(275 days)
The BD Vacutainer® Eclipse™ Blood Collection Needle is a sterile, single-use, medical device specifically intended to be used by healthcare professionals experienced with venipuncture on adults and children in accordance with the instructions for use for the collection of multiple venous blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needlesticks.
The BD Vacutainer® Eclipse™ Blood Collection Needle includes a one-piece double-ended needle/cannula fixed to a plastic hub. One end of the cannula is the intravenous (IV) end, and the other is the non-patient (NP) end covered with a sleeve. The whole device is encased in two plastic covers; one at each end of the cannula to protect the device, with a tamper-evident seal placed around the plastic covers. The protective cover/cap is provided to prevent damage and maintain the needle sterility before the point of use. A safety shield is connected to a hinge on a collar attached to the hub. The safety shield is manually activated by locking over the needle after removal from the vein, providing protection from accidental needlestick injuries.
The BD Vacutainer® Eclipse™ BCN consists of:
- Double-ended hollow stainless-steel cannula
- Threaded polystyrene hub
- Polystyrene collar
- Protective needle sleeve that interrupts blood flow between filling multiple tubes
- Safety shield that can be activated to cover the needle immediately after venipuncture to protect against accidental needle sticks during normal handling and disposal
- Pre-attached holder (for user convenience in some models)
The BD Vacutainer® Eclipse™ Blood Collection Needle with Pre-Attached Holder (PAH) consists of a BD Vacutainer® Eclipse™ Blood Collection Needle threaded and bonded to a BD Vacutainer® One Use Holder. The Eclipse™ BCN with PAH allows for the immediate use of the product without the need for assembling the two components. This provides increased convenience to the user and is designed to help minimize the exposure of the user to the non-patient (NP) end of the needle.
The provided FDA 510(k) clearance letter and summary for the BD Vacutainer® Eclipse™ Blood Collection Needle confirm its clearance based on substantial equivalence to a predicate device. However, this document does not contain specific acceptance criteria, reported device performance data, detailed study designs, or ground truth information typical of a clinical performance study for an AI/ML medical device.
The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance testing and biocompatibility testing, rather than clinical trials comparing diagnostic accuracy or AI performance.
Therefore, many of the requested details for an AI/ML device study, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and training set details, are not applicable or not provided in this type of submission.
Here's a breakdown based on the information available in the document, acknowledging the limitations for an AI/ML device context:
Device: BD Vacutainer® Eclipse™ Blood Collection Needle
The submission is for a medical device (blood collection needle) and not an AI/ML driven diagnostic device. Therefore, the detailed breakdowns requested for AI/ML performance studies are largely not applicable. The provided document details non-clinical performance and biocompatibility studies to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document performs non-clinical (engineering and material) tests to demonstrate that the device meets design specifications and relevant standards. The "acceptance criteria" are implied by compliance with these standards and successful completion of the tests.
| Acceptance Criteria (Implied by Standard/Test) | Reported Device Performance |
|---|---|
| Biocompatibility: | Conforms to ISO 10993-1, -2, -4, -5, -9, -10, -11, -12, -13, -15, -17, -18, -23. Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-mediated Pyrogenicity and Hemocompatibility all demonstrated acceptable. |
| Sterility: | Gamma Irradiation to Sterility Assurance Level (SAL) of 10⁻⁶. Compliant with ISO 556-1, ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2. |
| Sharps Injury Protection: | Complies with ISO 23908:2013 and FDA Guidance "Medical Devices with Sharps Injury Prevention Features (August 2005)". Demonstrated by "Sharps Injury Protection Feature/ ISO 23908– Simulated Use testing". |
| Needle Tubing Standards: | Complies with ISO 9626:2016 for Stainless steel needle tubing. Confirmed by "ISO 9626 - Stainless Steel Needle Tubing testing". |
| Packaging/Sterile Barrier: | Complies with ANSI AAMI ISO 11607-1 and ISO 11607-2. Confirmed by "Sterile Barrier Performance" testing. |
| Mechanical Performance: | Acceptable performance demonstrated for: Cannula-Hub Axial Pull Force, Safety Shield Engagement, Safety Shield Override, Cantilever Force to Break Hub, Sleeve Function, Torque to Break Hub, Torque to Unseat Holder, Holder Spinout from Needle Hub, IV and NP Shield Pull Force, IV and NP Label Torque. |
| Shelf Life: | Demonstrated acceptable performance over 5 years (Eclipse™ BCN) and 3 years (Eclipse™ Pre-Attached) through shelf life testing. |
Specific AI/ML Study Details (Not Applicable for this Device)
As this is a traditional medical device (blood collection needle) and not an AI/ML driven diagnostic device, the following points are not applicable and therefore, no information is provided in the document:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance was evaluated through non-clinical bench testing and material compatibility.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is based on engineering specifications, material standards, and validated testing protocols.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is for an AI/ML comparative study, which this device is not.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth is established by engineering specifications, international standards (e.g., ISO, AAMI), material properties, and validated test methods.
- The sample size for the training set: Not applicable. There is no AI/ML model for this device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document demonstrates the BD Vacutainer® Eclipse™ Blood Collection Needle meets its acceptance criteria through a comprehensive set of non-clinical performance tests and biocompatibility evaluations, ensuring it is safe and effective and substantially equivalent to a predicate device. The information requested regarding AI/ML specific study details is not part of this type of traditional device approval process.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.