FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The primary intended use of the EasySafe™ Retracting Needle Syringe is to inject fluid intramuscularly (IM) into the body. The secondary intended uses are:

to help prevent sharps injuries when using the product for its primary intended use, and;
to help reduce wasted medication when using the product for its primary intended use.

Device Description

Not Found

AI/ML Overview

The provided text describes the safety and effectiveness of the EasySafe™ Retracting Needle Syringe (K973792).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Measurement	Reported Device Performance	Comments from Document
Effectiveness	Successful IM injection	100% success rate	"All injections were successfully completed."
Safety - Sharps Injuries	No reported injuries	0 injuries reported	"No injuries of any kind were reported."
Safety - Biocompatibility	Safe for intended purpose	Found to be safe	"results indicating that, from a biocompatibility standpoint, the product is safe for its intended purpose."
Safety - Sterilization	Sterilization Assurance Level (SAL) of 10^-6	SAL of 10^-6 confirmed	"Sterilization to a SAL of 10^-6 was confirmed during the tests."
Safety - Pyrogenicity	Acceptable pyrogenicity	Acceptable results obtained	"Pyrogenicity was also evaluated and acceptable results obtained."

Study Details

2. Sample size used for the test set and data provenance

Sample Size (Effectiveness & Safety): Over 1,000 IM injections were administered.
Data Provenance: The study was a "simulated use study." The geographic origin of the study is not explicitly stated, but the manufacturer is based in Illinois, USA. The study appears to be prospective (a "recent simulated use study").

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

Experts (Effectiveness & Safety - Simulated Use): "A wide variety of clinicians" participated. The exact number and their specific qualifications (e.g., years of experience, specialty) are not detailed in the provided text.
Experts (Effectiveness - Focus Groups): "Twenty clinicians" indicated no impediments. Their specific qualifications are not detailed.

4. Adjudication method for the test set

The text does not describe an adjudication method for the simulated use study. The assessment of "successfully completed" injections and "no injuries of any kind" likely came directly from the clinicians observing or participating in the simulated use, without a separate adjudication process mentioned.

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

There is no MRMC comparative effectiveness study mentioned in the provided text. This study pertains to a medical device (syringe), not an AI/imaging diagnostic tool that would typically involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical instrument (syringe), not an algorithm or AI. The performance tests ("bench testing") represent a form of standalone testing against established physical standards.

7. The type of ground truth used

Effectiveness: Direct observation of injection completion in a simulated setting.
Safety (Injuries): Direct observation and reporting of injuries in a simulated setting.
Bench Testing (Effectiveness & Safety): Compliance with "applicable performance standards established by the International Standards Organization (ISO)" and "comparability with legally-marketed predicate devices for a variety of safety factors." This indicates a ground truth based on established engineering and regulatory standards.
Biocompatibility, Sterilization, Pyrogenicity: Laboratory test results against specified standards (e.g., SAL of 10^-6).

8. The sample size for the training set

This question is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require training sets.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as above.

Summary

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).