MicroAire® PAL® Single-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 intended to be used 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 Single-Use Cannulas consists of stainless-steel cannula with a plastic hub which attaches to the MicroAire® PAL-730 Manual Wand and has a connection for a standard vacuum (suction) tubing. The MicroAire® Single-Use Cannulas are supplied sterile by the manufacturer through a validated gamma irradiation process. The Single-Use Cannula are offered in various diameters (2.4, 3.0, 4 and 5.0mm diameters), lengths (15, 22, and 30 cm) and with various types of distal fenestrations (Single Port, Mercedes, Bent Flared Mercedes, Double Mercedes, Bent Mercedes, Tri-Port III, Helixed Tri-Port III, Spatula, Multi-Hole, Del Vecchio Track-12).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (PAL Single-Use Cannulas) and does not describe acceptance criteria, a study proving the device meets those criteria, or any information related to AI/ML performance.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

Indications for Use
Principles of Operation
Technological Characteristics
Performance Testing (non-clinical)

Therefore, I cannot provide the requested information. The text does not contain:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for test sets.
Number or qualifications of experts for ground truth.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study information.
Standalone (algorithm only) performance data.
Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

The "Non-Clinical Performance Data" section (point 9 in the K192694 summary) lists various engineering and biocompatibility tests performed (e.g., Sterilization validation, Biocompatibility testing, Mechanical Tensile Testing, Air leakage and tubing connection force test, Vacuum pressure testing, Transportation Testing). These tests have "specifications" or demonstrate compliance (e.g., "Met specifications," "PASSED," "demonstrates SAL of 10^-6"), but these are not the "acceptance criteria" for an AI/ML system's diagnostic performance as implied by your request. They are engineering and safety performance criteria for a physical medical device.

Summary

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MicroAire Surgical Instruments % Diane Sudduth Sr. Consultant, Regulatory Barile & Associates, Inc. PO Box 5199 Clinton, New Jersey 08809

June 9, 2021

Re: K192694

Trade/Device Name: PAL Single-Use Cannulas 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 May 14, 2020. 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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May 14, 2020

MicroAire Surgical Instruments % Diane Sudduth Sr. Consultant, Regulatory Barile & Associates, Inc. PO Box 5199 Clinton, New Jersey 08809

Re: K192694

Trade/Device Name: PAL Single-Use Cannulas Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: April 6, 2020 Received: April 8, 2020

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. 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 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

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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 (QS) 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.

Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192694

Device Name MicroAire® PAL® Single-Use Cannulas

Indications for Use (Describe)

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)

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510K Summary

PAL® Single-Use Cannulas K 192694

1. Submission Sponsor

MicroAire Surgical Instruments 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 USA Office Phone: (434) 975-8344 Email: glenn.gerstenfeld@microaire.com 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 Email: drsudduth05@gmail.com Contact: Diane Sudduth, Ph.D. Title: Senior Consultant, RA

3. Date Prepared

September 20, 2019 (amended April 21, 2020)

4. Device Identification

Trade/Proprietary Name:	PAL® Single-Use Cannulas
Common/Usual Name:	Cannula
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

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5. Legally Marketed Predicate Device(s)

Predicate Device:	K171286, MicroAire® PAL System, Multi-Use Cannula
Classification Name:	Suction Lipoplasty System
Regulation Number:	21 CFR 878.5040
Product Code:	MUU
Classification:	Class II
Reference 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

6. Indication for Use Statement

The MicroAire PAL Single-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 MicroAire PAL Single-Use Cannulas to the predicate device MicroAire PAL Multi-Use Cannulas and the reference device MicroAire PAD System Cannula with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

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Manufacturer	MicroAire Surgical Instruments		Comparison
Trade Name	MicroAire PAL Single-UseCannula	MicroAire PAL Multi-UseCannula
510k Number	K192694	K171286	N/A
Product Code	MUU	MUU	Same
RegulationNumber	21 CFR 878.5040	21 CFR 878.5040	Same
Regulation Name	Suction Lipoplasty System	Suction Lipoplasty System	Same
Indications forUse	Indicated for the removal oftissue or fluid from the bodyduring general surgicalprocedures, including suctionLipoplasty, for the purpose ofaesthetic body contouring	Indicated for the removal oftissue or fluid from the bodyduring general surgicalprocedures, including suctionLipoplasty, for the purpose ofaesthetic body contouring	Same
PerformanceCharacteristics	• Designed to be used withthe PAL-730 Manual Wand• Available in 2.4mm, 3mm,4mm and 5mm Diameters• Available in 15cm, 22cm,and 30cm Lengths	• Designed to be used withthe PAL-730 Manual Wand• Available in 2.4mm, 3mm,4mm and 5mm Diameters• Available in 15cm, 22cm,30cm and 40cm Lengths	Similar; multi-useavailable in 40cmlength
AvailableFenestrationtypes	Single Port, Mercedes, FlaredMercedes, Double Mercedes,Tri-port II, Mirrored Tri-port,Tri-port III, Spatula, Track-12,Helixed Tri-Port, Spatula,Multi-Hole, Bent Mercedes,Bent Flared Mercedes	Mercedes, Flared Mercedes,Double Mercedes, Tri-port II,Mirrored Tri-port, Tri-port III,Spatula, Track-12, Helixed Tri-Port, Multi-Hole, BentMercedes, Bent FlaredMercedes	Similar; single-useavailable in singleport and spatulafenestration type
Function	Used for removal of tissue orfluid from the body duringgeneral surgical proceduresincluding suction Lipoplastyfor the purpose of aestheticbody contouring	Used for removal of tissue orfluid from the body duringgeneral surgical proceduresincluding suction Lipoplastyfor the purpose of aestheticbody contouring	Same
Mechanism ofaction	The cannulas attach to thePAL-730 Manual Wand andsuction tubing via a cannulahub. This tubing connects toan external suction source(not part of the PAL System).	The cannulas attach to thePAL-730 Manual Wand andsuction tubing via a cannulahub. This tubing connects toan external suction source(not part of the PAL System).	Same

			Table 5A - Comparison of Characteristics with Predicate Device
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Manufacturer	MicroAire Surgical Instruments		Comparison
Trade Name	MicroAire PAL Single-UseCannula	MicroAire PAL Multi-UseCannula
	Fluid and tissue are removedfrom the body via the tubingassisted by the externalsuction source. Thehandpiece is not poweredand does not reciprocate.	Fluid and tissue are removedfrom the body via the tubingassisted by the externalsuction source. Thehandpiece is not poweredand does not reciprocate.
Material	Cannula is a blunt tippedhollow tube comprised of 304stainless steel. Cannula Hubis comprised of a ReleaseTab, made of Dupont ZytelST801 (nylon), a turbo plugmade of Silicon 70 Blue, USPClass VI, and the hub itselfmade of Polystyrene 825bonded together withcyanoacrylate adhesive	Cannula is a blunt tippedhollow tube comprised of 304stainless steel. Cannula Hubis comprised of a ReleaseTab, made of Dupont ZytelST801 (nylon), a Dowel Pin,made of 410 or 416 or 18-8Stainless Steel, and the hubitself made of Vectra MT1310bonded together withcyanoacrylate adhesive	Similar; hub materialis polystyrene vs.Vectra MT1310
Sterile	Supplied Sterile; GammaIrradiation	Supplied non-sterile; SteamSterilized by end user	Different; single-useis supplied gammasterilized
Single-Use	Yes	No	Different
Shelf Life	1 year	N/A	Different
Complies withISO 10993-1	Yes	Yes	Same

Table 5B – Comparison of Characteristics with Reference Device

Manufacturer	MicroAire Surgical Instruments		Comparison
Trade Name	MicroAire PAL Single-UseCannula	MicroAire PAD SystemCannula
510k Number	K192694	K981922	N/A
Product Code	MUU	MUU	Same
RegulationNumber	21 CFR 878.5040	21 CFR 878.5040	Same
Regulation Name	Suction Lipoplasty System	Suction Lipoplasty System	Same
Manufacturer	MicroAire Surgical Instruments		Comparison
Trade Name	MicroAire PAL Single-UseCannula	MicroAire PAD SystemCannula
Indications forUse	Indicated for the removal oftissue or fluid from the bodyduring general surgicalprocedures, including suctionlipoplasty, for the purpose ofaesthetic body contouring	For the removal of tissue orfluid from the body duringgeneral surgical procedures,including suction lipoplasty,for the purpose of aestheticbody contouring	same
Function	Used for removal of tissue orfluid from the body duringgeneral surgical proceduresincluding suction lipoplastyfor the purpose of aestheticbody contouring	Used for removal of tissue orfluid from the body duringgeneral surgical proceduresincluding suction lipoplastyfor the purpose of aestheticbody contouring	Same
Material	Cannula is a blunt tippedhollow tube comprised of 304stainless steel. Cannula Hubis comprised of a ReleaseTab, made of Dupont ZytelST801 (nylon), a turbo plugmade of Silicon 70 Blue, USPClass VI, and the hub itselfmade of Polystyrene 825bonded together withcyanoacrylate adhesive	Cannula is a blunt tippedhollow tube comprised of 304stainless steel with anattached PVC suction tubeand optional syringe. Thecannula hub is comprised of aRelease Tab, made of DupontZytel ST801 (nylon) and thehub is made of Polystyrene825.	same
Sterile	Supplied Sterile; GammaIrradiation	Supplied sterile; gammairradiation	same
Single-Use	Yes	Yes	Same
Shelf Life	1 year	4 years	Similar; testing isongoing to support a4-year shelf life forthe Single-UseCannula, however,was not available atthe time ofsubmission
Complies withISO 10993-1	Yes	Yes	Same

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The PAL Single-Use Cannulas share the same indications for use, and same or similar device operation, overall technical and functional capabilities, and therefore are substantially equivalent to the predicate and reference devices. The PAL Single-Use Cannulas are similar in design and function to

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the predicate and reference devices for the modes of operation and use. The PAL Single-Use Cannulas share the same indications for use, and same or similar device operation, overall technical and functional capabilities, and follow those of the reference device. The PAL Single-Use Cannula is sterilized by gamma irradiation, equal to the reference device.

9. Non-Clinical Performance Data

The following tests were performed to demonstrate that the proposed MicroAire PAL Single-Use Cannulas met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.

. Sterilization validation per ISO 11137 - demonstrates SAL of 10°
. Biocompatibility testing – Cytotoxicity, Sensitization, Irritation, per ISO 10993 - PASSED

In addition to the guidance and standards testing, the following testing was performed:

. Mechanical Tensile Testing (fatigue, axial strength, pullout force, pushout force, bend) – Met specifications
Air leakage and tubing connection force test - Met specifications
Vacuum pressure testing - Met specification
Transportation Testing per ASTM D4169 – demonstrates package integrity maintained

10. Statement of Substantial Equivalence – Conclusions Drawn

The MicroAire PAL® Single-Use Cannulas, as designed and manufactured, are determined to be substantially equivalent to the predicate and reference devices. Nonclinical testing demonstrates the subject device is substantially equivalent to the legally marked predicate and reference devices.

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.