The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

Neurosurgery
Gastrointestinal and Affiliated Organ Surgery
Urological Surgery
Plastic and Reconstructive Surgery
General Surgery
Orthopedic Surgery
Gynecological Surgery
Thoracic Surgery
Laparoscopic Surgery

The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

Device Description

The MicroAire LipoTower System is a modular wheeled cart that contains an adjustable vacuum source and a tumescent pump (110/120 VAC, 60 Hz). The vacuum source is a rotary vane type pump that delivers 0-29 inHG vacuum and drives the suction of tissue. The tumescent pump is a peristaltic type that delivers 50-600 ml/min of fluid as required. The system includes a control module with an LCD touch screen for control and status of the system and foot controls for controlling the vacuum pump and tumescent pump. Accessories include a bag holding pole, canister rack and shelves with are included. The system requires a biofilter (non-sterile) on the vacuum inlet and collection canisters (non-sterile - 1200ml and 2000ml) which are available separately.

AI/ML Overview

This FDA 510(k) summary for the MicroAire LipoTower System (K113128) does not describe a study to prove the device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Sound Surgical Technologies LLC - SoundVaser System, K022051) by comparing technical characteristics, indications for use, and compliance with recognized standards.

Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC/standalone studies are not applicable or not provided in this type of regulatory document.

However, I can extract information related to the technical characteristics and standards compliance, which serve as a form of "acceptance criteria" for electro-mechanical medical devices like the MicroAire LipoTower System.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this type of device are primarily related to its technical specifications matching or being comparable to the predicate device, and its compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.

Table of Acceptance Criteria (Technical/Compliance) and Reported Device Performance:

Acceptance Criteria Category	Specific Criterion / Standard	Predicate Device Performance (Sound Surgical Technologies, LLC (K022051))	Proposed Device Performance (MicroAire LipoTower System)
Indications for Use	Fragmentation, emulsification, and aspiration of soft tissue in specified surgical specialties, and subcutaneous fatty tissues for aesthetic body contouring.	Stated for predicate	Same
Physical Characteristics	Size (H x W x D)	89 x 46 x 43 cm	106 x 56 x 69 cm (Different but within expected range for such systems)
Electrical Input	Input Power	115 & 230 VAC, 50-60 Hz	115 VAC, 50-60 Hz (Comparable in relevant power range)
Irrigation System	Type	Adjustable Flow	Same
	Pump Type	Peristaltic	Same
	Flow Rate	(Not specified for predicate)	50-600 ml/min
Suction System	Vacuum	24 in Hg	Adjustable up to 29 in Hg (Improved/higher capability)
	Pump Type	(Not specified for predicate)	Rotary Vane
Control Interface	Footswitch control	Yes	Yes
Collection Canisters	Capacity	1250 ml	1200 ml, 2000 ml (Similar/additional capacity options)
Biofilter	Presence	N/A (not specified for predicate)	Yes
Regulatory Status	Prescription Use	Yes	Yes
IEC Classification	Class I, Type	Class I, Type BF	Class I, Type B (Different type, but both standard classifications for medical electrical equipment)
Electrical Safety	IEC EN 60601-1 (General Requirements for Safety - 2nd Edition)	Compliant	Compliant
	CAN/CSA C22.2 No. 601.1 (Medical Electrical Equipment, Part 1)	Compliant	Compliant
	UL 60601-1 (Medical Electrical Equipment, Part 1)	Compliant	Compliant
EMC - Radiated Emissions	CISPR 11 for IEC 60601-1-2 clause 36.201.1	Compliant	Compliant
EMC - Conducted Emissions	CISPR 11 for IEC 60601-1-2 clause 36.201.1	Compliant	Compliant
EMC - Harmonics	IEC 61000-3-2 for IEC 60601-1-2 clause 36.201.3.1	N/A (Predicate not specified)	Not applicable (to devices whose voltage < 220V)
EMC - Flicker	IEC 61000-3-3 for IEC 60601-1-2 clause 36.201.3.2	N/A (Predicate not specified)	Not applicable (to devices whose voltage < 220V or line-frequency of 60Hz)
EMC - ESD Immunity	IEC 61000-4-2 for IEC 60601-1-2 clause 36.202.2 (UL 801-2)	Compliant (Unknown for Air ESD specifically)	Compliant (to level of 2kV for UL 801-2; Compliant for Air ESD)
EMC - Radiated Immunity	IEC 61000-4-3 for IEC 60601-1-2 clause 36.202.3 (UL 801-3)	Compliant	Compliant
EMC - EFT Immunity	IEC 61000-4-4 for IEC 60601-1-2 clause 36.202.4 (UL 801-4)	Compliant	Compliant to level of 1.65kV
EMC - Surge Immunity	IEC 61000-4-5 for IEC 60601-1-2 clause 36.202.5 (UL 801-5)	Compliant	Compliant
EMC - Conducted Immunity	IEC 61000-4-6 for IEC 60601-1-2 clause 36.202.6	Unknown (Predicate not specified)	Compliant
EMC - Voltage dips/short-interruptions	IEC 61000-4-11 for IEC 60601-1-2 clause 36.202.7	Unknown (Predicate not specified)	Compliant (Note: Using 1kVA exclusion for 60% voltage dip)
EMC - Power-frequency magnetic-field	IEC 61000-4-8 for IEC 60601-1-2 clause 36.202.8.1	Unknown (Predicate not specified)	Compliant
Other Standards Compliance	ASME Y 14.5M-1994 (Mathematical Definition of Dimensioning and Tolerancing)	Unknown (Predicate not specified)	Compliant
	ISO 10079-1 (Medical suction equipment -- Safety requirements)	Unknown (Predicate not specified)	Compliant
	ISO 15223-1 (Medical devices -- Symbols to be used with medical device labels)	Unknown (Predicate not specified)	Compliant
	ISO 13485 (Medical devices -- Quality management systems)	Unknown (Predicate not specified)	Compliant
	ISO 14971 (Medical devices -- Application of risk management)	Unknown (Predicate not specified)	Compliant
	IEC 62304 (Medical device software - Software life cycle processes)	Unknown (Predicate not specified)	Compliant

Study Information (as applicable to this type of device submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This submission does not describe a clinical performance study with a "test set" in the diagnostic sense. The testing performed would have been laboratory-based verification and validation against engineering specifications and regulatory standards. The provenance of such lab data is typically internal to the manufacturer or from accredited testing laboratories, not clinical patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No ground truth established by experts for a diagnostic test set is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method for a diagnostic test set is mentioned.
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:
- N/A. This device is a surgical instrument (suction lipoplasty system), not an AI-powered diagnostic imaging device. No MRMC study was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is not an algorithm; it is an electro-mechanical surgical system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this device, "ground truth" would relate to engineering specifications, safety standards, and functional performance metrics (e.g., vacuum pressure, flow rates) validated through bench testing, not clinical diagnostic ground truth.
The sample size for the training set:
- N/A. This device does not use machine learning algorithms that require a "training set."
How the ground truth for the training set was established:
- N/A. Not applicable, as no training set is used.

Conclusion from the Document:

The document states in section 8, "Conclusion: The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and tested methods." This means the product's compliance with electrical safety, EMC standards, and its technical specifications, along with its intended use, were deemed sufficient to demonstrate substantial equivalence to the predicate device, not that it met a specific clinical performance acceptance criteria in terms of diagnostic accuracy.

Summary

{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 & 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.

Microaire Surgical Instruments, LLC Darren Reeves Consultant 7305 Hancock Village Dr Suite 109 Chesterfield, Virginia 23832

June 9, 2021

Re: K113128

Trade/Device Name: Microaire Surgical Instruments Llc Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Darren Reeves:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 17, 2012. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.

Sincerely,

Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Public Health Service

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

AUG 1 7 2012

MicroAire Surgical Instruments, LLC % DP Distribution & Consulting, LLC Mr. Darren Reeves Consultant 15637 Fox Cove Circle Moseley, Virginia 23120

Re: K113128

Trade/Device Name: MicroAire LipoTower System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: July 5, 2012 Received: July 9, 2012

Dear Mr. Reeves:

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

{2}------------------------------------------------

Page 2 - Mr. Darren Reeves

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours
Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

11/3/28 510(K) Number known:

Device Name: MicroAire LipoTower System

Indications for Use:

The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

-Neurosurgery
Gastrointestinal and Affiliated Organ Surgery -
ー Urological Surgery
Plastic and Reconstructive Surgery -
-General Surgery
Orthopedic Surgery -
Gynecological Surgery l
Thoracic Surgery -
Laparoscopic Surgery

The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

Prescription use
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krave for MM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113128

{4}------------------------------------------------

11 3 2 8

Section 5: 510(k) Summary

1. Preparation Date: October 12, 2011
1. Submitted by:

MicroAire Surgical Instruments LLC 1641 Edlich Drive Charlottesville, Virginia 22911 Owner/Operator #: 9004658

Contact Person/Prepared by:

Darren Reeves Phone: (804) 307-7706 Fax: Email: dreeves@dpdconline.com

Device Identification:

Trade Name: MicroAire LipoTower System Common Name: Lipoplasty Suction System Classification: Lipoplasty Suction System (21 CFR 878.5040, Product Code MUU)

1. Predicate Device: Sound Surgical Technologies LLC - SoundVaser System (K022051)
1. Device Description: The MicroAire LipoTower System is a modular wheeled cart that contains an adjustable vacuum source and a tumescent pump (110/120 VAC, 60 Hz). The vacuum source is a rotary vane type pump that delivers 0-29 inHG vacuum and drives the suction of tissue. The tumescent pump is a peristaltic type that delivers 50-600 ml/min of fluid as required. The system includes a control module with an LCD touch screen for control and status of the system and foot controls for controlling the vacuum pump and tumescent pump. Accessories include a bag holding pole, canister rack and shelves with are included. The system requires a biofilter (non-sterile) on the vacuum inlet and collection canisters (non-sterile - 1200ml and 2000ml) which are available separately.

6) Indications for Use:

The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

l Neurosurgery
-Gastrointestinal and Affiliated Organ Surgery
Urological Surgery l
Plastic and Reconstructive Surgery -
General Surgery |
Orthopedic Surgery 1
-Gynecological Surgery
Thoracic Surgery -
Laparoscopic Surgery -

The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

AUG 1 7 2012

{5}------------------------------------------------

7) Comparison to Predicate:

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

General Technical	Predicate - Sound Surgical Technologies, LLC	Proposed device
Characteristics	(K022051)
Indications for use	The MicroAire LipoTower System is indicated for use inthe following surgical specialties when thefragmentation, emulsification, and aspiration of softtissue is desired:- Neurosurgery- Gastrointestinal and Affiliated Organ Surgery- Urological Surgery- Plastic and Reconstructive Surgery- General Surgery- Orthopedic Surgery- Gynecological Surgery- Thoracic Surgery- Laparoscopic SurgeryThe System is indicated for use when thefragmentation, emulsification, and aspiration of softtissue is desired or subcutaneous fatty tissues foraesthetic body contouring is desired	Same
	Size (cm) (H x W x D)	89 x 46 x 43	106 x 56 x 69
	Input Power	115 & 230 VAC. 50-60 Hz	115VAC, 50-60 Hz
	Handpiece		N/A
	Diameter (cm)	2.5	N/A
	Length (cm)	17.5	N/A
	Transducer	PZT crystal	N/A
	Vibration Frequency	36-55 kHz	N/A
	Probes		N/A
	Material	Titanium alloy	N/A
	Diameter (mm)	2.9-3.7	N/A
	Length (cm)	7.7-27.0	N/A
	Irrigation
	Type	Adjustable Flow	Same
	Pump Type	Peristaltic	Same
	Flow Rate		50-600ml/min
Suction
Vacuum	24 in Hg	Adjustable up to 29 in Hg
Pump Type		Rotary Vane
Sterilization	Steam	N/A
Sterilization Validation		N/A
Residuals		N/A
Accessories		N/A
AC Power cord	3 prong, Hosp Grade	Same
Handpiece cable	3 m, silicone	N/A
Footswitch control	Yes	Yes
Collection Canister	1250ml	1200ml, 2000ml
Biofilter	N/A	Yes
Prescription	Yes	Yes
IEC Classification	Class I, Type BF	Class I, Type B
	Predicate Used	MicroAire
IEC EN 60601-1- Medical Electrical Equipment, Part 1: General Requirements for Safety - 2nd Edition
Radiated emissions
CISPR 11for IEC 60601-1-2 clause 36.201.1	Compliant	Compliant
Conducted emissions
CISPR 11for IEC 60601-1-2 clause 36.201.1	Compliant	Compliant
Harmonics
IEC 61000-3-2 for IEC 60601-1-2 clause 36.201.3.1	N/A	Not applicable (to devices whosevoltage < 220V).
Flicker
IEC 61000-3-3 for IEC 60601-1-2 clause 36.201.3.2	N/A	Not applicable (to devices whosevoltage < 220V or line-frequency of60Hz
ESD immunity
IEC 61000-4-2 for IEC 60601-1-2 clause 36.202.2
UL 801-2	Compliant	Compliant to level of 2kV
Air ESD	Unknown	Compliant
Radiated immunity
IEC 61000-4-3 for IEC 60601-1-2 clause 36.202.3
UL 801-3	Compliant	Compliant
EFT immunity
IEC 61000-4-4 for IEC 60601-1-2 clause 36.202.4
UL 801-4	Compliant	Compliant to level of 1.65kV
Surge immunity
IEC 61000-4-5 for IEC 60601-1-2 clause 36.202.5
UL 801-5	Compliant	Compliant
Conducted immunity
IEC 61000-4-6 for IEC 60601-1-2 clause 36.202.6	Unknown	Compliant
Voltage dips and short-interruptions immunity		Compliant.Note: Using 1kVAexclusion of 36.202.7 a)1) for 60%voltage dip
IEC 61000-4-11 for IEC 60601-1-2 clause 36.202.7	Unknown
Power-frequency magnetic-field immunity
IEC 61000-4-8 for IEC 60601-1-2 clause 36.202.8.1	Unknown	Compliant
CAN/CSA C22.2 No. 601.1 - Medical Electrical Equipment, Part 1: General Requirements forSafety - 1st Edition	Compliant	Compliant
UL 60601-1- Medical Electrical Equipment, Part 1: General Requirements for Safety - 1stEdition	Compliant	Compliant
ASME Y 14.5M-1994 - Mathematical Definition of Dimensioning and Tolerancing	Unknown	Compliant
ISO 10079-1 - Medical suction equipment -- Part 1: Electrically powered suction equipment --Safety requirements	Unknown	Compliant
ISO 15223-1- Medical devices -- Symbols to be used with medical device labels, labelling andinformation to be supplied -- Part 1: General requirements	Unknown	Compliant
ISO 13485 - Medical devices -- Quality management systems -- Requirements for regulatorypurposes	Unknown	Compliant
ISO 14971 - Medical devices -- Application of risk management to medical devices	Unknown	Compliant
IEC 62304- Medical device software - Software life cycle processes	Unknown	Compliant

UII 3128

{6}------------------------------------------------

UU3I28

1 - 3 of You

{7}------------------------------------------------

UU 3128

Yofy

8) Conclusion:

The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and tested methods.

9) Similarities/Differences of the proposed device when compared to the predicate:

The data within this submission demonstrates that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S.

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.