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 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

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the MicroAire PAL Multi-Use Cannula and PAL Manual Wand. It asserts substantial equivalence to legally marketed predicate devices rather than proving independent acceptance criteria through a standalone study with human data.

Therefore, the study design and results typically associated with AI/ML-driven medical devices (e.g., test set sample size, expert ground truth, MRMC studies, effect sizes) are not applicable to this submission. This device is a traditional mechanical surgical instrument, not an AI/ML device.

However, I can extract information about the non-clinical performance data which serves as the "proof" that the device meets its acceptance criteria for substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria (Non-Clinical Performance) and Reported Device Performance:

Acceptance Criteria (Internal/Standard Requirements)	Reported Device Performance
Overall Design Specifications	Meets all internal requirements for design output.
Sterilization	Meets requirements 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; and FDA guidance for reprocessing medical devices dated March 17, 2015. (Note: Device is supplied non-sterile and steam sterilized by end-user, so testing confirmed ability for end-user sterilization).
Biocompatibility	Passed testing per ISO 10993-1.
Bending Strength	Meets all internal specification requirements.
Fatigue Testing	Meets all internal specification requirements.
Pullout and Force Testing	Meets all internal specification requirements.
Compression Testing	Meets all internal specification requirements.
Cleaning	Conducted per FDA guidance dated March 17, 2015.
Shelf Life Testing	Not Applicable (N/A) as the device is provided non-sterile and is intended for multiple uses with end-user sterilization.
Storage and Distribution Testing	Meets internal specification requirements.

2. Sample size used for the test set and the data provenance:

Test set sample size: Not applicable in the context of clinical data for this 510(k) submission. For the non-clinical performance tests, specific sample sizes are not explicitly stated in the summary, but standard engineering and quality control practices would apply to each test (e.g., number of units tested for bending strength, fatigue, etc.).
Data provenance: Not explicitly stated for each non-clinical test, but implied to be internal laboratory testing performed by MicroAire Surgical Instruments, LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is not an AI/ML diagnostic device requiring expert interpretation of results. The "ground truth" for the non-clinical tests is established by engineering specifications and objective measurements against those specifications.

4. Adjudication method for the test set:

Not applicable. (See #3)

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This is not an AI/ML device.

7. The type of ground truth used:

For the non-clinical performance data, the ground truth is based on engineering specifications, material science properties, and adherence to recognized national and international standards related to medical device safety and performance (e.g., ISO 10993-1 for biocompatibility, AAMI standards for sterilization).

8. The sample size for the training set:

Not applicable. There is no AI/ML training set for this device.

9. How the ground truth for the training set was established:

Not applicable. (See #8)

Summary on Substantial Equivalence Justification:

The core of this 510(k) submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices (MicroAire® PAD System Cannula, K981922, and Black&Black Surgical Inc., Aspiration and Infiltration Cannulas, K113795). The applicant asserts that the device has the same intended use, similar technological characteristics, and that the non-clinical testing confirms it does not raise any new safety or effectiveness concerns compared to the predicates. The FDA concurred with this assessment in the 510(k) clearance letter. This approach is standard for many traditional medical devices.

Summary

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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

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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

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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

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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)

|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."

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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

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.

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K171286 Table 5A - Comparison of Characteristics

Manufacturer	MicroAire Surgical Instruments, Inc.		MicroAire Surgical Instruments, Inc.		Black & BlackSurgical Inc.
Trade Name	MicroAire® PALMulti-Use Cannula	MicroAire® PALManual Wand	MicroAire® PADSystem Cannula	MicroAire® PADSystem Handpiece	Aspiration andInfiltrationCannulas
510k Number			K981922	K981922	K113795
Product Code	MUU	MUU	MUU	MUU	MUU, GEA
Indications forUse	Indicated for theremoval of tissue orfluid from the bodyduring generalsurgical procedures,including suctionLipoplasty, for thepurpose ofaesthetic bodycontouring	Indicated for theremoval of tissue orfluid from the bodyduring generalsurgical procedures,including suctionLipoplasty, for thepurpose ofaesthetic bodycontouring	For the removal oftissue or fluid fromthe body duringgeneral surgicalproceduresincluding suctionLipoplasty for thepurpose ofaesthetic bodycontouring	Indicated for theremoval of tissue orfluid from the bodyduring generalsurgical procedures,including suctionLipoplasty, for thepurpose ofaesthetic bodycontouring	The aspiration andinfusion cannulasand needles areindicated foraesthetic bodycontouring andgeneral tissueaspiration
PerformanceCharacteristics	Designed to be usedwith the PAL-730Manual WandAvailable in 2.4mm,3mm, 4mm and5mm DiametersAvailable in 15cm,22cm, 30cm and40cm Lengths	Designed to be usedwith PAL Multi-UseCannulas	Designed to be usedwith the PADpneumatic orelectricreciprocatinghandpiece whichattaches to thecannula via a hub.	Designed to be usedwith PAD Single UseCannulas	Designed to be usedwith a manualliposuctionhandpiece witheither a Luer LockHub or a SyringehubAvailable in 2mm,3mm, 4mm, 5mmand 6mm DiametersAvailable in 15cm,20cm, 26cm, 32cmand 36cm Lengths
Mechanism ofaction	The cannulas attachto the PAL-730Manual Wand andsuction tubing via acannula hub. Thistubing connects toan external suctionsource (not part ofthe PAL System).Fluid and tissue isremoved from thebody via the tubingassisted by theexternal suctionsource.	The handpieceattaches to a Multi-Use Cannula andsuction tubing via acannula hub. Thetubing connects toan external suctionsource (not part ofthe PAL System).Fluid and tissue isremoved from thebody via the suctiontubing assisted bythe external suctionsource. Thehandpiece is notpowered and doesnot reciprocate.	The cannulas attachto the PADpneumatic orelectricreciprocatinghandpiece andsuction tubing via acannula hub. Thedisposable cannulawith attachedsuction tubingconnects to anexternal suctionsource that is notpart of the PADsystem.	The handpieceattaches to thedisposable cannulaand suction tubingvia a cannula hub.The tubing connectsto an externalsuction source (notpart of the PADSystem). Thereciprocatinghandpiece drivesthe cannula througha stroke distance of2.4-6mm at a rateof 4000 strokes perminute minimum.The device ispowered by aconsole and cable	The cannulasremove fluid, softtissue and exudatesand the needlesinfusion fluid byusing a hollowstainless steel tube,multiple tips, ahandle andattachmentconnector that areused in reusableand disposableconfigurations.
	K171286
Material	Cannula iscomprised of ablunt-tipped hollowtube of 304stainless steel. TheCannula hub iscomprised of VectraMT1310 with aRelease Tab madeof Dupont ZytelST801 (nylon), and aDowel Pin made of410 or 416 StainlessSteel	Anodized aluminumand stainless steel	Cannula iscomprised of ablunt-tipped hollowtube of 304stainless steel withan attached PVCsuction tube andoptional syringe.The Cannula hub iscomprised ofPolystyrene 825with a Release Tabmade of DupontZytel ST801 (nylon)	Anodized Aluminumand Stainless Steel	Cannula andNeedles aremanufactured ofstainless steel tubeswith aluminumhandles. Thepatient-contactingmaterial is stainlesssteel
Sterile	Supplied non-sterile; SteamSterilized by enduser	Supplied non-sterile; SteamSterilized by enduser	Supplied Sterile;Gamma Irradiation	Supplied non-sterile; SteamSterilized by enduser	Supplied non-sterile; SteamSterilized by enduser
Single-Use	No	No	Yes	No	No
Shelf Life	N/A	N/A	4 years	5 years	N/A
Complies withISO 10993-1	Yes	Yes	Yes	Yes	Yes

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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)

|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.

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

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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

{11}------------------------------------------------

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)

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.

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)

{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

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).

8. Substantial Equivalence Discussion

{15}------------------------------------------------

K171286 Table 5A - Comparison of Characteristics

Manufacturer	MicroAire Surgical Instruments, Inc.		MicroAire Surgical Instruments, Inc.		Black & BlackSurgical Inc.		K171286
Trade Name	MicroAire® PALMulti-Use Cannula	MicroAire® PALManual Wand	MicroAire® PADSystem Cannula	MicroAire® PADSystem Handpiece	Aspiration andInfiltrationCannulas	Material	Cannula iscomprised of ablunt-tipped hollowtube of 304stainless steel. TheCannula hub iscomprised of VectraMT1310 with aRelease Tab madeof Dupont ZytelST801 (nylon), and aDowel Pin made of410 or 416 StainlessSteel	Anodized aluminumand stainless steel	Cannula iscomprised of ablunt-tipped hollowtube of 304stainless steel withan attached PVCsuction tube andoptional syringe.The Cannula hub iscomprised ofPolystyrene 825with a Release Tabmade of DupontZytel ST801 (nylon)	Anodized Aluminumand Stainless Steel	Cannula andNeedles aremanufactured ofstainless steel tubeswith aluminumhandles. Thepatient-contactingmaterial is stainlesssteel
510k Number	-	-	K981922	K981922	K113795	Sterile	Supplied non-sterile; SteamSterilized by enduser	Supplied non-sterile; SteamSterilized by enduser	Supplied Sterile;Gamma Irradiation	Supplied non-sterile; SteamSterilized by enduser	Supplied non-sterile; SteamSterilized by enduser
Product Code	MUU	MUU	MUU	MUU	MUU, GEA	Single-Use	No	No	Yes	No	No
Indications forUse	Indicated for theremoval of tissue orfluid from the bodyduring generalsurgical procedures,including suctionLipoplasty, for thepurpose ofaesthetic bodycontouring	Indicated for theremoval of tissue orfluid from the bodyduring generalsurgical procedures,including suctionLipoplasty, for thepurpose ofaesthetic bodycontouring	For the removal oftissue or fluid fromthe body duringgeneral surgicalproceduresincluding suctionLipoplasty for thepurpose ofaesthetic bodycontouring	Indicated for theremoval of tissue orfluid from the bodyduring generalsurgical procedures,including suctionLipoplasty, for thepurpose ofaesthetic bodycontouring	The aspiration andinfusion cannulasand needles areindicated foraesthetic bodycontouring andgeneral tissueaspiration	Shelf Life	N/A	N/A	4 years	5 years	N/A
PerformanceCharacteristics	Designed to be usedwith the PAL-730Manual WandAvailable in 2.4mm,3mm, 4mm and5mm DiametersAvailable in 15cm,22cm, 30cm and40cm Lengths	Designed to be usedwith PAL Multi-UseCannulas	Designed to be usedwith the PADpneumatic orelectricreciprocatinghandpiece whichattaches to thecannula via a hub.	Designed to be usedwith PAD Single UseCannulas	Designed to be usedwith a manualliposuctionhandpiece witheither a Luer LockHub or a SyringehubAvailable in 2mm,3mm, 4mm, 5mmand 6mm DiametersAvailable in 15cm,20cm, 26cm, 32cmand 36cm Lengths	Complies withISO 10993-1	Yes	Yes	Yes	Yes	Yes
Mechanism ofaction	The cannulas attachto the PAL-730Manual Wand andsuction tubing via acannula hub. Thistubing connects toan external suctionsource (not part ofthe PAL System).Fluid and tissue isremoved from thebody via the tubingassisted by theexternal suctionsource.	The handpieceattaches to a Multi-Use Cannula andsuction tubing via acannula hub. Thetubing connects toan external suctionsource (not part ofthe PAL System).Fluid and tissue isremoved from thebody via the suctiontubing assisted bythe external suctionsource. Thehandpiece is notpowered and doesnot reciprocate.	The cannulas attachto the PADpneumatic orelectricreciprocatinghandpiece andsuction tubing via acannula hub. Thedisposable cannulawith attachedsuction tubingconnects to anexternal suctionsource that is notpart of the PADsystem.	The handpieceattaches to thedisposable cannulaand suction tubingvia a cannula hub.The tubing connectsto an externalsuction source (notpart of the PADSystem). Thereciprocatinghandpiece drivesthe cannula througha stroke distance of2.4-6mm at a rateof 4000 strokes perminute minimum.The device ispowered by a	The cannulasremove fluid, softtissue and exudatesand the needlesinfusion fluid byusing a hollowstainless steel tube,multiple tips, ahandle andattachmentconnector that areused in reusableand disposableconfigurations.

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9. Non-Clinical Performance Data

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

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10. Clinical Performance Data

11. Conclusion Statement of Substantial Equivalence

The MicroAire® PAL Multi-Use Cannula, as designed and manufactured, is deemed to be substantially equivalent to the referenced predicate device(s).

Regulation Number and Section

§ 878.5040 Suction lipoplasty system.

(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.