(89 days)
The MicroAire PAD System is indicated for the removal of tissue or fluid from the body during general surgical procedures.
The MicroAire® PAD™ System differs from the predicate devices in that it possesses a powered reciprocating cannula. The small (2-6 mm), rapid stroke of the PAD" cannula simulates the manual hand motion that the surgeon would use during aspiration with the predicate devices. Thus, use of the PAD" System does not raise safety and effectiveness issues that are significantly different from those of the predicate devices. 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 in an identical manner to the predicate devices.
This submission pertains to the MicroAire® “Power Aspiration Device” PAD™ System, which is a surgical aspiration system. The main difference from predicate devices is its powered reciprocating cannula.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Aspiration Rate | Comparable aspiration rate to predicate devices for both physiological saline and viscous solutions (like synovial fluid/mucus). | "There were no significant differences between the aspiration rates of the PAD™ System and the regular suction cannula. The reciprocating cannula did not affect the rate of aspiration." |
| Penetration Force | Reduced force required to enter soft tissue compared to non-reciprocating cannulae. | "The reciprocating cannula reduced the magnitude of penetration force by approximately 70%." |
| Sterility (Multiple-use components) | Compliance with AAMI's "Good Hospital Practice-Steam Sterilization and Sterility Assurance." | "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." |
| Sterility (Disposable components) | Pre-sterilization according to ANSI/AAMI/ISO 11137-1994, "Sterilization of Health Care Products-Requirements for Validation and Routine Control-Radiation Sterilization." | "The disposable suction cannulae and tubing are pre-sterilized according to ANSI/AAMI/ISO 11137-1994, Sterilization of Health Care Products-Requirements for Validation and Routine Control-Radiation Sterilization." |
| Electrical Safety | Compliance with UL-544 and IEC-601-1 electrical safety requirements. | "The MicroAire® 6025 electric console is 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. | "components of the MicroAire® PAD™ System are all comprised of materials with a long history of safety when incorporated in medical devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Aspiration Rate Study: The text indicates "The volume of aspirated fluid was measured several times for both tools." The exact sample size (number of repetitions or devices tested) is not specified.
- Penetration Force Study: No specific sample size is provided for the "in vitro animal experiments."
- Data Provenance: The studies are described as "Laboratory tests" and "Nonclinical evaluations... using in vitro animal experiments." This suggests the data is prospective and generated within a laboratory setting, likely in the US where MicroAire is based. Specific country of origin for the "animal experiments" is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a surgical instrument, and its performance evaluation focused on physical properties (aspiration rate, penetration force) and compliance with safety standards, not on diagnostic accuracy requiring expert interpretation of results.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements of physical properties, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is assessed. This submission is for a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies conducted (aspiration rate, penetration force, safety compliance) are standalone evaluations of the device's physical and functional properties without human interpretation of results being a primary endpoint. The device's function is evaluated intrinsically.
7. The Type of Ground Truth Used
- Aspiration Rate: The ground truth for comparative aspiration rate was the direct measurement of fluid volume aspirated under controlled conditions.
- Penetration Force: The ground truth for comparative penetration force was the direct measurement of force required for tissue entry.
- Sterility, Electrical Safety, Biocompatibility: The ground truth was established by adherence to recognized industry standards (AAMI, ANSI/AAMI/ISO 11137-1994, UL-544, IEC-601-1) and historical safety data for materials.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical surgical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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NOV 2 8 1997
XIII . 510(k) Summary
| Date: | August 27, 1997 |
|---|---|
| Submitted by: | MicroAire® Surgical Instruments1641 Edlich DriveCharlottesville, VA 22911 |
| Contact Person: | Carl AnglesDirector of Quality and Regulatory Affairs |
| Telephone:Fax: | (804) 975-8000(804) 975-4123 |
| Proprietary Name:Common Name:Classification Name: | MicroAire® “Power Aspiration Device” PAD™ SystemSurgical Aspiration SystemSurgical instrument motors and accessories/attachments,21CFR §878.4820; Manual surgical instrument for general use,21 CFR §878.4800 |
MicroAire believes the PAD" System to be substantially equivalent in basic form and function to the following legally marketed devices:
The predicate devices are cannulae that are capable of being attached to a suction source. These devices are indicated for general aspiration of fluid or loose tissue. Both devices are essentially a closed, hollow steel tube with one or more openings at the tip. The cannulae are available in different lengths, diameter sizes, and tip configurations. They are connected to a suction source to create a negative pressure within the cannula. This negative pressure causes fluid and friable tissue to be suctioned into the cannula when it is inserted surgically. The surgeon is able to remove undesirable fluid and tissue accumulation by manually guiding the cannula through the treatment area.
The MicroAire® PAD™ System differs from the predicate devices in that it possesses a powered reciprocating cannula. The small (2-6 mm), rapid stroke of the PAD" cannula simulates the manual hand motion that the surgeon would use during aspiration with the predicate devices. Thus, use of the PAD" System does not raise safety and effectiveness issues that are significantly different from those of the predicate devices. At the same time, the powered cannula minimizes surgeon effort by
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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 in an identical manner to the predicate devices.
Laboratory tests showed that the PAD" System was comparable to predicate devices for the purpose of aspiration. Physiological saline and a viscous wound cleansing solution were aspirated by the PAD" System and a standard suction cannula. 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. The volume of aspirated fluid was measured several times for both tools. There were no significant differences between the aspiration rates of the PAD" System and the regular suction cannula. The reciprocating cannula did not affect the rate of aspiration.
Nonclinical evaluations of the PAD" device also demonstrated its advantage over the predicate devices. The force required to enter soft tissue with reciprocating and nonreciprocating cannulae was quantified using in vitro animal experiments. The results of these tests demonstrated that the reciprocating cannula reduced the magnitude of penetration force by approximately 70%.
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. The disposable suction cannulae and tubing are pre-sterilized 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
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1997
Mr. Carl Angles Director of Quality and Regulatory Affairs MicroAire Surgical Instruments, Incorporated 1641 Edlich Drive Charlottesville, Virginia 22911
Re: K973268
Trade Name: MicroAire ® "Power Aspiration Device" Pad™ System Regulatory Class: II Product Code: BTA Dated: August 28, 1997 Received: August 29, 1997
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 cither class II (Special Controls) or class HIT (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 requirements , 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
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Page 2 - Mr. Angles
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k)Number(ifknown):_ K973268
MicroAire "Power Aspiration Device" PAD System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The MicroAire PAD System is indicated for the removal of tissue or fluid from the body during general surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
G:\USERS\GRS\[DA\LML0515
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.