PAL System
Device Facts
| Record ID | K212024 |
|---|---|
| Device Name | PAL System |
| Applicant | Microaire Surgical Instruments, LLC |
| Product Code | QPB · General, Plastic Surgery |
| Decision Date | Jun 10, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
For aesthetic body contouring
Device Story
PAL System is an electronic control system for power-assisted liposuction. It consists of a 5020 electric instrument console, a PAL-650 handpiece, and a 5006-PAL cable. The system connects to an independent aspiration source. During lipoplasty, the handpiece reciprocates a cannula at 4,000–5,000 strokes/min with a 2.8 mm stroke distance to assist in the aspiration of autologous adipose tissue. The device is operated by trained healthcare professionals in a clinical setting. The console features a color touchscreen for monitoring system status and adjusting parameters. The reciprocating motion of the cannula facilitates the mechanical removal of fat tissue, which is then suctioned out. This system is intended to provide a controlled, efficient method for fat removal, potentially reducing clinician fatigue compared to manual liposuction techniques.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1), mechanical tensile testing, and sterilization validation (SAL 10^-6).
Technological Characteristics
System includes 5020 electric console, PAL-650 handpiece, and 5006-PAL cable. Operates on 100-240 VAC, 50/60 Hz. Reciprocating mechanism: 4,000-5,000 strokes/min, 2.8 mm stroke distance. Handpiece and cable are steam autoclavable. Connectivity: standalone console with touchscreen interface. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 62366.
Indications for Use
Indicated for aesthetic body contouring in patients undergoing lipoplasty procedures.
Regulatory Classification
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 of 1/3 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.
Special Controls
*Classification.* Class II (special controls). Consensus standards and labeling restrictions.
Predicate Devices
- Vibrasat® Power (console and vibration handpiece for the liposuction cannula) (K053451)
Reference Devices
- MicroAire "Power Aspiration Device" PAD System (K973268)
Submission Summary (Full Text)
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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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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<br>Instruments | Moeller Medical GmbH & Co.<br>KG | |
| Trade Name | PAL® System<br>• 5020 Console | Vibrasat® Power<br>• Console | |
| 510(k) Number | K212024 | K053451 | N/A |
| Classification | | | |
| | COMPANY | PREDICATE | Device Comparison |
| | MicroAire® Surgical<br>Instruments | Moeller Medical GmbH & Co.<br>KG | |
| Trade Name | PAL® System<br>• 5020 Console | Vibrasat® Power<br>• 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<br>Class II | 21 CFR 878.5040<br>Class II | Same |
| Regulation Name | Suction Lipoplasty System | Suction Lipoplasty System | Same |
| Indications for Use | For aesthetic body<br>contouring | Aesthetic body contouring | Same |
| Device Overview | | | |
| User | Only trained and<br>experienced healthcare<br>providers/professionals<br>should use this medical<br>equipment. | Doctors who can demonstrate<br>that they have the necessary<br>expertise through the relevant<br>specialist training or<br>approved, specialist further<br>training. | Similar to subject<br>device |
| Mechanism of<br>Action | MicroAire power assisted<br>liposuction is an electronic<br>control system designed to<br>reciprocate a cannula in<br>lipoplasty applications. | Vibration liposuction is a<br>tried-and-tested method for<br>fat removal. With this<br>method, the suction cannula<br>is vibrated axially which, in<br>combination with the suction<br>vacuum, cuts and removes<br>the fatty tissue<br>microscopically and gently. | Same |
| Display | The color touch screen<br>display provides an intuitive<br>graphical user interface that<br>allows users to view system<br>status and set parameters<br>with a touch of the screen. | LED stroke rate display with<br>tactile control buttons for<br>stop/start, increase/decrease<br>rate and rate set. | Similar |
| Speed Control | • Touch screen<br>• Handpiece | • Console tactile buttons<br>• Foot pedal | Similar |
| Physical Characteristics | | | |
| | COMPANY | PREDICATE | Device Comparison |
| | MicroAire® Surgical<br>Instruments | Moeller Medical GmbH & Co.<br>KG | |
| Trade Name | PAL® System<br>• 5020 Console | Vibrasat® Power<br>• Console | |
| Dimensions | 304.8 mm x 355.6 mm x<br>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<br>Attachable Devices | Two (2) Handpieces | One (1) Handpiece<br>One (1) Footswitches | Different |
| Safety and Performance | | | |
| Electrical Safety<br>Testing Passed | IEC/EN 60601-1-2:2014<br>IEC 60601-1:2005<br>IEC 60601-1-6:2013<br>IEC 62366: 2015 | IEC/EN 60601-1-2:2007<br>IEC 60601-1:2005<br>IEC 60601-1-6:2010<br>IEC 62366: 2007 | Similar |
| Performance | 4000 – 5000 strokes/min. | 3000 – 5000 strokes/min. | Similar |
| Reuse | | | |
| Cleaning /<br>disinfecting | Validated germicidal wipe<br>down method in IFU | Validated alcohol wipe down<br>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<br>MicroAire® Surgical<br>Instruments | PREDICATE<br>Moeller Medical GmbH & Co.<br>KG | Device Comparison |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | PAL-650 Handpiece and<br>5006-PAL Cable | Vibrasat® Power Handpiece<br>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<br>MicroAire® Surgical<br>Instruments | PREDICATE<br>Moeller Medical GmbH & Co.<br>KG | Device Comparison |
| Trade Name | PAL-650 Handpiece and<br>5006-PAL Cable | Vibrasat® Power Handpiece<br>w/Cable | |
| Mechanism of<br>Action | The PAL-650 is a powered<br>surgical instrument that<br>reciprocates a cannula used<br>in liposuction procedures. | The Vibrasat® power transfers<br>very rapid vibrations in an<br>axial direction to a cannula<br>connected to the handle and<br>thus supports the user's hand<br>movements. | Same |
| User | Use of this device is limited<br>to those physicians who, by<br>means of formal professional<br>training or sanctioned<br>continuing medical<br>education (including<br>supervised operative<br>experience), have attained<br>proficiency in suction<br>lipoplasty. | Doctors who can demonstrate<br>that they have the necessary<br>expertise through the relevant<br>specialist training or<br>approved, specialist further<br>training. | Similar. The scope of<br>PAL System includes<br>professionals also<br>involved in the<br>operating procedure. |
| Technology<br>Overview | The reciprocating output<br>shaft of the handpiece drives<br>the cannula through a stroke<br>distance of 2.8 mm (±0.4<br>mm) at a rate of 4,000 to<br>5,000 strokes/minute. | Axial vibration liposuction<br>power through 3,000 to 5,000<br>strokes/min with a stroke of<br>2.8 mm | Similar. Predicate<br>device has a lower<br>threshold stroke rate. |
| Physical Characteristics | | | |
| Dimensions | 25 mm x 38 mm x 250 mm<br>(width x thickness x length)<br>[45.5 mm x 250 mm ~<br>equivalent diameter x length<br>envelope] | 55 mm x 180 mm (diameter x<br>length) | Similar |
| Weight | 0.5 kg (Handpiece)<br>0.28 kg (Cable) | 0.75 kg (handpiece and cable) | Similar. The weight<br>difference is<br>insignificant to the<br>overall weight. |
| Power source | Console, detachable cable. | Console, detachable cable | Same |
| Performance | | | |
| | COMPANY<br>MicroAire® Surgical<br>Instruments | PREDICATE<br>Moeller Medical GmbH & Co.<br>KG | Device Comparison |
| Trade Name | PAL-650 Handpiece and<br>5006-PAL Cable | Vibrasat® Power Handpiece<br>w/Cable | |
| Duty Cycle | Duty cycle of 2 hours<br>continuous use/ 2 hours off. | 30-minutes cycle with a<br>subsequent break of 60<br>minutes. This cycle may be<br>repeated as often as<br>necessary. | Different |
| Surface<br>Temperature during<br>Operation | <41°C | <43°C | Similar. Subject device<br>is slightly cooler at the<br>maximum temperature |
| Reuse | | | |
| Cleaning | • Manual<br>• Automated | • Manual<br>• Automated | Similar<br>• For manual cleaning,<br>predicate process is<br>≤40°C for soak and<br>rinse while subject's<br>process is ≥49°C.<br>• For automated<br>cleaning, the<br>predicate has a 7-<br>step process with a<br>neutralizing solution<br>while the subject's<br>process is 6 steps not<br>requiring<br>neutralizing.<br>Temperatures are<br>similar to equal<br>across process. |
| Sterilization | Handpiece and cable are<br>Autoclavable by end user,<br>steam sterilization | Handpiece and cable are<br>Autoclavable by end user,<br>steam sterilization | Same. Both callout<br>Dynamic-Air- Removal<br>steam method.<br>Subject's process also<br>allows for gravity<br>displacement steam<br>method. |
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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.
