(73 days)
These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection. The devices contain a piston locking mechanism which aids in the prevention of the accidental reuse of the syringe.
The SOLOGARD® LOCKING PLUS Syringe is a sterile, single-use, disposable hypodermic syringe with a plunger locking feature to prevent the accidental reuse of the syringe. It is manufactured in sizes of 1, 2.5, 3, 5, & 10 ml and is supplied with a G29 x ½" or G29 x 5/8" needle.
This document is a 510(k) summary for the SOLOGARD® LOCKING PLUS Syringe with Needle. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested items, such as multi-reader multi-case studies, expert ground truth, and separate training/test sets, are not applicable to this type of regulatory submission for this device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define acceptance criteria in terms of numerical performance metrics. Instead, the "acceptance criteria" for a 510(k) submission are met by demonstrating substantial equivalence to predicate devices. The reported "performance" is that the device is deemed equivalent.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Becton Dickinson Single Use Hypodermic Syringes and SafeGard Medical Products, Inc. SOLOGARD® LOCKING PLUS Syringe without Needle) | "The performance and use of this device do not differ significantly from the predicate devices. Therefore, SafeGard Medical Products, Inc. believes that this device is equivalent to the predicate devices." (Stated in the 510(k) summary). |
| Includes a plunger locking feature to prevent accidental reuse. | "The SOLOGARD® LOCKING PLUS Syringe with needle is designed with a locking feature which detains the plunger after it is depressed and prevents the plunger withdrawal for a subsequent accidental reuse." |
| Intended for general purpose fluid aspiration/injection by healthcare professionals. | "The syringe is intended for use by health care professionals for general purpose fluid aspiration/injection." |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This 510(k) summary does not describe a "test set" in the context of a performance study for the device's efficacy. The submission focuses on design comparison and intended use equivalence rather than a study with a test set of samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. No experts were used for establishing ground truth in a clinical study as described in this document. The equivalence determination is based on a review of device design specifications and intended use by the FDA.
4. Adjudication Method for the Test Set:
- Not Applicable. There was no "test set" and thus no adjudication method employed as part of a performance study described here.
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:
- Not Applicable. This device is a manual hypodermic syringe, not an AI-powered system or diagnostic imaging device. No MRMC studies were conducted or relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used:
- Not Applicable / Not Explicitly Stated. For a 510(k) for a device like a syringe, the "ground truth" for showing safety and effectiveness is primarily established through:
- Predicate Device Comparison: The established safety and effectiveness of legally marketed predicate devices.
- Engineering/Design Specifications: The design's ability to perform its intended function (e.g., fluid aspiration/injection, locking mechanism integrity). These are usually supported by internal testing data, but such data is not detailed in this summary.
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is not an algorithm or an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set was used.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).