(183 days)
The ARROW FlexBlock Continuous Peripheral Nerve Block Kit/Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
The Arrow® FlexBlock® Continuous Peripheral Nerve Block Catheter Kit/Set features a wire reinforced, polyurethane body with centimeter markings to facilitate placement for continuous plexus and peripheral nerve blocks. The catheter includes a SnapLock™ adapter to enable infusion of medications, and a stylet for enhanced maneuverability. Procedural trays also include a stimulating or non-stimulating plexus block needle, and other procedural components.
The provided document is a 510(k) premarket notification for the ARROW® FlexBlock® Continuous Peripheral Nerve Block Kit/Set. This submission focuses on updating the MR (Magnetic Resonance) Conditional statements in the Instructions for Use (IFU) based on new non-clinical testing. It explicitly states that "The device that is the subject of this submission is identical to its predicate in all other respects, including the technological characteristics, materials, indications for use, and FDA classification." Therefore, the study described here is not a clinical study involving human patients or a standalone algorithm performance study, but rather non-clinical testing to assess the device's compatibility with MRI environments.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for MRI compatibility. Instead, the non-clinical tests aimed to ensure the device could be labeled as "MR Conditional," meaning it can be safely used in a specified MRI environment under certain conditions. The reported device performance is that the tests concluded the FlexBlock Catheter should be labeled as MR Conditional and included labeling guidelines. This implies that the device successfully met the safety thresholds for MRI compatibility during the testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety thresholds for magnetic field interactions (3-Tesla) | Device passed, concluded suitable for MR Conditional labeling |
| Safety thresholds for MRI-related heating (1.5-Tesla and 3-Tesla) | Device passed, concluded suitable for MR Conditional labeling |
| Acceptable MRI imaging artifacts (3-Tesla) | Device passed, concluded suitable for MR Conditional labeling |
2. Sample sized used for the test set and the data provenance
The document specifies "the test article in both cases was the 19 ga FlexBlock catheter." This implies that the testing was performed on one or more samples of the 19 gauge FlexBlock catheter. The exact number of individual catheter units tested is not provided, but it would have been a sufficient number to represent the product and ensure robust testing according to ASTM guidelines.
The data provenance is from non-clinical laboratory testing conducted by specialized third-party organizations:
- Shellock R&D Services (MRI Testing, 2011)
- Exponent, Inc. (MRI Testing, 2015)
The testing was retrospective in the sense that it was performed on existing device designs to update labeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided document. The ground truth for MRI compatibility testing is established by physical measurements and adherence to recognized standards (e.g., ASTM F2182), not by expert consensus on clinical findings. The entities performing the tests (Shellock R&D Services and Exponent, Inc.) are specialized in medical device MRI safety assessments, implying their expertise in the field.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical scenarios where multiple human readers assess a case and a consensus or tie-breaking mechanism is used. Here, the "test set" involves physical measurements against technical standards for MRI safety. The "adjudication" is implicitly the adherence to and interpretation of the results according to the ASTM F2182 standard and other relevant guidelines by the testing facilities.
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 document describes non-clinical MRI compatibility testing of a medical device, not a comparative effectiveness study involving human readers and clinical cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This document is about the physical properties and MRI compatibility of a medical device, not a software algorithm.
7. The type of ground truth used
The ground truth used for this testing was based on established scientific principles, engineering measurements, and recognized industry standards for MRI compatibility, specifically:
- Physical measurements of magnetic field interactions.
- Measurements of temperature rise due to radiofrequency (RF)-induced heating.
- Evaluation of imaging artifacts.
- Methodologies prescribed in ASTM F2182 ("Standard Test Method for Measurement of Radiofrequency Induced Hearing Near Passive Implants During Magnetic Resonance Imaging") as a guide.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this document describes non-clinical physical testing of a medical device, not the development or evaluation of a machine learning algorithm.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).