(39 days)
Single use devices that are indicated for use as an accessory with prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
The Safety Syringes UltraSafe Delivery System/Needle Guard devices are antineedlestick accessories for pre-filled ISO Standard glass syringes. ISO Standard glass syringes are supplied in multiple sizes. These devices are designed to fit syringe sizes 0.5 mL, 1.0 mL, 1.0 mL long, 1.5 mL, 2.25 mL, 3.00 mL, and 5.0 mL.
This 510(k) summary describes a modification to an existing medical device, the Safety Syringes UltraSafe Delivery System/Needle Guard devices, which are anti-needlestick accessories for pre-filled ISO Standard glass syringes. The modification is an expansion of the Indications for Use to include self-injecting patients and those who assist them, beyond the original limitation to healthcare professionals.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a formal table of acceptance criteria or specific quantitative performance metrics for the device. Instead, it describes a qualitative assessment related to the expanded user group.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Non-healthcare personnel can understand and follow Instructions for Use (IFU) effectively. | "the results of that testing indicates that the devices will perform as intended in the hands of typical nonhealthcare users." |
| Device performance remains safe and effective for the expanded user group. | "No issues have arisen to indicate that this labeling change poses unreasonable risks to non-healthcare professional users." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the "testing" mentioned. It refers to "typical nonhealthcare users" without providing a number.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given it's a premarket notification for a US FDA approval, it's highly likely the testing was conducted in the US. The "testing" appears to be a prospective assessment of user comprehension and device interaction.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not describe the use of "experts" to establish ground truth for the usability testing with non-healthcare personnel. The assessment appears to be based on the ability of the users themselves to perform the task as intended. If "ground truth" refers to the correct execution of the device's function, it's implied that the device design and IFU served as the standard.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Given the nature of the evaluation (user comprehension and device interaction), it's unlikely a formal adjudication process (like 2+1 or 3+1) was used as would be common in diagnostic AI studies. The "testing" would more likely involve observation and direct assessment of task completion and understanding.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and their performance is compared with and without AI assistance. This device is an anti-needlestick accessory, not a diagnostic tool requiring interpretation.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone study was not done. This concept is relevant for AI algorithms. The device itself is a physical accessory designed to be used by humans. The "testing" mentioned focuses on human-in-the-loop performance, specifically the ability of non-healthcare users to correctly use the device.
7. Type of Ground Truth Used
The "ground truth" for the "testing" described is implicitly the intended and correct use of the device as per its design and Instructions for Use (IFU). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic medical device study. Instead, it's about evaluating user compliance and understanding.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning algorithms. This document describes a physical medical device. Therefore, there is no "training set" in the context of AI/ML. The device's design would have undergone engineering and design validation, but not "training" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML context for this device, a method for establishing its ground truth is not applicable or described. The performance of the device itself (e.g., its anti-needlestick effectiveness) would have been established through prior design verification and validation activities for the original device, likely involving engineering tests, material compatibility tests, and potentially simulated use tests. However, the document focuses only on the change in Indications for Use and the associated human factor/usability testing for the new user population.
§ 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).