(15 days)
The device is a vacuum suction device. It is to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory. It is for use on the order of a physician only.
The EMG AC/DC Suction unit is a compact medical suctioning device which can be powered by the AC current through a attached AC Adapter unit connecting to the wall electric outlet at home or DC power source through a set of built-in rechargeable battery or automobile DC 14V electric power through power cord connecting to the receptacle during transportation. The vacuum pressure of EMG AC/DC Suction unit is to be produced through a built-in vacuum pump which is consisted of DC motor, cylinder, piston connecting rod, cup seal, eccentric crank, inlet valve, outlet valve---etc parts. When turn on the suction unit, motor start to run, its shaft drive the eccentric crank which actuate 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 an one way inlet port, when the piston is being in the up stroke, it pressed out these suctioned air through another one way outlet port to the atmosphere, these two one way port avoid air being suctioned from the atmosphere as well as air in cylinder being pressed back to the inlet port. When motor keep running, then a continuous vacuum pressure source through inlet port is produced. One set of plastic cover enclose the vacuum pump, control p. c. board, battery and wire harness to protect user from electrical shock and mechanical hurt hazard. Following components on the cover are to be the operating interface to the use: a power switch, a receptacle, a vacuum adjusting set, vacuum meter and device vacuum inlet port. The vacuum adjusting set through inner tubing connecting to the inlet port of vacuum pump, the vacuum meter and the device vacuum inlet port are connecting 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 vacuum adjusting set, accuracy within +/-5%. The vacuum meter display the vacuum pressure data during operation, the device vacuum inlet port provide the vacuum pressure source. Connect the device vacuum inlet port, bacteria filter (Bacteria filter pore size: 0.2microns,Model:3928) and collection container with two PVC tubing respectively. then connect one end of a biocompatible patient tubing (comply with ISO10993 / material: PVC compound, Type: 3MSA060p3X) to the collection container inlet port, the other end of the patient tubing connected to the applied part (like drainage tubing). Put the applied part to the adequate location of patient body, then this device can start to carry out the suctioning sputum and other body liquid's operation.
The provided text describes a 510(k) premarket notification for the "EMG AC/DC Suction Unit, Model SUF01-XXX Series." This document primarily focuses on demonstrating substantial equivalence to a predicate device (DeVilbiss Suction Unit, Model 7305P-I) rather than presenting a detailed clinical study with numerical acceptance criteria and performance data in the format requested.
Here's a breakdown of the information that can be extracted and what is not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device is "designed and manufactured to comply with UL60601-1, CSA C22.2 No.601.1-M90 and IEC60601-1-2 EMC safety standards and meet the performance standard per ISO10079-1:1991." It also mentions that "Device's vacuum pressure can be adjusted by tuning the knob of vacuum adjusting set, accuracy within +/-5%."
However, specific numerical acceptance criteria (e.g., minimum flow rates, maximum vacuum levels, noise levels, battery life) and corresponding reported device performance values as typically presented in a summary table from a detailed performance study are not explicitly provided in this 510(k) summary. The document relies on compliance with established standards rather than detailing specific performance outcomes from a dedicated study.
| Acceptance Criteria (Based on standards compliance) | Reported Device Performance |
|---|---|
| Compliance with UL60601-1 | Not explicitly stated (implied by "designed and manufactured to comply") |
| Compliance with CSA C22.2 No.601.1-M90 | Not explicitly stated (implied by "designed and manufactured to comply") |
| Compliance with IEC60601-1-2 (EMC safety standards) | Not explicitly stated (implied by "designed and manufactured to comply") |
| Compliance with ISO10079-1:1991 (performance standard) | Not explicitly stated (implied by "designed and manufactured to comply") |
| Vacuum pressure adjustment accuracy | +/-5% (This is stated as a feature/spec, not necessarily a performance outcome from a test) |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical tests to establish substantial equivalence. It does not mention a "test set" in the context of human subjects or patient data. The tests performed are stated as "Compliance to the applicable voluntary standards include ISO10079-1, IEC60601-1-1 and IEC60601-1-2 requirements."
Therefore, information regarding:
- Sample size for a test set (human subjects/patient data): Not applicable or not provided. The evaluations mentioned are against engineering and safety standards.
- Data provenance (country of origin, retrospective/prospective): Not applicable or not provided. The tests described are compliance-based, likely performed in a lab setting by the manufacturer or a testing facility.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
As the document focuses on non-clinical compliance testing against standards, there is no mention of "experts" establishing a ground truth for a patient-based test set, as would be common in clinical studies for diagnostic or therapeutic efficacy.
4. Adjudication method for the test set:
Not applicable, as there is no patient-based clinical test set requiring adjudication in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study is not mentioned. The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and compliance with standards, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical suction unit, not an algorithm or AI system.
7. The type of ground truth used:
For the compliance testing mentioned:
- The "ground truth" would be the requirements and specifications outlined in the referenced international standards (ISO10079-1, UL60601-1, CSA C22.2 No.601.1-M90, IEC60601-1-2). The device performance is measured against these established engineering and safety benchmarks.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device 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.
In summary:
The provided 510(k) summary is a regulatory filing focused on establishing substantial equivalence for a physical medical device (an AC/DC suction unit). It demonstrates compliance with recognized safety and performance standards rather than presenting results from a clinical trial or AI evaluation. Therefore, many of the requested elements pertaining to clinical studies, human performance, and AI algorithms are not present in this type of document.
§ 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.