(64 days)
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector in 1ml Luer Slip. 3ml. 10ml and 20ml Luer Lok syringe sizes. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated plastic barrel with a graduated scale, a lubricated synthetic rubber stopper and a plastic plunger rod. The plunger rod is pulled along the inside of the barrel to aspirate fluids and pushed along the inside of the barrel to inject or expel fluids. The syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The BD Single Use, Hypodermic Syringe are provided sterile (EtO) in a syringe only configuration or with a hypodermic needle. The modified BD Single Use, Hypodermic Syringe includes a new resin material in the barrel of the syringe. The syringe performance characteristics are equivalent to the predicate device.
The provided document describes the FDA 510(k) summary for the BD Single Use, Hypodermic Syringe, focusing on its substantial equivalence to a predicate device. This is primarily a regulatory submission based on non-clinical testing and comparison to an existing device, rather than a study demonstrating clinical performance of a novel AI-powered device. Therefore, many of the requested categories related to AI studies (e.g., MRMC, standalone algorithm, training set size, expert qualifications for ground truth) are not applicable to this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Testing | ||
| Break Out Force | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Sustaining Force | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Flange Bend Force | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Dimensional Stability of Barrel ID (inner diameter) | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Barrel Scale Permanency | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Barrel Impact Test | Equivalence to Predicate | Performed in an equivalent manner to the predicate device. |
| Biocompatibility Testing | ||
| Cytotoxicity | Per ISO10993-5, Non-toxic | Non-toxic |
| Hemolysis | Per ISO10993-4, Non-toxic | Non-toxic |
| Acute Systemic Toxicity | Per ISO10993-11, Non-toxic | Non-toxic |
| Intracutaneous Reactivity | Per ISO10993-10, Non-Irritant | Non-Irritant |
| Sensitization | Per ISO10993-10, Non-Sensitizer | Non-Sensitizer |
| Pyrogenicity | Per ISO 10993-11 and USP 151, Non-Pyrogenic | Non-Pyrogenic |
| Chemical Extractable Analysis | Per ISO 10993-18, acceptable level of extracts. | Acceptable level of extracts. |
| Sterilization | SAL $10^{-6}$ | SAL $10^{-6}$ |
| Shelf Life | 5 Years | 5 Years |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test. The testing was conducted by BD (Becton, Dickinson and Company) to demonstrate equivalence to a predicate device. The data provenance is internal testing performed by the manufacturer, likely in a controlled laboratory environment. The country of origin of the data is not explicitly stated but would be associated with BD's testing facilities. These were non-clinical tests, not involving human subjects or real-world patient data in the typical sense of a test set for an AI/algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. For non-clinical tests like "Break Out Force" or "Cytotoxicity," the "ground truth" is established by the standardized test methods and their defined pass/fail criteria (e.g., ISO standards, equivalence to predicate device), not by clinical experts.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are relevant for clinical studies where subjective expert assessment is involved. For these non-clinical tests, the results are typically quantitative measurements compared against predefined criteria or the performance of a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This document does not pertain to an AI device or an MRMC study. It is for a physical medical device (hypodermic syringe) demonstrating substantial equivalence through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is not an AI/algorithm device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on:
- Standardized Test Methods: Adherence to established international standards (e.g., ISO 10993 for biocompatibility, USP 151 for pyrogenicity).
- Predicate Device Performance: Demonstrating performance equivalent to the legally marketed predicate device (K980987 BD Single Use, Hypodermic Syringe).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).