Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a mechanical filtering system for adipose tissue and does not mention any computational or algorithmic components indicative of AI/ML.

Therapeutic

No.
The device is used for the aspiration, filtering, and transferring of autologous adipose tissue, which is a collection and processing function, not a therapeutic treatment.

Diagnostic

No

The device description indicates that the system is used for the aspiration, filtering, and transferring of autologous adipose tissue, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, single-use system comprised of a canister, ports, and lid, intended for collecting and filtering adipose tissue. There is no mention of software as a component or the primary function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "aspiration, filtering and transferring of autologous adipose tissue for aesthetic body contouring." This describes a surgical procedure involving the collection and re-implantation of tissue within the patient's body.
Device Description: The device is a "closed loop tissue collection system" used with a liposuction aspiration system. It collects and filters fatty tissue for re-injection. This is a device used during a surgical procedure, not for testing samples outside the body to diagnose or monitor a condition.
Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. It's a tool for collecting and preparing tissue for re-implantation.

IVD devices are typically used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely related to the physical collection and preparation of tissue for a surgical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MUU

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 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:
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Sound Surgical Technologies - Origins LipoHarvesting System (K120328), Medical Device Resource Corporation - Lipisystems Aquavage Model AV2000 & 1200 (K092284)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure, with three profiles merging to form a single, abstract shape. The emblem is meant to symbolize health and human services.

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

1

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)

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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 Corp
Lipisystems Aquavage
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.	The Origins LipoHarvesting
System consists of a
reusable, closed loop
tissue collection system
comprised of a medical
grade canister, a drain
port and a lid intended to
be used with a standard
liposuction aspiration
pump to collect fatty
tissue for aesthetic body
contouring. As the tissue is
harvested from the
patient, it enters the
collection canister via a
port in the canister lid. The
physician removes
unwanted waste materials
from the collection system
via the drain port at the
base. This process leaves
fatty tissue that can be
transferred to syringes for
autologous fat re-
injection.	Device function:

Contains port
interfaces
between:
canister to
tubing and
aspirator to
canister.
Sterile tubing
to connect the
interfaces.
Funnel to
interface port
to tubing.
Syringe to
collect fat.
Device Design:
Contents
subjected to
sterility.
Material used:
Plastic canister,
syringe, silicone
tubing. |
| Picture of
Product | Image: MicroAire LipoFilter System | Image: Origins LipoHarvesting System | Image: Medical Device Resource Corp Lipisystems Aquavage |
| 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. | The Origins LipoHarvesting
System is used in the
aspiration, harvesting,
filtering and transferring
of autologous tissue. If
harvested fat is to be re-
implanted, the harvested
fat is only to be used
without any additional
manipulation. | For use in aspirating
subcutaneous fatty
tissue including
autologous fat
collection. |
| Technology
Comparison: | The MicroAire LipoFilter
System employs the same
technological characteristics
as the predicate device. | The Origins LipoHarvesting
System employs the same
technological
characteristics as the
predicate devices. | The Lipisytems
Aquavage employs the
same technological
characteristics as the
predicate device. |
| Suction
Source(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 to
use | Yes |
| Initial method | Gamma radiation | Not applicable | Gamma radiation |
| Sterility
assurance level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ |
| Disposable or
reusable | Single use, disposable | Reusable | Single use, disposable |
| Resterilization
method | 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.