(30 days)
Not Found
No
The device description details a manual instrument with mechanical components and an integrated light source. There is no mention of software, algorithms, data processing, or any terms associated with AI/ML. The performance studies listed are standard verification and validation tests for a mechanical medical device.
Yes
The device is indicated for "long-term reduction in the appearance of cellulite" and "soft tissue dissection during general and plastic surgical procedures," which are medical treatments or procedures.
No
The device description indicates that Avéli is a surgical tool used for tissue dissection and the release of fibrous tissue. Its function is to perform a physical alteration or treatment on the body, not to diagnose a condition or disease.
No
The device description clearly outlines a physical, manual instrument with a handle, distal end, blade, blocker, and integrated light source. The performance studies also include mechanical and electrical testing, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Avéli is used for "long-term reduction in the appearance of cellulite in the buttocks and thigh areas" and "soft tissue dissection during general and plastic surgical procedures." These are therapeutic and surgical procedures performed directly on the patient's body.
- Device Description: The device description details a manual instrument that physically interacts with and modifies tissue within the body (releasing fibrous tissue, dissecting soft tissue).
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. There is no mention of Avéli being used to analyze any biological samples.
The device is a surgical instrument used for a cosmetic and general surgical procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Aveli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas as supported by clinical data demonstrating treatment benefits through one year of observation. Avéli is also indicated for soft tissue dissection during general and plastic surgical procedures.
Product codes
OUP, GDI, FTD
Device Description
Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. Avéli also dissects soft tissue in general and plastic surgical procedures. 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 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 contains a Blade and a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook captures the nearby septa or other soft tissue resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression or other treatment area have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the soft tissue. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all appropriate soft tissue has been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression or other surgical area.
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
qualified health care professionals
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 following performance testing was completed or reviewed to verify or validate that the subject device meets all design specifications in 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
- 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)
- Packaging Validation (ISO 11607-1:2020+A11:2022)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 18, 2023
Revelle Aesthetics, Inc. Melissa Viotti Sr. Director, Quality and Regulatory Affairs 2570 W El Camino Real, Suite 310 Mountain View, California 94040
Re: K232153
Trade/Device Name: Avéli 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, GDI, FTD Dated: July 19, 2023 Received: July 19, 2023
Dear Melissa 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/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.
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
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (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,
| Mark
Trumbore -S | Digitally signed by
Mark Trumbore -S |
|---------------------|-----------------------------------------|
| | Date: 2023.08.18
10:21:15 -04'00' |
Mark Trumbore, 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) K232153
Device Name Avéli
Indications for Use (Describe)
Aveli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas as supported by clinical data demonstrating treatment benefits through one year of observation. Avéli is also indicated for soft tissue dissection during general and plastic surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for "REVELLE AESTHETICS". The word "REVELLE" is in a sans-serif font with horizontal lines above each letter. Below "REVELLE" is the word "AESTHETICS" in a smaller, sans-serif font.
510(k) Summary
1 Contact Details
2
| Applicant Name: | Revelle Aesthetics, Inc. |
|---|---|
| Applicant Address: | 2570 W El Camino Real Suite 310 |
| Mountain View CA 94040 United States | |
| Applicant Contact Telephone: | 650-336-5985 |
| Applicant Contact: | Ms. Melissa Viotti |
| Applicant Contact Email: | mviotti@revelleax.com |
| Date Summary Prepared: | 08/17/2023 |
| Device Name | |
| Device Trade Name: | Avéli |
| Common Name: | Powered surgical instrument for improvement in the appearance of cellulite |
| Classification Name: | Powered surgical instrument for improvement in the appearance of cellulite |
| Regulation Number: | 878.4790 |
| Product Code: | OUP |
| Regulation Number: | 878.4800 |
| Product Code: | GDI |
| Regulation Number: | 878.4580 |
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| Predicate # | Predicate Trade Name | Product Code |
|---|---|---|
| K221336 | Avéli | OUP |
| K111020 | AtriCure Dissector | GDI, FTD |
3 Legally Market Predicate Devices
4 Device Description Summary
Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. Avéli also dissects soft tissue in general and plastic surgical procedures. 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 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 contains a Blade and a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook captures the nearby septa or other soft tissue resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression or other treatment area have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the soft tissue. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all appropriate soft tissue has been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression or other surgical area.
5 Intended Use / Indications for Use
Avéli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating treatment benefits through one year of observation. Avéli is also indicated for soft tissue dissection during general and plastic surgical procedures.
6 Indications for Use Comparison
The device modifications do not constitute a new intended use compared to the legally marketed predicate devices. The subject device has the same principles of operation and same technological characteristics as the previously cleared predicate Avéli. Revelle proposes to add an indication to Avéli for soft tissue dissection in general and plastic surgical procedures. Revelle has identified an additional predicate
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Image /page/5/Picture/0 description: The image shows the logo for "REVELLE AESTHETICS". The word "REVELLE" is in a sans-serif font with horizontal lines above each letter. Below "REVELLE" is the word "AESTHETICS" in a smaller, sans-serif font.
510(k) Summary
Special 510(k) The Avéli Precision Cellulite Release Device
device, the AtriCure Dissector, that has similar indications for use and similar technological characteristics as the modified device. The AtriCure Dissector is indicated for soft tissue dissection during general, ENT, thoracic, urological and gynecological surgical procedures. The modified Aveli device is not intended for a different use compared to the legally marketed AtriCure Dissector predicate device for the same use (soft tissue dissection), and the indicated surgical procedures (general/plastic surgery) are more limited than the predicate device's (general, ENT, thoracic, urological and gynecological). In other words, the modified Avéli device labeling (soft tissue dissection in general and plastic surgical procedures) does not constitute a new intended use compared to the cleared AtriCure Dissector device.
7 Technological Comparison
The modified Avéli device has the same technological characteristics as the cleared Avéli device. Like Avéli, the AtriCure Dissector has a battery-powered light source which is used to navigate soft tissue for identification and isolation of anatomic structures. Both devices would be used by qualified health care professionals. Both devices operate under the same fundamental scientific technology (nonpowered tissue dissection and battery powered illumination). Both devices provide controlled dissection with a mechanical articulating feature and have a stainless steel dissecting component. The AtriCure Dissector, like Avéli, is single use only and is EO sterilized.
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Image /page/6/Picture/1 description: The image shows the logo for "REVELLE AESTHETICS". The word "REVELLE" is in a sans-serif font with thin lines, and the word "AESTHETICS" is in a smaller sans-serif font below it. The logo is simple and modern.
8 Non-Clinical and/or Clinical Tests Summary & Conclusions.
The following performance testing was completed or reviewed to verify or validate that the subject device meets all design specifications in 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
-
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)
-
Packaging Validation (ISO 11607-1:2020+A11:2022)
9 Conclusion
This 510(k) Premarket Notification is to expand indications for use to include soft tissue dissection during general and plastic surgical procedures. The updated indications for use do not pose any new questions of safety or efficacy. Performance test data demonstrates sufficient performance for soft tissue dissection. Therefore, Avéli device is substantially equivalent to the predicate device in terms of safety and effectiveness for requested intended use.