(19 days)
The BD Eclipse™ Hypodermic Needle is used for general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse™ Hypodermic Needle is compatible for use with standard luer-slip and luer-lock syringes.
The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needle point after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
The BD Eclipse™ Hypodermic Needle (BD Eclipse™ Hypodermic Needle 510(k): K010188) is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting cover that is connected to the adapter. The hub of the modified device has a metal clip assembled in it to ensure that the BD Eclipse™ Hypodermic Needle is attached to a luer slip syringe with sufficient force by the user. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint making the product safe for disposal.
The basic needle dimensions (diameter, injection length, needle tip geometry, materials and lubrication) are the same for the BD Eclipse™ Hypodermic Needle, modified device, the standard BD Hypodermic Needle and the predicate device BD Eclipse™ Hypodermic Needle.
The document describes a 510(k) premarket notification for a modified BD Eclipse™ Hypodermic Needle. The primary focus of the submission is to demonstrate substantial equivalence to a predicate device, which is the original BD Eclipse™ Hypodermic Needle.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define quantitative acceptance criteria for specific performance metrics in a readily digestible table. Instead, it relies on demonstrating equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs equivalently to the predicate device | Bench tests and Simulated Use Tests demonstrate equivalence to the predicate device. |
| Safe and effective when used as intended | Bench tests and Simulated Use Tests demonstrate the device is safe and effective when used as intended. |
| Maintains basic needle dimensions (diameter, injection length, needle tip geometry, materials, lubrication) | The basic needle dimensions are the same as the predicate device. |
| Attached with sufficient force to a luer slip syringe | The metal clip ensures the device is attached to a luer slip syringe with sufficient force. |
| Securely encapsulates the needlepoint after use | The pivoting cover can be manually rotated forward after use, allowing for secure encapsulation. |
| Guards against accidental needle sticks in activated position | The needle cover guards against accidental needle sticks during normal handling and disposal. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes for the "Bench tests" and "Simulated Use Test."
- Data Provenance: The data appears to be prospective, as new "Bench tests and Simulated Use Test" were conducted for the modified device. The country of origin is not explicitly stated, but the submission is to the US FDA and the manufacturer is based in New Jersey, USA, suggesting the tests were likely conducted in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This type of information is not applicable to this device submission. The tests performed are engineering-focused (bench tests and simulated use) rather than clinical studies requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" for these tests would be objective measurements and observations of the device's physical performance, not expert consensus on medical findings.
4. Adjudication Method for the Test Set:
This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially for assessing diagnostic accuracy where expert disagreement on ground truth might occur. The tests described are direct performance evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic aid (like AI) on physician performance. The BD Eclipse™ Hypodermic Needle is a physical medical device, not a diagnostic aid or software, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
This question is not applicable as the device is a physical hypodermic needle and not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation of the BD Eclipse™ Hypodermic Needle would be:
- Objective Engineering Measurements: For characteristics like needle dimensions, attachment force, and the functionality of the safety mechanism.
- Direct Observation and Verification: During "Simulated Use Tests" to confirm proper function, secure encapsulation, and protection against accidental needle sticks.
- Comparison to Predicate Device Performance: The primary ground truth is the established performance characteristics and safety profile of the legally marketed predicate device.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set.
§ 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).