Search Results

The BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.

The BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle is intended for use by health care professionals 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 contains a mechanism that covers the needlepoint 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 1mL Luer-Lok™ Insulin Syringe is intended for subcutaneous injection of U-100 insulin.

The BD 1mL Luer-Lok™ Hypodermic Syringe and BD 1mL Luer-Lok™ Insulin Syringe are three-piece sterile, single use, hypodermic syringes with male 6% (Luer) conical lock fittings, which are connectable to a compatible female 6% (Luer) connector. The syringe assemblies for both products are identical and consist of a lubricated styrene acrylic copolymer barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the BD 1mL Luer-Lok™ Hypodermic Syringe incorporates a scale graduated in units of milliliters, while the barrel scale of the BD 1mL Luer-Lok™ Insulin Syringe incorporates a scale graduated in units of insulin.

The BD 1mL Luer-Lok™ Hypodermic Syringe is provided sterile by an irradiation sterilization method in a syringe only configuration or with a BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle.

The BD 1mL Luer-Lok™ Insulin Syringe is provided sterile by an irradiation sterilization method in a syringe only configuration.

The modified BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe include a change in the barrel resin material from a polycarbonate resin to a styrene acrylic copolymer resin. The syringe performance characteristics are equivalent to the predicate device.

The document describes a 510(k) premarket notification for Becton, Dickinson and Company for various 1mL Luer-Lok™ syringes. The submission claims substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is titled "Non-Clinical Testing" and "design verification testing." The document states that "the results of these tests demonstrate that the BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe performed in an equivalent manner to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not specify the sample size used for any of the non-clinical or design verification tests.
• Data Provenance: The data provenance is implied to be from internal testing conducted by Becton, Dickinson and Company. The country of origin is not explicitly stated, but the company is based in Franklin Lakes, New Jersey, USA. The testing is retrospective in the sense that it evaluates the performance of a manufactured device against established criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document. For non-clinical testing of medical devices, "experts" typically refer to qualified laboratory personnel or engineers with expertise in the relevant testing methodologies and standards (e.g., ISO 10993 for biocompatibility).

4. Adjudication Method for the Test Set:

• The document does not describe any adjudication method. For non-clinical testing, adjudication (like 2+1 or 3+1 for clinical evaluations) is generally not applicable in the same way. The results are typically quantitative measurements or qualitative assessments against defined standards.

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:

• No MRMC comparative effectiveness study was done. This submission is for a medical device (syringes), not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance. The document explicitly states: "Clinical testing was not required for this submission."

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

• No standalone algorithm performance study was done. This device is a physical medical instrument (syringe), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The "ground truth" for the non-clinical testing is implicitly based on established performance standards and predicate device performance. For functional tests like "Break Out Force" or "Sustaining Force," the ground truth is often a range of acceptable values or comparability to the predicate device's performance. For biocompatibility tests, the ground truth is defined by international standards (e.g., ISO 10993 series) which specify methodologies and acceptance criteria (e.g., "non-hemolytic," "non-toxic"). Similarly, for insulin compatibility, the ground truth is simply a "Pass" result against a defined test.

8. The Sample Size for the Training Set:

• This information is not applicable. Since this device is a physical product and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The design and manufacturing process would involve engineering principles and material science, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable as there is no training set for this type of medical device submission.

Ask a specific question about this device

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

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.

Ask a specific question about this device

The BD Eclipse™ Hypodermic Needle 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™ Hypodermic Needle is compatible for use with standard luer-slip and luer-lock syringes.

The BD Eclipse™ Hypodermic Needle 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) 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 hub of the modified device has a metal clip assembled in it to ensure that the BD Eclipse™ Hypodermic Needle is attached to a luer slip syringe with sufficient force by the user. The pivoting cover can be manually rotated forward after use allowing for secure encapsulation of the needlepoint 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™ Hypodermic Needle, modified device, the standard BD Hypodermic Needle and the predicate device BD Eclipse™ Hypodermic Needle.

The document describes a 510(k) premarket notification for a modified BD Eclipse™ Hypodermic Needle. The primary focus of the submission is to demonstrate substantial equivalence to a predicate device, which is the original BD Eclipse™ Hypodermic Needle.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define quantitative acceptance criteria for specific performance metrics in a readily digestible table. Instead, it relies on demonstrating equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the exact sample sizes for the "Bench tests" and "Simulated Use Test."
• Data Provenance: The data appears to be prospective, as new "Bench tests and Simulated Use Test" were conducted for the modified device. The country of origin is not explicitly stated, but the submission is to the US FDA and the manufacturer is based in New Jersey, USA, suggesting the tests were likely conducted in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This type of information is not applicable to this device submission. The tests performed are engineering-focused (bench tests and simulated use) rather than clinical studies requiring expert interpretation of diagnostic images or patient outcomes. The "ground truth" for these tests would be objective measurements and observations of the device's physical performance, not expert consensus on medical findings.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially for assessing diagnostic accuracy where expert disagreement on ground truth might occur. The tests described are direct performance evaluations.

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 evaluating the impact of a diagnostic aid (like AI) on physician performance. The BD Eclipse™ Hypodermic Needle is a physical medical device, not a diagnostic aid or software, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:

This question is not applicable as the device is a physical hypodermic needle and not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the BD Eclipse™ Hypodermic Needle would be:

• Objective Engineering Measurements: For characteristics like needle dimensions, attachment force, and the functionality of the safety mechanism.
• Direct Observation and Verification: During "Simulated Use Tests" to confirm proper function, secure encapsulation, and protection against accidental needle sticks.
• Comparison to Predicate Device Performance: The primary ground truth is the established performance characteristics and safety profile of the legally marketed predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set.

Ask a specific question about this device

Ask a specific question about this device