Search Results

The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.

ARROW® FlexTip Plus® Epidural Catheters are single lumen catheters featuring a wire re-enforced polyurethane body with centimeter markings to facilitate placement.

This document is a 510(k) premarket notification for an ARROW FlexTip Plus Epidural Catheter (K140110). This specific submission is an update to the Magnetic Resonance (MR) Conditional statements in the Instructions for Use (IFU) for the previously cleared device (K103658).

Therefore, this document does not contain information about acceptance criteria and studies demonstrating device performance in the context of efficacy or clinical outcomes for an AI/software device. Instead, it focuses on demonstrating substantial equivalence for an updated MR safety label.

Here's an analysis of the provided text based on your request, highlighting why direct answers to some of your questions are not applicable to this type of medical device submission:

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

This document does not specify "acceptance criteria" and "device performance" in the context of clinical efficacy or diagnostic accuracy, as it is not an AI/software device. The performance testing mentioned is specifically for MR compatibility.

Table: MR Conditional Labeling Updates and Performance

The following questions (2-9) are not applicable to this 510(k) submission because it is for a physical medical device (epidural catheter) with an update to its MR safety labeling, not a software or AI-driven diagnostic/therapeutic device. The concept of "test sets," "ground truth," "experts," "training sets," and "human-in-the-loop performance" are not relevant to demonstrating the MR compatibility of a catheter.

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

• Not Applicable. This is not a study involving human data, but rather a physical device being tested for MR compatibility in a controlled laboratory environment.

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. Ground truth, in this context, refers to scientific measurement and engineering principles for MR compatibility, established by trained personnel in the testing laboratory (Shellock R&D Services).

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

• Not Applicable. No adjudication method is relevant for MR compatibility testing of a physical device.

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 or diagnostic imaging device.

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

• Not Applicable. This is not an AI or software algorithm.

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

• Not Applicable. The "ground truth" for MR compatibility is derived from standardized testing methodologies and measurements (e.g., using phantoms, thermocouples, and physical measurements) as outlined by relevant standards (e.g., ASTM F2119, F2182, F2052).

8. The sample size for the training set

• Not Applicable. There is no training set for a physical device's MR compatibility testing.

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

• Not Applicable. There is no training set for a physical device's MR compatibility testing.

Summary of Relevant Information from the Document:

• Device: ARROW FlexTip Plus Epidural Catheter
• 510(k) Number: K140110
• Predicate Device: FlexTip Plus Epidural Catheter (K103658)
• Purpose of Submission: To update the MR Conditional statements in the Instructions for Use (IFU) based on revised magnetic resonance testing.
• Modification: Only the MR Conditional labeling was changed. The device's technological characteristics, materials, indications for use, and classification remain identical to the predicate.
• Performance Testing: "Evaluation of Magnetic Field Interactions, Heating and Artifacts for FlexTip Plus Epidural Catheter, 19-gauge x 90-cm, Nonmagnetic SS Version" by Shellock R&D Services, revised 7/15/2013. This testing was submitted to support the updated MR Conditional statements.
• Substantial Equivalence Conclusion: The updated MR Conditional labeling establishes parameters for safe use in an MRI environment, does not impact safety or effectiveness, and does not raise new questions of safety or efficacy. Substantial equivalence is based on the device being identical to its predicate in all other respects.

Ask a specific question about this device