(31 days)
The BD Eclipse™M Hypodermic Need 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-lock syringes.
The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards accidental needle sticks during normal handling and disposal of the used needle/ syringe combination.
The BD Eclipse™ Hypodermic Needle 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 pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint making the product safe for disposal. These needles have a regular, short or intradermal bevel type. The needle assembly is protected with a polypropylene shield.
The Eclipse™ Hypodermic Needles are offered in a variety of gauge sizes (18-30 gauge) and needle length (½''- 1/2''). The needle hub is color-coded to the appropriate gauge needle per ISO 6009.
The BD Eclipse™ Hypodermic Needle hub incorporates a female 6% (Luer) connector which can be used with a compatible male 6% (Luer) connector. The BD Eclipse™ Hypodermic Needle is not to be used with luer-slip syringe as the needle may become disengaged from the syringe when activating the safety cover. This product is single use and provided sterile.
The change described in this submission is the replacement of current silicone based HCFC-containing needle lubricant with silicone based HCFC-free lubricant.
The provided document describes the FDA 510(k) summary for the BD Eclipse™ Hypodermic Needle (K161170). This document is for a medical device (hypodermic needle) and does not contain information related to an AI/ML powered device, nor does it describe a study involving human readers or ground truth established by experts/pathology for algorithm training or testing.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML powered device, as the document does not pertain to such a device.
The document discusses the substantial equivalence of the new BD Eclipse™ Hypodermic Needle (K161170) to a predicate device (K010188), primarily due to a change in the needle lubricant and some additional needle length/gauge sizes. The evaluations performed are typical for a conventional medical device modification, focusing on physical performance characteristics and biocompatibility.
Here's what can be extracted from the document, tailored as much as possible to the request, but highlighting the absence of AI-specific information:
Description of Acceptance Criteria and Studies (Conventional Device)
The device being reviewed is the BD Eclipse™ Hypodermic Needle, which is a conventional medical device (not AI-powered). The acceptance criteria and studies are related to the physical and functional performance of the needle, and its biocompatibility. The primary change in this submission is the replacement of a silicone-based HCFC-containing needle lubricant with an HCFC-free lubricant.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Met Internal BD Specification or Standard) | Reported Device Performance (Summary) |
|---|---|---|
| Functional Testing | ||
| Hub Color | Per ISO 6009 | Met ISO 6009 |
| Hub/Needle Bond Strength | Met internal BD specification | Met internal BD specification |
| Needle Penetration Test | Met internal BD specification | Met internal BD specification |
| Needle Shield Removal Forces | Met internal BD specification | Met internal BD specification |
| Leak Testing | Per ISO 594-2 | Met ISO 594-2 |
| Sterilization | ||
| Process | Per ISO 11135 | Performed per ISO 11135 |
| SAL Level | SAL 10-6 | SAL 10-6 |
| Shelf Life | ||
| Durability | 5 Years | Demonstrated 5 years |
| Biocompatibility | Per ISO 10993-1, including specific tests | Acceptable according to ISO 10993-1 |
| Safety Mechanism Performance | Predetermined acceptance criteria (e.g., activation/unlocking forces, impact resistance) | Met predetermined acceptance criteria |
| Cannula Pull-out Forces | Predetermined acceptance criteria | Met predetermined acceptance criteria |
| Ship Test | Predetermined acceptance criteria | Ensured needle/safety shield integrity |
| Risk Management | In accordance with ISO 14971 | Performed in accordance with ISO 14971 |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each test mentioned (e.g., Hub/Needle Bond Strength, Needle Penetration Test). It refers to "validation/verification/verification activities" and "Design Verification activities." The data provenance is internal to Becton, Dickinson and Company's testing procedures. It is implicitly "prospective" in the sense that the new device (with the changed lubricant) was tested, but the data itself is from internal laboratory testing, not clinical trials or population data from specific countries.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not applicable to this submission. The "ground truth" for a hypodermic needle's performance is established by objective engineering specifications, international standards (e.g., ISO), and internal company specifications, not by human experts adjudicating clinical or imaging data.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" in the context of physical performance testing of a hypodermic needle. Results are measured against predefined numerical or qualitative standards.
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 diagnostic or screening devices where human interpretation is involved. This is a hypodermic needle.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an algorithm or AI-powered device.
7. The type of ground truth used
The "ground truth" for this device's performance is established by:
- International Standards: e.g., ISO 6009 for hub color coding, ISO 594-2 for leak testing, ISO 11135 for sterilization, ISO 10993-1 for biocompatibility, ISO 14971 for risk management.
- Internal BD Specifications: For characteristics like Hub/Needle Bond Strength, Needle Penetration Test, Needle Shield Removal Forces, cannula pull-out forces, activation/unlocking forces, impact resistance, and ship testing.
- Objective Measurements: Laboratory and engineering tests generate quantitative data that is compared against these predefined standards and specifications.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is not an AI/ML device.
§ 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).