LipoSurg ARTIST
Device Facts
| Record ID | K254135 |
|---|---|
| Device Name | LipoSurg ARTIST |
| Applicant | NOUVAG AG |
| Product Code | QPB · General, Plastic Surgery |
| Decision Date | Sep 5, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The NOUVAG LipoSurg ARTIST is indicated for removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring.
Device Story
LipoSurg ARTIST is a software-controlled, electro-mechanical surgical system for fluid infiltration and tissue aspiration. It comprises a peristaltic pump for infiltration and an optional internal vacuum pump for aspiration, housed in a wheeled tower; a table-top configuration (LipoSurg POWER) excludes the vacuum pump. The system uses a handpiece (with optional vibrational mode) and foot controller. Operated by surgeons and supported by clinical staff in sterile surgical environments (hospitals/clinics), the device manages operational parameters via software. The provider uses the handpiece to infiltrate tumescent solution and aspirate adipose tissue/fluids into collection canisters. The vibrational handpiece provides ergonomic assistance to improve surgical efficiency. The device benefits patients by facilitating body contouring procedures through controlled tissue removal.
Clinical Evidence
No clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1-1), electromagnetic compatibility (IEC 60601-1-2, IEC TR 60601-4-2), and biocompatibility (ISO 10993-1, -5, -10, -11, -23, USP <151>). Performance testing followed ISO 10079-1 and ISO 10079-4.
Technological Characteristics
Electro-mechanical system with peristaltic infiltration pump and optional vacuum aspiration pump. Materials include stainless steel, aluminum, silicones, and chromium-plated brass. Features include LCD display, tactile buttons, foot pedal, and vibrational handpiece. Connectivity is standalone. Sterilization of handpiece/accessories via steam. Software-controlled parameters. Power: 100-230 VAC, 50/60 Hz. Complies with IEC 60601-1-1, IEC 60601-1-2, and IEC 62304.
Indications for Use
Indicated for removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring in patients requiring such procedures.
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
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
September 5, 2026
Nouvag Ag
% Kenneth Block
President
Ken Block Consulting, LLC
3400 Central Expy, Suite 100-265
Richardson, Texas 75080
Re: K254135
Trade/Device Name: LipoSurg ARTIST
Regulation Number: 21 CFR 878.5040
Regulation Name: Suction Lipoplasty System
Regulatory Class: Class II
Product Code: QPB
Dated: September 3, 2026
Received: September 4, 2026
Dear Kenneth Block:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
ALICIA
HEMPHILL -S
Digitally signed by ALICIA
HEMPHILL -S
Date: 2026.09.05 11:33:50 -05'00'
Alicia L. Hemphill (Johnson), MS
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254135 | ? |
| Please provide the device trade name(s). | | ? |
| LipoSurg ARTIST | | |
| Please provide your Indications for Use below. | | ? |
| The NOUVAG LipoSurg ARTIST is indicated for removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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# 510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Sponsor / Applicant: | NOUVAG AG St. Gallerstrasse 25 Goldach, Sankt Gallen, 9403 Switzerland Sponsor Contact: Christof Künz Chief Technology Officer TEL: + 41-71-846-66-00 |
| --- | --- |
| Submission Correspondent: | Ken Block Consulting, LLC 3400 N Central Expy, Suite 100-265 Richardson, TX 75080 Submission Contact: Kenneth L. Block, RAC President TEL: 972-480-9554 Email: block@kenblockconsulting.com |
| --- | --- |
| Date Prepared: | September 3, 2026 |
| --- | --- |
| Subject Device: | Submission Number: | K254135 |
| --- | --- | --- |
| | Manufacturer: | NOUVAG AG |
| | Trade Name: | LipoSurg ARTIST |
| | FDA Product Code: | QPB |
| | Device Classification Name: | System, Suction, Lipoplasty for Removal |
| | Classification / Review Panel: | General & Plastic Surgery |
| | FDA Regulation: | 21 CFR 878.5040 |
| | Regulation Description: | Suction lipoplasty system |
| | Regulatory Class: | II |
| | Prescription or OTC Use: | Rx Only |
| Primary Predicate Device: | Submission Number: | K244050 |
| --- | --- | --- |
| | Manufacturer: | Apyx Medical Corporation |
| | Trade Name: | AYON™ Body Contouring System (AYON™ SYSTEM) |
| | FDA Product Code: | QPB |
| | Device Classification Name: | System, Suction, Lipoplasty for Removal |
| | Classification / Review Panel: | General & Plastic Surgery |
| | FDA Regulation: | 21 CFR 878.5040 |
| | Regulation Description: | Suction lipoplasty system |
| | Regulatory Class: | II |
| | Prescription or OTC Use: | Rx Only |
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# Additional Predicate Device:
Submission Number:
Manufacturer:
Trade Name:
FDA Product Code:
Device Classification Name:
Classification / Review Panel:
FDA Regulation:
Regulation Description:
Regulatory Class:
Prescription or OTC Use:
K053451
Moeller Medical GmbH & Co. Kg
Liposat / Vacusat / Vibrasat
QPB
System, Suction, Lipoplasty for Removal
General & Plastic Surgery
21 CFR 878.5040
Suction lipoplasty system
II
Rx Only
# Indications for Use:
The NOUVAG LipoSurg ARTIST is indicated for removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring.
# Device Description:
LipoSurg ARTIST is a comprehensive surgical device, integrating both fluid infiltration and tissue aspiration functions. In its full configuration, the LipoSurg ARTIST houses an electrically powered peristaltic pump for infiltration and an internal vacuum pump for aspiration, within a table-height tower including integrated wheels for ease of surgical positioning.
For clinical environments where an external (hospital-grade) vacuum source is already established, the LipoSurg ARTIST vacuum pump is not needed. Therefore, the partial configuration of the LipoSurg ARTIST (table-top LipoSurg POWER) retains the identical peristaltic pump and software architecture for infiltration, but excludes the internal vacuum pump components and wheeled tower.
Operational parameters for both configurations are managed via the LipoSurg ARTIST software. Both the full and partial LipoSurg ARTIST device configurations utilize the same LipoSurg foot controller and LipoSurg handpieces.
Additional commercially available devices/accessories used with the LipoSurg ARTIST include the following:
- Infiltration and aspiration cannulas
- Sterile, single-use infiltration and aspiration tubing
- Cleaning brushes
- Collection canisters
# Performance Data
Relevant FDA guidance documents and FDA Recognized Consensus Standards were followed for assessing all aspects of the LipoSurg ARTIST system.
# Mechanical & Bench Testing
The LipoSurg ARTIST was tested to demonstrate system performance in both configurations, as well as compatibility with commercially available cannulas and tubing. LipoSurg ARTIST testing was performed in accordance with ISO 10079-1 and ISO 10079-4.
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# Electrical Safety & Electromagnetic Compatibility
- Electrical safety testing was performed in accordance with IEC 60601-1-1.
- Electromagnetic Compatibility testing was performed in accordance with FDA guidance document Electromagnetic Compatibility (EMC) of Medical Devices and FDA Recognized Consensus Standards IEC 60601-1-2 and IEC TR 60601-4-2.
# Software
- Software verification and validation were conducted in accordance with FDA Guidance document Content of Premarket Submissions for Device Software Functions and FDA Recognized Consensus Standard IEC 62304.
# Biocompatibility
- Biocompatibility assessment was conducted in accordance with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and FDA Recognized Consensus Standard ISO 10993-1. For device components having indirect patient contact, biocompatibility-related testing was conducted to FDA Recognized Consensus Standards regarding Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10, Irritation / Intracutaneous Reactivity (ISO 10993-23), Acute Systemic Toxicity (ISO 10993-11), and Material-Mediated Pyrogenicity (USP <151>).
# Reprocessing
- Reprocessing was conducted in accordance with the FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, and related FDA Recognized Consensus Standards.
# Summary of Technological Characteristics:
Both the subject LipoSurg ARTIST device and the primary predicate device have similar system components: an electro-mechanical infiltration pump (for infiltration of tumescent solution), an electro-mechanical aspiration/suction pump (for removal of adipose tissue, fluids, waste), and software-controlled technology for setting and adjusting subsystem parameters. The primary predicate device has an ultrasound subsystem for the fragmentation and emulsification of fatty tissue, which is not present in the subject device.
In addition to the same similarities as stated above, the subject LipoSurg ARTIST device and the additional predicate device both employ a handpiece (for increased ergonomics) that may be operated in a vibrational mode (for surgical efficiency).
# Description of Device Attributes:
In accordance with FDA guidance document The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], the following details regarding subject device attributes are provided below.
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# Key Device Components
- Electro-mechanical infiltration pump subsystem (peristaltic pump)
- Optional electro-mechanical aspiration/suction pump (vacuum pump)
- Handpiece (with optional vibrational mode)
- Foot controller
- Software control (for setting and adjusting subsystem parameters)
- Optional table-height tower including integrated wheels
# Configurations
- Full configuration (LipoSurg ARTIST): peristaltic and vacuum pumps, handpiece, foot controller, software control, table-height tower
- Partial configuration (LipoSurg POWER): peristaltic pump, handpiece, foot controller, software control
# Device Characteristics
- Software
- Indirect patient contact
- Sterilization required (handpiece and handpiece accessories)
- Sterilization method: steam
# Environment of Use
- Sterile surgical environment
- Healthcare facility (surgical center, hospital, etc.)
# Principles of Operation
- Software-controlled, electrically powered peristaltic pump allows for infiltration of tumescent solution into the patient, using the LipoSurg handpiece and commercially-available infiltration cannulas and commercially available infiltration tubing.
- Software-controlled, electrically powered vacuum pump allows for removal of adipose tissue, fluids, and waste from the patient, using the LipoSurg handpiece and commercially-available aspiration cannulas, commercially available aspiration tubing, and commercially available collection canisters.
- Operational parameters for the above function are managed via the LipoSurg ARTIST software and LipoSurg foot controller.
# Materials of Use
- Items with indirect patient contact (handpiece including the cannula adapter and cable) are constructed of stainless steel, aluminum, silicones and chromium plate brass that were subjected to and passed biocompatibility testing per applicable FDA Recognized Consensus Standards.
- Nature and duration of contact are categorized as an externally communicating device contacting tissue, bone, or dentin for less than 24 hours.
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# **User Profile:**
As with the predicate devices, primary users of the LipoSurg ARTIST device are experienced healthcare practitioners who are qualified to conduct surgery (e.g., general surgeons, plastic surgeons, etc.) who employ the LipoSurg ARTIST device in surgical settings (e.g., hospitals, clinics, etc.). Secondary users who may assist the primary users (e.g., device setup, accessory connection, device cleaning, etc.) are also experienced healthcare practitioners, but work in supporting roles in relation to the primary users (e.g., nurses, surgical technicians, clinical technicians, etc.). There are no differences in the user profile (i.e., primary users, secondary users, use environment, intended patients, etc.) between the subject and the predicate devices (both primary and additional).
# **Tabular Comparison of Subject and Primary Predicate Devices**
The primary predicate device has an ultrasound subsystem for the fragmentation and emulsification of fatty tissue, which is not present in the subject device. For the sake of simplicity, the ultrasound subsystem aspects of the primary predicate device are thus excluded from the tables below. First, the regulatory characteristics of the primary predicate and subject device are compared in the table below. Except for more condensed wording of the Indications for Use for the LipoSurg ARTIST, the compared contents in each row are identical.
| Regulatory Characteristics | K244050 Primary Predicate Device | K254135 LipoSurg ARTIST Subject Device |
| --- | --- | --- |
| Device Name | System, Suction, Lipoplasty For Removal | System, Suction, Lipoplasty For Removal |
| Regulation Name | Suction Lipoplasty System | Suction Lipoplasty System |
| FDA Regulatory Definition | A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring | A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring |
| Regulation | 21 CFR 878.5040 | 21 CFR 878.5040 |
| Target Area | Body | Body |
| Regulatory Class | II | II |
| Medical Specialty | General & Plastic Surgery | General & Plastic Surgery |
| Product Code | QPB | QPB |
| FDA Review Panel | General & Plastic Surgery | General & Plastic Surgery |
| FDA Review Center | CDRH | CDRH |
| Indications for Use | The AYON™ Body Contouring System is intended for the aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring. The AYON™ Infiltration and Aspiration Sub-System(s) are used for the infiltration and suction/aspiration of fluids and tissue during surgical procedures. Infiltration and Suction is designed to operate as a stand-alone function. | The NOUVAG LipoSurg ARTIST is indicated for removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring. |
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| Intended Use | Intended for the removal of adipose tissue for purposes of aesthetic body contouring | Intended for the removal of adipose tissue for purposes of aesthetic body contouring |
| --- | --- | --- |
| Rx or OTC Use | Prescription Use Only | Prescription Use Only |
Next, the device functional characteristics of the primary predicate and subject device are compared in the table below (including the major system components and accessories), where the compared contents in each row are identical or nearly identical.
| Functional Characteristics | K244050 Primary Predicate Device | K254135 LipoSurg ARTIST Subject Device |
| --- | --- | --- |
| Infiltration | Electrically powered infiltration/peristaltic pump subsystem, utilizing sterile infiltration tubing and commercially available cannulas to infiltrate tissue with fluids. | Electrically powered infiltration/peristaltic pump subsystem, utilizing sterile infiltration tubing and commercially available cannulas to infiltrate tissue with fluids. |
| Aspiration | Electrically powered suction/aspiration subsystem, utilizing sterile suction tubing and commercially available cannulas to aspirate fluids and soft tissue. | Electrically powered suction/aspiration subsystem, utilizing sterile suction tubing and commercially available cannulas to aspirate fluids and soft tissue. |
| Additional Manufacturer Components | Manufacturer supplied devices/accessories for the infiltration and aspiration and subsystem(s) include the following: • Infiltration and aspiration handles • Foot pedals • Integrated wheeled base • Mounting poles and canister mounts • Power cords | Manufacturer supplied devices/accessories for the infiltration and aspiration and subsystem(s) include the following: • Infiltration and aspiration handpiece • Foot pedal • Integrated wheeled base • Mounting poles and canister mounts • Power cord |
| Additional Commercial Components | Additional commercially available devices/accessories include the following: • Infiltration and aspiration cannulas • Sterile, single-use infiltration and aspiration tubing • Sterilization tray and cleaning brushes • Collection canisters • Infiltration fluid warming unit | Additional commercially available devices/accessories include the following: • Infiltration and aspiration cannulas • Sterile, single-use infiltration and aspiration tubing • Cleaning brushes • Collection canisters |
| Control Mechanism | Software-controlled | Software-controlled |
Basic technical specifications of the primary predicate and subject device are compared in the table below, where the compared contents in each row are substantially equivalent.
| Technical Specifications | K244050 Primary Predicate Device | K254135 LipoSurg ARTIST Subject Device |
| --- | --- | --- |
| Primary Control Unit Dimensions | Unknown | 520 cm (Width) x 470 cm (Depth) x 1150 cm (Height) |
| Weight | Unknown | 32 kg |
| Display Type | LCD | LCD |
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| Control Methods | Tactile Buttons, Foot Pedals | Tactile Buttons, Foot Pedal, Handpiece |
| --- | --- | --- |
| Power | 120 VAC, 50/60 Hz | 100 VAC – 230 VAC, 50/60 Hz |
| Electrical Safety | IEC Class I, Type BF | IEC Class I, Type BF |
| Infiltration Pump | Peristalic | Peristalic |
| Infiltration Rate | Adjustable flow rate from 40 – 1000 mL/min | Adjustable flow rate from 50 – 1,000 ml/min |
| Aspiration pump | Suction Vacuum: 27 in Hg at sea level | Adjustable vacuum = -0.95 bar / -95 kPa / 713 mmHg Adjustable airflow = 40 – 100 l/min Pressure gauge accuracy = ± 10 % |
### Substantial Equivalence Discussion (Subject and Primary Predicate Devices)
Both the subject and predicate devices are software-controlled electro-mechanical suction lipoplasty systems, regulated under FDA product code QPB. As such, both devices share the same Regulatory Characteristics, including Regulatory Class, Regulation Number, Target Area and Intended Use. In addition, the Indications for Use are similar (with subject device having more condensed wording).
As demonstrated by both the identical Functional Characteristics and the nearly identical list of Manufacturer Supplied and Commercially Available Components, both the predicate and subject devices employ the same overall characteristics to achieve their shared Intended Use.
As shown in the Comparison of Key Technological Characteristics, the dimensions and weight of the subject device differ from those of the predicate device; however, these variations are acceptable and do not impact the device's safety or effectiveness. In addition to tactile buttons and a foot pedal, the subject device includes a handpiece control feature that allows the user to start and stop the procedure, enhancing operational convenience. While the minimum infiltration rate of the subject device is slightly higher than that of the predicate device, the overall infiltration rate range remains within the limits established by the predicate device.
Extensive testing was conducted for the subject device using well established methods, including testing to FDA Recognized Consensus Standards for electrical safety, electromagnetic compatibility (EMC), and biocompatibility. In addition, software documentation and testing has been provided within this premarket notification, in compliance with FDA final guidance document Content of Premarket Submissions for Device Software Functions. Finally, the risk management information within this 510(k) demonstrates that the subject device is as safe and effective as the identified primary predicate device.
### Tabular Comparison of Subject and Additional Predicate Devices
Since the primary predicate device does not have a vibrational handpiece, an additional predicate device is used to as a comparison against the subject LipoSurg ARTIST device handpiece, which may be operated in a vibrational mode.
First, the regulatory characteristics of the additional predicate and subject device are compared in the table below, where the compared contents in each row are identical except for the lengthier wording of the Indications for Use for the subject device (which was written to more closely match the Indications for Use of the primary predicate device).
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| Regulatory Characteristics | K053451 Additional Predicate Device | K254135 LipoSurg ARTIST Subject Device |
| --- | --- | --- |
| Device Name | System, Suction, Lipoplasty For Removal | System, Suction, Lipoplasty For Removal |
| Regulation Name | Suction Lipoplasty System | Suction Lipoplasty System |
| FDA Regulatory Definition | A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring | A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring |
| Regulation | 21 CFR 878.5040 | 21 CFR 878.5040 |
| Target Area | Body | Body |
| Regulatory Class | II | II |
| Medical Specialty | General & Plastic Surgery | General & Plastic Surgery |
| Product Code | QPB | QPB |
| FDA Review Panel | General & Plastic Surgery | General & Plastic Surgery |
| FDA Review Center | CDRH | CDRH |
| Indications for Use | For aesthetic body contouring. | The NOUVAG LipoSurg ARTIST is indicated for removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring. |
| Intended Use | Intended for the removal of adipose tissue for purposes of aesthetic body contouring | Intended for the removal of adipose tissue for purposes of aesthetic body contouring |
| Rx or OTC Use | Prescription Use Only | Prescription Use Only |
Next, the primary functional characteristics of the additional predicate and subject devices are compared in the table below, with the specific area of focus being the vibrational handpiece of each device (which is merely a design choice not included with the primary predicate device). The compared contents in each row are identical.
| Functional Characteristics | K053451 Additional Predicate Device | K254135 LipoSurg ARTIST Subject Device | Comparison |
| --- | --- | --- | --- |
| Infiltration | Electrically powered infiltration/peristaltic pump subsystem, utilizing sterile infiltration tubing and commercially available cannulas to infiltrate tissue with fluids. Vibrational handpiece is used to execute the infiltration function. | Electrically powered infiltration/peristaltic pump subsystem, utilizing sterile infiltration tubing and commercially available cannulas to infiltrate tissue with fluids. Vibrational handpiece is used to execute the infiltration function. | Identical |
| Aspiration | Electrically powered suction/aspiration subsystem, utilizing sterile suction tubing and commercially available cannulas to aspirate fluids and soft tissue. | Electrically powered suction/aspiration subsystem, utilizing sterile suction tubing and commercially available cannulas to aspirate fluids and soft tissue. | Identical |
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| | Vibrational handpiece is used to execute the aspiration function. | Vibrational handpiece is used to execute the aspiration function. | |
| --- | --- | --- | --- |
| Vibrational Handpiece | Electrically powered vibrational handpiece providing ergonomical assistance to the user, when conducting the infiltration and aspiration functions. | Electrically powered vibrational handpiece providing ergonomical assistance to the user, when conducting the infiltration and aspiration functions. | Identical |
| Control Mechanism | Software-controlled | Software-controlled | Identical |
### Substantial Equivalence Discussion (Subject and Additional Predicate Devices)
Both the subject and additional predicate devices are software-controlled electro-mechanical suction lipoplasty systems, regulated under FDA product code QPB. As such, both devices share the same Regulatory Characteristics, including Regulatory Class, Regulation Number, Target Area and Intended Use. In addition, the Indications for Use are identical (other than the addition of the LipoSurg proprietary name for the subject device).
As demonstrated by the identical Functional Characteristics, both the additional predicate and subject devices employ the same overall characteristics to achieve their shared Intended Use, including a vibrational handpiece (not offered by the primary predicate device).
### Clinical Performance:
As was determined for clearance of both predicate devices (primary predicate and additional predicate), no clinical studies were required to support the substantial equivalence of the subject LipoSurg ARTIST device. These types of lipoplasty system devices have been in common clinical use on the U.S. market for many years, with well-established safety and effectiveness profiles. Therefore, the thorough non-clinical validation activities summarized above were conducted to directly support the substantial equivalence of the subject LipoSurg ARTIST device.
### Conclusion:
The subject and both predicate devices (primary predicate and additional predicate) are software-controlled electro-mechanical suction lipoplasty systems for removal, regulated under FDA product code QPB. Both devices offer infiltration of fluids and removal of fluids and tissue. As such, all devices share the same Regulatory Characteristics, including Regulatory Class, Regulation Number, Target Area and Intended Use. In addition, the Indications for Use is similar for all devices.
As demonstrated by both the identical Functional Characteristics and the identical list of Major Device Components, both the primary predicate and subject devices employ the same overall functional and performance characteristics to achieve their shared Intended Use. Both the additional predicate and subject devices employ a vibrational handpiece.
Extensive testing was conducted for the subject device using well established methods, including testing to FDA Recognized Consensus Standards for electrical safety, electromagnetic compatibility (EMC), and biocompatibility. In addition, software documentation and testing has been provided within this premarket notification, in compliance with FDA final guidance document Content of Premarket Submissions for Device Software Functions. Finally, the risk management information within this 510(k) demonstrates that the subject device is as safe and effective as the identified primary predicate device.
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In summary, as demonstrated within the tabular comparisons within this document, the subject and predicate devices all have shared intended use, design, functions and technological characteristics. Any differences in the implementation of these shared characteristics do not raise new or different questions of safety and effectiveness. Therefore, the subject LipoSurg ARTIST device is substantially equivalent to the identified predicate devices.
