(212 days)
The Micro Rx catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature. The device is contraindicated for use in the neurovasculature.
The Micro Rx is a guide wire support catheter intended to be used in the coronary and/ or peripheral vasculature for patients suffering from coronary or peripheral artery disease. The target lesion can be reached by using the femoral or brachial approach. The Micro Rx is a single lumen 0.014" rapid exchange catheter. The 135 cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section. The Micro Rx catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm from the distal tip, respectively. Furthermore, two distal shaft exit markers are located at 110 cm and 120 cm to indicate the distal shaft exit.
The provided document is an FDA 510(k) clearance letter for a medical device called "Micro Rx," a guidewire support catheter. It details the device's characteristics, intended use, and comparison to a predicate device, as well as the summary of studies conducted to demonstrate substantial equivalence.
However, the document does not contain the kind of information typically found in studies for AI/ML-based medical devices or devices where performance is measured against a ground truth using expert readers. The provided text is for a mechanical medical device (a catheter), and the "studies" mentioned are performance and biocompatibility tests for that physical device, not studies involving image analysis or expert adjudication.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set details) are not applicable to this type of device and the information provided in this 510(k) document.
I will populate the table and answer the questions based on the information that is available in the provided text, and explicitly state when information is not present or applicable.
Acceptance Criteria and Device Performance for Micro Rx Catheter
1. A table of acceptance criteria and the reported device performance
The document lists "verification tests" that were performed and states that "The results of the verification tests met the specified acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the numerical results for each test. It simply states that they passed.
| Performance Characteristic | Acceptance Criteria (Not Explicitly Stated Numerically) | Reported Device Performance (Summary Statement) |
|---|---|---|
| Kink resistance/flexibility | Met requirements | Results met specified acceptance criteria. |
| Device introduction, deployment, and retraction | Met requirements | Results met specified acceptance criteria. |
| Radiopacity | Met requirements | Results met specified acceptance criteria. |
| Distal tip length | Met requirements | Results met specified acceptance criteria. |
| Tensile strength | Met requirements | Results met specified acceptance criteria. |
| Effective length | Met requirements | Results met specified acceptance criteria. |
| Shaft inner diameter | Met requirements | Results met specified acceptance criteria. |
| Torque robustness | Met requirements | Results met specified acceptance criteria. |
| Outer diameter | Met requirements | Results met specified acceptance criteria. |
| Surface coating lubricity | Met requirements | Results met specified acceptance criteria. |
| Coating integrity | Met requirements | Results met specified acceptance criteria. |
| Coating particulate evaluation | Met requirements | Results met specified acceptance criteria. |
| Packaging integrity | Met requirements | Results met specified acceptance criteria. |
| Biocompatibility | ||
| Cytotoxicity | Met ISO 10993-1 requirements | Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1. |
| Sensitization | Met ISO 10993-1 requirements | Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1. |
| Irritation | Met ISO 10993-1 requirements | Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1. |
| Systemic toxicity | Met ISO 10993-1 requirements | Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1. |
| Pyrogenicity | Met ISO 10993-1 requirements | Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1. |
| Hemocompatibility | Met ISO 10993-1 requirements | Results met specified acceptance criteria and requirements for biocompatibility in accordance with ISO 10993-1. |
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: The document does not specify the sample sizes (number of units tested) for each of the performance or biocompatibility tests.
- Data Provenance: Not specified. These are laboratory/bench tests, not clinical studies involving patient data from specific countries. The manufacturing company, IMDS Operations B.V., is located in Roden, Drenthe, Netherlands.
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 mechanical catheter. The "ground truth" for its performance is established by engineering specifications, physical measurements, and adherence to ISO standards (e.g., ISO 10993-1 for biocompatibility), not by expert human interpretation or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication of results in the traditional sense (e.g., for image interpretation) is mentioned or relevant for these types of engineering and biocompatibility tests. The tests yield objective, measurable data.
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 a mechanical device, not an AI/ML-driven diagnostic or image analysis tool. Therefore, an MRMC study and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering specifications, direct physical measurements, and adherence to established international standards (e.g., ISO 10993-1 for biocompatibility). There is no "expert consensus" or "pathology" in the context of diagnostic accuracy.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
§ 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).