(77 days)
The BD Intima II IV Catheter is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly.
The Intima II IV Catheter consists of a Vialon® material catheter, a notched needle to enhance flashback visualization, septum, extension tubing and either a straight or Y Luer connector. A needle-accessed PRN is attached to the Luer connector. An end cap is attached to the second Luer connector on the Y design. Blood is contained within the device. A slide clamp is provided on the extension tube. A notched needle resides within the catheter until it is withdrawn through the septum after the catheter has been threaded into the vein. The needle unit includes a paddle that is held during the insertion process. This device does not include a needle-shielding mechanism.
The provided 510(k) summary for the BD Intima II™ IV Catheter (K100775) describes non-clinical tests to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting with defined performance metrics for AI.
Therefore, the requested information elements related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI are not applicable to this document. This submission focuses on traditional medical device testing for safety and effectiveness.
However, I can extract information regarding the non-clinical test results which serve as the "acceptance criteria" and "reported device performance" in the context of this traditional device submission.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BD Intima II™ IV Catheter are based on compliance with various ISO standards and in-house protocols. The reported device performance is indicated by "Passed" for each test.
| Test | Test Method | Acceptance Criteria (Implied by Standard Compliance) | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | Conformance to ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity). This standard specifies methods to assess the in vitro cytotoxicity of medical devices. The implied acceptance criterion is no cytotoxic effect beyond acceptable limits, as defined by the standard. | Passed |
| Sensitization | ISO 10993-10 | Conformance to ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization). This standard specifies tests for the assessment of irritation and skin sensitization potential of medical devices. The implied acceptance criterion is no significant sensitization reaction beyond acceptable limits. | Passed |
| Irritation or Intracutaneous Reactivity | ISO 10993-10 | Conformance to ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization). This standard specifies tests for the assessment of irritation and skin sensitization potential of medical devices, including intracutaneous reactivity. The implied acceptance criterion is no significant irritation or intracutaneous reactivity beyond acceptable limits. | Passed |
| Acute Systemic Toxicity | ISO 10993-11 | Conformance to ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity). This standard specifies procedures for the assessment of systemic toxicity produced by medical devices. The implied acceptance criterion is no acute systemic toxic effects beyond acceptable limits. | Passed |
| Subacute or Subchronic Toxicity | ISO 10993-11 | Conformance to ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity). This standard specifies procedures for the assessment of systemic toxicity produced by medical devices, including subacute/subchronic effects. The implied acceptance criterion is no subacute or subchronic systemic toxic effects beyond acceptable limits. | Passed |
| Genotoxicity | ISO 10993-3 | Conformance to ISO 10993-3 (Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity). This standard covers the assessment of genotoxic potential. The implied acceptance criterion is no genotoxic effects beyond acceptable limits. | Passed |
| Implantation | ISO 10993-6 | Conformance to ISO 10993-6 (Biological evaluation of medical devices - Part 6: Tests for local effects after implantation). This standard specifies methods for the assessment of local tissue responses to medical devices after implantation. The implied acceptance criterion is an acceptable local tissue response. | Passed |
| Hemocompatibility | ISO 10993-4 | Conformance to ISO 10993-4 (Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood). This standard provides guidance for assessing the interaction of medical devices with blood. The implied acceptance criterion is no adverse interactions with blood that would lead to safety concerns. | Passed |
| Biocompatibility (overall) | ISO 10993-1 | Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) and FDA Blue Book Memorandum #G95-1. The implied acceptance criterion is that the device material is biologically safe for its intended use. | Passed (Overall Statement) |
| Distal end configuration | ISO 10555-5 | Conformance to ISO 10555-5 (Sterile, single-use intravascular catheters - Part 5: Peripheral intravascular catheters). This standard covers various physical characteristics of these catheters, including distal end configuration. The implied acceptance criterion is that the configuration meets the specified requirements of the standard. | Determined substantially equivalent |
| Minimum catheter/adapter bond strength | In-house protocol | Demonstrated bond strength comparable or superior to the predicate devices and sufficient for safe use. (Specific values not provided in summary). | Determined substantially equivalent |
| Maximum cannula penetration force | In-house protocol | Penetration force comparable or superior to the predicate devices, ensuring ease of insertion without excessive force/damage. (Specific values not provided in summary). | Determined substantially equivalent |
| Maximum catheter tip penetration | In-house protocol | Tip penetration characteristics comparable or superior to predicate devices, ensuring proper and safe insertion. (Specific values not provided in summary). | Determined substantially equivalent |
| Maximum catheter drag | In-house protocol | Catheter drag force comparable or superior to predicate devices, ensuring smooth insertion and removal. (Specific values not provided in summary). | Determined substantially equivalent |
| Luer Lock fittings | ISO 594/2 | Conformance to ISO 594-2 (Conical fittings with 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 2: Lock fittings). This ensures proper and secure connection with other Luer fittings. The acceptance criterion is compliance with the dimensional and performance requirements of this standard. | Conformed with all sections |
| General Requirements for Catheters | ISO 10555-1 | Conformance to ISO 10555-1 (Sterile, single-use intravascular catheters -. Part 1 General Requirements). This standard specifies general requirements for single-use intravascular catheters. The acceptance criterion is compliance with all sections of this standard. | Conformed with all sections |
| Shelf Life (Stability) | In-house protocol | The device must maintain its safety and effectiveness characteristics over a specified period. The acceptance criterion is demonstration of these characteristics for the claimed shelf life. | Supported a shelf life of 3 years |
Study Details (Relevant to this Traditional Device Submission)
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Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes for the individual non-clinical tests (e.g., number of catheters tested for bond strength). It refers to "in-house protocol" for some tests and specifies compliance with ISO standards, which typically outline sample size requirements, but the specifics are not detailed in this summary.
- All data provenance is in vitro or in vivo animal testing (for biocompatibility components like implantation, sensitization), conducted by the submitting company (Becton Dickinson Infusion Therapy Systems Inc.) or their contracted labs. This is not human clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this non-clinical submission. "Ground truth" in this context is defined by objective measurements against established international standards (ISO) and internal protocols. Expert opinion is not used to establish truth for these performance metrics.
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Adjudication method for the test set:
- Not applicable. Results are typically based on quantitative measurements and pass/fail criteria defined by the test methods and standards, not human adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is a non-clinical submission for a physical medical device, not an AI software.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
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The type of ground truth used:
- The "ground truth" for the non-clinical tests is established by objective measurements against the specified requirements and methodologies of international standards (ISO) and validated in-house protocols. For biocompatibility, this includes biological responses observed in in vitro or in vivo models according to the relevant ISO 10993 parts.
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The sample size for the training set:
- Not applicable. This is not an AI algorithm.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI algorithm.
Conclusion:
The BD Intima II™ IV Catheter's substantial equivalence was demonstrated through non-clinical testing against established physical, chemical, and biological performance standards (primarily ISO standards) and validated in-house protocols. All enumerated tests "Passed" or were "Determined substantially equivalent," indicating that the device meets the defined acceptance criteria for safety and effectiveness in a non-clinical context. No clinical studies or AI-related evaluations were conducted or are relevant to this 510(k) submission.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).