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.

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.

AI/ML Overview

The provided text describes the Avéli device, which is indicated for long-term reduction in the appearance of cellulite and for soft tissue dissection. The 510(k) submission (K232153) is to expand the indications of use to include soft tissue dissection during general and plastic surgical procedures.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the expanded indication of "soft tissue dissection during general and plastic surgical procedures" in the same format as a table with reported device performance against specific numerical targets.

Instead, it lists types of verification testing conducted to support the substantial equivalence determination for this expanded indication. The conclusion states that "Performance test data demonstrates sufficient performance for soft tissue dissection." This implies that the device met internal design specifications and performance requirements for the soft tissue dissection function.

Here's a summary of the types of performance testing that serve as the basis for demonstrating compliance for the soft tissue dissection indication:

Acceptance Criteria (General Categories based on testing)	Reported Device Performance (Implied by Conclusion)
Design Specifications & Functional Performance	Sufficient performance for soft tissue dissection
Visual Inspections	Met visual specifications
Dimensional Inspections	Met dimensional specifications
Functional testing (Simulated use, Force measurements, Tensile testing)	Performed adequately in simulated use, force and tensile tests were within acceptable limits
Mechanical testing	Met mechanical performance requirements
Electrical testing	Met electrical performance requirements
Optical output testing	Provided adequate illumination
Safety and Regulatory Compliance	Compliance with relevant standards
Electrical Safety Testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6/IEC 62366-1)	Met electrical safety standards
Biocompatibility Testing (ISO 10993-1)	Demonstrated biocompatibility
Sterilization Validation (ISO 11135-1, ISO 14161)	Sterilization process validated
Packaging Validation (ISO 11607-1)	Packaging maintained sterility and integrity

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample sizes used for the various non-clinical verification tests (e.g., number of devices tested for functional, mechanical, or electrical tests). It only lists the types of tests performed.

The document also does not provide any information about the provenance of data (e.g., country of origin, retrospective or prospective) for these non-clinical tests. These are typically internal lab tests conducted by the manufacturer.

For the initial indication of "long-term reduction in the appearance of cellulite in the buttocks and thigh areas," the text states it is "supported by clinical data demonstrating treatment benefits through one year of observation." However, details on this clinical data (sample size, provenance, study design) are not provided within this document specifically for the cellulite indication. This submission focuses on the expanded indication for soft tissue dissection which is supported by non-clinical testing for substantial equivalence to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The tests described are non-clinical verification tests, which typically involve laboratory measurements and assessments against engineering specifications, rather than expert-derived ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests listed are non-clinical engineering and performance tests, an "adjudication method" in the sense of resolving disagreements among expert reviewers of test data is not typically applicable or described in this type of summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study is mentioned for the expanded indication of soft tissue dissection. The review pathway is based on substantial equivalence to predicate devices through non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The Avéli device is a powered surgical instrument used by a human operator, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used

For the expanded indication of soft tissue dissection, the "ground truth" for the non-clinical tests is represented by the design specifications, performance requirements, and relevant international standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization) that the device was tested against. The tests verify that the device performs as intended and meets these established engineering and regulatory benchmarks.

For the cellulite indication, the ground truth would likely have been based on clinical assessment of appearance reduction (e.g., by investigators or independent evaluators) as stated by "clinical data demonstrating treatment benefits." However, the details of this ground truth establishment are not provided here.

8. The Sample Size for the Training Set

No training set is mentioned in the context of this device. The Avéli is a physical surgical instrument, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for this device.

Summary

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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

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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,

MarkTrumbore -S	Digitally signed byMark Trumbore -S
	Date: 2023.08.1810:21:15 -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

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Indications for Use

510(k) Number (if known) K232153

Device Name Avéli

Indications for Use (Describe)

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

Applicant Name:	Revelle Aesthetics, Inc.
Applicant Address:	2570 W El Camino Real Suite 310Mountain 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

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:

1. Visual Inspections
1. Dimensional Inspections
1. 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.

Regulation Number and Section

§ 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.