The MicroAire LipoFilter System is used in the aspiration, filtering and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted fat is only to be used without any additional manipulation.

Device Description

The MicroAire LipoFilter System consists of a single use, closed loop tissue collection system comprised of a medical grade canister, vacuum port, collection port, tissue port and lid intended to be used with a standard liposuction aspiration system pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the canister via the collection port in the canister lid. The physician removes unwanted waste materials from the collection system via the vacuum port by closing a valve. This process leaves fatty tissue that can be transferred to syringes via the tissue port for autologous fat re-injection.

AI/ML Overview

The provided text describes the MicroAire LipoFilter System, a device for aspirating, filtering, and transferring autologous adipose tissue for aesthetic body contouring. The document is a 510(k) premarket notification from the FDA, aiming to establish substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or target performance metric format with corresponding reported values. Instead, it describes various tests and validations that demonstrate the device meets certain standards. These can be inferred as the "acceptance criteria" for demonstrating substantial equivalence.

Acceptance Criterion (Inferred)	Reported Device Performance
Sterility	Complies with ISO 11137-1:2006 and ISO 11137-2:2006 for gamma radiation validation. Sterility Assurance Level (SAL) of $10^{-6}$.
Shelf Life	Validated for a 2-year shelf life. Complies with ISO 11607-1:2006 and ISO 11607-2:2006 regarding packaging.
Biocompatibility	Made from medical grade biocompatible materials. Complies with ISO 10993-1:2009.
Performance/Functionality	Tested in accordance with predetermined specifications on file at MicroAire, which includes: - Functionality testing - ISO 10079-1 testing - Tubing connection strength testing - Vacuum leak testing - Adipocyte viability testing - Aging Studies
Volume Range	Up to 2500mL (compared to predicate devices of up to 2000mL; deemed "insignificant").
Separation Method	Uses decantation to separate tissue (same method as predicate devices).
Intended Use	Has no new intended uses compared to predicate devices.

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

The document does not specify sample sizes for any of the tests conducted (e.g., how many units were tested for sterility, shelf life, or biocompatibility). It only states that various tests were performed.

The data provenance is not explicitly mentioned in terms of country of origin or whether the studies were retrospective or prospective. All testing appears to be pre-clinical (bench testing, lab validation), not involving human subjects.

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

This information is not provided in the document. The tests described (sterility, shelf life, biocompatibility, performance) are objective validations against international standards (ISO) and internal specifications. They do not typically involve experts establishing a "ground truth" in the way a clinical study might for diagnostic accuracy, where interpretations are made.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging, pathology) by multiple reviewers to resolve discrepancies and establish a consensus "ground truth." Since the studies described are pre-clinical validation tests (sterility, shelf life, biocompatibility, mechanical performance), an adjudication method is not applicable and therefore not mentioned.

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

No MRMC comparative effectiveness study was done or is applicable. This device is a surgical instrument system for fat processing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no discussion of human readers, AI, or effect sizes related to AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No standalone algorithm performance study was done or is applicable. As mentioned, this is a physical medical device, not a software algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the pre-clinical tests, the "ground truth" is established by:

International Standards: e.g., ISO 11137-1:2006, ISO 11137-2:2006 for sterility; ISO 11607-1:2006, ISO 11607-2:2006 for packaging/shelf life; ISO 10993-1:2009 for biocompatibility; ISO 10079-1 for specific performance aspects.
Predetermined Internal Specifications: "MicroAire LipoFilter System was tested for performance in accordance with its predetermined specifications on file at MicroAire."
Direct Measurement/Observation for Functionality: Testing for tubing connection strength, vacuum leaks, and adipocyte viability would involve direct objective measurements against predefined pass/fail criteria.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these pre-clinical validations.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and not an AI or machine learning model that requires a "training set."

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

Not applicable. As above, there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2015

MicroAire Surgical Instruments LLC Mr. Chris Spofford Regulatory Affairs and Compliance Officer 3590 Grand Forks Boulevard Charlottesville, Virginia 22911

Re: K150779

Trade/Device Name: Microaire LipoFilter System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: March 25, 2015 Received: March 26, 2015

Dear Mr. Spofford:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K150779

Device Name Microaire LipoFilter System

Indications for Use (Describe)

The MicroAire LipoFiter System is used in the aspiration, filtering and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted fat is only to be used without any additional manipulation.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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1. Preparation Date: March 24, 2015

Submitted by: MicroAire Surgical Instruments LLC 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 Owner/Operator #: 9004658
Contact Person/Prepared by:

Chris Spofford Regulatory Affairs and Compliance Officer MicroAire Surgical Instruments (434) 975-8344 Chriss@microaire.com

3590 Grand Forks Boulevard Charlottesville, Virginia 22911

1. Device Identification:
  Trade Name: MicroAire LipoFilter System Common Name: Lipoplasty Suction System Classification: Suction lipoplasty system (21 CFR 878.5040, Product Code MUU)
1. Predicate Device:
  Sound Surgical Technologies - Origins LipoHarvesting System (K120328) Medical Device Resource Corporation - Lipisystems Aquavage Model AV2000 & 1200 (K092284)
1. Device Description: The MicroAire LipoFilter System consists of a single use, closed loop tissue collection system comprised of a medical grade canister, vacuum port, collection port, tissue port and lid intended to be used with a standard liposuction aspiration system pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the canister via the collection port in the canister lid. The physician removes unwanted waste materials from the collection system via the vacuum port by closing a valve. This process leaves fatty tissue that can be transferred to syringes via the tissue port for autologous fat re-injection.
1. Intended Use: The MicroAire LipoFilter System is used in the aspiration, harvesting, filtering and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

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8) Comparison to Predicate:

FEATURES	DEVICES
	MicroAire LipoFilter System	Origins LipoHarvesting System	Medical Device Resource CorpLipisystems Aquavage
DeviceDescription:	The MicroAire LipoFilterSystem consists of a singleuse, closed loop tissuecollection systemcomprised of a medicalgrade canister, vacuumport, collection port, tissueport and lid intended to beused with a standardliposuction aspirationsystem pump to collectfatty tissue for aestheticbody contouring. As thetissue is harvested from thepatient, it enters thecanister via the collectionport in the canister lid. Thephysician removesunwanted waste materialsfrom the collection systemvia the vacuum port byclosing a valve. This processleaves fatty tissue that canbe transferred to syringesvia the tissue port forautologous fat re-injection.	The Origins LipoHarvestingSystem consists of areusable, closed looptissue collection systemcomprised of a medicalgrade canister, a drainport and a lid intended tobe used with a standardliposuction aspirationpump to collect fattytissue for aesthetic bodycontouring. As the tissue isharvested from thepatient, it enters thecollection canister via aport in the canister lid. Thephysician removesunwanted waste materialsfrom the collection systemvia the drain port at thebase. This process leavesfatty tissue that can betransferred to syringes forautologous fat re-injection.	Device function:1. Contains portinterfacesbetween:canister totubing andaspirator tocanister.2. Sterile tubingto connect theinterfaces.3. Funnel tointerface portto tubing.4. Syringe tocollect fat.Device Design:1. Contentssubjected tosterility.Material used:Plastic canister,syringe, siliconetubing.
Picture ofProduct	Image: MicroAire LipoFilter System	Image: Origins LipoHarvesting System	Image: Medical Device Resource Corp Lipisystems Aquavage
Intended Use:	The MicroAire LipoFilterSystem is used in theaspiration, harvesting,filtering and transferring ofautologous adipose tissuefor aesthetic bodycontouring. If the harvestedfat is to be re-implanted,the harvested fat is only tobe used without anyadditional manipulation.	The Origins LipoHarvestingSystem is used in theaspiration, harvesting,filtering and transferringof autologous tissue. Ifharvested fat is to be re-implanted, the harvestedfat is only to be usedwithout any additionalmanipulation.	For use in aspiratingsubcutaneous fattytissue includingautologous fatcollection.
TechnologyComparison:	The MicroAire LipoFilterSystem employs the sametechnological characteristicsas the predicate device.	The Origins LipoHarvestingSystem employs the sametechnologicalcharacteristics as thepredicate devices.	The LipisytemsAquavage employs thesame technologicalcharacteristics as thepredicate device.
SuctionSource(s)	Aspiration device	Aspiration device	Aspiration device
Volume Range	Up to 2500mL	100 to 2,000 mL	2000cc or 1200cc
Shipped sterile	Yes	No, sterilized by user prior touse	Yes
Initial method	Gamma radiation	Not applicable	Gamma radiation
Sterilityassurance level	$10^{-6}$	$10^{-6}$	$10^{-6}$
Disposable orreusable	Single use, disposable	Reusable	Single use, disposable
Resterilizationmethod	Not applicable	Autoclave	Not applicable

Table 1: Substantial Equivalence Comparison Chart

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9) Pre-Clinical Testing

The MicroAire LipoFilter System has been tested in various ways to demonstrate equivalence to the predicate devices including Gamma Radiation validation, shelf life validation, biocompatibility, and various performance testing. Specifics include the following:

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Validated for sterility using gamma radiation. Test results and analyses indicate that the MicroAire LipoFilter System sterility complies in accordance with ISO 11137-1:2006 and ISO 11137-2:2006.

Validated for a 2 year shelf life. Test results and analyses indicate that the MicroAire LipoFilter System packaging complies in accordance with ISO 11607-1: 2006 and ISO 11607-2: 2006.

The MicroAire LipoFilter System has patient contact materials and is made from medical grade biocompatible materials. Test results and analyses indicate that the MicroAire LipoFilter System materials' complies in accordance with ISO 10993-1: 2009.

The MicroAire LipoFilter System was tested for performance in accordance with its predetermined specifications on file at MicroAire which includes functionality testing, ISO 10079-1 testing, tubing connection strength testing, vacuum leak testing, adipocyte viability testing, and Aging Studies.

10) Conclusion:

The MicroAire LipoFilter System uses decantation to separate the tissue which is the same method as the two identified predicate devices. The MicroAire LipoFilter System does not have any new intended uses as compared to the two predicate devices. The MicroAire LipoFilter System has a slightly larger volume (2500 mL) whereas the predicate devices have a volume of up to 2000 mL which is insignificant given the intended use of the devices. The MicroAire LipoFilter System is provided sterile whereas the predicate devices are either provided sterile and/or sterilized by the user. The results of these activities demonstrate that the MicroAire LipoFilter System is considered substantially equivalent to the two predicate devices.

The results of the evaluation above demonstrate that the MicroAire LipoFilter System is considered substantially equivalent to the two predicate devices.

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.