(81 days)
Not Found
No
The device description and performance studies focus on a manual, mechanical instrument for cutting fibrous tissue. There is no mention of AI, ML, image processing, or data-driven decision-making within the device's operation or evaluation.
Yes.
The device is used for the "temporary reduction in the appearance of cellulite," which is a physical condition. Its primary function is to cut fibrous tissue to achieve this outcome, directly impacting the body to treat a condition.
No
The device description clearly states that Avéli is a "manual instrument that cuts fibrous tissue (septa)" and is used for "temporary reduction in the appearance of cellulite." The device description of its use, including identifying septa by tugging and then severing them, indicates an interventional/therapeutic purpose rather than a diagnostic one.
No
The device description explicitly states it is a "sterile, single-use manual instrument" with a handle, distal end, and integrated light source, indicating it is a physical hardware device, not software only.
Based on the provided information, the Avéli device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of Avéli clearly states it is a manual instrument that is advanced into subcutaneous tissue to cut fibrous tissue. It does not involve the analysis of blood, urine, tissue samples, or any other biological specimen.
- The intended use is for temporary reduction in the appearance of cellulite. This is a cosmetic/aesthetic indication, not a diagnostic one.
- The device description focuses on mechanical action. The mechanism of action involves cutting fibrous septa, which is a physical intervention, not a diagnostic test.
Therefore, Avéli is a medical device used for a therapeutic/cosmetic procedure, not an IVD.
N/A
Intended Use / Indications for Use
Avéli is indicated for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating benefits through three months of observation.
Product codes (comma separated list FDA assigned to the subject device)
OUP
Device Description
Avéli is a sterile, single-use manual instrument that cuts fibrous tissue (septa) beneath moderate to severe cellulite for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. The device consists of a handle and a distal end. The handle houses components used to actuate the moving parts at the distal end of the device. The distal end of the device is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The distal end of the device contains a blunt link and a sharpened link forming a distal hook. When the handle is moved in a retrograde fashion, the distal hook next to a fibrous septum captures the septum resulting in tugging. The user feels the resistance, confirming that a septum under a cellulite depression has been identified. The user then engages a sharpened link to be exposed at the distal end of the device. The user applies additional retrograde motion to sever the fibrous septum, and then retracts the sharpened link and the blunt link into the device, allowing removal without further tissue capture. The step is repeated for each visible cellulite depression.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
buttocks and thigh areas
Indicated Patient Age Range
adult females
Intended User / Care Setting
Clinic/Doctor's office
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The in vivo performance of the device was evaluated in a pivotal clinical study. A prospective, nonrandomized, multi-center study was conducted to evaluate the safety and effectiveness of Avéli for the treatment of cellulite in the buttock and thigh areas across nine (9) investigational sites. All participants served as their own control and underwent a single treatment with Avéli.
The primary safety endpoint was achieved. There were no Serious Adverse Events (SAE) related to the device or procedure at 30 days. No Unanticipated Adverse Device Effects (UADE) occurred in the study. Therefore, as no SAE were determined to be related to the device or procedure, the primary safety endpoint for the study was achieved. There were three advice effects (ADEs) that occurred in two participants: 1) an extended incision, 2) a skin laceration, and 3) a small scar following the skin laceration. Ecchymosis was reported by most participants. Many participants experienced tenderness or pain within the first 24 hours, and most returned to normal activities one day after the procedure.
The primary effectiveness endpoint was achieved. Effectiveness was evaluated by improvement assessment by independent physician evaluation of participant photographs. All reliability and repeatability measures were met and validated the methodology. The primary effectiveness endpoint was to demonstrate that the mean change (improvement) in the Cellulite Severity Score (CSS) is more than 1 for the study population, as determined by three independent, blinded physician evaluators of photos obtained before and 3-months after the investigational procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
mean change (improvement) in the Cellulite Severity Score (CSS) is more than 1
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
(a)
Identification. A powered surgical instrument for improvement in the appearance of cellulite is a prescription device that is used for the controlled release of subcutaneous tissue for improvement in the appearance of cellulite. The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device.
(2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites.
(3) All elements of the device that may contact the patient must be demonstrated to be biocompatible.
(4) Electrical safety and electromagnetic compatibility of the device must be demonstrated.
(5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications.
(6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font, also in blue.
October 22, 2021
NC8, Inc. (Revelle Aesthetics, Inc.) Mellissa Viotti Sr. Director, Quality & Regulatory Affairs 2570 W. El Camino Real, Suite 310 Mountain View, California 94040
Re: K212399
Trade/Device Name: Aveli Regulation Number: 21 CFR 878.4790 Regulation Name: Powered Surgical Instrument for Improvement in the Appearance of Cellulite Regulatory Class: Class II Product Code: OUP Dated: July 30, 2021 Received: August 2, 2021
Dear Mellissa Viotti:
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/cfpm/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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212399
Device Name Avéli
Indications for Use (Describe)
Aveli is indicated for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating benefits through three months of observation.
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."
3
K212399
NC8 Inc. Traditional 510(k) The Avéli Precision Cellulite Release Device
Submitter Information
| Submitter: | NC8, Inc. (name changed to Revelle Aesthetics, Inc.
2570 W. El Camino Real, Suite 310
Mountain View, CA 94040 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Melissa Viotti
Senior Director, Quality and Regulatory Affairs
Telephone and Fax: 650-336-5985
Email: mviotti@exploramed.com) |
| Date Summary Prepared: | September 29, 2021 |
| Subject Device Information | |
| Device Trade Name: | Avéli(TM) |
| Common Name: | Precision Cellulite Release Device |
| Regulation Number: | 21 CFR 878.4790 |
| Product Code: | OUP |
Predicate Device Information
| Predicate Device: | The Cellfina System (K192185) |
|---|---|
| Predicate Device Manufacturer: | Ulthera Inc. (now Merz Aesthetics) |
Device Description
Avéli is a sterile, single-use manual instrument that cuts fibrous tissue (septa) beneath moderate to severe cellulite for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. The device consists of a handle and a distal end. The handle houses components used to actuate the moving parts at the distal end of the device. The distal end of the device is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The distal end of the device contains a blunt link and a sharpened link forming a distal hook. When the handle is moved in a retrograde fashion, the distal hook next to a fibrous septum captures the septum resulting in tugging. The user feels the resistance, confirming that a septum under a cellulite depression has been identified. The user then engages a sharpened link to be exposed at the distal end of the device. The user applies additional retrograde motion to sever the fibrous septum, and then retracts the sharpened link and the blunt link into the device, allowing removal without further tissue capture. The step is repeated for each visible cellulite depression.
4
Indications for Use
Avéli is indicated for temporary reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating benefits through three months of observation.
Comparison of Technological Characteristics with the Predicate Device
A comparison of Avéli to the predicate device is provided in the table below. This table demonstrates that Avéli is substantially equivalent to the predicate device for its indication for use, performance, and technological characteristics.
| Device Name | SUBJECT DEVICE | PREDICATE DEVICE |
|---|---|---|
| Avéli | The Cellfina System | |
| 510(k) Number | TBD (K212399) | K192185 |
| Manufacturer | NC8, Inc. (name changed to Revelle | |
| Aesthetics, Inc.) | Merz Aesthetics (previously Ulthera, | |
| Inc.) | ||
| Device Class | II | Same, II |
| Regulation | ||
| Number | 878.4790 | Same, 878.4790 |
| Product Code | OUP | Same, OUP |
| Clearance Date | TBD | October 9, 2019 |
| Intended Use | Avéli is intended for temporary | |
| reduction in the appearance of cellulite | ||
| in the buttocks and thigh areas of adult | ||
| females as supported by clinical data | ||
| demonstrating benefits through three | ||
| months of observation. | The Cellfina System is intended for | |
| long term improvement in the | ||
| appearance of cellulite in the buttocks | ||
| and thigh areas of adult females as | ||
| supported by clinical data | ||
| demonstrating no significant reduction | ||
| in treatment benefits through five years | ||
| of observation. | ||
| Indications for | ||
| Use | Avéli is indicated for temporary | |
| reduction in the appearance of cellulite | ||
| in the buttocks and thigh areas of adult | ||
| females as supported by clinical data | ||
| demonstrating benefits through three | ||
| months of observation. | The Cellfina System is indicated for | |
| long term improvement in the | ||
| appearance of cellulite in the buttocks | ||
| and thigh areas of adult females as | ||
| supported by clinical data | ||
| demonstrating no significant reduction | ||
| in treatment benefits through five years | ||
| of observation. | ||
| Where Used | Clinic/Doctor's office | Same, Clinic/Doctor's office |
| Anatomical Site | Buttocks and thighs | Same, Buttocks and thighs |
| Device Name | SUBJECT DEVICEAvéli | PREDICATE DEVICEThe Cellfina System |
| Technological | ||
| Characteristics | Blade dissects soft tissue | Same, Blade dissects soft tissue |
| Material of Distal | ||
| End Dissecting | ||
| Zone | Stainless steel | Same, Stainless steel |
| Illumination | ||
| Feature | Yes | No |
| Controlled | ||
| Dissection | Yes | Same, Yes |
| Biological Effect | Controlled mechanical cutting of the | |
| fibrous tissue which contributes to the | ||
| appearance of cellulite. | Same, Controlled mechanical cutting of the | |
| fibrous tissue which contributes to the | ||
| appearance of cellulite. | ||
| Single Use | Yes | The blade component is single use and |
| the motorized component is reusable | ||
| Sterile | Yes | Same, Yes |
| Electromagnetic | ||
| Compatibility | ||
| Standards | Compatible | Same, Compatible |
| Medical Electrical | ||
| Equipment Safety | ||
| Standards | Compatible | Same, Compatible |
5
Performance Data
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
-Verification Testing:
-
- Visual Inspections
-
- Dimensional Inspections
-
- Functional testing including:
- Simulated use testing ●
- . Force measurements
- . Tensile testing
- Mechanical testing
- Electrical testing ●
- Optical output testing .
6
-Electrical Safety Testing (IEC 60601-1:2005 +A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010 + AMD1:2013/IEC 62366-1:2020)
-Biocompatibility Testing (ISO 10993-1:2018)
-Sterilization Validation (ISO 11135-1:2014, ISO 14161:2009)
Clinical Performance Data
The in vivo performance of the device was evaluated in a pivotal clinical study. A prospective, nonrandomized, multi-center study was conducted to evaluate the safety and effectiveness of Avéli for the treatment of cellulite in the buttock and thigh areas across nine (9) investigational sites. All participants served as their own control and underwent a single treatment with Avéli. The enrolled study population included females between the ages of 26 and 54 with moderate to severe cellulite and BMI between 19 and 30. In addition, participants were excluded that smoked or had recently quit smoking (within the last 6 months).
The primary safety endpoint was achieved. There were no Serious Adverse Events (SAE) related to the device or procedure at 30 days. No Unanticipated Adverse Device Effects (UADE) occurred in the study. Therefore, as no SAE were determined to be related to the device or procedure, the primary safety endpoint for the study was achieved. There were three advice effects (ADEs) that occurred in two participants: 1) an extended incision, 2) a skin laceration, and 3) a small scar following the skin laceration. Ecchymosis was reported by most participants. Many participants experienced tenderness or pain within the first 24 hours, and most returned to normal activities one day after the procedure.
The primary effectiveness endpoint was achieved. Effectiveness was evaluated by improvement assessment by independent physician evaluation of participant photographs. All reliability and repeatability measures were met and validated the methodology. The primary effectiveness endpoint was to demonstrate that the mean change (improvement) in the Cellulite Severity Score (CSS) is more than 1 for the study population, as determined by three independent, blinded physician evaluators of photos obtained before and 3-months after the investigational procedure.
Conclusion
The subject Aveli device is similar to the predicate device with respect to the principles of operation. Some technological and performance characteristics of subject device are different from some of the predicate device. Pre-clinical and clinical testing was conducted to evaluate the differences in technological and performance characteristics. Results of clinical testing have demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for the intended use.