(518 days)
The Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
The FlexTip Plus Epidural Catheter has the following characteristics:
- 19 Ga. single lumen 900 mm
- Available in open or closed tip
- Internal radiopaque, echogenic coiled reinforced wire
- Catheters are provided in sterile kit configurations
The provided document is a 510(k) summary for a medical device (Arrow FlexTip Plus Closed Tip Epidural Catheter) and focuses on demonstrating substantial equivalence to a predicate device. It primarily details non-clinical laboratory testing rather than a clinical study with acceptance criteria and device performance in a human context.
Therefore, the requested information cannot be fully provided from the given text as it does not describe a clinical study in humans to prove device performance against acceptance criteria typically associated with such studies (e.g., sensitivity, specificity, accuracy for a diagnostic device, or effect size for an intervention).
However, I can extract the information related to the non-clinical testing that was performed to demonstrate substantial equivalence.
Here's the information based on the provided text, with an explanation for elements that are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Tensile Strength | The results of the performance testing (including tensile strength) demonstrate that the FlexTip Plus Closed Tip Epidural Catheter is as safe, as effective, and performs comparably to the predicate Epidural catheter. |
| Column Strength | The results of the performance testing (including column strength) demonstrate that the FlexTip Plus Closed Tip Epidural Catheter is as safe, as effective, and performs comparably to the predicate Epidural catheter. |
| Flow Rate | The results of the performance testing (including flow rate) demonstrate that the FlexTip Plus Closed Tip Epidural Catheter is as safe, as effective, and performs comparably to the predicate Epidural catheter. |
| Biocompatibility (In vivo) | Pre-clinical evaluations have been conducted on the catheter and extracts thereof. No adverse effects were observed in any in vivo study conducted. |
| Biocompatibility (E&L Studies) | Extractable and Leachable (E&L) studies were performed using Bupivacaine, Naropin, Polocaine, Hydromorphone, Morphine, Meperidine, and Fentanyl. The toxicity of the relevant leachable chemicals relating to these drugs was reviewed and addressed. A comparative chemical analysis study was conducted to assess potential differences in the E&L profile between devices that were EO sterilized after one cycle versus devices that were processed with two EO cycles. There were no appreciable qualitative differences in the extractable profiles for the one-time vs. two-time EO-sterilized devices. The relevant patient contacting components meet the requirements of applicable ISO 10993 Guidelines. There was no evidence of significant risk of acute toxicity under the proposed conditions and duration of clinical use based on review of available toxicological data for a surrogate leachable chemical. |
2. Sample Size Used for the Test Set and Data Provenance:
This document describes non-clinical engineering and biocompatibility testing. It does not refer to a "test set" in the context of human data or AI performance. The tests were performed on the device itself and its extracts in a laboratory setting. No country of origin for human data is applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This was non-clinical lab testing; there was no "ground truth" established by human experts in the context of a clinical study. Biocompatibility and performance testing would follow established international standards (like ISO 10993) and internal protocols, with analysis performed by qualified lab personnel.
4. Adjudication Method for the Test Set:
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a 510(k) submission for an epidural catheter, not an AI or diagnostic device. Therefore, no MRMC study was conducted, and the concept of "human readers improving with AI vs. without AI assistance" is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. This is a physical medical device, not an algorithm or AI product.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was based on established industry standards, engineering specifications, and validated laboratory methodologies for physical properties (tensile strength, column strength, flow rate) and chemical analysis (extractables and leachables).
8. Sample Size for the Training Set:
Not applicable. This is not an AI or machine learning device; therefore, 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 this device.
§ 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).