(57 days)
The Functional Anaesthetic Discography (F.A.D.) Catheter System is intended for use in delivering either a single dose or continuous administration of a radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The Functional Anaesthetic Discography (F.A.D.) Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating placement of the F.A.D. Catheter and Guidewire into the intradiscal space.
The F.A.D. Catheter is a micro-catheter with a flexible shaft. The F.A.D. Catheter has a polymer balloon located near the distal tip. Once the F.A.D. Catheter is properly positioned, the balloon is inflated with a radiopaque contrast medium and assists in maintaining proper catheter placement during the procedure. The balloon is then deflated prior to removal of the F.A.D. Catheter. Two stainless steel tubes are contained inside the polymer shaft of the F.A.D. Catheter and serve as lumena. The inflation lumen is used for inflating and deflating the balloon and the guidewire / injection lumen is used for insertion of a guidewire and injection of radiopaque contrast, local anaesthetics, and/or saline solution. The proximal portion of both lumena are connected to the Portex® Epidural Catheter Connector Adapters during the procedure. There are two radiopaque markers on the F.A.D. catheter shaft, located proximally and distally within the balloon, allowing for radiographic positioning of the balloon. There are eight markers on the proximal end of the catheter which can be utilized to monitor stable catheter placement during the course of the procedure. The F.A.D. Introducer Needle is designed specifically for use with the F.A.D. Catheter System. The F.A.D. Introducer Needle is manufactured from stainless steel and has a stainless steel stylet. The F.A.D. Introducer Needle has a square cut distal tip with rounded edges. The stylet has a bevel tip. The F.A.D. Introducer Needle provides access to the area adjacent to the intradiscal space. The F.A.D. Catheter is delivered through the F.A.D. Introducer Needle and is tracked over the guidewire. The F.A.D. Catheter System is comprised of the following: One F.A.D. Catheter, One F.A.D. Introducer Needle, One Spinal Needle, One Guidewire, One Stopcock, One 3cc syringe, Two 1cc syringes, Two Catheter Connectors (toughy-borst adapters), One package of sterile labels. The F.A.D. Introducer Needle is also offered a la carte.
This document is a 510(k) Premarket Notification for the Kyphon Functional Anaesthetic Discography (F.A.D.) Catheter System and Introducer Needle. It primarily focuses on an addition of labeling information and asserts substantial equivalence to a previously cleared device (K043500), rather than presenting a study to prove a device meets specific performance acceptance criteria through clinical or analytical testing.
Therefore, many of the requested elements (e.g., acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not explicitly present in the provided text.
Based on the provided information, here's what can be extracted:
- No new study was conducted to prove the device meets acceptance criteria. The submission is focused on labeling changes for an already-cleared device. The "study" mentioned is implicitly the original submission (K043500) that established substantial equivalence for the device itself.
1. Table of Acceptance Criteria and Reported Device Performance:
- This information is not provided in the current document because it's a labeling update submission, not an initial clearance for a new device requiring performance studies. The original predicate device (K043500) would have contained such data.
2. Sample size used for the test set and the data provenance:
- Not applicable to this submission, as no new test set or performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this submission.
4. Adjudication method for the test set:
- Not applicable to this submission.
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 MRMC study was done. This device is a mechanical catheter system, not an AI-driven diagnostic or assistive tool, so MRMC studies and AI effect sizes are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This is a medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable to this submission. The "ground truth" for this 510(k) is the assertion that the updated labeling does not change the fundamental safety or effectiveness demonstrated by the predicate device.
8. The sample size for the training set:
- Not applicable to this submission.
9. How the ground truth for the training set was established:
- Not applicable to this submission.
Summary based on the document:
This 510(k) submission (K061210) for the Kyphon Functional Anaesthetic Discography (F.A.D.) Catheter System and Introducer Needle is a labeling update only. It explicitly states: "This 510(k) is being filed for the addition of labeling information in the Instructions for Use... The additional contraindication, warnings, and adverse events noted in this submission do not represent a change to either device's intended use or indications for use. There are also no changes to the primary design elements for either device that are the subject of this submission. Therefore, devices and the device labeling are substantially equivalent to the devices already cleared under K043500."
Because this is a labeling update and not a submission for a new device or a significant modification, the typical performance data and study details requested are not part of this specific document. The evidence of the device meeting acceptance criteria would have been established during the clearance of the predicate device, K043500.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).