PAL Infiltration System

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To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ## 10/14/2022 MicroAire Surgical Instruments, LLC Glenn Gerstenfeld Vice President, OA/RA and Compliance Officer 3590 Grand Forks Blvd Charlottesville, Virginia 22911 Re: K220318 Trade/Device Name: PAL Infiltration System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: QPB Dated: June 19, 2022 Received: June 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 {1}------------------------------------------------ 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220318 Device Name MicroAire PAL Infiltration System Indications for Use (Describe) The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Summary #### MicroAire PAL Infiltration System #### 1. Submission Sponsor MicroAire Surgical Instruments, LLC. 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 USA Glenn Gerstenfeld Vice President, QA/RA, and Compliance Officer Glenn.gerstenfeld@microaire.com Phone: (434) 975-8344 Fax: (434) 975-4144 ### 2. Submission Correspondent Glenn Gerstenfeld Vice President, QA/RA and Compliance Officer MicroAire® Surgical Instruments, LLC Phone: (434) 975-8344 Fax: (434) 975-4144 Email: Glenn.gerstenfeld@microaire.com ### 3. Date Prepared 10/13/2022 ### 4. Device Identification | Trade/Proprietary Name: | PAL® Infiltration System | |-------------------------|-------------------------------------| | Common/Usual Name: | Infiltration System | | Classification Name: | Suction Lipoplasty System | | Regulation Number: | 21 CFR 878.5040 | | Product Code: | QPB | | Class: | II | | Classification Panel: | General and Plastic Surgery Devices | ### 5. Legally Marketed Predicate Device(s) Device name: Vitruvian Infiltration Pump 510(k) number: K170629 Manufacturer: Black & Black Surgical, Inc. {4}------------------------------------------------ Device name: Liposuction Aspiration and Tumescent Infiltration Cannulae and Needles 510(k) number: K113795 Manufacturer: Black & Black Surgical Device name: Single Spike 15' Large Bore Tubing 510(k) number: N/A – 510K exempt Manufacturer: Black & Black Surgical ### Reference Devices: Device name: Wells Johnson Infusion System, Mode 20-6000-00 510(k) number: K991437 Manufacturer: Wells Johnson Co. Device name: PAL System 510(k) number: K212024 Manufacturer: MicroAire Surgical Instruments, LLC Device name: PAL Single-Use Cannulas 510(k) number: K192694 Manufacturer: MicroAire Surgical Instruments, LLC Device name: PAL Multi-Use Cannulas and PAL Manual Wand 510(k) number: K171286 Manufacturer: MicroAire Surgical Instruments, LLC Device name: MicroAire LipoFilter System 510(k) number: BK220674 Manufacturer: MicroAire Surgical Instruments, LLC Device name: INEX Lipoplasty/Liposuction and Tumescent Infiltration Cannulae/Needles 510(k) number: K132353 Manufacturer: INEX ## 6. Indications for Use Statement The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring. ### 7. Device Description The MicroAire® Power Assisted Liposuction (PAL®) Infiltration System is a medical device intended for aesthetic body contouring. The PAL Infiltration System is a stand-alone peristaltic Infiltration Pump, with the ability to control ON/OFF function to the PAL Handpiece (sold separately), the Infiltration Pump, or a Foot Switch (INF-FOOT-1) depending on the doctor's preference. Page 2 of 10 K220318 {5}------------------------------------------------ The PAL® Infiltration System is comprised of the following components that are subject to this 510K: - INF-PUMP PAL Infiltration Pump - Accessories - o PAL-INF-1600 Infiltration Tubing - o PAL-INF-XXXXX Single-Use Infiltration Cannulas - o PAL-INF-RXXXXX Multi-Use Infiltration Cannula - o INF-CBL-5020, Infiltration Pump to 5020 Console Connector Cable - o INF-FOOT-1, Infiltration Foot Switch ## 8. Substantial Equivalence Discussion The following table compares the subject device to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The minor differences in the subject device does not raise any new questions of safety or effectiveness as compared to the predicate device. | Attribute | SUBJECT DEVICE | PREDICATE DEVICE /<br>510(k) HOLDER | Comparison | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K220318 | K170629 | N/A | | Product Code | QPB | QPB | N/A | | Regulation Number | 878.5040 | 878.5040 | N/A | | Indications For Use | The PAL® Infiltration<br>System is indicated for<br>the purpose of aesthetic<br>body contouring. | The Vitruvian Infiltration<br>Pump is intended to be<br>used for: Aesthetic Body<br>Contouring | Same | | Mechanism of Operation | | | | | Pump type | Peristaltic | Peristaltic | Same | | Maximum flow rate | 630 mL/min – with HK<br>Surgical ITS-10 tubing<br><br>1300 mL/min – with<br>MicroAire PAL<br>Infiltration Tubing PAL-<br>INF-1600 | 475 mL/min*<br><br>999 mL/min** | Different; The flow<br>rate is determined by<br>the peristaltic pump<br>geometry and speed<br>as well as the inner<br>diameter of the<br>section of tubing<br>which is placed inside<br>of the pump.<br>Lower flow rates can<br>be achieved using the<br>Subject Device if a<br>smaller diameter<br>tubing is connected. | | | Table 5A - Comparison of Characteristics for Pump | | |--|---------------------------------------------------|--| |--|---------------------------------------------------|--| {6}------------------------------------------------ | Attribute | SUBJECT DEVICE | PREDICATE DEVICE /<br>510(k) HOLDER | Comparison K2203 | |-------------------------------------|---------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Housing/Materials | Steel | ABS Plastic | Higher flow rates can<br>be achieved using the<br>Subject Device if a<br>larger diameter tubing<br>is connected.<br>Different; Tumescent<br>Infiltration pumps are<br>non-patient<br>contacting devices.<br>They are utilized and<br>maintained outside of<br>the sterile field.<br>Although the housing<br>materials are<br>different, this has no<br>impact on the<br>performance or the<br>Intended Use of the<br>pump. | | Footswitch | Electric | Air powered | Different; Both<br>footswitches activate<br>the rotation of the<br>pump. The difference<br>between air powered<br>and electric activation<br>does not change the<br>footswitch interaction<br>with the device or<br>how user interfaces<br>with the footswitches<br>during its use. | | Pressure control | Knob to control RPM | Knob to control RPM | Same | | Display | LED | LED | Same | | Complies with ISO<br>10993-1 | Yes | Yes | Same | | Electrical Safety<br>Testing Passed | Yes | Yes | Same | {7}------------------------------------------------ | Attribute | Predicate Device | Subject Device: | Reference Device | Comparison | |--------------|-------------------|---------------------|------------------------|-----------------------| | | #J | | | | | Device Name | Vitruvian | PAL Infiltration | Wells Johnson Infusion | N/A | | | Infiltration Pump | System | System, 20-6000-00 | | | Device | Black & Black | MicroAire Surgical | Wells Johnson | N/A | | Manufacturer | Surgical, Inc. | Instruments, LLC | | | | 510(k) | K170629 | K220318 | K991437 | N/A | | Reference | | | | | | Maximum flow | 475 mL/min* | 630 mL/min — with | Maximum flow rate | Similar; The flow | | rate | 999 mL/min** | HK Surgical ITS-10 | 1300mL/min (per IFU) | rate is determined | | | | tubing | | by the peristaltic | | | | | | pump geometry and | | | | 1200 mL/min - with | | speed as well as the | | | | MicroAire PAL | | inner diameter of | | | | Infiltration Tubing | | the section of tubing | | | | PAL-INF-1600 | | which is placed | | | | | | inside of the pump. | | | | | | Lower flow rates | | | | | | can be achieved | | | | | | using the Subject | | | | | | Device if a smaller | | | | | | diameter tubing is | | | | | | connected. Higher | | | | | | flow rates can be | | | | | | achieved using the | | | | | | Subject Device if a | | | | | | larger diameter | | | | | | tubing is connected. | ## Table 5B – Comparison of Flow Rate against Reference Device ## Table 5C – Comparison of Characteristics: Infiltration Single-Use and Multi-Use Cannulas | Attribute | Predicate Device #2<br>– Black & Black<br>Surgical Multi-Use | Subject Device –<br>PAL Infiltration<br>Single-Use | Subject Device –<br>PAL Infiltration Multi-Use | Comparison | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | Device Name | Liposuction<br>Aspiration and<br>Tumescent<br>Infiltration Cannulae<br>and Needles | PAL Infiltration Single<br>Use Cannulas | PAL Infiltration Multi-<br>Use Cannulas | N/A | | Device<br>Manufacturer | Black & Black<br>Surgical | MicroAire Surgical, LLC | MicroAire Surgical, LLC | N/A | | Attribute | Predicate Device #2 – Black & Black Surgical Multi-Use | Subject Device – PAL Infiltration Single-Use | Subject Device – PAL Infiltration Multi-Use | Comparison | | 510(k) Reference | K113795 | K220318 | K220318 | N/A | | FDA Product Code | QPB | QPB | QPB | Same | | FDA Classification Name | System, suction lipoplasty for removal | System, suction lipoplasty for removal | System, suction lipoplasty for removal | Same | | FDA Regulation Number | 878.5040 | 878.5040 | 878.5040 | Same | | FDA Device Class | Class II | Class II | Class II | Same | | Indications for Use | The aspiration and infusion cannulae and needles are indicated for aesthetic body contouring and general tissue aspiration. | The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring. | The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring. | Similar | | Design | Cannula tube;<br>Cannula tip;<br>Cannula hub | Cannula tube;<br>Blunt tip;<br>Cannula hub | Cannula tube;<br>Blunt tip;<br>Cannula hub | Same | | Fenestration | Multi-hole:<br>Hole Size - 1mm<br>Number of holes - 7<br>Hole Pattern - Wrap around in a spiral formation.<br>Basket:<br>Three holes equally spaced radially with remaining material flared. | Multi-hole:<br>Hole Size - 1.9mm<br>Number of Holes - 22<br>Hole Pattern - Straight Formation 11 thru holes 90 degrees apart<br>Flared Mercedes:<br>Three holes equally spaced radially with remaining material flared. | Multi-hole:<br>Hole Size - 1.9mm<br>Number of Holes - 22<br>Hole Pattern - Straight Formation 11 thru holes 90 degrees apart<br>Flared Mercedes:<br>Three holes equally spaced radially with remaining material flared. | Different | | Length | Available in 15cm, 26cm, 32cm, and 40cm lengths. | Available in 15cm, 22cm, and 30cm lengths. | Available in 15cm, 22cm, 30cm and 40cm lengths. | Similar | | Attribute | Predicate Device #2 – Black & Black Surgical Multi-Use | Subject Device – PAL Infiltration Single-Use<br>Note: No 40 cm length. | Subject Device – PAL Infiltration Multi-Use | Comparison | | Diameter | Available in 3.2mm (10 Gauge), 4mm, 5mm diameters | Available in 3mm, 4mm and 5mm diameters | Available in 3mm, 4mm and 5mm diameters | Similar | | Style | Straight | Straight | Straight | Same | | Materials | Cannula Tube – Stainless Steel<br>Cannula Hub – Stainless Steel and Aluminum | Cannula Tube – Stainless Steel<br>Cannula Hub Lexan HPS1R (polycarbonate) and Dupont Zytel ST801 (nylon) | Cannula Tube – Stainless Steel<br>Cannula Hub –Vectra MT1310 (LCP) and Dupont Zytel ST801 (nylon) and a Dowel Pin made of 410 or 416 Stainless Steel | Cannula Tube – Same<br>Cannula Hub – Different | | Function | Black and Black Surgical Cannulae and Needles are used to remove fluid, soft tissue, and exudates and for infusion, utilizing a hollow stainless-steel tube and multiple tips, handle and attachment connectors that are in reusable and disposable configuration. | The Cannula steel tube is used to provide length and strength.<br><br>The Cannula Tip is used to provide infiltration through eyelets (holes) in the tip.<br><br>The hub is used to connect to the handpiece and tubing | The Cannula steel tube is used to provide length and strength.<br><br>The Cannula Tip is used to provide infiltration through eyelets (holes) in the tip.<br><br>The hub is used to connect to the handpiece and tubing | Similar | | Sterile | Supplied non-sterile; Steam Sterilized by end user | Supplied sterile, Gamma sterilization | Supplied non-sterile; Steam Sterilized by end user | Different | | Single-Use | No | Yes | No | Different | | Complies with ISO 10993 | Yes | Yes | Yes | Same | | Attribute | Predicate Device #3:<br>Black & Black Single Spike<br>15' Large Bore Tubing | Subject Device:<br>PAL Infiltration Tubing,<br>K220318 | Comparison | | | Device Name | Single Spike 15' Large Bore<br>Tubing | PAL Infiltration Tubing | N/A | | | Device<br>Manufacturer | Black & Black | MicroAire Surgical, LLC | N/A | | | 510(k) Reference | N/A | K220318 | N/A | | | FDA Product Code | GAZ | QPB | Different | | | FDA Classification<br>Name | Tubing, Noninvasive | Suction Lipoplasty System | Different | | | FDA Regulation<br>Number | 880.6740 | 878.5040 | Different | | | FDA Device Class | Class II | Class II | Same | | | Indications for Use | The suction and irrigation<br>tubes are intended for<br>instillation or aspiration of<br>fluid to/from a targeted<br>area of the body during<br>liposuction procedures. | The PAL® Infiltration System<br>is indicated for the purpose<br>of aesthetic body contouring. | Similar | | | Design<br>Characteristics | Available in one length ~15<br>feet | Available in one length<br>~16feet | Similar | | | Design | 3-piece tubing<br>construction; one<br>peristaltic section, two<br>length sections<br>Single bag spike<br>luer connection | 3-piece tubing construction;<br>one peristaltic section, two<br>length sections<br>Single bag spike<br>No luer connection | Similar | | | Materials | Peristaltic section - Silicone | Peristaltic Section - PVC<br>Length Section – PVC<br>Bag Spike - ABS<br>Tubing Connectors - PC | Different | | | Function | The peristaltic section<br>interfaces with a peristaltic<br>pump to provide fluid flow.<br>The length sections of the<br>tubing provide connections<br>for the bag spike, tubing<br>connectors, and luer<br>connector | The peristaltic section<br>interfaces with a peristaltic<br>pump to provide fluid flow.<br>The length sections of the<br>tubing provide connections<br>for the bag spike, tubing<br>connectors, and MicroAire<br>infiltration cannula | Similar | | | Attribute | Predicate Device #3:<br>Black & Black Single Spike<br>15' Large Bore Tubing | Subject Device:<br>PAL Infiltration Tubing,<br>K220318 | Comparison | | | Sterile | Supplied Sterile<br>(Gamma Irradiation) | Supplied sterile<br>(EtO) | Similar | | | Single-Use | Yes | Yes | Same | | | Complies with ISO<br>10993 | Yes | Yes | Same | | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ## Table 5D – Comparison of Characteristics: Infiltration Tubing {11}------------------------------------------------ ### Table 5E - Comparison of Single-Use Data against Reference Device | Attribute | Reference Device:<br>INEX Lipoplasty/Liposuction<br>Aspiration and Tumescent<br>Infiltration<br>Cannulae/Needles | Subject Device:<br>MicroAire PAL Infiltration<br>Single-Use Cannula | Comparison | |------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------| | Device Name | Lipoplasty/Liposuction<br>Aspiration and Tumescent<br>Infiltration Cannulae/Needles | MicroAire PAL Infiltration<br>Single-Use Cannula | N/A | | Device<br>Manufacturer | INEX | MicroAire Surgical, LLC | N/A | | 510(k) Reference | K132353 | K220318 | N/A | | Single-Use | Yes | Yes | Same | | Supplied Sterile | Yes | Yes | Same | ### 9. Non-Clinical Performance Data To demonstrate safety and effectiveness of MicroAire PAL Infiltration System and to show substantial equivalence to the predicate device, MicroAire completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The PAL Infiltration 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: - Cytotoxicity testing per ISO 10993-5 – Passed - Sensitization and Irritation testing per ISO 10993-10 – Passed - Irritation testing per ISO 10993-10 – Passed - Pyrogenicity per USP <151> - Passed - Acute Systemic Toxicity per ISO 10993-11 - Passed - Electrical safety testing per IEC 60601-1 Passed ● - Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 - Passed - . Infiltration Pump Flow Rate - -meets internal specifications {12}------------------------------------------------ - Transportation Testing per ASTM D4169 Demonstrates package integrity maintained ● #### 10. Statement of Substantial Equivalence Based on the information provided in this submission, it is concluded that the MicroAire PAL Infiltration System has the same indications for use as the Vitruvian Infiltration System. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, MicroAire PAL Infiltration System has been determined to be substantially equivalent to Vitruvian Infiltration Pump.