(159 days)
The Sol-Care Safety Hypodermic Needle is used in conjunction with a standard syringe. This device is used for aspiration and administration of medication.
The Sol-Care Safety Hypodermic Needle safety mechanism covers the needle after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
The Sol-Care Safety Needle is a sterile, single use, standard hypodermic needle with a shield to enclose the needle after use. The device is available in 18 to 30 gauge and in lengths from 3/8" to 1-1/2". In addition, the needle tip is available in a regular bevel.
The Sol-Care Safety Needle has a shield that covers the needle point after use. In the activated position, the needle shield guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
The Sol-Care Safety Needles are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
Here's a breakdown of the acceptance criteria and the study information for the Sol-Care Safety Needle, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|
| ISO 7864:1993, Sterile Hypodermic Needles for Single Use | Met appropriate requirements |
| ISO 594-2:1998, Conical Fittings with a 6% (Luer) Taper | Met appropriate requirements |
| ISO 9626:1991, Stainless Steel Needle Tubing for Medical Devices | Met appropriate requirements |
| ISO 14971:2009, Medical Devices, Application of Risk Analysis | Met appropriate requirements |
| ISO 11135:2007, Medical Apparatus Epoxy Ethane Sterilization | Met appropriate requirements |
| ISO 11607-1, 1:2006, Packaging for Terminally Sterilized Medical Devices | Met appropriate requirements |
| ISO 10993-1:2006, Biological Evaluation of Medical Devices Part 1 | Met appropriate requirements |
| ISO 23908:2007, Sharps Injury Protection Requirements and Test Methods | Met appropriate requirements |
| FDA Guidance on Premarket Notification [510(k)] for Hypodermic Needles (1993) | Met appropriate requirements |
| Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features (2005) | Met appropriate requirements |
| All Product Specifications and Requirements | Device met all product specifications and requirements |
| Performance over Life of Device (Accelerated Aging) | Verified performance over the life of the device |
| Safety and Effectiveness for Intended Use (Simulated Use Study) | Concluded to be safe and effective for intended use |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the Simulated Use Study. It only states that a "Simulated Use Study was conducted."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications for the Simulated Use Study.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set in the Simulated Use Study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as described in the provided summary. The study mentioned is a "Simulated Use Study" for the device itself, not a comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study, as typically understood for algorithms, was not conducted as this device is a physical medical device (a safety needle), not an AI algorithm. The "Simulated Use Study" evaluates the device's physical safety mechanism.
7. Type of Ground Truth Used
For the "Simulated Use Study," the type of ground truth would be based on the objective criteria of sharps injury prevention and proper function of the safety mechanism as defined by the relevant standards (e.g., ISO 23908:2007). It isn't explicitly stated as expert consensus, pathology, or outcomes data in the traditional sense, but rather adherence to performance standards and avoidance of accidental needle sticks in a simulated environment.
8. Sample Size for the Training Set
The document does not specify a training set sample size. This is a physical device, and the evaluation relies on adherence to engineering and safety standards, rather than machine learning training data.
9. How Ground Truth for the Training Set Was Established
Since this is a physical device and not an AI algorithm, there is no "training set" in the context of machine learning. The "ground truth" for the device's design and performance is established through adherence to recognized international and FDA standards for medical devices and safety features. The "Simulated Use Study" would verify that the device performs as intended in accordance with these established standards.
§ 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).