(84 days)
N/A
No
The description focuses on mechanical components and processes for tissue handling, with no mention of AI/ML or related concepts like image processing, data analysis, or algorithms.
Yes
The device aids in the collection, processing, and transfer of autologous adipose tissue for re-implantation for aesthetic body contouring. Aesthetic body contouring and reconstructive applications, by definition, serve a therapeutic purpose.
No
The A123 is described as a suction lipoplasty system for harvesting, washing, filtering, concentrating, and transferring autologous adipose tissue for reinjection, which is a therapeutic and surgical function, not a diagnostic one.
No
The device description explicitly lists multiple physical components (Collection chamber, Collection mesh basket, Concentration chamber, AuraClens™ powder packets, Outlet tube and drain valve, Mixing spatula) and describes it as a "suction lipoplasty system" which is a hardware device.
Based on the provided information, the A123 device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. This is a surgical procedure involving the manipulation of tissue within the body (or immediately after removal for re-implantation), not the examination of samples outside the body for diagnostic purposes.
- Device Description: The description details a suction lipoplasty system used in the operating room to process adipose tissue. This aligns with a surgical device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect markers, or provide any information for diagnosing a disease or condition. The focus is on the physical processing of tissue.
- Bench Testing: The bench testing described focuses on the performance of the device in processing the tissue (cell viability, fat volume, concentration, time-to-graft, usability, and structural integrity under vacuum), not on diagnostic accuracy or analytical performance.
- Predicate Device: The predicate device (K120902 GID 700 Tissue Canister) is also a device used for collecting and processing tissue during surgical procedures, not a diagnostic device.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The A123 does not fit this definition. It is a surgical device used for tissue processing.
N/A
Intended Use / Indications for Use
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.
Product codes
MUU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, operating room
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 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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 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 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 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
4
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.
Intended Use / Indications for Use
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.
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