(132 days)
The AYON Body Contouring System is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.
- The AYON Ultrasound Sub-System is used for the fragmentation and emulsification of subcutaneous fatty tissues for 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 AYON Body Contouring System includes an Ultrasound Sub-system, an Infiltration Sub-system, and an Aspiration Sub-system. The Ultrasound Sub-system includes an ultrasound amplifier, an ultrasound handpiece, and ultrasound probes which are to be used with compatible skin ports and plugs. The Infiltration Sub-system includes a peristaltic pump and weighing scale and utilizes sterile infiltration tubing, handles and cannulas to infiltrate tissue with fluids. The Aspiration Sub-system includes two suction units that have the capability to function separately or together in series, such that it can be used as two separate suction units by two operators, or as a single suction unit (in series) by a single operator. The Aspiration Sub-system utilizes sterile suction tubing, handles and cannulas to aspirate fluids and soft tissue. The Infiltration and Aspiration Sub-systems are designed to operate independent of the Ultrasound Sub-system such that the system may be offered with only Infiltration and Aspiration to support standard suction-assisted liposuction (SAL) or with Ultrasound enabled to support ultrasound-assisted liposuction (UAL).
Apyx Medical devices/accessories for the system include the following:
- Infiltration and aspiration handles
- Ultrasound handpiece
- Ultrasound handpiece cables
- Ultrasound probes
- Footswitches: Two (2) wireless footswitches to control ultrasound and infiltration
- Skin ports and skin port tool
- AYON Base Tower mounting poles and canister mounts
- Power cords
Additional commercially available devices/accessories include the following:
- Infiltration and aspiration cannulas
- Aspiration filters
- Sterile, single-use infiltration and aspiration tubing
- Wrench
- Sterilization tray and cleaning brushes
- Collection canisters and liners
- Infiltration fluid warming unit(s)
The AYON Body Contouring System may also accommodate other equipment, including commercially available electrosurgical generators owned by Apyx Medical, such as the Apyx One Console.
The provided FDA 510(k) clearance letter for the AYON Body Contouring System does not contain acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/software-driven medical device for diagnosis or prognosis.
Instead, this document describes a traditional medical device clearance process for a hardware-based system (liposuction system), which relies on substantial equivalence to a predicate device rather than performance against defined metrics.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies are not applicable or cannot be extracted from this document.
However, I can still extract information related to the performance data provided, even if it's not structured around explicit acceptance criteria and corresponding performance metrics for an AI algorithm.
Non-Applicable Sections for this Device Type:
- Acceptance Criteria for AI Performance: No explicit acceptance criteria (e.g., sensitivity, specificity, F1-score thresholds) for AI performance are stated because the device is not an AI/software diagnostic or prognostic tool.
- Study Proving Acceptance Criteria: No such study is described.
- Sample size used for the test set and the data provenance: No test set for AI/software performance is mentioned. The "testing" refers to mechanical, electrical, software, biocompatibility, and reprocessing validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for AI performance is established.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI performance.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Extracted Relevant Information (related to device performance and testing):
While not in the requested format of AI acceptance criteria, here's a summary of the performance testing conducted and the "reported device performance" as described in the 510(k) summary for the AYON Body Contouring System:
1. Table of "Acceptance Criteria" (interpreted as performance characteristics compared to predicate) and Reported Device Performance:
| Feature/Specification | Acceptance Criteria (Predicate Device K110306) | Reported Device Performance (AYON Body Contouring System) | Comments (from document) |
|---|---|---|---|
| Intended Use (Overall System) | Fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for aesthetic body contouring. Other surgical specialties. | Fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for aesthetic body contouring. | Identical (for aesthetic body contouring). Subject Device not pursuing expanded indications. |
| Ultrasound Sub-System: Operating Frequency | 36 kHz nominal | 37 kHz nominal | Similar |
| Ultrasound Sub-System: Vibratory Power/Amplitude | Settings ranging from 10% to 100% | Low Power = 8 watts, Medium Power = 20 watts, High Power = 28 watts | Similar |
| Aspiration Sub-System: Suction Vacuum | 20 in Hg at 5000 ft. (~25 in Hg at sea level) | 27 in Hg at sea level | Similar¹ (within 0-29.9 in Hg range) |
| Infiltration Sub-System: Infiltration Rate | Adjustable flow rate from 50-550 mL/min | Adjustable flow rate from 40-1000 mL/min | Similar² (ranges overlap and extend) |
| Mechanism of Action | Ultrasonic fragmentation/emulsification, infiltration, and aspiration. | Ultrasonic fragmentation/emulsification, infiltration, and aspiration. | Identical |
| Electrical Safety | IEC Class I, Type BF | IEC Class I, Type BF | Identical for all sub-systems. |
Notes for Table:
- ¹ Suction vacuum for the Subject Device falls within the vacuum range of 0 to 29.9 in Hg included in the Product Code description and falls below the maximum vacuum range for other FDA cleared devices. Vitruvian Ultimate Aspirator (K161722), PSI-TEC Aspirator (K981215).
- ² The infiltration flow rates for the Subject Device are identical or fall below the maximum flow rates for other FDA cleared infiltration and infusion pumps. Reference devices; Klein Surgical Infiltration pump (K031432) and the Wells Johnson Infusion pump (K991437).
2. Sample size used for the test set and the data provenance:
- Test Set (for AI/software performance): Not applicable.
- Data Provenance: Not applicable.
However, the document lists various non-clinical performance tests:
- Mechanical and Physical Bench Testing: Each subsystem (ultrasound, infiltration, aspiration) was tested separately and as a combined system for overall performance, tip vibrational amplitude, thermal effects on tissue, voltage/current outputs, and compatibility. Aspiration testing was in accordance with ISO 10079-1 and ISO 10079-4.
- Electrical Safety and EMC: Testing performed per IEC 60601-1-1, IEC 60601-1-2, and 60601-4-2. Wireless emissions testing for footswitch.
- Software and Cybersecurity: Verification and Validation (V&V) performed in accordance with ISO 62304.
- Biocompatibility Testing: Conducted per ISO 10993-1 on patient-contacting materials.
- Reprocessing: Tested in accordance with ISO 17665.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device does not use an expert-established ground truth for performance evaluation in the context of AI. The performance is assessed through engineering and bench testing, and comparison of specifications to a predicate device.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. The device is not a diagnostic imaging or AI-assisted diagnostic tool. No clinical studies were required or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. The product is a physical electro-mechanical system.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" is derived from established engineering standards (e.g., ISO, IEC), physical measurements, and direct comparison of specifications to the legally marketed predicate device. There is no biological or expert consensus "ground truth" in the AI sense.
8. The sample size for the training set:
- Not applicable. The device is a hardware system, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
FDA 510(k) Clearance Letter - AYON Body Contouring System
Page 1
May 12, 2025
Apyx Medical Corporation
Angela Huber
Global Director of Regulatory Affairs
5115 Ulmerton Road
Clearwater, Florida 33760
Re: K244050
Trade/Device Name: AYON Body Contouring System (AYON SYSTEM)
Regulation Number: 21 CFR 878.5040
Regulation Name: Suction Lipoplasty System
Regulatory Class: Class II
Product Code: QPB
Dated: December 31, 2024
Received: April 11, 2025
Dear Angela Huber:
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.
Page 2
K244050 - Angela Huber
Page 2
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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.
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.
Page 3
K244050 - Angela Huber
Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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 L. Hemphill (Johnson), M.S.
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
Page 4
INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K244050
Device Name: AYON™ Body Contouring System (AYON SYSTEM)
Indications for Use (Describe)
The AYON Body Contouring System is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.
- The AYON Ultrasound Sub-System is used for the fragmentation and emulsification of subcutaneous fatty tissues for 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.
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."
Page 5
510(k) SUMMARY
1. General Information
Submitted by: Apyx Medical Corporation
5115 Ulmerton Road
Clearwater, Florida 33760-4004
United States of America
Contact Person: Angela Huber, PhD, RAC,
Global Director of Regulatory Affairs
Phone: 218-343-4881
Email: angela.huber@apyxmedical.com
Date Prepared: May 5, 2025
Trade Name (Model Numbers): AYON™ Body Contouring System (AYON SYSTEM)
Common Name: Liposuction System
Classification: Class II per 21CFR 878.5040 - Suction Lipoplasty System
Product Code: QPB
Predicate Device: VASER 2.1 Lipo System (K110306)
2. Proposed Indications for Use
The AYON Body Contouring System is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.
- The AYON Ultrasound Sub-System is used for the fragmentation and emulsification of subcutaneous fatty tissues for 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.
3. Device Description
The AYON Body Contouring System includes an Ultrasound Sub-system, an Infiltration Sub-system, and an Aspiration Sub-system. The Ultrasound Sub-system includes an ultrasound amplifier, an ultrasound handpiece, and ultrasound probes which are to be used with compatible skin ports and plugs. The Infiltration Sub-system includes a peristaltic pump and weighing scale and utilizes sterile infiltration tubing, handles and cannulas to infiltrate tissue
Page 6
with fluids. The Aspiration Sub-system includes two suction units that have the capability to function separately or together in series, such that it can be used as two separate suction units by two operators, or as a single suction unit (in series) by a single operator. The Aspiration Sub-system utilizes sterile suction tubing, handles and cannulas to aspirate fluids and soft tissue. The Infiltration and Aspiration Sub-systems are designed to operate independent of the Ultrasound Sub-system such that the system may be offered with only Infiltration and Aspiration to support standard suction-assisted liposuction (SAL) or with Ultrasound enabled to support ultrasound-assisted liposuction (UAL).
Apyx Medical devices/accessories for the system include the following:
- Infiltration and aspiration handles
- Ultrasound handpiece
- Ultrasound handpiece cables
- Ultrasound probes
- Footswitches: Two (2) wireless footswitches to control ultrasound and infiltration
- Skin ports and skin port tool
- AYON Base Tower mounting poles and canister mounts
- Power cords
Additional commercially available devices/accessories include the following:
- Infiltration and aspiration cannulas
- Aspiration filters
- Sterile, single-use infiltration and aspiration tubing
- Wrench
- Sterilization tray and cleaning brushes
- Collection canisters and liners
- Infiltration fluid warming unit(s)
The AYON Body Contouring System may also accommodate other equipment, including commercially available electrosurgical generators owned by Apyx Medical, such as the Apyx One Console.
4. Performance Data
The relevant FDA guidance documents were followed for all aspects of performance testing.
a. Mechanical and Physical Bench Testing
Each subsystem was tested separately and as a combined system to demonstrate system compatibility of the subsystems and devices/accessories. The subsystem testing included:
- The ultrasound subsystem was assessed for overall performance, tip vibrational amplitude, thermal effects on tissue, voltage and current outputs.
- The infiltration subsystem was assessed for overall performance, and compatibility with commercially available cannulas and tubing.
- The aspiration subsystem testing was performed in accordance with ISO 10079-1 and ISO 10079-4.
Page 7
b. Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety testing was performed in accordance with IEC 60601-1-1. Electromagnetic Compatibility testing was performed in accordance with IEC 60601-1-2 and 60601-4-2. Wireless emissions testing was conducted for the wireless footswitch.
c. Software and Cybersecurity
Software and Cybersecurity Verification and Validation testing were performed in accordance with ISO 62304.
d. Biocompatibility Testing
Biological evaluation per ISO 10993-1 was conducted on the patient contacting materials (direct and indirect contacting).
e. Reprocessing
The reprocessing of sterile products was tested in accordance with ISO 17665.
5. Clinical Performance
No clinical studies were required to support the substantial equivalence of the device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy. The non-clinical testing detailed in this submission support the substantial equivalence of the device.
6. Substantial Equivalence
The Subject Device for this submission is the AYON Body Contouring System. The identified Predicate Device is the Sound Surgical VASER 2.1 Lipo System, manufactured by Solta Medical under K110306. A comparison between the Subject Device and the Predicate Device is provided in Table 1.
Table 1. Substantial Equivalence Table
| AYON Body Contouring System Subject Device (This Submission) | VASER 2.1 Lipo System Predicate Device K110306 | Comments | |
|---|---|---|---|
| Overall System | AYON Body Contouring System | VASER 2.1 Lipo System | |
| Components of the System | Includes an Ultrasound Sub-System | Includes the Sound Surgical VASER 2.1 ultrasound system | Identical |
| Includes an Aspiration Sub-System | Includes an aspiration system as part of the Sound Surgical VentX 2.1 system | Identical |
Page 8
| AYON Body Contouring System Subject Device (This Submission) | VASER 2.1 Lipo System Predicate Device K110306 | Comments | |
|---|---|---|---|
| Includes an Infiltration Sub-System | Includes an infiltration system as part of the Sound Surgical VentX 2.1 system | Identical | |
| Intended Use | Overall System: The AYON Body Contouring System is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring. | Overall 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. | Identical |
| Overall System: 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 tissue: • Neurosurgery; • Gastrointestinal and affiliated organ surgery; • Urological surgery; • Plastic and reconstructive surgery; • General surgery; • Gynecological surgery; • Thoracic surgery; and • Laparoscopic surgery. | The Subject Device is not pursuing the expanded indications for additional surgical specialties included in the intended use for the Predicate Device. | ||
| Ultrasound Sub-System: The AYON Ultrasound Sub-System is used for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. | Ultrasound Sub-System: The Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. | Same intent and purpose of use with minor changes. | |
| Infiltration and Aspiration Sub-Systems: 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. | Infiltration and Aspiration Sub-Systems: 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. | Same intent and purpose of use with minor changes for clarity. |
Page 9
| AYON Body Contouring System Subject Device (This Submission) | VASER 2.1 Lipo System Predicate Device K110306 | Comments | |
|---|---|---|---|
| Includes an Infiltration Sub-System | Includes an infiltration system as part of the Sound Surgical VentX 2.1 system | Identical | |
| Intended Use | Overall System: The AYON Body Contouring System is intended for the fragmentation, emulsification, and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring. | Overall 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. | Identical |
| Overall System: 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 tissue: • Neurosurgery; • Gastrointestinal and affiliated organ surgery; • Urological surgery; • Plastic and reconstructive surgery; • General surgery; • Gynecological surgery; • Thoracic surgery; and • Laparoscopic surgery. | The Subject Device is not pursuing the expanded indications for additional surgical specialties included in the intended use for the Predicate Device. | ||
| Ultrasound Sub-System: The AYON Ultrasound Sub-System is used for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. | Ultrasound Sub-System: The Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. | Same intent and purpose of use with minor changes. | |
| Infiltration and Aspiration Sub-Systems: 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. | Infiltration and Aspiration Sub-Systems: 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. | Same intent and purpose of use with minor changes for clarity. |
Page 10
| AYON Body Contouring System Subject Device (This Submission) | VASER 2.1 Lipo System Predicate Device K110306 | Comments | |
|---|---|---|---|
| Product Code /Regulation | QPB, 21 CFR 878.5040 | QPB, 21 CFR 878.5040 | Identical |
| User | Used by trained Physicians in an operating environment. | Used by trained Physicians in an operating environment. | Identical |
| Mechanism of Action | The ultrasound system fragments and emulsifies subcutaneous fatty tissue. The infiltration and aspiration systems utilize sterile infiltration tubing, a handle and cannula to infiltrate the tissue with fluids, and sterile suction tubing, a handle and cannula to aspirate fluids and soft tissue. | The ultrasound system fragments and emulsifies subcutaneous fatty tissue. The infiltration and aspiration systems utilize sterile infiltration tubing, a handle and cannula to infiltrate the tissue with fluids, and sterile suction tubing, a handle and cannula to aspirate fluids and soft tissue. | Identical |
| User Interface/Controls | Single touchscreen utilizing a graphical user interface, on/off switches | Knobs and dials in various locations, on/off switches. | The single touchscreen of the Subject Device enables ease of use through control of the entire system in one centralized location. |
Ultrasound Sub-System
| AYON Body Contouring System Subject Device (This Submission) | VASER 2.1 Lipo System Predicate Device K110306 | Comments | |
|---|---|---|---|
| Voltage and Frequency | AC Powered Voltage: 100-120 VAC Frequency: 60/50 Hz | AC Powered Voltage: 115C/230VAC Frequency: 60/50 Hz | Similar |
| Electrical Safety | IEC Class I, Type BF | IEC Class I, Type BF | Identical |
| Method of Fragmentation and Emulsification | Ultrasonic | Ultrasonic | Identical |
| Operating Frequency | 37 kHz nominal | 36 kHz nominal | Similar |
| Ultrasound Handpiece Transducer Material | Piezoelectric crystal | Piezoelectric crystal | Identical |
| Ultrasound Probes | Types: Diameters – 2.2mm to 3.7mm Lengths – 18cm to 33cm | Types: Diameters – 1.0mm to 6.0mm Lengths – 7cm to 40cm | Similar |
| Material: Titanium alloy | Material: Titanium alloy | Identical | |
| Ultrasound Vibratory Power / Amplitude | Three different power or amplitude settings: Low power = 8 watts Medium power = 20 watts | Power or amplitude settings ranging from 10% to 100% | Similar |
Page 11
| AYON Body Contouring System Subject Device (This Submission) | VASER 2.1 Lipo System Predicate Device K110306 | Comments | |
|---|---|---|---|
| High power = 28 watts | |||
| Modes of Operation | Standard Mode - Delivers the ultrasonic energy in pulses of two different amplitudes. The pulses alternate between full amplitude for 50 milliseconds and an amplitude of 50% of the full amplitude for 50 milliseconds. | VASER (Pulse) Mode - Delivers the ultrasonic energy in pulses of two different amplitudes. The pulses alternate between full amplitude for 50 milliseconds and an amplitude of 50% of the full amplitude for 50 milliseconds. | Identical |
| Continuous Mode – Delivers the ultrasonic energy continuously at full amplitude. | Continuous Mode – Delivers the ultrasonic energy continuously at full amplitude. | Identical |
Aspiration Sub-System
| AYON Body Contouring System Subject Device (This Submission) | VASER 2.1 Lipo System Predicate Device K110306 | Comments | |
|---|---|---|---|
| Power | AC Powered Voltage: 120 VAC Frequency: 50-60 Hz Power: 950 VA | AC Powered Voltage 120 VAC Frequency 60 Hz Power: 1000 VA | Similar |
| Electrical Safety | IEC Class I, Type BF | IEC Class I, Type BF | Identical |
| Suction Vacuum | 27 in Hg at sea level | 20 in Hg at 5000 ft. (~25 in Hg at sea level) | Similar¹ |
Infiltration Sub-System
| AYON Body Contouring System Subject Device (This Submission) | VASER 2.1 Lipo System Predicate Device K110306 | Comments | |
|---|---|---|---|
| Power | AC Powered Voltage: 120 VAC Frequency: 50-60 Hz Power: 950 VA | AC Powered Voltage 120 VAC Frequency 60 Hz Power: 1000 VA | Similar |
| Electrical Safety | IEC Class I, Type BF | IEC Class I, Type BF | Identical |
| Infiltration Pump | Peristaltic | Peristaltic | Identical |
| Infiltration Rate | Adjustable flow rate from 40-1000mL/min | Adjustable flow rate from 50-550mL/min | Similar² |
7. Substantial Equivalence Determination
The Subject and Predicate Devices have the same intended use, the minor clarifications do not change safety of the device or use of the device. The devices have identical mechanisms of action to produce the fragmentation and emulsification of subcutaneous fatty tissues. The technological features of the two devices are either identical or very similar in nature. Minor differences in the Ultrasound Sub-systems were found not to have an impact on the substantial equivalence of the two devices through comparative bench testing. Based on the information contained in this submission, it is concluded that the AYON Body Contouring System is substantially equivalent in function and intended use to the identified predicate device, the Sound Surgical VASER 2.1 Lipo System, manufactured by Solta Medical under
¹ Suction vacuum for the Subject Device falls within the vacuum range of 0 to 29.9 in Hg included in the Product Code description and falls below the maximum vacuum range for other FDA cleared devices. Vitruvian Ultimate Aspirator (K161722), PSI-TEC Aspirator (K981215).
² The infiltration flow rates for the Subject Device are identical or fall below the maximum flow rates for other FDA cleared infiltration and infusion pumps. Reference devices; Klein Surgical Infiltration pump (K031432) and the Wells Johnson Infusion pump (K991437).
8. Conclusion
The performance data presented in this submission, supports substantially equivalent performance between the subject device and its predicate.
§ 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.