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

The primary intended use of the EasySafe® Retracting Needle Syringe is to inject fluid into, or withdraw fluid from 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

Here's an analysis of the provided text regarding the EasySafe™ Retracting Needle Syringe, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance for EasySafe™ Retracting Needle Syringe

Note: This device is a medical syringe, not a software or AI-powered device. Therefore, many of the typical questions for AI/software (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable here. The focus is on physical device performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Metric	Reported Device Performance	Supporting Study Type
Effectiveness	Successful Injection/Fluid Withdrawal: Ability to administer injections or withdraw fluids effectively.	"All injections/withdrawals were successfully completed." (across >1,500 procedures)	Simulated Use Studies (2)
	Compliance with ISO Performance Standards:	"Bench testing of the product confirms its compliance with the applicable performance standards established by the International Standards Organization (ISO)."	Bench Testing
	No Impediments to Administration (Clinician Feedback):	"Twenty clinicians indicated that they saw no impediments to being able to effectively administer injections to patients using the product."	Focus Groups (Qualitative Feedback)
Safety	No Reported Injuries: Absence of harm to users (clinicians) or patients during use.	"No injuries of any kind were reported." (across >1,500 procedures)	Simulated Use Studies (2)
	Comparability to Predicate Devices (various safety factors): Includes graduation accuracy and needle guard puncture resistance.	"Bench testing of the product confirms its comparability with legally-marketed predicate devices for a variety of safety factors, including but not limited to graduation accuracy and needle guard puncture resistance."	Bench Testing
	Biocompatibility: Device materials are safe for biological contact.	"Biocompatibility testing was performed by outside contract laboratories, with the results indicating that, from a biocompatibility standpoint, the product is safe for its intended purpose."	Biocompatibility Testing (by outside contract labs)
	Low Risk of Harm (Risk Analysis):	"A detailed risk analysis was performed on the product and, based on information currently available, the risk of harm from the product appears to be relatively low."	Risk Analysis
	Sterilization Efficacy: Achieves required sterility assurance level.	"Sterilization to a SAL of 10⁻⁶ was confirmed during the tests."	Sterilization Validation (by outside contract lab)
	Apyrogenicity: Absence of pyrogens.	"Pyrogenicity was also evaluated and acceptable results obtained."	Sterilization Validation (by outside contract lab)
	Positive Clinician Reaction to Safety Features:	"Clinicians have reacted in a unanimous fashion to those factors." (referring to design factors intended to improve safety)	Qualitiative Clinician Feedback (though statistical study was not performed)

2. Sample Size for Test Set and Data Provenance

Sample Size (Simulated Use Studies): Over 1,500 injections/fluid withdrawals were administered across two simulated use studies.
Data Provenance: The text does not explicitly state the country of origin. Given the manufacturer (Saf-T-Med, Inc. based in Barrington, IL) and the FDA submission, it is highly probable the studies were conducted in the United States. The studies were prospective as they were described as "simulated use studies" performed "to test the effectiveness" and "to test the safety" of the product.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. This device is a physical syringe, not an algorithmic diagnostic device requiring expert interpretation for ground truth.
For the simulated use studies, "a wide variety of clinicians" were used, but their qualifications other than being "clinicians" are not further specified.
For the focus groups, "twenty clinicians" provided feedback. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not Applicable. As this is a physical device testing scenario (simulated use, bench testing), an adjudication method in the context of diagnostic interpretation (like 2+1 radiology review) is not relevant. The "ground truth" for effectiveness was successful completion of the procedures, and for safety, the absence of reported injuries.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Performed. The studies described are not MRMC studies. They focus on the performance and safety of the device itself, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only)

Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance metrics described (e.g., successful injections, no injuries) are the standalone performance of the physical device.

7. Type of Ground Truth Used

Observed Performance/Outcome:
- Effectiveness: "All injections/withdrawals were successfully completed" (direct observation of successful procedure execution).
- Safety: "No injuries of any kind were reported" (direct observation/reporting of adverse events).
- Bench Testing: Conformance to ISO standards, comparability to predicate devices, graduation accuracy, needle guard puncture resistance (measured physical properties).
- Biocompatibility: Laboratory test results.
- Sterilization/Pyrogenicity: Laboratory test results confirming SAL and acceptable pyrogenicity.
- Clinician Feedback: Subjective assessment from clinicians in focus groups and during simulated use regarding ease of use and safety features.

8. Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The design and development of the syringe would have involved engineering and design iterations, but these are distinct from an algorithmic training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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).