(253 days)
No
The description focuses on a peristaltic pump and mechanical components for infiltration, with no mention of AI or ML capabilities.
Yes
The device is clearly indicated for "aesthetic body contouring," which is a therapeutic purpose aiming to improve a patient's physical appearance.
No
The device description and intended use clearly state that the system is for aesthetic body contouring and infiltration, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a peristaltic Infiltration Pump, tubing, cannulas, cables, and a foot switch.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aesthetic body contouring." This is a procedure performed on the human body, not on samples taken from the body.
- Device Description: The device is described as a "peristaltic Infiltration Pump" used in conjunction with a "PAL Handpiece" and "Infiltration Cannulas." These are tools used for surgical procedures, not for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to infiltrate fluid into the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring.
Product codes (comma separated list FDA assigned to the subject device)
QPB
Device Description
The MicroAire® Power Assisted Liposuction (PAL®) Infiltration System is a medical device intended for aesthetic body contouring. The PAL Infiltration System is a stand-alone peristaltic Infiltration Pump, with the ability to control ON/OFF function to the PAL Handpiece (sold separately), the Infiltration Pump, or a Foot Switch (INF-FOOT-1) depending on the doctor's preference.
The PAL® Infiltration System is comprised of the following components that are subject to this 510K:
- INF-PUMP PAL Infiltration Pump
- Accessories
- o PAL-INF-1600 Infiltration Tubing
- o PAL-INF-XXXXX Single-Use Infiltration Cannulas
- o PAL-INF-RXXXXX Multi-Use Infiltration Cannula
- o INF-CBL-5020, Infiltration Pump to 5020 Console Connector Cable
- o INF-FOOT-1, Infiltration Foot Switch
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate safety and effectiveness of MicroAire PAL Infiltration System and to show substantial equivalence to the predicate device, MicroAire completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The PAL Infiltration System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
- Cytotoxicity testing per ISO 10993-5 – Passed
- Sensitization and Irritation testing per ISO 10993-10 – Passed
- Irritation testing per ISO 10993-10 – Passed
- Pyrogenicity per USP - Passed
- Acute Systemic Toxicity per ISO 10993-11 - Passed
- Electrical safety testing per IEC 60601-1 Passed
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 - Passed
- Infiltration Pump Flow Rate - -meets internal specifications
- Transportation Testing per ASTM D4169 Demonstrates package integrity maintained
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K991437, K212024, K192694, K171286, K220674, K132353
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
10/14/2022
MicroAire Surgical Instruments, LLC Glenn Gerstenfeld Vice President, OA/RA and Compliance Officer 3590 Grand Forks Blvd Charlottesville, Virginia 22911
Re: K220318
Trade/Device Name: PAL Infiltration System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: QPB Dated: June 19, 2022 Received: June 21, 2022
Dear Glenn Gerstenfeld:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Deborah Fellhauer RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K220318
Device Name MicroAire PAL Infiltration System
Indications for Use (Describe)
The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
MicroAire PAL Infiltration System
1. Submission Sponsor
MicroAire Surgical Instruments, LLC. 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 USA Glenn Gerstenfeld Vice President, QA/RA, and Compliance Officer Glenn.gerstenfeld@microaire.com Phone: (434) 975-8344 Fax: (434) 975-4144
2. Submission Correspondent
Glenn Gerstenfeld Vice President, QA/RA and Compliance Officer MicroAire® Surgical Instruments, LLC Phone: (434) 975-8344 Fax: (434) 975-4144 Email: Glenn.gerstenfeld@microaire.com
3. Date Prepared
10/13/2022
4. Device Identification
| Trade/Proprietary Name: | PAL® Infiltration System |
|---|---|
| Common/Usual Name: | Infiltration System |
| Classification Name: | Suction Lipoplasty System |
| Regulation Number: | 21 CFR 878.5040 |
| Product Code: | QPB |
| Class: | II |
| Classification Panel: | General and Plastic Surgery Devices |
5. Legally Marketed Predicate Device(s)
Device name: Vitruvian Infiltration Pump 510(k) number: K170629 Manufacturer: Black & Black Surgical, Inc.
4
Device name: Liposuction Aspiration and Tumescent Infiltration Cannulae and Needles 510(k) number: K113795 Manufacturer: Black & Black Surgical
Device name: Single Spike 15' Large Bore Tubing 510(k) number: N/A – 510K exempt Manufacturer: Black & Black Surgical
Reference Devices:
Device name: Wells Johnson Infusion System, Mode 20-6000-00 510(k) number: K991437 Manufacturer: Wells Johnson Co.
Device name: PAL System 510(k) number: K212024 Manufacturer: MicroAire Surgical Instruments, LLC
Device name: PAL Single-Use Cannulas 510(k) number: K192694 Manufacturer: MicroAire Surgical Instruments, LLC
Device name: PAL Multi-Use Cannulas and PAL Manual Wand 510(k) number: K171286 Manufacturer: MicroAire Surgical Instruments, LLC
Device name: MicroAire LipoFilter System 510(k) number: BK220674 Manufacturer: MicroAire Surgical Instruments, LLC
Device name: INEX Lipoplasty/Liposuction and Tumescent Infiltration Cannulae/Needles 510(k) number: K132353 Manufacturer: INEX
6. Indications for Use Statement
The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring.
7. Device Description
The MicroAire® Power Assisted Liposuction (PAL®) Infiltration System is a medical device intended for aesthetic body contouring. The PAL Infiltration System is a stand-alone peristaltic Infiltration Pump, with the ability to control ON/OFF function to the PAL Handpiece (sold separately), the Infiltration Pump, or a Foot Switch (INF-FOOT-1) depending on the doctor's preference.
Page 2 of 10 K220318
5
The PAL® Infiltration System is comprised of the following components that are subject to this 510K:
- INF-PUMP PAL Infiltration Pump
- Accessories
- o PAL-INF-1600 Infiltration Tubing
- o PAL-INF-XXXXX Single-Use Infiltration Cannulas
- o PAL-INF-RXXXXX Multi-Use Infiltration Cannula
- o INF-CBL-5020, Infiltration Pump to 5020 Console Connector Cable
- o INF-FOOT-1, Infiltration Foot Switch
8. Substantial Equivalence Discussion
The following table compares the subject device to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The minor differences in the subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /
510(k) HOLDER | Comparison |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K220318 | K170629 | N/A |
| Product Code | QPB | QPB | N/A |
| Regulation Number | 878.5040 | 878.5040 | N/A |
| Indications For Use | The PAL® Infiltration
System is indicated for
the purpose of aesthetic
body contouring. | The Vitruvian Infiltration
Pump is intended to be
used for: Aesthetic Body
Contouring | Same |
| Mechanism of Operation | | | |
| Pump type | Peristaltic | Peristaltic | Same |
| Maximum flow rate | 630 mL/min – with HK
Surgical ITS-10 tubing
1300 mL/min – with
MicroAire PAL
Infiltration Tubing PAL-
INF-1600 | 475 mL/min*
999 mL/min** | Different; The flow
rate is determined by
the peristaltic pump
geometry and speed
as well as the inner
diameter of the
section of tubing
which is placed inside
of the pump.
Lower flow rates can
be achieved using the
Subject Device if a
smaller diameter
tubing is connected. |
| Table 5A - Comparison of Characteristics for Pump | ||
|---|---|---|
| -- | --------------------------------------------------- | -- |
6
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /
510(k) HOLDER | Comparison K2203 |
|-------------------------------------|---------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Housing/Materials | Steel | ABS Plastic | Higher flow rates can
be achieved using the
Subject Device if a
larger diameter tubing
is connected.
Different; Tumescent
Infiltration pumps are
non-patient
contacting devices.
They are utilized and
maintained outside of
the sterile field.
Although the housing
materials are
different, this has no
impact on the
performance or the
Intended Use of the
pump. |
| Footswitch | Electric | Air powered | Different; Both
footswitches activate
the rotation of the
pump. The difference
between air powered
and electric activation
does not change the
footswitch interaction
with the device or
how user interfaces
with the footswitches
during its use. |
| Pressure control | Knob to control RPM | Knob to control RPM | Same |
| Display | LED | LED | Same |
| Complies with ISO
10993-1 | Yes | Yes | Same |
| Electrical Safety
Testing Passed | Yes | Yes | Same |
7
| Attribute | Predicate Device | Subject Device: | Reference Device | Comparison |
|---|---|---|---|---|
| #J | ||||
| Device Name | Vitruvian | PAL Infiltration | Wells Johnson Infusion | N/A |
| Infiltration Pump | System | System, 20-6000-00 | ||
| Device | Black & Black | MicroAire Surgical | Wells Johnson | N/A |
| Manufacturer | Surgical, Inc. | Instruments, LLC | ||
| 510(k) | K170629 | K220318 | K991437 | N/A |
| Reference | ||||
| Maximum flow | 475 mL/min* | 630 mL/min — with | Maximum flow rate | Similar; The flow |
| rate | 999 mL/min** | HK Surgical ITS-10 | 1300mL/min (per IFU) | rate is determined |
| tubing | by the peristaltic | |||
| pump geometry and | ||||
| 1200 mL/min - with | speed as well as the | |||
| MicroAire PAL | inner diameter of | |||
| Infiltration Tubing | the section of tubing | |||
| PAL-INF-1600 | which is placed | |||
| inside of the pump. | ||||
| Lower flow rates | ||||
| can be achieved | ||||
| using the Subject | ||||
| Device if a smaller | ||||
| diameter tubing is | ||||
| connected. Higher | ||||
| flow rates can be | ||||
| achieved using the | ||||
| Subject Device if a | ||||
| larger diameter | ||||
| tubing is connected. |
Table 5B – Comparison of Flow Rate against Reference Device
Table 5C – Comparison of Characteristics: Infiltration Single-Use and Multi-Use Cannulas
| Attribute | Predicate Device #2
– Black & Black
Surgical Multi-Use | Subject Device –
PAL Infiltration
Single-Use | Subject Device –
PAL Infiltration Multi-Use | Comparison |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Device Name | Liposuction
Aspiration and
Tumescent
Infiltration Cannulae
and Needles | PAL Infiltration Single
Use Cannulas | PAL Infiltration Multi-
Use Cannulas | N/A |
| Device
Manufacturer | Black & Black
Surgical | MicroAire Surgical, LLC | MicroAire Surgical, LLC | N/A |
| Attribute | Predicate Device #2 – Black & Black Surgical Multi-Use | Subject Device – PAL Infiltration Single-Use | Subject Device – PAL Infiltration Multi-Use | Comparison |
| 510(k) Reference | K113795 | K220318 | K220318 | N/A |
| FDA Product Code | QPB | QPB | QPB | Same |
| FDA Classification Name | System, suction lipoplasty for removal | System, suction lipoplasty for removal | System, suction lipoplasty for removal | Same |
| FDA Regulation Number | 878.5040 | 878.5040 | 878.5040 | Same |
| FDA Device Class | Class II | Class II | Class II | Same |
| Indications for Use | The aspiration and infusion cannulae and needles are indicated for aesthetic body contouring and general tissue aspiration. | The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring. | The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring. | Similar |
| Design | Cannula tube;
Cannula tip;
Cannula hub | Cannula tube;
Blunt tip;
Cannula hub | Cannula tube;
Blunt tip;
Cannula hub | Same |
| Fenestration | Multi-hole:
Hole Size - 1mm
Number of holes - 7
Hole Pattern - Wrap around in a spiral formation.
Basket:
Three holes equally spaced radially with remaining material flared. | Multi-hole:
Hole Size - 1.9mm
Number of Holes - 22
Hole Pattern - Straight Formation 11 thru holes 90 degrees apart
Flared Mercedes:
Three holes equally spaced radially with remaining material flared. | Multi-hole:
Hole Size - 1.9mm
Number of Holes - 22
Hole Pattern - Straight Formation 11 thru holes 90 degrees apart
Flared Mercedes:
Three holes equally spaced radially with remaining material flared. | Different |
| Length | Available in 15cm, 26cm, 32cm, and 40cm lengths. | Available in 15cm, 22cm, and 30cm lengths. | Available in 15cm, 22cm, 30cm and 40cm lengths. | Similar |
| Attribute | Predicate Device #2 – Black & Black Surgical Multi-Use | Subject Device – PAL Infiltration Single-Use
Note: No 40 cm length. | Subject Device – PAL Infiltration Multi-Use | Comparison |
| Diameter | Available in 3.2mm (10 Gauge), 4mm, 5mm diameters | Available in 3mm, 4mm and 5mm diameters | Available in 3mm, 4mm and 5mm diameters | Similar |
| Style | Straight | Straight | Straight | Same |
| Materials | Cannula Tube – Stainless Steel
Cannula Hub – Stainless Steel and Aluminum | Cannula Tube – Stainless Steel
Cannula Hub Lexan HPS1R (polycarbonate) and Dupont Zytel ST801 (nylon) | Cannula Tube – Stainless Steel
Cannula Hub –Vectra MT1310 (LCP) and Dupont Zytel ST801 (nylon) and a Dowel Pin made of 410 or 416 Stainless Steel | Cannula Tube – Same
Cannula Hub – Different |
| Function | Black and Black Surgical Cannulae and Needles are used to remove fluid, soft tissue, and exudates and for infusion, utilizing a hollow stainless-steel tube and multiple tips, handle and attachment connectors that are in reusable and disposable configuration. | The Cannula steel tube is used to provide length and strength.
The Cannula Tip is used to provide infiltration through eyelets (holes) in the tip.
The hub is used to connect to the handpiece and tubing | The Cannula steel tube is used to provide length and strength.
The Cannula Tip is used to provide infiltration through eyelets (holes) in the tip.
The hub is used to connect to the handpiece and tubing | Similar |
| Sterile | Supplied non-sterile; Steam Sterilized by end user | Supplied sterile, Gamma sterilization | Supplied non-sterile; Steam Sterilized by end user | Different |
| Single-Use | No | Yes | No | Different |
| Complies with ISO 10993 | Yes | Yes | Yes | Same |
| Attribute | Predicate Device #3:
Black & Black Single Spike
15' Large Bore Tubing | Subject Device:
PAL Infiltration Tubing,
K220318 | Comparison | |
| Device Name | Single Spike 15' Large Bore
Tubing | PAL Infiltration Tubing | N/A | |
| Device
Manufacturer | Black & Black | MicroAire Surgical, LLC | N/A | |
| 510(k) Reference | N/A | K220318 | N/A | |
| FDA Product Code | GAZ | QPB | Different | |
| FDA Classification
Name | Tubing, Noninvasive | Suction Lipoplasty System | Different | |
| FDA Regulation
Number | 880.6740 | 878.5040 | Different | |
| FDA Device Class | Class II | Class II | Same | |
| Indications for Use | The suction and irrigation
tubes are intended for
instillation or aspiration of
fluid to/from a targeted
area of the body during
liposuction procedures. | The PAL® Infiltration System
is indicated for the purpose
of aesthetic body contouring. | Similar | |
| Design
Characteristics | Available in one length ~15
feet | Available in one length
~16feet | Similar | |
| Design | 3-piece tubing
construction; one
peristaltic section, two
length sections
Single bag spike
luer connection | 3-piece tubing construction;
one peristaltic section, two
length sections
Single bag spike
No luer connection | Similar | |
| Materials | Peristaltic section - Silicone | Peristaltic Section - PVC
Length Section – PVC
Bag Spike - ABS
Tubing Connectors - PC | Different | |
| Function | The peristaltic section
interfaces with a peristaltic
pump to provide fluid flow.
The length sections of the
tubing provide connections
for the bag spike, tubing
connectors, and luer
connector | The peristaltic section
interfaces with a peristaltic
pump to provide fluid flow.
The length sections of the
tubing provide connections
for the bag spike, tubing
connectors, and MicroAire
infiltration cannula | Similar | |
| Attribute | Predicate Device #3:
Black & Black Single Spike
15' Large Bore Tubing | Subject Device:
PAL Infiltration Tubing,
K220318 | Comparison | |
| Sterile | Supplied Sterile
(Gamma Irradiation) | Supplied sterile
(EtO) | Similar | |
| Single-Use | Yes | Yes | Same | |
| Complies with ISO
10993 | Yes | Yes | Same | |
8
9
10
Table 5D – Comparison of Characteristics: Infiltration Tubing
11
Table 5E - Comparison of Single-Use Data against Reference Device
| Attribute | Reference Device:
INEX Lipoplasty/Liposuction
Aspiration and Tumescent
Infiltration
Cannulae/Needles | Subject Device:
MicroAire PAL Infiltration
Single-Use Cannula | Comparison |
|------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------|
| Device Name | Lipoplasty/Liposuction
Aspiration and Tumescent
Infiltration Cannulae/Needles | MicroAire PAL Infiltration
Single-Use Cannula | N/A |
| Device
Manufacturer | INEX | MicroAire Surgical, LLC | N/A |
| 510(k) Reference | K132353 | K220318 | N/A |
| Single-Use | Yes | Yes | Same |
| Supplied Sterile | Yes | Yes | Same |
9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of MicroAire PAL Infiltration System and to show substantial equivalence to the predicate device, MicroAire completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The PAL Infiltration System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
- Cytotoxicity testing per ISO 10993-5 – Passed
- Sensitization and Irritation testing per ISO 10993-10 – Passed
- Irritation testing per ISO 10993-10 – Passed
- Pyrogenicity per USP - Passed
- Acute Systemic Toxicity per ISO 10993-11 - Passed
- Electrical safety testing per IEC 60601-1 Passed ●
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 - Passed
- . Infiltration Pump Flow Rate - -meets internal specifications
12
- Transportation Testing per ASTM D4169 Demonstrates package integrity maintained ●
10. Statement of Substantial Equivalence
Based on the information provided in this submission, it is concluded that the MicroAire PAL Infiltration System has the same indications for use as the Vitruvian Infiltration System. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, MicroAire PAL Infiltration System has been determined to be substantially equivalent to Vitruvian Infiltration Pump.