(9 days)
The device is intended to be used to remove body fluids from a patient's airway or respiratory system. It is for use on the order of a physician only.
The EMG Suction Unit is a compact medical suctioning device which can be powered by AC current (115V 60Hz) through the wall electric outlet at home. The vacuum pressure of the EMG Suction Unit is to be produced through a built-in vacuum pump which is consisted of an AC motor, a cylinder, a piston connecting rod, a cup seal, an eccentric crank, an inlet valve, an outlet valve, etc. When turn on the suction unit, the motor starts to run, its shaft drive the eccentric crank which actuates the piston connecting rod moving up and down in the cylinder. When the piston is being in the down stroke, a vacuum pressure is produced in the cylinder, then air will be suctioned into the cylinder through a one-way inlet port, when the piston is being in the up stroke, it pressed out the suctioned air through another one-way outlet port to the atmosphere, these two one-way ports avoid air being suctioned from the atmosphere as well as air in cylinder being pressed back to the inlet port. When the motor keep running, a continuous vacuum pressure source through inlet port is produced. A set of plastic cover enclose the vacuum pump, wire harness, etc. to profect the user from electrical shock and mechanical hurt hazard. The operating interface includes: a power switch, a vacuum adjusting set, a vacuum meter and a device vacuum inlet port. The vacuum adjusting set is connected to the inlet port of the vacuum pump through inner tubing, the vacuum meter and the device vacuum inlet port are connected to the vacuum adjusting set through a three-way connector and inner tubing. Device's vacuum pressure can be adjusted by tuning the knob of the vacuum adjusting set, accuracy within +/-5%. The vacuum meter display the vacuum pressure data during operation, the device vacuum inlet port provides the vacuum pressure source. One end of a connection tubing is connected to a bacteria filter which is connected to the device vacuum inlet port, and the other end of the connection tubing is connected to a collection container. Furthermore, one end of a patient tubing is connected to the inlet port of the collection container, and the other end of the patient tubing is connected to an applied part (like suction catheter). Put the applied part to the adequate location of the patient body, then this device can start suctioning sputum or other body fluid.
The provided 510(k) summary describes the EMG Suction Unit, Model SUA01-AXX Series, and focuses on demonstrating substantial equivalence to a predicate device (Medi-Pump Aspirator, Model 1615). This type of submission generally relies on demonstrating compliance with recognized performance standards and comparing technical characteristics rather than extensive clinical studies with detailed acceptance criteria for diagnostic performance metrics like sensitivity, specificity, or AUC as seen in AI/ML medical devices.
Therefore, the requested information regarding diagnostic performance, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance is largely not applicable (N/A) in the context of this device and submission type. The "acceptance criteria" here are primarily compliance with engineering and safety standards.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| UL 60601-1 (Electrical Safety) | Complies |
| CAN/CSA-C22.2 No. 601.1-M90 (Electrical Safety) | Complies |
| IEC 60601-1-2:2007 (EMC Compliance) | Complies |
| ISO 10079-1:2009 (Performance Standard) | Complies |
| Vacuum range (operational specification) | Details not provided, but "difference does not affect safety and effectiveness" |
| Flow rate (operational specification) | Details not provided, but "difference does not affect safety and effectiveness" |
| Sound level (operational specification) | Details not provided, but "difference does not affect safety and effectiveness" |
| Operational power consumption | Details not provided, but "difference does not affect safety and effectiveness" |
Note: For the operational specifications (vacuum range, flow rate, sound level, operational power consumption), the document only states that the differences from the predicate device "do not affect safety and effectiveness of the device or the application." Specific numerical acceptance criteria or performance values for these metrics are not explicitly presented. The core "acceptance criteria" are the compliance with the listed safety and performance standards.
2. Sample size used for the test set and the data provenance
N/A. This device is a hardware medical device (suction unit), not a diagnostic algorithm. The "test set" would refer to units of the device being tested under specified conditions according to the standards. The document doesn't specify a number of units tested, but rather refers to "non-clinical tests performed." The data provenance for such tests is typically from the manufacturer's testing or accredited laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Ground truth in the context of a diagnostic algorithm is not relevant for this device. Compliance with engineering standards does not involve expert adjudication of diagnostic outcomes.
4. Adjudication method for the test set
N/A. Not applicable as there is no diagnostic ground truth to adjudicate.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a hardware device; the concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used
N/A. For a medical device like a suction unit, "ground truth" would relate to its physical performance and safety characteristics as measured against established engineering and safety standards.
8. The sample size for the training set
N/A. This is a hardware device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
N/A. Not applicable.
§ 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.