(165 days)
No
The description focuses on mechanical components and standard performance testing, with no mention of AI/ML or related concepts.
Yes
The device is indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring, which is a therapeutic intervention.
No
The device is indicated for the removal of tissue or fluid from the body during general surgical procedures, specifically suction lipoplasty, which is a therapeutic procedure rather than a diagnostic one.
No
The device description clearly details physical hardware components (cannulas, wand) and their materials (stainless steel, plastic), along with physical performance testing (bending strength, fatigue, pullout, compression). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a surgical instrument (cannula and wand) used for aspiration during surgery. It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the device (bending strength, fatigue, pullout force, etc.), sterilization, and biocompatibility. These are typical tests for surgical instruments, not IVDs which would involve analytical and clinical performance studies related to the accuracy of a diagnostic test.
- Lack of IVD characteristics: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other characteristics associated with in vitro diagnostics.
In summary, the device is a surgical instrument used for tissue and fluid removal during procedures, which falls under the category of medical devices used in vivo (within the body), not in vitro (in glass/outside the body for diagnostic purposes).
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QPB, MUU
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
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
Prescription Use
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)
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
- 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
- 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)
- Storage and Distribution Testing meets internal specification requirements
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.
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.
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 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)
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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
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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.
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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. | | | | | | |
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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
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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).