(189 days)
The Kyphon Discyphor Catheter System for the Functional Anaesthetic Discography™ Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space.
The Kyphon Discyphor Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Spinal Needle, Discyphor Catheter and Discyphor Guidewire into the intradiscal space. The Kyphon Discyphor Introducer Needle is intended to be used only with the Kyphon Discyphor Catheter System.
The Kyphon Discyphor Spinal Needle is intended to access the nucleus of an intervertebral disc for the purpose of nerforming provocative discography and facilitating placement of the Discyphor Catheter and Guidewire into the intradiscal space. The Discyphor Spinal Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Kyphon Discyphor Spinal Needle is intended to be used only with the Kyphon Discyphor Catheter System.
The Discyphor" Catheter System is comprised of a Discyphor" Catheter with guidewire funnel, a Discyphor" Guidewire, a Discyphor" Introducer Needle, a Discyphor" Spinal Needle, a stopcock, syringes, catheter connectors and labels. The Discyphor Catheter is a micro-catheter with a flexible shaft and a balloon located near the distal tip. The metallic Discyphor Guidewire is .009" in diameter and is radiopaque when viewed using fluoroscopy. The stopcock retains pressure within the balloon when used in conjunction with the syringes. The catheter connectors are connected to the lumens of the Discyphor Catheter and provide access to the lumens. Labels are used to identify the solutions used during the procedure or to denote the level at which the Discyphor Catheter has been placed.
The Discyphor Introducer Needle is designed specifically for use with the Discyphor Catheter System. The Discyphor Introducer Needle is stainless steel with a removable stainless steel stylet. The Discyphor Catheter is delivered through the Discyphor Introducer Needle and is tracked over the Discyphor Guidewire.
The Discyphor" Spinal Needle is a standard stainless steel needle with a removable stainless steel stylet. The hubs of the needle and stylet are comprised of polymer.
Here's an analysis of the provided text regarding the Discyphor™ Catheter System, focusing on acceptance criteria and supporting studies:
It is important to note that this 510(k) submission describes a material change to one component (the guidewire) of an existing device system, rather than an entirely new device. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that the new guidewire material is equivalent to the previous one and that the overall system remains safe and effective for its stated intended use. This is a common approach in 510(k) submissions for modifications to previously cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Material Properties | Bending Stiffness | Evaluated | In vitro testing |
| Peak Axial Strength | Evaluated | In vitro testing | |
| Fracture Resistance | Evaluated | In vitro testing | |
| Kink Resistance | Evaluated | In vitro testing | |
| User Performance | Physician Preference | Conducted | Laboratory physician preference testing |
| Biocompatibility | Acceptability for Intended Use | Demonstrates materials are acceptable | Biocompatibility testing |
| Overall Safety & Effectiveness | Safe and Effective for Intended Use | Demonstrated by testing results | Combination of in vitro, lab, and biocompatibility testing |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for any of the individual tests. The document refers to "in vitro testing" and "laboratory physician preference testing" without providing specific numbers of samples or participants.
- Data Provenance: The studies were in vitro (laboratory-based) and "laboratory physician preference testing." There is no mention of human clinical data or animal studies in this submission for the material change. The data provenance is likely research and development labs (Kyphon Inc. or contract labs).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: For the "laboratory physician preference testing," the number of physicians involved is not specified.
- Qualifications of Experts: The document refers to "physician preference testing," implying that the experts were medical doctors. However, their specific qualifications (e.g., years of experience, specialization) are not detailed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable or not specified. This type of engineering and preference testing typically doesn't involve formal adjudication methods like "2+1" or "3+1" that are common in clinical image-reading studies. Physician preference is often a direct assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance, typically in diagnostic imaging. The Discyphor Catheter System is a medical device (catheter, needles, guidewire), not an AI-powered diagnostic tool. The submission is for a material change to a guidewire, which focuses on physical and biological properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
- Not applicable. The Discyphor Catheter System is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply. The tests described (in vitro, biocompatibility, physician preference) evaluate the device components themselves.
7. The Type of Ground Truth Used:
- Ground Truth: For the material properties (bending stiffness, axial strength, fracture, kink resistance), the "ground truth" would be established by engineering and material science standards and measurements.
- For "physician preference testing," the "ground truth" is subjective expert opinion/preference from the participating physicians.
- For biocompatibility, the "ground truth" is compliance with established biocompatibility standards and guidelines (e.g., ISO 10993).
8. The Sample Size for the Training Set:
- Not applicable/Not mentioned. This submission is for a physical medical device and a material change, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no AI training set, there is no ground truth established for one.
§ 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).