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510(k) Data Aggregation
(272 days)
EDEN ControlCath
EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.
EDEN ControlCath consists of a flexible catheter, steering handle, and a port for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The port facilitates the connection of syringes to deliver therapeutic agents by physicians as appropriate to their diagnosis. It is supplied sterile and it is for single use.
The provided text is a 510(k) summary for a medical device called "EDEN ControlCath." This document details the device's characteristics, intended use, and its comparison to a predicate device to demonstrate substantial equivalence.
However, the provided text DOES NOT contain information regarding:
- Acceptance criteria beyond "test criteria" for various bench tests.
- Specific device performance metrics that meet these criteria.
- Study design for proving acceptance criteria, particularly regarding clinical studies or AI model performance. The document explicitly states, "Clinical testing was not required for this submission."
- Sample sizes used for test or training sets for AI models.
- Data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone AI performance, or how ground truth was established, as these are typically relevant for AI/ML-based medical devices or diagnostics.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate conventional medical device through bench testing and material comparisons, not an AI/ML device.
To answer your request based on the provided text, I can only state the following:
1. A table of acceptance criteria and the reported device performance:
The document mentions that various properties were tested based on referenced standards, and "All the test results support substantial equivalence to the predicate devices." However, it does not provide specific numerical acceptance criteria (e.g., "tensile strength > X N") or measured device performance values. It broadly states that the device "passed the test criteria."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-Clinical Properties (Bench Tests) | The device "passed the test criteria for the side-by-side test" for Diameter and Catheter Length. |
| Key Performance Specification/Characteristics | The device's performance for "Catheter: Tensile Load, Liquid Leakage, Corrosion Resistance, Fatigue, Flexural Strength"; "Trocar: Outer and Inner Surface, Flexural Strength, Pull Out, Elasticity, Pierce"; "Sheath: Tensile Load, Flexural Strength"; and "Guide Wire: Strength" is "Same as predicate device(*)" and passed relevant tests. |
| Raw Materials (Biocompatibility) | The device "passed the test criteria for the bench test according to the recognized consensus standard (ISO 10993-1 Series)." All directly/indirectly contacting materials are "compliant with ISO10993 requirements." |
| Sterilization | The device "passed the test criteria for the bench test according to the recognized consensus" for E.O. gas sterilization, which is a different method than the predicate's Gamma Sterilization, but deemed not to have a "significant difference." |
| General Characteristics | The device shows "no significant differences in most parameters" compared to the predicate, and "the differences do not affect the substantial equivalence." |
2. Sample sized used for the test set and the data provenance:
The document does not specify sample sizes for any of the bench tests or material evaluations. It refers to "bench test results" generally. It does not involve patient data, so concepts like "country of origin" or "retrospective/prospective" are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is not an AI/ML diagnostic tool, and its evaluation relies on established engineering and materials testing standards, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There is no human adjudication process described for the non-clinical bench testing.
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. This is not an AI-assisted device, and no MRMC study was conducted or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical epidural catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on compliance with international standards for medical devices (e.g., ISO, ASTM) through various physical and chemical bench tests (tensile strength, leakage, biocompatibility, etc.) and comparison to a legally marketed predicate device.
8. The sample size for the training set:
Not applicable. There is no training set mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set involved.
In summary, the provided FDA 510(k) summary is for a traditional medical device (an anesthesia conduction catheter), not an AI/ML-driven product. Therefore, the detailed questions about AI model performance, data sets, and expert ground truth establishment are not addressed in this document.
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