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The BD OneCath™ peripherally inserted central catheters are used to sample blood and administer fluids into the central vascular system such as medication, fluids, nutrients, blood and blood products.

The BD OneCath PICC products are similar in design to other PICC products. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer. The BD OneCath PICC is available in both single and dual lumens.

I am sorry, but based on the provided document, I cannot fulfill your request for information on the acceptance criteria and a study proving the device meets them.

The document is a Premarket Notification [510(k)] Summary for the BD OneCath™ Peripherally Inserted Central Catheter. It primarily focuses on demonstrating "substantial equivalence" to a predicate device (BD L-Cath PICC), rather than presenting specific acceptance criteria and a detailed study proving the device meets those criteria for performance metrics like accuracy, sensitivity, or specificity.

Here's a breakdown of why the requested information is not available in the provided text:

• Acceptance Criteria and Reported Device Performance: This document states that "Biocompatibility testing of the new polyurethane tubing and physical testing on the areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts) were conducted." It concludes from these nonclinical tests that the BD OneCath PICC and the predicate device are substantially equivalent. However, it does not provide specific numerical acceptance criteria for these tests (e.g., "pull strength must be X Newtons" or "biocompatibility results must meet ISO X standard with Y score") nor does it report the specific performance results against such criteria. The "Conclusion" is a qualitative statement of substantial equivalence.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set Information: These are all concepts related to the evaluation of algorithms or diagnostic devices against a "ground truth" using a test set and a training set. The BD OneCath is a physical medical device (a catheter), not an algorithm or a diagnostic tool that produces a read-out to be compared with a ground truth. Therefore, these types of studies (MRMC, standalone, etc.) are not applicable in this context and are not mentioned in the document. The "tests" mentioned are physical and biocompatibility tests on the material and components, not clinical studies in the typical sense of evaluating diagnostic performance.

In summary, the provided document is a regulatory submission for a physical device, aiming to prove substantial equivalence through non-clinical testing of materials and physical components. It does not contain the specific information you are looking for regarding acceptance criteria, study methodologies for performance metrics (like sensitivity/specificity), or details about expert-reviewed ground truth, which are typically associated with diagnostic software or imaging devices.

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The BD OneCath™ midline catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. This intravascular catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

The BD OneCath midline products are similar in design to other midline catheters. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer.

The provided documentation (K042862) describes the BD OneCath™ Midline Catheter. However, it does not include detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device. This submission is for a traditional medical device (catheter) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, for aspects related to AI/ML device performance, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for training, the information is not applicable or not provided in this document.

Here's the information that can be extracted or inferred from the document:

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

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

• Sample Size for Test Set: Not specified. The document refers to "biocompatibility testing" and "physical testing" but does not detail the number of units or samples tested for each.
• Data Provenance: Not specified. These are non-clinical (laboratory/bench) tests conducted by the manufacturer, Becton Dickinson.

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)

• Not Applicable. This device is a physical medical device (catheter), not an AI/ML diagnostic or image analysis tool. Ground truth is established through laboratory measurements and established biocompatibility standards, not expert interpretation of outputs.

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

• Not Applicable. Ground truth is based on objective laboratory measurements and standardized test results rather than expert adjudication.

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. This is not an AI/ML device, and no MRMC study was conducted or is relevant to this submission.

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

• No. This is not an AI/ML device.

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

• The ground truth for the non-clinical tests would be based on objective laboratory measurements (e.g., tensile strength, elongation, burst pressure, material composition analysis, radiopacity measurements) and established industry standards for biocompatibility (e.g., ISO 10993 series). Performance measurements would be compared against defined specifications or the performance of the predicate device.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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The BD OneCath™ peripherally inserted central catheters are used to sample blood and administer fluids into the central vascular system such as medication, fluids, nutrients, blood and blood products.

The BD OneCath PICC products are similar in design to other PICC products. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer.

The provided text is a 510(k) Premarket Notification Summary for the BD OneCath™ Peripherally Inserted Central Catheter (PICC). This type of submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through extensive clinical studies with reported performance metrics like sensitivity, specificity, etc.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance measurements, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's why the requested information is absent and what the document does provide:

1. A table of acceptance criteria and the reported device performance: This is not available because 510(k) submissions for devices like PICCs typically do not involve establishing specific performance criteria like accuracy, sensitivity, or specificity as one would for an AI/CAD diagnostic device. The "performance" demonstrated here is primarily through non-clinical testing to show the new device characteristics are comparable to the predicate.

   • Acceptance Criteria (Implied): The implied acceptance criteria for a 510(k) for this type of device are met if the device can demonstrate "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
   • Reported Device Performance:
     • Nonclinical Tests conducted: Biocompatibility testing of the new polyurethane tubing.
     • Nonclinical Tests conducted: Physical testing on areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts).
     • Key Technological Improvement: The new polyurethane tubing has "improved radiopacity and resistance to alcohol" compared to the predicate device (BD L-Cath PICC).

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned because there wasn't a clinical performance study in the way requested for an AI/CAD diagnostic device. The evaluation was primarily through non-clinical laboratory testing of materials and device integrity.

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): Not applicable. There was no "ground truth" derived from expert consensus on patient data described in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication 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 (PICC), not an AI/CAD diagnostic software, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this type of submission is typically based on established engineering standards, material science testing results, and comparison to the predicate device's known performance for safety and efficacy.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of developing an AI model for this physical medical device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is for a traditional medical device (Catheter) seeking 510(k) clearance, which focuses on demonstrating "substantial equivalence" through non-clinical testing and comparison to a predicate device. It does not involve the types of studies, metrics, or data sets that would be associated with AI/CAD diagnostic devices referenced in your prompt.

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