Search Results

The Easy Go Aspirator provides a portable, AC/DC powered medical vacuum source. It is intended for use in the homecare / health care environments.

Small DC motor that powers a suction pump monitored by a gauge, vacuum is set by the care provider up to 21 inches of mercury. Uses an internal battery, with internal charger/power supply, on two models, and AC only on the third model.

I am sorry, but based on the provided text, there is no information regarding acceptance criteria related to device performance, nor any study conducted to prove the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence of a new medical aspirator (PM66) to a predicate device (PM65) by highlighting:

• Device Descriptions: Comparing the general features and specific models of the new device (PM66LI, PM66AC, PM66S) to the predicate (PM65).
• Differences: Listing the new features and enhancements in the PM66 models, such as internal battery chargers, Lithium batteries, AC-only operation, charge/battery level indicators, and waste container options.
• Conclusion of Equivalence: Stating that the new devices are substantially equivalent to the predicate, with added features that ease and enhance operation, implying that their safety and effectiveness are comparable.
• Intended Use: Defining the purpose and environment for the device.
• Applied Standards: Listing various ISO and IEC standards that the device adheres to.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about a study with sample sizes, data provenance, or ground truth establishment.
• Information on expert involvement or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone algorithm performance study.
• Information on training set sample sizes or ground truth establishment for a training set.

This type of 510(k) submission generally relies on demonstrating that the new device has "substantially equivalent" technological characteristics and/or intended use to a legally marketed predicate device, rather than requiring extensive clinical performance studies with specific statistical outcomes to meet "acceptance criteria" in the way one might see for a novel AI/software device. The equivalence often relies on engineering comparisons, bench testing (to ensure it meets listed standards like vacuum pressure), and sometimes non-clinical performance data to show the new features don't negatively impact safety or effectiveness.

Ask a specific question about this device