Search Results

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.

Ask a specific question about this device

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

Ceftazidime/avibactam has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent.

Active In Vitro and in Clinical Infections Against Citrobacter freundii complex Citrobacter koseri Escherichia coli Enterobacter aerogenes Enterobacter cloacae Klebsiella pneumoniae Klebsiella oxytoca Proteus spp. Pseudomonas aeruginosa

Active In Vitro but clinical significance is unknown Morganella morganii Providencia stuartii Serratia marcescens

The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:

• . BD Phoenix instrument and software.
• . BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents for AST determinations.
• BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. ●
• BD Phoenix AST Broth used for performing AST tests only. ●
• BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth ● determination.

The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a Gram-negative or Gram-positive isolate. Phoenix panels are inoculated with a specified organism density and placed into the instrument. Inoculum for use with the Phoenix system may be prepared either manually or may be automated using the BD Phoenix™ AP System.

The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.

The instrument houses the panels where they are continuously incubated at a nominal temperature of 35° ± 1°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, R or N (susceptible, intermediate, resistant or not susceptible).

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

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

The document references the FDA guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", August 28, 2009 for the acceptance criteria. While the specific numerical thresholds for Essential Agreement (EA) and Category Agreement (CA) from this guidance aren't explicitly stated in the provided text, the reported performance is presented. Typically, for AST devices, acceptance criteria are set for these metrics.

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

• Sample Size for Test Set: 1348 isolates (This is the 'n' value reported for EA and CA).
• Data Provenance:
  • Clinical Studies: The study used "Clinical, stock and challenge isolates".
  • Geographic Origin: Tested "across multiple geographically diverse sites across the United States."
  • Retrospective or Prospective: Not explicitly stated, but the nature of a clinical study comparing to a reference method often involves prospective collection and testing or retrospective testing of collected isolates from clinical settings. The term "Clinical isolates were compared to the results obtained from the CLSI reference broth microdilution method" suggests these were real-world samples. "Challenge isolates" often refers to a pre-defined set of strains used to test specific performance aspects.

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

This information is not explicitly provided in the text. The ground truth for clinical isolates was established by the "CLSI reference broth microdilution method." While this is a standardized laboratory method, the number and qualifications of individuals performing these reference tests (who could be considered experts in applying the reference method) are not detailed.

4. Adjudication method for the test set

This information is not explicitly provided. The comparison is between the BD Phoenix System results and the CLSI reference broth microdilution method results. It's implied that discrepancies were evaluated to determine EA and CA, but a formal adjudication process (e.g., 2+1, 3+1 expert review in case of disagreement between tests) is not 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

This is not an MRMC study. The device is an automated antimicrobial susceptibility testing (AST) system. It performs the test and provides results (MIC values and categorical interpretations) directly, without requiring human "readers" in the same way an imaging or diagnostic AI system would. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply here. This is an automated system being compared to a reference standard.

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

Yes, this is essentially a standalone (algorithm only) performance study. The BD Phoenix Automated Microbiology System is an automated device designed to determine antimicrobial susceptibility without continuous human intervention in the result interpretation once the samples are loaded. The study assesses the performance of this automated system directly against a reference method.

7. The type of ground truth used

• Clinical Isolates: The ground truth for clinical isolates was established by the CLSI reference broth microdilution method. This is a laboratory-based, standardized, and widely accepted "gold standard" method for antimicrobial susceptibility testing.
• Challenge Isolates: The ground truth for challenge isolates was compared to "expected results." This implies a pre-defined, known susceptibility profile for these specific strains, likely determined by the CLSI reference method or other validated methods.

8. The sample size for the training set

The document does not explicitly state the sample size for a training set. The descriptions focus on the validation (test) set. Automated microbiology systems like the BD Phoenix are generally developed and validated extensively over time, but the specific "training set" used for this particular antimicrobial agent's incorporation is not detailed in this regulatory summary. The system itself is "predicated" on an earlier cleared device (VITEK®2), suggesting that the base technology has been "trained" over many years/studies.

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

As the document does not explicitly identify a "training set" for this specific clearance, it also does not describe how its ground truth was established. For the system as a whole, the ground truth would have been established through extensive comparisons to reference methods (like CLSI broth microdilution) during its initial development and subsequent updates.

Ask a specific question about this device

The BD FlowSmart™ set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.

The BD FlowSmart™ set is a subcutaneous administration set intended to interface with commercially available infusion pumps with suitable connections. The infusion set features a flexible perforated catheter perpendicular to an adhesive patch and detachable tubing. The tubing is connected on one end to the medication reservoir of an external infusion pump and on the other end to the patient, attached to the skin by an adhesive base. It is a single-use sterile device.

This document is a 510(k) summary for the BD FlowSmart™ Set, an infusion set. It does not describe an AI/ML powered medical device, therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted.

The document primarily focuses on demonstrating "substantial equivalence" of the BD FlowSmart™ Set to existing predicate devices (Medtronic's MiniMed Quickset and Ypsomed's Orbit Infusion Set). This process typically involves comparing the new device's technological characteristics, intended use, and performance data (often non-clinical testing) to those already cleared devices, rather than establishing acceptance criteria for a novel AI algorithm.

Here's what can be extracted, albeit not directly addressing an AI device's acceptance criteria:

1. Acceptance Criteria and Reported Device Performance (General, not AI-specific): The document states that "Results of these tests were found to be acceptable and demonstrated that the BD FlowSmart™ set met requirements for its intended use and is as safe and as effective as its predicate devices." However, it does not provide a table of specific quantitative acceptance criteria or detailed performance metrics. The testing performed includes broad categories:

   • Biocompatibility: ISO 109993: Biological evaluation of medical devices
   • Functional Performance: ISO 10555-1: Sterile single use intravascular catheters, ISO ID26: Medical Electrical Equipment. Part 2: Particular requirements for the safety of infusion pumps, ISO 1135-1: Sterilization of healthcare products
   • Animal Testing: United States Department of Agriculture (USDA) standards, US Animal Welfare Act
   • Human Factor Evaluations: IEC 62366:2007

   The "reported device performance" is a general statement of meeting requirements and being "as safe and as effective," without specific numerical values.

2. Sample Size and Data Provenance for Test Set: This information is not provided for individual tests. The document refers to "non-clinical testing," "animal testing," and "human factor evaluations," but does not specify the sample sizes within these tests or the data provenance (e.g., country of origin, retrospective/prospective). It's likely that for a device like an infusion set, "test set" wouldn't mean a clinical data set in the same way it would for an AI algorithm.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. The "ground truth" for an infusion set would be adherence to scientific and engineering standards (e.g., material properties, flow rates, sterility) rather than expert interpretation of a clinical dataset.

4. Adjudication Method: Not applicable. This concept is typically relevant to clinical studies involving human interpretation or disagreements, which is not the primary focus here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study assesses the impact of AI on human reader performance, which is not relevant for an infusion set.

6. Standalone (Algorithm Only) Performance: Not applicable. The device is a physical infusion set, not an AI algorithm.

7. Type of Ground Truth Used: The "ground truth" for this device would be established by validated scientific and engineering methods, regulatory standards (like ISO standards), and animal models for biocompatibility and function. It's not based on expert consensus, pathology, or outcomes data in the context of an AI system.

8. Sample Size for Training Set: Not applicable. The device is not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document details the submission for a medical device (infusion set) under the 510(k) pathway, focusing on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not involve an AI/ML component, and therefore, the requested information pertinent to AI device evaluation criteria is not present.

Ask a specific question about this device