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510(k) Data Aggregation
(97 days)
The CES FG Infusion Catheter is intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.
CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CES FG Infusion Catheter:
Based on the provided text, the submission is a 510(k) premarket notification for a Class II medical device, an infusion catheter. The text primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and reported device performance in the way one might expect for a diagnostic or AI-based device.
Therefore, the information you've requested regarding direct performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies is largely not present in the provided document, as it's not typically required for a 510(k) submission for this type of device.
However, I can extract the information that is available and highlight what is missing.
Acceptance Criteria and Study Information for CES FG Infusion Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Biocompatibility | Compatibility with biological tissue as stipulated in FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1) test protocols. | Met acceptance criteria. | The document states "The catheters demonstrated compatibility with biological tissue by meeting the acceptance criteria stipulated in the test protocols." |
| Substantial Equivalence | Equivalence in basic design, construction, indications for use, performance characteristics, packaging, and sterilization to other commercially available infusion catheters. | Determined to be substantially equivalent to predicate devices. | The FDA letter confirms the device is "substantially equivalent (for the indications of use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." The summary also states, "The CES FG Infusion Catheter is substantially equivalent in its basic design, construction, indications for use, performance characteristics, packaging and sterilization to other commercially available infusion catheters." |
| Intended Use | To be used as a mechanism for selective infusion of various diagnostic, embolic, and therapeutic agents into peripheral, coronary, and neurovasculatures. | Intended use matches description and is similar to predicate devices. | The intended use is clearly stated and is a basis for comparison to predicate devices. |
Missing Information for a Performance Study (Not applicable for this type of 510(k) submission):
- Specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall)
- Quantitative thresholds for these metrics
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document.
- For biocompatibility, the phrase "Entire FG Infusion Catheters were subjected to biocompatibility testing" implies that samples of the finished device were used, but a specific number is not given.
- For the substantial equivalence claim, no specific test set sample size or data provenance (country, retrospective/prospective) is detailed, as this is typically based on design comparison and existing data from predicate devices or general clinical performance history for this device type, rather than a novel clinical trial with a defined test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document, as it did not involve a study requiring expert-established ground truth for performance evaluation in the context of a diagnostic or AI device.
4. Adjudication Method for the Test Set
This information is not provided in the document, as it did not involve a study requiring an adjudication method for performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or at least is not reported in this document. This type of study is typically associated with diagnostic imaging devices or AI-assisted diagnostic tools, not an infusion catheter seeking substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (in the context of an algorithm) was not done or is not reported in this document. This device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
- For biocompatibility: The "ground truth" was established by the specified ISO-10993 (Blue Book Memorandum G95-1) test protocols and their acceptance criteria for biological compatibility.
- For substantial equivalence: The "ground truth" is essentially the established safety and effectiveness of the legally marketed predicate devices. The claim is that the new device is functionally identical or very similar in all critical aspects to these already approved devices.
8. The Sample Size for the Training Set
This information is not provided in the document, as it is not relevant for this type of device and submission. There is no "training set" in the context of a machine learning model for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document, as it is not relevant for this type of device and submission.
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