(192 days)
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.
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 syringe to facilitate manual suction.
The pneumatic reciprocating handpieces 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 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.
The cannula is essentially a blunt tipped hollow tube comprised of stainless steel with an attached PVC suction tube and optional syringe. 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroAire® PAD™ System, structured according to your request.
Please note: The provided document is a 510(k) summary and FDA clearance letter for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study report typical of a clinical trial for a novel AI/software as a medical device (SaMD) product. Therefore, much of the requested information (especially regarding AI-specific criteria, human readers, ground truth establishment for training, etc.) is not present in this historical regulatory submission for a physical surgical device. I will extract what is available and note what is not.
Description of Acceptance Criteria and Study for MicroAire® PAD™ System
The MicroAire® PAD™ System is a surgical aspiration device indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for aesthetic body contouring. Its regulatory clearance (K981922) was based on demonstrating substantial equivalence to a legally marketed predicate device, with its performance affirmed through nonclinical evaluations and compliance with voluntary standards.
The document does not specify explicit "acceptance criteria" in a quantitative, pre-defined manner for device performance, as would be common for new AI/SaMD devices. Instead, it relies on demonstrating that the device functions as intended and safely, primarily through engineering specifications and in-vitro testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a mechanical surgical tool) and the document (510(k) summary), the "acceptance criteria" are implied by the performance specifications provided and tested.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical Reciprocating Action: | |
| Pneumatic Handpieces: Stroke Distance & Rate | Capable of driving cannula through a stroke distance of 2.4-6mm (0.093-0.240in.) at a rate of 3500-4500 strokes per minute. |
| Electric Handpiece: Stroke Distance & Rate | Capable of driving cannula through a stroke distance of 2.4mm (0.093in.) at a rate of 3500-4500 strokes per minute. |
| Tissue Penetration Force Reduction: | Reciprocating cannula reduced the magnitude of penetration force by approximately 70% compared to non-reciprocating cannulae in successive trials of in vitro animal experiments. |
| Aspiration Performance: | Demonstrated ability to aspirate physiological saline and a viscous wound cleansing solution (consistency similar to synovial fluid or mucus) with a vacuum pressure of 20 cm Hg for ten seconds. The reciprocating cannula did not affect the rate of aspiration. Specific volume measurements were taken (details in Appendix F, which is not provided). |
| Sterilization Efficacy (Multiple-Use Instruments): | Gravity Discharge: 35 minutes @ 270°F (132°C) with an 8-minute drying cycle. Prevaccum System: 4 minutes @ 270°F (132°C) with an 8-minute drying cycle. (This demonstrates the ability to achieve sterility per AAMI's Good Hospital Practice). |
| Sterilization Efficacy (Disposable Components): | Pre-sterilized at 25-40 kiloGray according to ANSI/AAMI/ISO 11137-1994 (Radiation Sterilization). |
| Electrical Safety (Electric Console): | Designed to meet the electrical safety requirements of UL-544 and IEC-601-1. |
| Biocompatibility/Material Safety: | Components comprised of materials with a long history of safety when incorporated in medical devices. |
| Compliance with Special Controls for Suction Lipoplasty: | The device "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." (While stated, specific details of these "voluntary standards" beyond the mentioned sterility and electrical safety ones are not fully enumerated here, but are implied to be met to ensure substantial equivalence for a suction lipoplasty system). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" sample size in the context of a clinical study or a large dataset for algorithmic evaluation. The performance metrics reported (e.g., 70% force reduction, aspiration rates) are derived from "successive trials of in vitro animal experiments" and "laboratory tests" measuring aspirated fluid volume. The exact number of trials or animal subjects is not detailed in the summary.
- Data Provenance: The testing appears to be prospective, in-vitro laboratory testing and animal experiments conducted by MicroAire® Surgical Instruments. Country of origin for data is implicitly the USA, where MicroAire® is located. This is not a study involving human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a summary for a mechanical device, not an AI/SaMD requiring ground truth established by medical experts on diagnostic images or patient data. The "ground truth" for the performance tests would be the measured physical properties (e.g., force, volume, stroke rate) as determined by engineering and laboratory testing protocols.
4. Adjudication Method for the Test Set
- Not Applicable. There was no "test set" in the sense of a dataset requiring expert adjudication for ground truth. Performance was measured objectively in a laboratory setting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/SaMD product. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an electro-mechanical surgical device, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply. The device's performance characteristics (e.g., stroke rate, force reduction) are inherent to its mechanical design.
7. The Type of Ground Truth Used
- The ground truth for the performance evaluation was based on objective physical measurements from laboratory and in-vitro animal experiments (e.g., force transducers for penetration force, volume measurements for aspiration, RPM/stroke counters for mechanical rates).
- For safety, ground truth was established by adherence to recognized voluntary standards (e.g., AAMI for sterility, UL/IEC for electrical safety) and material biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML system and does not involve a "training set" in that context. The device design and engineering are based on principles of mechanics and fluid dynamics, not data-driven learning.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, there is no ground truth for it. The "truth" informing the device's design would be engineering principles, material science, and the clinical understanding of surgical aspiration.
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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
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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.
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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
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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)
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XIV . 510(k) Summary
| Date: | May 29, 1998 |
|---|---|
| Submitted by: | MicroAire® Surgical Instruments1641 Edlich DriveCharlottesville, VA 22911 |
| Contact Person: | Carl AnglesDirector 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
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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.
§ 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.