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The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle is a sterile, single use, medical device specifically intended to be used by trained healthcare professionals in accordance with the instructions for use for the collection of multiple blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. The device incorporates a flash technology to indicate venous access and a hinged safety shield. In the activated position, the safety shield protects against an accidental needle stick injury during normal handling and disposal.

The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle is a sterile, single use, straight blood collection needle intended to be used by a trained Healthcare Worker (HCW) for conducting venipuncture. The device consists of a stainless steel cannula bonded into the front needle hub which is the intravenous (IV) end that is inserted into the patient's vein and nonpatient (np) cannula that is inserted into a holder. Blood collection tubes are inserted for venous blood collection. The device contains an additional blood flash visibility feature to provide the HCW with confirmation that the vein has been accessed.

After blood collection, when the needle is removed from a vein, a drop of blood may form at the IV patient end of the needle. This droplet may cause blood splatter during activation of the safety shield. The Eclipse™ Signal™ Blood Collection Needle minimizes the size of the blood droplet and by design, draws the blood into the lumen of the needle and away from the healthcare professional.

The Eclipse™ Signal™ BCN has the same pivoting safety shield as the predicate Eclipse™ BCN. The device has a pivoting safety shield which is designed to be activated using a single-handed technique and gives an audible confirmation of the safety lock engagement. The shield locks over and covers the needle after use, protecting the healthcare worker from an accidental needle stick injury.

The needles are manufactured in specific diameters and lengths. The color of the IV shield indicates the needle gauge (green shield for the 21G needle and black shield for the 22G needle).

The purpose of this Traditional 510(k) is to expand the product family with an additional safety blood collection needle with a flash visibility feature. The premarket notification also includes other small modifications to the needle hub, needle cannula, integrated holder and safety shield, The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle has the same intended use, operating principles and performance and scientific technology as the predicate device.

There are two variants of Eclipse™ Signal™ Blood Collection Needle (BCN) and a total of 4 models.

• BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle, 21G and 22G .
• BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle with Integrated Holder, . 21G and 22G.

The document provided describes the BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle (K170824) and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:

Description of Device and Claims:

The BD Vacutainer® Eclipse™ Signal™ Blood Collection Needle is a sterile, single-use blood collection needle intended for use by trained healthcare professionals for collecting multiple blood samples for in vitro diagnostic testing. Key features include:

• Flash technology to indicate venous access.
• Hinged safety shield for protection against accidental needle stick injuries during handling and disposal.
• Minimizes blood droplet size and draws blood into the lumen to reduce blood splatter during safety shield activation.

Acceptance Criteria and Reported Device Performance:

The document does not explicitly list "acceptance criteria" in a separate section with specific numerical targets. Instead, it states that "The results of all these tests either met the predetermined acceptance criteria and BD's internal specification or performed to the standard." and "The results of these activities... either met BD's internal specification or performed according to the standard." The performance data section broadly describes the types of tests conducted:

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify the numerical sample sizes for any of the performance tests (e.g., number of needles tested for bond strength, number of samples for hemolysis).
   • Data Provenance: The studies appear to be internal laboratory studies conducted by Becton, Dickinson and Company ("BD's internal specification"). No information is provided regarding the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) submission for a medical device (not AI), these are typically lab-based design verification and validation tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable in the context of this device and submission. The device is a physical blood collection needle, not a diagnostic AI algorithm that requires expert adjudication of image data or similar. The "ground truth" for its performance is objective physical characteristics and material compatibility, measured by instruments and standardized methods, not expert consensus.

3. Adjudication method for the test set:

   • Not applicable. See point 2.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This study is for a physical medical device (blood collection needle), not an AI diagnostic algorithm. Therefore, MRMC studies and AI assistance metrics are irrelevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This study is for a physical medical device.

6. The type of ground truth used:

   • The "ground truth" for the performance studies of the blood collection needle is based on objective measurements, quantitative results from standardized tests, and compliance with recognized industry standards (e.g., ISO 10993 for biocompatibility, ISO 6009 for hub color) and BD's own internal product specifications. For example, "Needle Penetration" would involve measuring force or success rate, not expert opinion.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

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