Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components and their function in liposuction, with no mention of AI or ML terms or capabilities.

Therapeutic

No
The device is described as being used for "aesthetic body contouring" and "aspiration of autologous adipose tissue in lipoplasty procedures," which are typically considered aesthetic procedures rather than therapeutic interventions aimed at treating a disease or disorder.

Diagnostic

No
Explanation: The device is intended for aesthetic body contouring and the aspiration of adipose tissue in lipoplasty procedures, which are interventional rather than diagnostic. It does not identify or characterize diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of three hardware components: an electric instrument console, a handpiece, and a cable. This indicates it is a hardware-based medical device, not software-only.

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 aesthetic body contouring" and "for the aspiration of autologous adipose tissue in lipoplasty procedures." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The device is a "Power Assisted Liposuction (PAL) System" that uses a handpiece and cannula to aspirate fat tissue. This is a physical device used in a surgical procedure.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening

IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health status. This device is used to physically remove tissue from the body for aesthetic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For aesthetic body contouring

Product codes

QPB,MUU

Device Description

The MicroAire® Power Assisted Liposuction (PAL) System is a medical device intended to be used for the aspiration of autologous adipose tissue in lipoplasty procedures. The PAL system consists of three components: electric instrument console, handpiece, and cable. The PAL-650 handpiece is powered by the MicroAire 5020 Electric Instrument Control console via the 5006 PAL cable and connected to an independent aspiration source. The PAL-650 handpiece reciprocates a cannula used in liposuction procedures for aspiration of fat tissue.

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

Only trained and experienced healthcare providers/professionals should use this medical equipment.
Use of this device is limited to those physicians who, by means of formal professional training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty.

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)

Non-Clinical Performance Data:

o Biological evaluation per ISO 10993-1 - The 5006-PAL Instrument cable was considered biocompatible for the intended use.
o Electrical safety testing per IEC 60601-1 – The PAL System was tested for electrical safety per the standard, details for testing are in Section 18 - Non-clinical Bench Testing.
. Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 - The PAL System underwent interference testing, details for testing are in Section 17 – Electromagnetic Compatibility.
. Software verification and validation per IEC 62304/FDA Guidance – results /conclusion are detailed in Section 16 - Software.
. Mechanical Tensile Testing, results /conclusion are detailed in Section 18 – Non-clinical Bench Testing.
. Sterilization validation – The Handpiece and Cable demonstrates SAL of 10 , for details of testing see Section 14 – Sterilization and Shelf life.
Transportation Testing per ASTM D4169-Demonstrates package integrity maintained. Details for testing are in Section 18 - Non-clinical Bench Testing.

Clinical Performance Data:
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

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

Not Found

Predicate Device(s)

K053451

Reference Device(s)

K973268

Predetermined Change Control Plan (PCCP) - All Relevant Information

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

6/21/2022

MicroAire Surgical Instruments, LLC Glenn Gerstenfeld Vice President, QA/RA and Compliance Officer 3590 Grand Forks Blvd Charlottesville, Virginia 22911

Re: K212024

Trade/Device Name: PAL System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Glenn Gerstenfeld:

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 June 10, 2022. Specifically, FDA is updating this SE Letter to update the correct product code from MUU to QPB as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Deborah Fellhauer, OHT4: Office of Surgical and Infection Control Devices, 301-796-9570, Deborah.Fellhauer@FDA.HHS.GOV.

Sincerely, Digitally signed by Deborah A. Deborah A. Fellhauer -S Fellhauer -S

Deborah Fellhauer RN, BSN 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

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Image /page/1/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right of that is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square, followed by the full name of the agency in blue text.

June 10, 2022

MicroAire Surgical Instruments, LLC Glenn Gerstenfeld Vice President, OA/RA and Compliance Officer 3590 Grand Forks Blvd Charlottesville, Virginia 22911

Re: K212024

Trade/Device Name: PAL System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: March 11, 2022 Received: March 21, 2022

Dear Glenn Gerstenfeld:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Deborah A. Fellhauer -S

Deborah Fellhauer RN, BSN 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

Enclosure

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Indications for Use

510(k) Number (if known)

K212024

Device Name MicroAire® PAL® System

Indications for Use (Describe) For aesthetic body contouring.

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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510(k) Summary

PAL® System

K212024

1. Submission Sponsor

MicroAire® Surgical Instruments, LLC

3590 Grand Forks Blvd

Charlottesville

VA, 22911

USA

Contact: Glenn Gerstenfeld

Title: Vice President, QA/RA and Compliance Officer

2. Date Prepared

23 June 2021

3. Device Identification

Trade/Proprietary Name:	PAL® System
Common/Usual Name:	Suction Lipoplasty System
Classification Name:	System, Suction, Lipoplasty For Removal
Regulation Number:	878.5040
Product Code:	QPB
Device Class:	Class II
Classification Panel:	General & Plastic Surgery

4. Predicate Device(s)

Device name: Vibrasat® Power (console and vibration handpiece for the liposuction cannula)

510(k) number: K053451

Manufacturer: Moeller Medical GMBH & Co. KG.

The device of interest for comparison are the Vibrasat® power console and handpiece. These two devices are controlled by the user during Lipoplasty procedures, the console for settings and the handpiece for the manipulation of the cannula for the fat removal. The predicate device and subject device are detailed further for comparison in Section 12 - Substantial Equivalence.

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Reference Predicate

Device name: MicroAire "Power Aspiration Device" PAD System

510(k) number: K973268

Manufacturer: MicroAire® Surgical Instruments, LLC

The MicroAire Power Aspiration Device (PAD) System is the original PAL System without the enhanced features. The reference device and subject device are detailed further Section 12 - Substantial Equivalence, though the reference device is only used in the historical context. The predicate serves as the substantial equivalence.

5. Intended Use / Indication for Use Statement

For aesthetic body contouring

6. Device Description

The MicroAire® Power Assisted Liposuction (PAL) System is a medical device intended to be used for the aspiration of autologous adipose tissue in lipoplasty procedures. The PAL system consists of three components: electric instrument console, handpiece, and cable. The PAL-650 handpiece is powered by the MicroAire 5020 Electric Instrument Control console via the 5006 PAL cable and connected to an independent aspiration source. The PAL-650 handpiece reciprocates a cannula used in liposuction procedures for aspiration of fat tissue. For more details on device see Section 11 – Device Description.

7. Substantial Equivalence Discussion

The following table compares the PAL® System to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

	COMPANY	PREDICATE	Device Comparison
	MicroAire® Surgical
Instruments	Moeller Medical GmbH & Co.
KG
Trade Name	PAL® System
• 5020 Console	Vibrasat® Power
• Console
510(k) Number	K212024	K053451	N/A
Classification
	COMPANY	PREDICATE	Device Comparison
	MicroAire® Surgical
Instruments	Moeller Medical GmbH & Co.
KG
Trade Name	PAL® System
• 5020 Console	Vibrasat® Power
• Console
Image	Image: MicroAire Surgical Instruments	Image: Moeller Medical GmbH & Co. KG	N/A
Product Code	QPB	QPB	Same
Regulation Number	21 CFR 878.5040
Class II	21 CFR 878.5040
Class II	Same
Regulation Name	Suction Lipoplasty System	Suction Lipoplasty System	Same
Indications for Use	For aesthetic body
contouring	Aesthetic body contouring	Same
Device Overview
User	Only trained and
experienced healthcare
providers/professionals
should use this medical
equipment.	Doctors who can demonstrate
that they have the necessary
expertise through the relevant
specialist training or
approved, specialist further
training.	Similar to subject
device
Mechanism of
Action	MicroAire power assisted
liposuction is an electronic
control system designed to
reciprocate a cannula in
lipoplasty applications.	Vibration liposuction is a
tried-and-tested method for
fat removal. With this
method, the suction cannula
is vibrated axially which, in
combination with the suction
vacuum, cuts and removes
the fatty tissue
microscopically and gently.	Same
Display	The color touch screen
display provides an intuitive
graphical user interface that
allows users to view system
status and set parameters
with a touch of the screen.	LED stroke rate display with
tactile control buttons for
stop/start, increase/decrease
rate and rate set.	Similar
Speed Control	• Touch screen
• Handpiece	• Console tactile buttons
• Foot pedal	Similar
Physical Characteristics
	COMPANY	PREDICATE	Device Comparison
	MicroAire® Surgical
Instruments	Moeller Medical GmbH & Co.
KG
Trade Name	PAL® System
• 5020 Console	Vibrasat® Power
• Console
Dimensions	304.8 mm x 355.6 mm x
152.4 mm	150 mm x 100 mm x 200 mm	Different.
Weight	6.35 kg	2.8 kg	Different
Display	Color touchscreen display	Led display illumination	Different
AC Powered	100 VAC – 240 VAC, 50/60 Hz	100 VAC – 240 VAC, 50/60 Hz	Same
Number of
Attachable Devices	Two (2) Handpieces	One (1) Handpiece
One (1) Footswitches	Different
Safety and Performance
Electrical Safety
Testing Passed	IEC/EN 60601-1-2:2014
IEC 60601-1:2005
IEC 60601-1-6:2013
IEC 62366: 2015	IEC/EN 60601-1-2:2007
IEC 60601-1:2005
IEC 60601-1-6:2010
IEC 62366: 2007	Similar
Performance	4000 – 5000 strokes/min.	3000 – 5000 strokes/min.	Similar
Reuse
Cleaning /
disinfecting	Validated germicidal wipe
down method in IFU	Validated alcohol wipe down
method in IFU	Similar
Operating Environment
Environment:	Operation conditions	Operation conditions	Similar
Temperature	15°C to +24°C	+10°C to +25°C
Humidity	20%-60%	30 to 75%

Table 5A - Comparison of Characteristics of PAL® 5020 Console to Vibrasat® Power Console

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Table 5B – Comparison of Characteristics of PAL-650 Handpiece to Vibrasat® Handpiece

| | COMPANY
MicroAire® Surgical
Instruments | PREDICATE
Moeller Medical GmbH & Co.
KG | Device Comparison |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | PAL-650 Handpiece and
5006-PAL Cable | Vibrasat® Power Handpiece
w/Cable | |
| 510(k) Number | K212024 | K053451 | N/A |
| Device Overview | | | |
| Image | Image: PAL-650 Handpiece and 5006-PAL Cable | Image: Vibrasat Power Handpiece w/Cable | N/A |
| | COMPANY
MicroAire® Surgical
Instruments | PREDICATE
Moeller Medical GmbH & Co.
KG | Device Comparison |
| Trade Name | PAL-650 Handpiece and
5006-PAL Cable | Vibrasat® Power Handpiece
w/Cable | |
| Mechanism of
Action | The PAL-650 is a powered
surgical instrument that
reciprocates a cannula used
in liposuction procedures. | The Vibrasat® power transfers
very rapid vibrations in an
axial direction to a cannula
connected to the handle and
thus supports the user's hand
movements. | Same |
| User | Use of this device is limited
to those physicians who, by
means of formal professional
training or sanctioned
continuing medical
education (including
supervised operative
experience), have attained
proficiency in suction
lipoplasty. | Doctors who can demonstrate
that they have the necessary
expertise through the relevant
specialist training or
approved, specialist further
training. | Similar. The scope of
PAL System includes
professionals also
involved in the
operating procedure. |
| Technology
Overview | The reciprocating output
shaft of the handpiece drives
the cannula through a stroke
distance of 2.8 mm (±0.4
mm) at a rate of 4,000 to
5,000 strokes/minute. | Axial vibration liposuction
power through 3,000 to 5,000
strokes/min with a stroke of
2.8 mm | Similar. Predicate
device has a lower
threshold stroke rate. |
| Physical Characteristics | | | |
| Dimensions | 25 mm x 38 mm x 250 mm
(width x thickness x length)
[45.5 mm x 250 mm ~
equivalent diameter x length
envelope] | 55 mm x 180 mm (diameter x
length) | Similar |
| Weight | 0.5 kg (Handpiece)
0.28 kg (Cable) | 0.75 kg (handpiece and cable) | Similar. The weight
difference is
insignificant to the
overall weight. |
| Power source | Console, detachable cable. | Console, detachable cable | Same |
| Performance | | | |
| | COMPANY
MicroAire® Surgical
Instruments | PREDICATE
Moeller Medical GmbH & Co.
KG | Device Comparison |
| Trade Name | PAL-650 Handpiece and
5006-PAL Cable | Vibrasat® Power Handpiece
w/Cable | |
| Duty Cycle | Duty cycle of 2 hours
continuous use/ 2 hours off. | 30-minutes cycle with a
subsequent break of 60
minutes. This cycle may be
repeated as often as
necessary. | Different |
| Surface
Temperature during
Operation |