Who is the manufacturer of PAL Multi-Use Cannulas and PAL Manual Wand?

Microaire Surgical Instruments, LLC filed the 510(k) submission for PAL Multi-Use Cannulas and PAL Manual Wand (K171286).

What is the FDA product code for PAL Multi-Use Cannulas and PAL Manual Wand?

QPB. It is classified under 21 CFR 878.5040 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PAL Multi-Use Cannulas and PAL Manual Wand?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PAL Multi-Use Cannulas and PAL Manual Wand?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PAL Multi-Use Cannulas and PAL Manual Wand

K171286 · Microaire Surgical Instruments, LLC · QPB · Oct 13, 2017 · General, Plastic Surgery

Device Facts

Record ID	K171286
Device Name	PAL Multi-Use Cannulas and PAL Manual Wand
Applicant	Microaire Surgical Instruments, LLC
Product Code	QPB · General, Plastic Surgery
Decision Date	Oct 13, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The MicroAire PAL Manual Wand and Multi Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

Device Story

The MicroAire PAL Multi-Use Cannula and PAL Manual Wand (PAL-730) are surgical instruments used for tissue or fluid removal during lipoplasty. The system consists of a stainless steel cannula with a plastic hub that attaches to the manual wand and connects to an external vacuum source. Unlike powered reciprocating systems, the PAL-730 is a non-powered manual handpiece. The cannulas are reusable, supplied non-sterile, and designed for steam sterilization between patients. They are available in various diameters (2.4mm–5.0mm), lengths (15cm–40cm), and distal fenestration patterns. The device is operated by a surgeon in a clinical setting. The output is the physical aspiration of tissue/fluid, which aids the surgeon in achieving aesthetic body contouring. The device benefits patients by providing a reusable, versatile tool for fat removal procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), mechanical performance testing, and sterilization validation.

Technological Characteristics

Cannula: 304 stainless steel tube, Vectra MT1310 hub, Dupont Zytel ST801 release tab, 410/416 stainless steel dowel pin. Manual Wand: Anodized aluminum and stainless steel. Non-powered, manual operation. Steam sterilization. Complies with ISO 10993-1.

Indications for Use

Indicated for removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring.

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

MicroAire Power Aspiration Device (PAD) System Cannula (K981922)

Reference Devices

Black & Black Surgical Inc. Aspiration and Infiltration Cannulas (K113795)

Related Devices

K192694 — PAL Single-Use Cannulas · Microaire Surgical Instruments · May 14, 2020
K992282 — MICRO-FRANCE LIPOSUCTION CANNULAS · Xomed, Inc. · Sep 23, 1999
K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEM · Macropore Biosurgery, Inc. · Sep 20, 2004
K081039 — LIPO CANNULA · Millennium Medical Technologies, Inc. · Jul 10, 2008
K012236 — STARS2000 POWER CANNULA · Kmi Kolster Methods, Inc. · Nov 19, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 9, 2021 MicroAire Surgical Instruments, LLC % Diane Sudduth Sr Consultant, Regulatory Barile & Associates, Inc P.O. Box 5199 Clinton, New Jersey 08809 Re: K171286 Trade/Device Name: PAL Multi-Use Cannulas and PAL Manual Wand Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB Dear Diane Sudduth: 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 October 13, 2017. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov. Sincerely, Cindy Chowdhury -S Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA 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 Department of Health and Human Services seal features an emblem with an eagle and other symbolic elements. The FDA acronym is in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font, also in blue. October 13, 2017 MicroAire Surgical Instruments, LLC % Ms. Diane Sudduth Sr Consultant, Regulatory Barile & Associates, Inc P.O. Box 5199 Clinton, New Jersey 08809 Re: K171286 Trade/Device Name: PAL Multi-Use Cannulas and PAL Manual Wand Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: September 11, 2017 Received: September 12, 2017 Dear Ms. Sudduth: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov {2}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Device Name MicroAire PAL Multi-Use Cannula and PAL-730 Manual Wand Indications for Use (Describe) The MicroAire PAL Manual Wand and Multi Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring. |X | 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." {4}------------------------------------------------ # 510(k) Summary PAL Multi-Use Cannula and PAL Manual Wand K171286 ### 1. Submission Sponsor MicroAire® Surgical Instruments, Inc. 3590 Grand Forks Boulevard Charlottesville Virginia, 22911 USA Contact: Glenn Gerstenfeld Title: Vice President, QA/RA and Compliance Officer ### 2. Submission Correspondent Barile & Associates, Inc. PO Box 5199 Clinton, NJ 08809 Office Phone: (561) 305-5075 Contact: Diane Sudduth Title: Senior Consultant, RA ### 3. Date Prepared April 28, 2017 ### 4. Device Identification | Trade/Proprietary Name: | PAL Multi-Use Cannula and PAL Manual Wand | |-------------------------|-------------------------------------------| | Common/Usual Name: | Cannula and wand or handpiece | | Classification Name: | Suction Lipoplasty system | | Regulation Number: | 21 CFR 878.5040 | | Product Code: | MUU | | Device Class: | Class II | | Classification Panel: | GENERAL AND PLASTIC SURGERY DEVICES | #### 5. Legally Marketed Predicate Device(s) Predicate Device: K981922, MicroAire® "Power Aspiration Device" PAD System Cannula, Classification Name: Suction Lipoplasty System Regulation Number: 21 CFR 878.5040 Product Code: MUU Classification: Class II {5}------------------------------------------------ Reference Device #1: K113795, Black& Black Surgical Inc., Aspiration and Infiltration Cannulas Classification Name: Suction Lipoplasty System, Regulation Number: 21 CFR 878.5040 Product Code: MUU Classification: Class II ## 6. Indication for Use Statement The MicroAire® PAL Manual Wand and Multi-Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures including suction Lipoplasty for the purpose of aesthetic body contouring ## 7. Device Description The MicroAire® PAL liposuction family of instruments is indicated for use for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty for the purpose of aesthetic body contouring. The MicroAire® PAL Multi-Use Cannula consists of a stainless steel cannula with a plastic hub which attaches to the MicroAire® PAL-730 Manual Wand and has a connection for standard vacuum (suction) tubing. The MicroAire® Multi-Use Cannula is supplied non-sterilized by the user, and may be steam sterilized for use on subsequent patients. The Multi-Use Cannula are offered in various diameters (2.4mm, 4.0mm and 5.0mm diameters), lengths (15cm, 30cm and 40 cm) and with various types of distal fenestrations (Mercedes, Flared Mercedes, Double Mercedes, Offset Double Mercedes, Tri-Port II, Mirrored Tri-Port III, Tri-Port III, Helixed Tri-Port III, Multi-Hole, Del Vecchio Track-12). The MicroAire® PAL Manual Wand (PAL-730) is indicated for use in the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty for the purpose of aesthetic body contouring. The MicroAire® PAL Multi-Use Cannulas are supplied non-sterilized by the user prior to use, and may be steam sterilized for use on subsequent patients ### 8. Substantial Equivalence Discussion The following table compares the characteristics of the MicroAire® PAL Multi-Use of the predicate device MicroAire® PAD System Cannula with respect to indications for use, principles of operation, technological characteristics, materials and performance testing. The comparison of the devices provides more detailed information 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. Below is a portion of the comparison of devices. {6}------------------------------------------------ K171286 Table 5A - Comparison of Characteristics | Manufacturer | MicroAire Surgical Instruments, Inc. | | MicroAire Surgical Instruments, Inc. | | Black & Black Surgical Inc. | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | MicroAire® PAL Multi-Use Cannula | MicroAire® PAL Manual Wand | MicroAire® PAD System Cannula | MicroAire® PAD System Handpiece | Aspiration and Infiltration Cannulas | | 510k Number | | | K981922 | K981922 | K113795 | | Product Code | MUU | MUU | MUU | MUU | MUU, GEA | | Indications for Use | Indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty, for the purpose of aesthetic body contouring | Indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty, for the purpose of aesthetic body contouring | For the removal of tissue or fluid from the body during general surgical procedures including suction Lipoplasty for the purpose of aesthetic body contouring | Indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty, for the purpose of aesthetic body contouring | The aspiration and infusion cannulas and needles are indicated for aesthetic body contouring and general tissue aspiration | | Performance Characteristics | Designed to be used with the PAL-730 Manual Wand Available in 2.4mm, 3mm, 4mm and 5mm Diameters Available in 15cm, 22cm, 30cm and 40cm Lengths | Designed to be used with PAL Multi-Use Cannulas | Designed to be used with the PAD pneumatic or electric reciprocating handpiece which attaches to the cannula via a hub. | Designed to be used with PAD Single Use Cannulas | Designed to be used with a manual liposuction handpiece with either a Luer Lock Hub or a Syringe hub Available in 2mm, 3mm, 4mm, 5mm and 6mm Diameters Available in 15cm, 20cm, 26cm, 32cm and 36cm Lengths | | Mechanism of action | The cannulas attach to the PAL-730 Manual Wand and suction tubing via a cannula hub. This tubing connects to an external suction source (not part of the PAL System). Fluid and tissue is removed from the body via the tubing assisted by the external suction source. | The handpiece attaches to a Multi- Use Cannula and suction tubing via a cannula hub. The tubing connects to an external suction source (not part of the PAL System). Fluid and tissue is removed from the body via the suction tubing assisted by the external suction source. The handpiece is not powered and does not reciprocate. | The cannulas attach to the PAD pneumatic or electric reciprocating handpiece and suction tubing via a cannula hub. The disposable cannula with attached suction tubing connects to an external suction source that is not part of the PAD system. | The handpiece attaches to the disposable cannula and suction tubing via a cannula hub. The tubing connects to an external suction source (not part of the PAD System). The reciprocating handpiece drives the cannula through a stroke distance of 2.4-6mm at a rate of 4000 strokes per minute minimum. The device is powered by a console and cable | The cannulas remove fluid, soft tissue and exudates and the needles infusion fluid by using a hollow stainless steel tube, multiple tips, a handle and attachment connector that are used in reusable and disposable configurations. | | | K171286 | | | | | | Material | Cannula is comprised of a blunt-tipped hollow tube of 304 stainless steel. The Cannula hub is comprised of Vectra MT1310 with a Release Tab made of Dupont Zytel ST801 (nylon), and a Dowel Pin made of 410 or 416 Stainless Steel | Anodized aluminum and stainless steel | Cannula is comprised of a blunt-tipped hollow tube of 304 stainless steel with an attached PVC suction tube and optional syringe. The Cannula hub is comprised of Polystyrene 825 with a Release Tab made of Dupont Zytel ST801 (nylon) | Anodized Aluminum and Stainless Steel | Cannula and Needles are manufactured of stainless steel tubes with aluminum handles. The patient-contacting material is stainless steel | | Sterile | Supplied non- sterile; Steam Sterilized by end user | Supplied non- sterile; Steam Sterilized by end user | Supplied Sterile; Gamma Irradiation | Supplied non- sterile; Steam Sterilized by end user | Supplied non- sterile; Steam Sterilized by end user | | Single-Use | No | No | Yes | No | No | | Shelf Life | N/A | N/A | 4 years | 5 years | N/A | | Complies with ISO 10993-1 | Yes | Yes | Yes | Yes | Yes | {7}------------------------------------------------ ### 9. Non-Clinical Performance Data As part of demonstrating the safety and effectiveness of MicroAire® PAL Multi-Use Cannula and in showing substantial equivalence, MicroAire completed a number of non-clinical performance tests. The PAL Multi-Use Cannula meets all the requirements for overall design, sterilization and biocompatibility results confirming that the design output meets the design input and specifications for the device. The MicroAire® PAL Multi-Use Cannula and Pal Manual Wand passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device: - . Biocompatibility testing per ISO 10993-1 - Bending Strength - meets all internal specification requirements, see Section 18 - Fatigue Testing - meets all internal specification requirements, see Section 18 - Pullout and Force Testing – meets all internal specification requirements, see Section 18 - Compression Testing - meets all internal specification requirements, see Section 18 - Cleaning - conducted per FDA guidance dated March 17, 2015 - Sterilization - conducted per AAMI TIR12:2010; ANSI/AAMI/ISO 17665-1: 2006 (EN ISO 17665-1: 2006); ANSI/AAMI ST79:2010/A1:2010/A2:2011/A3:2012/A4:2013/®2014; FDA guidance for reprocessing medical devices dated March 17, 2015. - Shelf Life Testing - N/A (device provided non-sterile); see Section 14 - Storage and Distribution Testing meets internal specification requirements, See Section 14 ● {8}------------------------------------------------ ### 10. 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. ### 11. Conclusion Statement of Substantial Equivalence MicroAire® PAL Multi-Use Cannula and is substantially equivalent to predicate devices MicroAire® PAD system Cannula + Handpiece, as well as the Black Aspiration Cannulas wherein the device has the same intended use to the predicate even with slightly different design characteristics, the new device does not raise additional questions regarding safety and effectiveness as compared to the predicate device(s). The testing completed support this claim. The MicroAire® PAL Multi-Use Cannula, as designed and manufactured, is deemed to be substantially equivalent to the referenced predicate device(s). {9}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Device Name MicroAire PAL Multi-Use Cannula and PAL-730 Manual Wand Indications for Use (Describe) The MicroAire PAL Manual Wand and Multi Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring. |X | 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." {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION". October 13, 2017 MicroAire Surgical Instruments, LLC % Ms. Diane Sudduth Sr Consultant, Regulatory Barile & Associates. Inc P.O. Box 5199 Clinton, New Jersey 08809 Re: K171286 Trade/Device Name: PAL Multi-Use Cannulas and PAL Manual Wand Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: September 11, 2017 Received: September 12, 2017 Dear Ms. Sudduth: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {11}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {12}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Device Name MicroAire PAL Multi-Use Cannula and PAL-730 Manual Wand Indications for Use (Describe) The MicroAire PAL Manual Wand and Multi Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of 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) ### 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." {13}------------------------------------------------ # 510(k) Summary PAL Multi-Use Cannula and PAL Manual Wand K171286 ### 1. Submission Sponsor MicroAire® Surgical Instruments, Inc. 3590 Grand Forks Boulevard Charlottesville Virginia, 22911 USA Contact: Glenn Gerstenfeld Title: Vice President, QA/RA and Compliance Officer ### 2. Submission Correspondent Barile & Associates, Inc. PO Box 5199 Clinton, NJ 08809 Office Phone: (561) 305-5075 Contact: Diane Sudduth Title: Senior Consultant, RA ### 3. Date Prepared April 28, 2017 ### 4. Device Identification | Trade/Proprietary Name: | PAL Multi-Use Cannula and PAL Manual Wand | |-------------------------|-------------------------------------------| | Common/Usual Name: | Cannula and wand or handpiece | | Classification Name: | Suction Lipoplasty system | | Regulation Number: | 21 CFR 878.5040 | | Product Code: | MUU | | Device Class: | Class II | | Classification Panel: | GENERAL AND PLASTIC SURGERY DEVICES | ### 5. Legally Marketed Predicate Device(s) Predicate Device: K981922, MicroAire® "Power Aspiration Device" PAD System Cannula, Classification Name: Suction Lipoplasty System Regulation Number: 21 CFR 878.5040 Product Code: MUU Classification: Class II {14}------------------------------------------------ Reference Device #1: K113795, Black& Black Surgical Inc., Aspiration and Infiltration Cannulas Classification Name: Suction Lipoplasty System, Regulation Number: 21 CFR 878.5040 Product Code: MUU Classification: Class II # 6. Indication for Use Statement The MicroAire® PAL Manual Wand and Multi-Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures including suction Lipoplasty for the purpose of aesthetic body contouring # 7. Device Description The MicroAire® PAL liposuction family of indicated for use for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty for the purpose of aesthetic body contouring. The MicroAire® PAL Multi-Use Cannula consists of a stainless steel cannula with a plastic hub which attaches to the MicroAire® PAL-730 Manual Wand and has a connection for standard vacuum (suction) tubing. The MicroAire® Multi-Use Cannula is supplied non-sterilized by the user, and may be steam sterilized for use on subsequent patients. The Multi-Use Cannula are offered in various diameters (2.4mm, 4.0mm and 5.0mm diameters), lengths (15cm, 30cm and 40 cm) and with various types of distal fenestrations (Mercedes, Flared Mercedes, Double Mercedes, Offset Double Mercedes, Tri-Port II, Mirrored Tri-Port II, Tri-Port III, Helixed Tri-Port III, Multi-Hole, Del Vecchio Track-12). The MicroAire® PAL Manual Wand (PAL-730) is indicated for use in the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty for the purpose of aesthetic body contouring. The MicroAire® PAL Multi-Use Cannulas are supplied non-sterilized by the user prior to use, and may be steam sterilized for use on subsequent patients # 8. Substantial Equivalence Discussion The following table compares the characteristics of the MicroAire® PAL Multi-Use of the predicate device MicroAire® PAD System Cannula with respect to indications for use, principles of operation, technological characteristics, materials and performance testing. The comparison of the devices provides more detailed information 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. Below is a portion of the comparison of devices. {15}------------------------------------------------ K171286 Table 5A - Comparison of Characteristics | Manufacturer | MicroAire Surgical Instruments, Inc. | | MicroAire Surgical Instruments, Inc. | | Black & Black Surgical Inc. | | K171286 | | | | | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | MicroAire® PAL Multi-Use Cannula | MicroAire® PAL Manual Wand | MicroAire® PAD System Cannula | MicroAire® PAD System Handpiece | Aspiration and Infiltration Cannulas | Material | Cannula is comprised of a blunt-tipped hollow tube of 304 stainless steel. The Cannula hub is comprised of Vectra MT1310 with a Release Tab made of Dupont Zytel ST801 (nylon), and a Dowel Pin made of 410 or 416 Stainless Steel | Anodized aluminum and stainless steel | Cannula is comprised of a blunt-tipped hollow tube of 304 stainless steel with an attached PVC suction tube and optional syringe. The Cannula hub is comprised of Polystyrene 825 with a Release Tab made of Dupont Zytel ST801 (nylon) | Anodized Aluminum and Stainless Steel | Cannula and Needles are manufactured of stainless steel tubes with aluminum handles. The patient-contacting material is stainless steel | | 510k Number | - | - | K981922 | K981922 | K113795 | Sterile | Supplied non- sterile; Steam Sterilized by end user | Supplied non- sterile; Steam Sterilized by end user | Supplied Sterile; Gamma Irradiation | Supplied non- sterile; Steam Sterilized by end user | Supplied non- sterile; Steam Sterilized by end user | | Product Code | MUU | MUU | MUU | MUU | MUU, GEA | Single-Use | No | No | Yes | No | No | | Indications for Use | Indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty, for the purpose of aesthetic body contouring | Indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty, for the purpose of aesthetic body contouring | For the removal of tissue or fluid from the body during general surgical procedures including suction Lipoplasty for the purpose of aesthetic body contouring | Indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty, for the purpose of aesthetic body contouring | The aspiration and infusion cannulas and needles are indicated for aesthetic body contouring and general tissue aspiration | Shelf Life | N/A | N/A | 4 years | 5 years | N/A | | Performance Characteristics | Designed to be used with the PAL-730 Manual Wand Available in 2.4mm, 3mm, 4mm and 5mm Diameters Available in 15cm, 22cm, 30cm and 40cm Lengths | Designed to be used with PAL Multi-Use Cannulas | Designed to be used with the PAD pneumatic or electric reciprocating handpiece which attaches to the cannula via a hub. | Designed to be used with PAD Single Use Cannulas | Designed to be used with a manual liposuction handpiece with either a Luer Lock Hub or a Syringe hub Available in 2mm, 3mm, 4mm, 5mm and 6mm Diameters Available in 15cm, 20cm, 26cm, 32cm and 36cm Lengths | Complies with ISO 10993-1 | Yes | Yes | Yes | Yes | Yes | | Mechanism of action | The cannulas attach to the PAL-730 Manual Wand and suction tubing via a cannula hub. This tubing connects to an external suction source (not part of the PAL System). Fluid and tissue is removed from the body via the tubing assisted by the external suction source. | The handpiece attaches to a Multi- Use Cannula and suction tubing via a cannula hub. The tubing connects to an external suction source (not part of the PAL System). Fluid and tissue is removed from the body via the suction tubing assisted by the external suction source. The handpiece is not powered and does not reciprocate. | The cannulas attach to the PAD pneumatic or electric reciprocating handpiece and suction tubing via a cannula hub. The disposable cannula with attached suction tubing connects to an external suction source that is not part of the PAD system. | The handpiece attaches to the disposable cannula and suction tubing via a cannula hub. The tubing connects to an external suction source (not part of the PAD System). The reciprocating handpiece drives the cannula through a stroke distance of 2.4-6mm at a rate of 4000 strokes per minute minimum. The device is powered by a | The cannulas remove fluid, soft tissue and exudates and the needles infusion fluid by using a hollow stainless steel tube, multiple tips, a handle and attachment connector that are used in reusable and disposable configurations. | | | | | | | {16}------------------------------------------------ ### 9. Non-Clinical Performance Data As part of demonstrating the safety and effectiveness of MicroAire® PAL Multi-Use Cannula and in showing substantial equivalence, MicroAire completed a number of non-clinical performance tests. The PAL Multi-Use Cannula meets all the requirements for overall design, sterilization and biocompatibility results confirming that the design output meets the design input and specifications for the device. The MicroAire® PAL Multi-Use Cannula and Pal Manual Wand passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device: - Biocompatibility testing per ISO 10993-1 - . Bending Strength - meets all internal specification requirements, see Section 18 - Fatigue Testing – meets all internal specification requirements, see Section 18 - Pullout and Force Testing - meets all internal specification requirements, see Section 18 - Compression Testing - meets all internal specification requirements, see Section 18 - Cleaning - conducted per FDA guidance dated March 17, 2015 - Sterilization - conducted per AAMI TIR12:2010; ANSI/AAMI/ISO 17665-1: 2006 (EN ISO 17665-1: 2006); ANSI/AAMI ST79:2010/A1:2010/A2:2011/A3:2012/A4:2013/®2014; FDA guidance for reprocessing medical devices dated March 17, 2015. - Shelf Life Testing - N/A (device provided non-sterile); see Section 14 - Storage and Distribution Testing - meets internal specification requirements, See Section 14 {17}------------------------------------------------ ### 10. 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. ## 11. Conclusion Statement of Substantial Equivalence MicroAire® PAL Multi-Use Cannula and is substantially equivalent to predicate devices MicroAire® PAD system Cannula + Handpiece, as well as the Black Aspiration Cannulas wherein the device has the same intended use to the predicate even with slightly different design characteristics, the new device does not raise additional questions regarding safety and effectiveness as compared to the predicate device(s). The testing completed support this claim. The MicroAire® PAL Multi-Use Cannula, as designed and manufactured, is deemed to be substantially equivalent to the referenced predicate device(s).