(192 days)
The MicroAire® PAD" System does not have a substantially equivalent predicate device that is legally marketed for the intended purpose of suction lipoplasty.
Not Found
No
The description focuses on mechanical and pneumatic/electric operation, with no mention of AI, ML, or data processing for decision-making or analysis.
No
The device is indicated for removing tissue and fluid from the body during surgical procedures, specifically for aesthetic body contouring through suction lipoplasty, which is not a therapeutic-intended use.
No
The device is indicated for the removal of tissue or fluid, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical hardware components including handpieces, cannulas, tubing, and an electric console. It is not solely software.
Based on the provided information, the MicroAire® PAD™ System is not an IVD (In Vitro Diagnostic) device.
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 (handpiece and cannula) used for aspiration and tissue removal. It does not describe a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The MicroAire® PAD™ System is a surgical tool used for tissue removal and body contouring.
N/A
Intended Use / Indications for Use
The MicroAire® PAD™ System is 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)
OPB, MUU
Device Description
The MicroAire® PAD" System consists of two primary components: a pneumatic or electric reciprocating handpiece and a disposable cannula with attached suction tubing. The disposable cannula with attached suction tubing connects to an external suction sources that is not part of the PAD" System. A disposable cannula with attached tubing is also available with a svringe to facilitate manual suction.
The pneumatic reciprocating handpieces (Appendix E.1, E.4) operate with an air or nitrogen power supply. The handpieces are capable of driving the cannula through a stroke distance of 2.4-6mm (0.093-0.240in.) at a rate of 3500-4500 strokes per minute. The electric reciprocating handpiece (Appendix E.3) is capable of driving a cannula through a stroke distance of 2.4mm (0.093in.) at a rate of 3500-4500 strokes per minute. The electric handpiece is powered and controlled by the MicroAire® Smartdrive" electric console (Appendix E.7).
The cannula is essentially a blunt tipped hollow tube comprised of stainless steel with an attached PVC suction tube and optional syringe (Appendix E.5, E.6). The cannula internal diameter is approximately 3mm and ranges from 26-33cm in overall length. Fluid and tissue is aspirated through windows located near the tip of the cannula when the tubing is connected to a suction source. The number of windows varies between 3-6 openings with window lengths from 7-10mm at 2mm in width.
The small (2-6 mm), rapid stroke of the PAD" cannula simulates the manual hand motion that a surgeon would use during aspiration. At the same time, the powered cannula minimizes surgeon effort by reducing the amount of necessary arm motion. Furthermore, the slight reciprocating action of the PAD" System facilitates the passage of the cannula through tissue. When the reciprocating action is not activated by the surgeon, the PAD" device functions as a manual aspiration device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body
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)
Nonclinical evaluations also demonstrate that the PAD" reciprocating cannula reduces the force required to enter soft tissue. Comparison of reciprocating and nonreciprocating cannulae was accomplished by alternating the PAD" instrument between the "on" and "off" positions during successive trials of in vitro animal experiments. The results of these tests demonstrated that the reciprocating cannula reduced the magnitude of penetration force by approximately 70% (Appendix F).
Laboratory tests demonstrated the PAD™ Systems ability to perform aspiration. Physiological saline and a viscous wound cleansing solution were aspirated. The wound cleansing solution had a consistency similar to synovial fluid or mucus. The fluids were aspirated by a vacuum pressure of 20 cm Hg for ten seconds and the volume of aspirated fluid was measured (Appendix F). The reciprocating cannula did not affect the rate of aspiration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reduced the magnitude of penetration force by approximately 70%.
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.
The MicroAire® PAD" System does not have a substantially equivalent predicate device that is legally marketed for the intended purpose of suction lipoplasty.
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.
Not Found
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). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a human figure, while the text reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The logo is commonly used to represent the FDA and its role in regulating food and drugs in the United States.
Microaire Surgical Instruments, Inc. Carl Angles Director Of Quality And Regulatory Affairs 1641 Edlich Dr. Charlottesville, Virginia 22911
June 8, 2021
Re: K981922
Trade/Device Name: Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument Model Pad-200, Light Duty Electri Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB
Dear Carl Angles:
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 December 10, 1998. 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines beneath them, resembling water or fabric.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1998
Mr. Carl Angles Director of Regulatory Affairs and Quality Assurance MicroAire Surgical Instruments 1641 Edlich Drive Charlottesville, Virginia 22911
Re: K981922
Trade Name: MicroAire® Power Aspiration Device, PAD™ System Regulatory Class: II Product Code: MUU Dated: September 9, 1998 Received: September 10, 1998
Dear Mr. Angles:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Carl Angles
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of of 1
510(k) Number (if Known):_
MicroAire® "Power Aspiration Device" PAD™ System Device Name: J
Indications For Use:
The MicroAire® PAD™ System is 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K981922 |
Prescription Use J (Per 21 CFR 801.109)
OR
Over-The-Counter______________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
4
XIV . 510(k) Summary
| Date: | May 29, 1998 |
|---|---|
| Submitted by: | MicroAire® Surgical Instruments |
| 1641 Edlich Drive | |
| Charlottesville, VA 22911 | |
| Contact Person: | Carl Angles |
| Director of Quality and Regulatory Affairs | |
| Telephone: | (804) 975-8000 |
| Fax: | (804) 975-4123 |
| Proprietary Name: | MicroAire® “Power Aspiration Device” PAD™ System |
| Common Name: | Surgical Aspiration System |
| Classification Name: | Suction lipoplasty system, 21CFR §878.5040. |
The MicroAire® PAD" System does not have a substantially equivalent predicate device that is legally marketed for the intended purpose of suction lipoplasty. The MicroAire® PAD" System complies with appropriate voluntary standards designated as special controls to assure safety and effectiveness of the device in accordance with the requirements of 21 CFR $878.5040.
The MicroAire® PAD" System consists of two primary components: a pneumatic or electric reciprocating handpiece and a disposable cannula with attached suction tubing. The disposable cannula with attached suction tubing connects to an external suction sources that is not part of the PAD" System. A disposable cannula with attached tubing is also available with a svringe to facilitate manual suction. Performance specifications for these devices can be found in Appendix D.
The pneumatic reciprocating handpieces (Appendix E.1, E.4) operate with an air or nitrogen power supply. The handpieces are capable of driving the cannula through a stroke distance of 2.4-6mm (0.093-0.240in.) at a rate of 3500-4500 strokes per minute. The electric reciprocating handpiece (Appendix E.3) is capable of driving a cannula through a stroke distance of 2.4mm (0.093in.) at a rate of 3500-4500 strokes per minute. The electric handpiece is powered and controlled by the MicroAire® Smartdrive" electric console (Appendix E.7).
The cannula is essentially a blunt tipped hollow tube comprised of stainless steel with an attached PVC suction tube and optional syringe (Appendix E.5, E.6). The cannula
2981922
5
internal diameter is approximately 3mm and ranges from 26-33cm in overall length. Fluid and tissue is aspirated through windows located near the tip of the cannula when the tubing is connected to a suction source. The number of windows varies between 3-6 openings with window lengths from 7-10mm at 2mm in width.
The small (2-6 mm), rapid stroke of the PAD" cannula simulates the manual hand motion that a surgeon would use during aspiration. At the same time, the powered cannula minimizes surgeon effort by reducing the amount of necessary arm motion. Furthermore, the slight reciprocating action of the PAD" System facilitates the passage of the cannula through tissue. When the reciprocating action is not activated by the surgeon, the PAD" device functions as a manual aspiration device.
Nonclinical evaluations also demonstrate that the PAD" reciprocating cannula reduces the force required to enter soft tissue. Comparison of reciprocating and nonreciprocating cannulae was accomplished by alternating the PAD" instrument between the "on" and "off" positions during successive trials of in vitro animal experiments. The results of these tests demonstrated that the reciprocating cannula reduced the magnitude of penetration force by approximately 70% (Appendix F).
Laboratory tests demonstrated the PAD™ Systems ability to perform aspiration. Physiological saline and a viscous wound cleansing solution were aspirated. The wound cleansing solution had a consistency similar to synovial fluid or mucus. The fluids were aspirated by a vacuum pressure of 20 cm Hg for ten seconds and the volume of aspirated fluid was measured (Appendix F). The reciprocating cannula did not affect the rate of aspiration.
To ensure the safety of the MicroAire® PAD™ System, the instruments comply with applicable standards. Sterility of the multiple-use PAD" instruments and power supply hoses can be achieved through the procedures detailed in AAMI's Good Hospital Practice-Steam Sterilization and Sterility Assurance. A steam validation study was conducted on the handpiece with the following results: Gravity Discharge (wrapped or unwrapped) - 35 minutes @ 270°F (132°C) and 8 minute drying cycle. Prevacuum System - 4 minutes (@ 270°F (132°C) and 8 minute drying cycle. The disposable suction cannulae and tubing are pre-sterilized at 25-40 kiloGray according to ANSI/AAMI/ISO 11137-1994, Sterilization of Health Care Products-Requirements for Validation and Routine Control-Radiation Sterilization. The MicroAire® 6025 electric console is designed to meet the electrical safety requirements of UL-544 and IEC-601-1. In addition, the components of the MicroAire® PAD" System are all comprised of materials with a long history of safety when incorporated in medical devices.