PowerX Lipo System

- 4. 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.

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.

- 5. 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.

- 6. Summary of Technological Characteristics

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| Characteristic | Subject Device<br>PowerX Lipo<br>System | Predicate<br>K110255 |
|-------------------------|------------------------------------------------|-------------------------------------------|
| Intended Use | Removal of tissue<br>or fluid from the<br>body | Identical to<br>subject device |
| Operating<br>Frequency | 36kHz Nominal | Identical to<br>subject device |
| Suction Vacuum<br>(max) | 20 inHg at 5,000 ft | Identical to subject device |
| Cannula<br>dimensions | 1-6 mm diameter<br>7-40 cm length | 2.4 -4.6 mm diameter<br>17 – 34 cm length |

The technological characteristics of the PowerX Lipo System are substantially equivalent to those of the predicate device.

- 7. 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.

- 8. Brief Summary of Nonclinical Tests and Results
Safety tests of the System have demonstrated its compliance with applicable requirements of the following electrical standards:

| IEC 60601-<br>1:2005/AM1:2012 | Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| ISO 10079-1:2015 | Medical suction equipment -- Part 1: Electrically powered<br>suction equipment |
| Cannula deformation<br>resistance | $20°±5°$ and straightening without the shaft exhibiting any<br>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.