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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

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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The primary function of the NOVAguard™ Safety Needle is for the injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin. The needle stick prevention feature helps prevent accidental needle sticks by shielding the needle after use.

NOV Aguard™ is a sharps injury protection device with a passively activated safety shield. The NOV Aguard™ product has a female luer connector, compatible with a luer-lock syringe, on one side and a stainless steel cannula on the other. A shield is mounted around the cannula. This product is packaged in a rigid container sealed by a Tyvek lid to facilitate sterilization. The product is removed from the package and connected to a luer-lock syringe simultaneously; this is accomplished when attaching the syringe, turning it in a clockwise direction. During this process, the shield is automatically moved to a position where the cannula tip is exposed so that the user can easily see it. An injection is given using the standard common technique. Inserting the cannula into the patient displaces the shield causing the shield legs to move apart and act like a spring. Upon removal, the spring force of the shield legs forces the shield over the tip of the cannula into a locked position.

The NOV Aguard™ Safety Needle is an assembly of three components. A cannula, a hub and a safety shield.

The provided text describes a 510(k) submission for the NOVAguard™ Safety Needle, asserting its substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria. Therefore, the information requested in the prompt based on "acceptance criteria" and a "study that proves the device meets the acceptance criteria" is largely not present in the provided document.

Here's an analysis based on the information available and what is not present:

Missing Information:
The document does not provide:

• A table of specific acceptance criteria (e.g., minimum performance thresholds for parameters like activation force, shield engagement time, etc.).
• Reported device performance against such specific criteria.
• Details of a standalone study specifically designed to prove acceptance criteria (e.g., a performance study with a test set, ground truth, expert readers, etc.). This document focuses on demonstrating substantial equivalence to already approved predicate devices.
• Sample sizes for a test or training set in the context of performance evaluation.
• Data provenance for such tests.
• Citations of experts, their qualifications, or adjudication methods for establishing ground truth for performance.
• Information about a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Information on how ground truth for training or test sets was established.

Information that can be inferred or is partially present:

The document asserts the device's safety and effectiveness implicitly through its comparison to predicate devices, and through general quality control measures.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The "acceptance criteria" here are inferred from the claims of the 510(k) submission regarding its similarity to predicate devices and general regulatory compliance rather than explicit metrics from a performance study.

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

• Sample Size: Not specified for any performance testing. The submission relies on demonstrating substantial equivalence, not novel performance data from a specific test set.
• Data Provenance: Not applicable in the context of a performance study test set. The biocompatibility testing likely involved laboratory tests following international standards.

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

• Not applicable. The document does not describe a performance study involving expert assessment or ground truth establishment for a test set.

4. Adjudication method for the test set:

• Not applicable. No test set adjudication method is described.

5. 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 device is a physical medical device (safety needle), not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

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

• Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For biocompatibility: Ground truth was established by adherence to FDA General Program Memorandum #G95-1 and ISO-10993 testing results.
• For manufacturing quality: Finished products are tested against "required release specifications." The specific criteria for these specifications are not detailed in the summary but would constitute the "ground truth" for manufacturing quality.
• For functional aspects (e.g., safety shield activation, luer-lock compatibility): Implied to be verified through engineering and functional testing, comparing favorably to predicate devices, though specific "ground truth" methodologies are not described.

8. The sample size for the training set:

• Not applicable. No "training set" in the context of a machine learning algorithm is mentioned.

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

• Not applicable.

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