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BD Insulin Syringes are intended for subcutaneous injection of U-100 insulins.

The BD Insulin Syringe, 0.3mL size, is a plastic syringe designed for subcutaneous injection of a desired dose of U-100 insulins. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, cannula shield, stopper, plunger, and plunger cap. The needle is a single ended lubricated stainless-steel cannula, which is permanently attached to the barrel nozzle with an adhesive. The needle is covered by a polyethylene cannula shield which is placed on the barrel. The barrel is molded from polypropylene with the exterior permanently marked with the proper scale markings. The stopper is attached to the plunger and a polyethylene cap is placed over the plunger rod. All products are gamma sterilized. The BD Insulin Syringe, 0.3mL size, are packaged in polybags as self-contained syringes. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years.

The provided text describes a 510(k) premarket notification for the BD Insulin Syringe (0.3mL). This document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove a device meets specific clinical acceptance criteria. Therefore, many of the requested details about a clinical study, such as sample sizes for test and training sets, expert qualifications, and ground truth methodologies, are not applicable or provided.

However, the document does list conformity to recognized standards and performance testing for the device's physical and biological properties.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of "acceptance criteria" against which "reported device performance" is explicitly measured in a comparative numerical way for clinical efficacy. Instead, it states that the device conforms to recognized standards and passed specific performance testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes performance testing (material, sterility, biocompatibility, etc.) but does not detail the sample sizes for these tests, nor does it specify the provenance of the data in terms of country or whether it was retrospective/prospective. As this is not a clinical study, these details would not typically be present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this submission is for a medical device (insulin syringe) and describes physical, chemical, and biological testing, not an algorithmic or diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as this submission is for a medical device (insulin syringe) and describes performance testing, not a study involving human interpretation or adjudication for a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not the subject of this 510(k) submission.

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

A standalone performance study of an algorithm was not done. This type of study is relevant for AI algorithms, which is not the subject of this 510(k) submission.

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

The concept of "ground truth" (in the sense of expert consensus, pathology, or outcomes data) is not applicable to the performance testing described for this medical device. The "ground truth" for physical and biological tests are the established standards and test specifications (e.g., ISO 9626, ISO 8537, USP , ISO 10993-1, etc.) against which the device's measurable physical and chemical properties and biological reactions are evaluated.

8. The sample size for the training set

This information is not applicable as this submission describes a medical device (insulin syringe) and does not involve AI/machine learning requiring training data.

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

This information is not applicable as this submission describes a medical device (insulin syringe) and does not involve AI/machine learning requiring a training set or its associated ground truth.

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Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins

The subject BD Insulin Syringes are a plastic syringe designed for subcutaneous injection of a desired dose of U 100 insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. The BD Insulin Syringes are sterile, single use, and non-pyrogenic. These devices operate on the principles of a piston syringe. The BD Insulin Syringe with 6mm length cannula have a sub-brand name of BD Veo™ Insulin Syringe.

This document describes the premarket notification (510(k)) for the BD Insulin Syringe (K190054). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria in the context of diagnostic performance or clinical outcomes.

However, based on the non-clinical testing section, we can infer the acceptance criteria for various performance aspects and that the device met these criteria through testing.

Here's an interpretation of the requested information, focusing on the available details from the document:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission for an insulin syringe, the "acceptance criteria" discussed are largely related to functional performance and biocompatibility, as defined by international standards. The document states that the "Results of testing demonstrated the BD Insulin Syringes met requirements for its intended use" for all listed tests. Specific numerical acceptance criteria are not provided in this summary, but rather the standards against which compliance was demonstrated.

Specific functional performance tests mentioned under ISO 8537 and ISO 9626 (for which the device met requirements):

• Air Leakage
• Cannula Pull Force
• Hub Pull Force
• Liquid Leakage
• Needle Break-Off Force
• Penetration Force
• Scale Print Permanency
• Shield Pull Force
• Syringe Filling Force
• Syringe Injection Force (Force to Expel Water)
• Volumetric Accuracy
• Dead Space
• Corrosion Resistance

Specific biocompatibility tests mentioned under ISO 10993 (for which the device met requirements):

• Cytotoxicity
• Sensitization (GP Max)
• Sensitization, Intracutaneous Reactivity
• Irritation
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity
• Subacute/Subchronic Toxicity
• Hemocompatibility
• Genotoxicity (Bacterial and Mammalian)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each non-clinical performance and biocompatibility test. It mentions that "required testing was conducted to validate the cumulative modifications." The data provenance (e.g., country of origin) is not detailed, but it would typically be internal testing conducted by Becton Dickinson. These are prospective tests conducted on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. The "ground truth" for a medical syringe is its physical and chemical properties and functional performance, which are evaluated against international standards by laboratory testing, not by expert consensus on clinical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human readers or interpretation. The performance is objectively measured against established criteria in laboratory settings.

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 is not an AI/imaging device or a diagnostic device, and no MRMC study was performed or required.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For this device, the "ground truth" is defined by the technical specifications and performance requirements outlined in the referenced international standards (e.g., ISO 8537, ISO 9626, ISO 10993). Compliance with these standards, as measured by objective laboratory tests, serves as the basis for demonstrating safety and effectiveness.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulin.

The subject BD Insulin Syringes (BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle) are a 1.0mL self-contained plastic syringe designed for subcutaneous injection of a desired dose of insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm, 8mm, 12.7mm and 16mm). The BD Insulin Syringes are sterile, single use, and non-toxic. The fluid path of the syringe is sterile and non-pyrogenic. These devices operate on the principles of a piston syringe.

The document describes the acceptance criteria and the study that proves the device meets those criteria for the BD Ultra-Fine™ Insulin Syringe and related insulin syringes.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general categories of testing and confirms that the results were "acceptable" and met "requirements for its intended use." Based on the provided text, the acceptance criteria are implicitly defined by compliance with ISO standards and the demonstrated equivalence to predicate devices.

• Hemolysis: Acceptable
• Acute Systemic Toxicity: Acceptable
• Intracutaneous Reactivity: Acceptable
• Pyrogenicity: Acceptable
• Sensitization: Acceptable
• Comparative Extractables/Leachables: Acceptable
• Primary Dermal Irritation: Acceptable |
  | Device Functional Performance | - Cannula-Syringe Bond: Acceptable (met requirements)
• Scale Mark Permanency: Acceptable (met requirements)
• Scale Mark Legibility: Acceptable (met requirements)
• Drug Compatibility/Stability: Acceptable (met requirements) |
  | Sterility | Yes (Gamma Irradiation), SAL 10^-6 |
  | Single Use Only | Yes |
  | Non-pyrogenic | Yes |
  | Substantial Equivalence to Predicate Devices | Demonstrated through analysis and testing of modifications. |

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

The document does not specify the sample sizes used for any of the described tests (biocompatibility or functional performance tests).

The data provenance is from non-clinical testing performed by Becton, Dickinson and Company. The document does not provide information regarding the country of origin of the data or whether it was retrospective or prospective, as these are non-clinical (laboratory) tests.

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

This information is not applicable as the study described is non-clinical performance and biocompatibility testing of medical devices, not a study involving human subjects or expert assessment of clinical data to establish ground truth. The "ground truth" here is determined by objective laboratory measurements against established standards (ISO 10993-1, ISO 8537) and internal company specifications.

4. Adjudication Method for the Test Set

This information is not applicable to non-clinical laboratory testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for independent review of patient cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The described study focuses on the physical and chemical properties and performance of an insulin syringe.

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

This concept is not applicable to this device. A standalone algorithm performance study relates to AI/machine learning algorithms. The device in question is a physical insulin syringe, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing is established by:

• Compliance with International Standards: Specifically ISO 10993-1 (Biological evaluation of medical devices) and ISO 8537 (Sterile single-use syringes, with or without needle, for insulin).
• Established Test Methodologies: Standardized laboratory tests for properties like cytotoxicity, bond strength, scale readability, and material compatibility.
• Substantial Equivalence: Comparison against the performance characteristics of predicate devices already cleared by the FDA.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The testing focuses on manufacturing processes, materials, and mechanical/chemical performance.

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

This information is not applicable for the same reason as above.

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BD Insulin Syringes are intended for the subcutaneous injection of insulins

The BD Insulin Syringes - Ultra-Fine™ and Ultra-Fine™ II are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Ultra-Fine™ Insulin Syringe has a 30g x 1/2" (12.7mm) needle and is available in 1cc (100 units), 1/2 cc (50 units), and 1/3 cc (30 units) sizes. The Ultra-Fine™ II 31g x 1/2" (8mm) needle and is available in 1cc (100 units), ½ cc (50 units), and 1/3 cc (30 units) sizes. These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (gamma irradiation sterilization), non-toxic, non-pyrogenic and single use, disposable.

Here's an analysis of the provided information regarding the BD Insulin Syringe K024112, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not specify quantitative acceptance limits (e.g., "pull-out force must be > 5 N"). Instead, the acceptance criteria are implicitly met by demonstrating "equivalence" to the predicate devices across these performance aspects.

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

The document does not provide details on the specific sample sizes used for each of the "bench tests" or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Bench tests relating to the performance of the needle length were conducted."

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

This information is not applicable to this type of device and study. The "ground truth" for the performance tests of an insulin syringe is based on objective physical measurements and engineering specifications, not expert consensus on interpretations like in medical imaging.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the performance tests involve objective physical measurements, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic devices where human readers interpret medical images or data, and the focus is on how an AI system can assist or replace human performance. The BD Insulin Syringe is a physical medical device, not a diagnostic AI tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone study was not performed. This concept applies to AI algorithms. The BD Insulin Syringe is a physical device, and its performance is evaluated through bench tests directly on the device itself.

7. Type of Ground Truth Used

The ground truth used for the performance tests was based on objective engineering and physical measurements demonstrating the functional characteristics of the syringe (e.g., force required for needle pull-out, accuracy of dose delivery). The standard for comparison (the "ground truth" for demonstrating acceptable performance) was the performance of the predicate devices (K941657 and K955235).

8. Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device. The study involves bench testing of a physical product, not training of an algorithm.

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

This is not applicable as this is not an AI/machine learning device, and there is no "training set."

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