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510(k) Data Aggregation
(25 days)
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY
The BD Eclipse™ Needle with SmartSlip™ Technology 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™ Needle with SmartSlip™ Technology is compatible for use with standard luer-slip and luer-lock syringes.
The BD Eclipse™ Needle with SmartSlip™ Technology 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 and K043397 with the metal clip) is a device that is composed of a typical hypodermic needle with a one-piece hub/adapter and pivoting safety cover that is connected to the adapter. The metal clip is inserted into the hub to minimize the incidence of needle detachment from a luer slip tip syringe.
The modified device, BD Eclipse™ Needle with SmartSlip™ Technology, has the same characteristics as the predicate devices except for the clip in the hub. The material of the clip has been changed from metal to plastic. The function of the plastic clip remains the same as the metal. When assembled into the hub. the clip ensures that the needle is attached to a luer slip syringe with sufficient force by the user. The pivoting safety cover can be manually rotated forward after use allowing for secure encapsulation of the needleroint 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™ Needle with SmartSlip™ Technology modified device, the standard BD Hypodermic Needle and the predicate device BD Eclipse™ Hypodermic Needle with the metal clip.
The provided text describes the BD Eclipse™ Needle with SmartSlip™ Technology and its substantial equivalence to predicate devices, focusing on a material change in a clip within the hub. The document details performance testing specifically for this change.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clip engagement force must meet force requirements as specified in the product specification | "The principal device demonstrated equivalent performance to the predicate device during bench testing." |
| Snap Clip Drop Test: clip must remain intact in the hub | "The principal device demonstrated equivalent performance to the predicate device during bench testing." and "The results of these tests demonstrate that the The BD Eclipse™ Needle with SmartSlip™ Technology, modified, perform equivalent to the predicate device and is safe and effective when used as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the bench tests. It broadly states "Bench tests relating to the performance...were conducted."
- Data Provenance: Not explicitly stated, but given it's a submission to the FDA by Becton, Dickinson and Company (a US-based company), the testing was likely conducted in the US or under conditions acceptable for US regulatory submission. The document implies these were internal company tests. The data is retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is not applicable to this submission. The "ground truth" for this device's performance is objective physical measurements and functional tests (e.g., force measurements, structural integrity after a drop test) against predefined engineering specifications, not expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is based on objective physical measurements and performance against specifications, expert adjudication methods (like 2+1 or 3+1 for clinical assessments) are not relevant here. The tests likely involved standardized methods and measurement tools to determine compliance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., radiologists reading images) and the AI's impact on their performance is being evaluated. This submission is for a medical device (a hypodermic needle) where performance is assessed through bench testing against engineering specifications, not through human interpretation of clinical cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent in its physical and mechanical properties.
7. Type of Ground Truth Used
The ground truth used for these performance tests was based on objective engineering specifications and physical measurements. For example:
- Predefined "force requirements" for clip engagement.
- The criterion that the "clip must remain intact" after a drop test.
These are verifiable, quantitative, or qualitative outcomes determined by a product's design specifications.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is based on the physical design and material properties of the needle and its components.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML algorithm requiring training, there is no training set ground truth to establish.
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