(202 days)
The Maxi PTA catheter is intended to dilute lesions in large vessels.
The device is an overthe-wire balloon catheter, with a distal balloon and a proximal hub. The balloon is indicated by two radiopaque marker bands.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cordis Maxi PTA Balloon Catheter, structured according to your request.
Based on the provided text, it's immediately apparent that this 513(j) summary is for a medical device (PTA Balloon Catheter), not an AI/software-based diagnostic tool. Therefore, many of the requested fields, especially those related to AI model performance, expert ground truth, and training data, are not applicable to this type of device submission.
I will fill in the relevant sections based on the provided text and mark the inapplicable sections clearly.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Established Specifications) | Reported Device Performance (Summary) | Notes |
|---|---|---|---|
| In vitro Testing | "Established specifications" | "All test results met or exceeded established specifications." | Specific criteria (e.g., burst pressure, inflation/deflation times) are not detailed in this summary. |
| Biocompatibility | "Appropriate biocompatibility testing" | "All appropriate biocompatibility testing was performed, and successfully passed..." | Specific tests conducted (e.g., cytotoxicity, irritation) are not detailed. |
| Substantial Equivalence (Design) | Similar design to predicate devices | Has "several of the same materials, design characteristics and dimensions" as predicate devices. | Relates to overall device design, not specific performance metrics. |
| Substantial Equivalence (Intended Use) | Same intended use as predicate devices | "The Maxi PTA catheter is designed for dilatation of stenotic lesions in large vessels." | Same intended use as mentioned for predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not specified in the provided text for in vitro or biocompatibility testing. These are typically material and device-level tests, not human subject studies in the sense of a "test set" for a diagnostic algorithm.
- Data Provenance: Not applicable/Not specified. The testing described is "in vitro" (bench testing) and "biocompatibility" testing, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. This device is a physical medical instrument, not an AI diagnostic algorithm requiring expert-established ground truth for its performance assessment. Ground truth for in vitro testing is typically derived from engineering specifications and calibrated measurement equipment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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
- Not Applicable. This is a hardware device, not an AI assistance tool. No MRMC study was conducted or is relevant for this type of submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This submission is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For in vitro testing: The "ground truth" or "reference standard" is typically defined by engineering specifications, physical measurement standards, and established laboratory protocols. For example, for a burst pressure test, the ground truth is whether the balloon withstands a certain pressure as specified in its design.
- For biocompatibility testing: The ground truth is established by international standards (e.g., ISO 10993 series) and pre-defined acceptable biological responses to the materials.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of a physical device's performance validation as described here. Design and manufacturing involve engineering iterations, but not "training data" for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).