The A123 is used for aspiration, harvesting, filtering and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is to be used without any additional manipulation.

The A123 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

Device Description

The A123 is a suction lipoplasty system designed to be used in the operating room in conjunction with, and attached to, a user-provided liposuction cannula, a vacuum source, and a waste canister. The A123 allows the surgeon to conveniently and accurately harvest, wash, filter, concentrate, and transfer autologous adipose tissue for reinjection into the same patient for body contouring in cosmetic and reconstructive surgery applications during the same procedure in which autologous adipose tissue is collected. The system is a sterile, disposable unit for single patient use.

The A123 consists of the following components:

Collection chamber
Collection mesh basket
Concentration chamber with fluid-absorbing pads
AuraClens™ powder packets
Outlet tube and drain valve with tube clamp
Mixing spatula

The A123 is to be used together with FDA-cleared devices (such as a lipoplasty device [Product Code MUU, Requlation Number 21 CFR 878.50401, liposuction cannula, high vacuum tubing, waste container, syringes [e.g. 60 cc Toomev-tip svringes, Luer-Lock, Product Code KYZ1, and roomtemperature, sterile 0.9% normal saline solution, all provided by the user.

AI/ML Overview

The provided text describes the 510(k) summary for the AuraGen 123™ Suction Lipoplasty System (A123). This device is a Class II medical device used for aspirating, harvesting, filtering, and transferring autologous adipose tissue for aesthetic body contouring. The summary details bench testing conducted to demonstrate substantial equivalence to a predicate device.

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

1. A table of acceptance criteria and the reported device performance:

The document mentions that "The A123 meets the acceptance criteria for all tests," but it does not provide a table detailing the specific acceptance criteria for each test nor the quantitative reported device performance values. It lists the bench tests performed but not the specific thresholds for "meeting" the criteria.

Bench Test	Acceptance Criteria (Not Explicitly Stated in Document)	Reported Device Performance (Not Explicitly Stated in Document)
Cell Viability	(e.g., Minimum percentage of viable cells)	"Found to be biocompatible"
Fat Volume	(e.g., Minimum recovered fat volume, consistency across trials)	"Volume of the fat layer was measured"
Fat Concentration	(e.g., Minimum fat concentration in processed tissue)	"Fat concentration was calculated"
Time-to-Graft (TTG)	(e.g., Maximum allowed processing time)	"Time from the start of the washing step to the end of the transfer/extraction step was measured"
Device Usability	(e.g., Meets predefined usability objectives, no critical errors)	"Usability of the device was evaluated"
Canister implosion	(e.g., Withstands specified vacuum pressure without implosion)	"A123 units were tested for medical vacuum suction canister implosion test requirements"
Tubing collapse	(e.g., Withstands specified vacuum pressure without collapse)	"A123 units were tested for medical vacuum suction canister tubing collapse test requirements"
System leak	(e.g., Meets leakage specifications)	"A123 units were tested for vacuum seal to determine leakage"
Tubing tensile strength (pull-off force)	(e.g., Withstands specified pull-off force)	"A123 units were tested to measure the tensile strength (pull-off force)"
Biocompatibility	(e.g., No cytotoxic, irritation, or sensitization effects)	"The test articles were found to be biocompatible"
Sterility	(e.g., Sterile per ISO 11137)	"Both met the sterility requirements per ISO 11137"

2. Sample size used for the test set and the data provenance:

The document mentions "A123 units were tested" for various bench tests, but it does not specify the sample size (number of units) used for each test.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in the sense that it's bench testing on manufactured units, rather than a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to this type of submission. The ground truth for bench testing of a lipoplasty system involves quantifiable physical measurements and material properties, rather than expert interpretation of medical images or conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable. Adjudication methods are typically used in studies involving subjective human interpretation (e.g., reading medical images) to resolve discrepancies. For bench testing, the results are typically objective measurements.

5. 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:

This is not applicable. This submission is for a medical device used for tissue processing, not an AI-assisted diagnostic tool that supports human readers/interpreters.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance evaluation is based on objective, quantitative measurements obtained through standardized bench testing methods (e.g., centrifugation for fat volume, time measurement for TTG, force measurement for tensile strength, and established ISO standards for sterility, biocompatibility, implosion, collapse, and leak tests).

8. The sample size for the training set:

This is not applicable. The device is a physical product and not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable. As stated above, the device is not an AI algorithm.

Summary

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May 3, 2019

AuraGen Aesthetics LLC % Mr. Randy Prebula Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004

Re: K190278

Trade/Device Name: AuraGen 123 Suction Lipoplasty System (A123) Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: February 8, 2019 Received: February 8, 2019

Dear Mr. Prebula:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

David Krause, Ph.D. Acting Division Director Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMANSERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page

510(k) Number (if known) K190278

Device Name

The AuraGen 123TM Suction Lipoplasty System (A123)

Indications for Use (Describe)

The A123 is intended for use in the following surgical speciation of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

AuraGen Aesthetics' AuraGen 123TM Suction Lipoplasty System (A123)

Submitter

AuraGen Aesthetics LLC 11 Dellbrook Road, Weston, MA 02493

Phone: 617-818-4008 Facsimile: 857-999-3929 Contact Person: Yiannis Monovoukas, Ph.D. Date Prepared: April 26, 2019

Name of Device: AuraGen 123TM Suction Lipoplasty System Common or Usual Name: A123 Classification Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU (General and Plastic Surgery Panel)

Predicate Device

510(K) # K120902 Trade name: GID 700 Tissue Canister Manufacturer: The GID Group, USA (Distributed in the US as REVOLVE™ System by LifeCell Inc.)

Reference Device: N/A

Device Description

The A123 consists of the following components:

Collection chamber ●
. Collection mesh basket
. Concentration chamber with fluid-absorbing pads
AuraClens™ powder packets ●
Outlet tube and drain valve with tube clamp
Mixing spatula

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Intended Use / Indications for Use

Performance Data

The Company conducted biocompatibility testing for the A123 and the AuraClens powder in accordance with the requirements of ISO 10993 for external communicating devices having contact < 24hours. In all instances, the test articles were found to be biocompatible.

The A123 and the AuraClens powder were sterilized by Gamma irradiation and both met the sterility requirements per ISO 11137 - Sterilization of Health Care Products.

In addition, the following table summarizes the bench testing performed with the device:

Bench Test	Methods
Cell Viability	Trypan Blue Dye Exclusion test
Fat Volume	Processed adipose tissue was centrifuged to separate the oil, fat, and aqueous phases. The volume of the fat layer was measured.
Fat Concentration	Processed adipose tissue was centrifuged to separate the oil, fat, and aqueous phases. The fat concentration was calculated as: volume of the fat layer/volume of adipose tissue processed.
Time-to-Graft (TTG)	Time from the start of the washing step to the end of the transfer/extraction step was measured.)
Device Usability	Usability of the device was evaluated.
Canister implosion	A123 units were tested for medical vacuum suction canister implosion test requirements per ISO 10079-1:2015(E) Medical Suction Equipment Part 1, Section 6.1.3 and Annex A.3
Tubing collapse	A123 units were tested for medical vacuum suction canister tubing collapse test requirements per ISO 10079-1:2015(E) Medical Suction Equipment Part 1, Section 6.3.1 and Annex A.4.
System leak	A123 units were tested for vacuum seal to determine leakage per the

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Bench Test	Methods
	specification in ISO 10079-1:2015(E) Medical Suction Equipment Part 1, Section 7.7.1 and Annex A.8.1.
Tubing tensile strength(pull-off force) (to assesstubing connections)	A123 units were tested to measure the tensile strength (pull-off force) of the A123 tubing assembly and the user-supplied liposuction and aspiration tubing from the A123 tubing connectors.

The A123 meets the acceptance criteria for all tests.

Substantial Equivalence

The A123 is as safe and effective as the GID 700 Tissue Canister (the "Predicate Device") that FDA has already cleared (K120902). The A123 has the same intended uses and indications for use, as well as similar technological characteristics and principles of operation as its predicate device. In addition, the minor technological differences between the A123 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the A123 is as safe and effective as the GID 700 Tissue Canister. Thus, the A123 is substantially equivalent.

Regulation Number and Section

§ 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.