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.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of AI/ML performance.

The document is a 510(k) premarket notification for a medical device called the "PAL System" (Power Assisted Liposuction System) manufactured by MicroAire Surgical Instruments, LLC. It details the device's substantial equivalence to a predicate device, the Vibrasat® Power, for the indication of aesthetic body contouring.

The information provided focuses on:

Regulatory information: FDA clearance, product codes, regulation numbers.
Device description: Components (console, handpiece, cable), mechanism of action, physical characteristics.
Comparison to a predicate device: Highlighting similarities and differences in intended use, technology, user, physical characteristics, performance (e.g., strokes/min), electrical safety, and reuse (cleaning/sterilization).
Non-clinical performance data: Listing various bench tests performed (biocompatibility, electrical safety, EMD, software verification/validation, mechanical tensile testing, sterilization validation, transportation testing).
Clinical performance data: Stating that no human clinical testing was required because the indications for use are equivalent to the predicate device and the device type has a long history of safe and effective use.

Therefore, the document does not include:

A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
Sample sizes or provenance of a test set for AI/ML.
Information about experts establishing ground truth for AI/ML.
Adjudication methods for AI/ML test sets.
MRMC studies for AI assistance.
Standalone performance of an algorithm.
Type of ground truth (beyond "proven safety and efficacy" for a mechanical device).
Sample size for a training set or how its ground truth was established, as this is not an AI/ML device submission.

The document describes the regulatory pathway for a conventional medical device, not an AI/ML model.

Summary

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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

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)
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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

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® SurgicalInstruments	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® SurgicalInstruments	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 878.5040Class II	21 CFR 878.5040Class II	Same
Regulation Name	Suction Lipoplasty System	Suction Lipoplasty System	Same
Indications for Use	For aesthetic bodycontouring	Aesthetic body contouring	Same
Device Overview
User	Only trained andexperienced healthcareproviders/professionalsshould use this medicalequipment.	Doctors who can demonstratethat they have the necessaryexpertise through the relevantspecialist training orapproved, specialist furthertraining.	Similar to subjectdevice
Mechanism ofAction	MicroAire power assistedliposuction is an electroniccontrol system designed toreciprocate a cannula inlipoplasty applications.	Vibration liposuction is atried-and-tested method forfat removal. With thismethod, the suction cannulais vibrated axially which, incombination with the suctionvacuum, cuts and removesthe fatty tissuemicroscopically and gently.	Same
Display	The color touch screendisplay provides an intuitivegraphical user interface thatallows users to view systemstatus and set parameterswith a touch of the screen.	LED stroke rate display withtactile control buttons forstop/start, increase/decreaserate and rate set.	Similar
Speed Control	• Touch screen• Handpiece	• Console tactile buttons• Foot pedal	Similar
Physical Characteristics
	COMPANY	PREDICATE	Device Comparison
	MicroAire® SurgicalInstruments	Moeller Medical GmbH & Co.KG
Trade Name	PAL® System• 5020 Console	Vibrasat® Power• Console
Dimensions	304.8 mm x 355.6 mm x152.4 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 ofAttachable Devices	Two (2) Handpieces	One (1) HandpieceOne (1) Footswitches	Different
Safety and Performance
Electrical SafetyTesting Passed	IEC/EN 60601-1-2:2014IEC 60601-1:2005IEC 60601-1-6:2013IEC 62366: 2015	IEC/EN 60601-1-2:2007IEC 60601-1:2005IEC 60601-1-6:2010IEC 62366: 2007	Similar
Performance	4000 – 5000 strokes/min.	3000 – 5000 strokes/min.	Similar
Reuse
Cleaning /disinfecting	Validated germicidal wipedown method in IFU	Validated alcohol wipe downmethod 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

	COMPANYMicroAire® SurgicalInstruments	PREDICATEMoeller Medical GmbH & Co.KG	Device Comparison
Trade Name	PAL-650 Handpiece and5006-PAL Cable	Vibrasat® Power Handpiecew/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
	COMPANYMicroAire® SurgicalInstruments	PREDICATEMoeller Medical GmbH & Co.KG	Device Comparison
Trade Name	PAL-650 Handpiece and5006-PAL Cable	Vibrasat® Power Handpiecew/Cable
Mechanism ofAction	The PAL-650 is a poweredsurgical instrument thatreciprocates a cannula usedin liposuction procedures.	The Vibrasat® power transfersvery rapid vibrations in anaxial direction to a cannulaconnected to the handle andthus supports the user's handmovements.	Same
User	Use of this device is limitedto those physicians who, bymeans of formal professionaltraining or sanctionedcontinuing medicaleducation (includingsupervised operativeexperience), have attainedproficiency in suctionlipoplasty.	Doctors who can demonstratethat they have the necessaryexpertise through the relevantspecialist training orapproved, specialist furthertraining.	Similar. The scope ofPAL System includesprofessionals alsoinvolved in theoperating procedure.
TechnologyOverview	The reciprocating outputshaft of the handpiece drivesthe cannula through a strokedistance of 2.8 mm (±0.4mm) at a rate of 4,000 to5,000 strokes/minute.	Axial vibration liposuctionpower through 3,000 to 5,000strokes/min with a stroke of2.8 mm	Similar. Predicatedevice has a lowerthreshold 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 lengthenvelope]	55 mm x 180 mm (diameter xlength)	Similar
Weight	0.5 kg (Handpiece)0.28 kg (Cable)	0.75 kg (handpiece and cable)	Similar. The weightdifference isinsignificant to theoverall weight.
Power source	Console, detachable cable.	Console, detachable cable	Same
Performance
	COMPANYMicroAire® SurgicalInstruments	PREDICATEMoeller Medical GmbH & Co.KG	Device Comparison
Trade Name	PAL-650 Handpiece and5006-PAL Cable	Vibrasat® Power Handpiecew/Cable
Duty Cycle	Duty cycle of 2 hourscontinuous use/ 2 hours off.	30-minutes cycle with asubsequent break of 60minutes. This cycle may berepeated as often asnecessary.	Different
SurfaceTemperature duringOperation	<41°C	<43°C	Similar. Subject deviceis slightly cooler at themaximum temperature
Reuse
Cleaning	• Manual• Automated	• Manual• Automated	Similar• For manual cleaning,predicate process is≤40°C for soak andrinse while subject'sprocess is ≥49°C.• For automatedcleaning, thepredicate has a 7-step process with aneutralizing solutionwhile the subject'sprocess is 6 steps notrequiringneutralizing.Temperatures aresimilar to equalacross process.
Sterilization	Handpiece and cable areAutoclavable by end user,steam sterilization	Handpiece and cable areAutoclavable by end user,steam sterilization	Same. Both calloutDynamic-Air- Removalsteam method.Subject's process alsoallows for gravitydisplacement steammethod.

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8. Non-Clinical Performance Data

To demonstrate safety and effectiveness of the PAL® System and to show substantial equivalence to the predicate device, MicroAire® Surgical Instruments completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The

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PAL® System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device.

o Biological evaluation per ISO 10993-1 - The 5006-PAL Instrument cable was considered biocompatible for the intended use. For more details see Section 15 – Biocompatibility.
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.

9. 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.

10. Statement of Substantial Equivalence

The PAL® System, the subject device, has the same intended use and similar technological characteristics that has been compared and contrasted with the chosen predicate device, and that the subject does not raise additional questions regarding its safety and effectiveness. Clinical and non-clinical testing has demonstrated the PAL® System is as safe and effective as the predicate device. Therefore, through intended use, technology, and performance testing, the PAL® System is substantially equivalent to the predicate device.

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.