(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.
§ 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.