(298 days)
This device is intended to infuse therapeutic agents into the extra-cardiac vasculature.
Not Found
Here's an analysis of the provided text regarding the Uresil® VASCU-FLO® Infusion Catheter.
It's important to note that the provided documents are a 510(k) summary letter and an Indications for Use statement for a medical device. These types of documents do not typically contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way a clinical study report or a pre-market approval (PMA) submission would.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving efficacy and safety through extensive clinical trials for new device types. Therefore, many of the requested details about acceptance criteria, study data, and ground truth establishment are not present in these documents.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not explicitly available in the provided documents. The 510(k) letter states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce..." This indicates that the device met the criteria for substantial equivalence, which is the core "acceptance criteria" for a 510(k) submission. However, the specific performance metrics used to demonstrate this equivalence are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not explicitly available in the provided documents. The letter mentions a "510(k) notification of intent to market," which refers to a submission with performance data, but does not provide details of any test set sample size or data provenance.
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/Not available. For a 510(k) submission, the "ground truth" is typically established by comparing the new device's performance to the predicate device's established performance, often through bench testing and sometimes limited clinical data. There is no mention of expert consensus for ground truth establishment in these documents as one might find in an AI/imaging device submission for diagnostics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not available. Adjudication methods are typically relevant for studies involving human interpretation (e.g., clinical trials or radiology reading studies). This information is not present in the provided 510(k) letter.
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/Not available. The Uresil® VASCU-FLO® Infusion Catheter is a physical infusion catheter, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI assistance comparisons are not relevant to this device type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not available. As above, this device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implicitly established by comparison to a predicate device. For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence often relies on:
- Bench testing data: Comparing physical properties, material compatibility, flow rates, and other engineering specifications to the predicate device.
- Biocompatibility data: Showing the device materials are safe.
- Sterilization validation: Ensuring the device can be sterilized.
- Performance data: Showing the device performs as intended for its stated Indications for Use, often by demonstrating similar functional characteristics to the predicate.
- The documents do not specify the exact nature of this comparative data.
8. The sample size for the training set
- Not applicable/Not available. "Training set" is a concept primarily used in machine learning and AI development. This is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable/Not available. As above, this is not an AI algorithm.
Summary of available information from the provided documents:
- Device Name: Uresil® VASCU-FLO® Infusion Catheter
- Regulatory Class: II
- Product Code: DQY
- Indications For Use: "This device is intended to infuse therapeutic agents into the extra-cardiac vasculature."
- Regulatory Outcome: Substantial equivalence determined by the FDA to legally marketed predicate devices available prior to May 28, 1976. This determination allows the device to be marketed.
- Implicit Acceptance Criteria Met: The device demonstrated sufficient equivalence to a predicate device as required for a 510(k) clearance, covering aspects like safety, fundamental technology, and performance for its indications. Specific numeric criteria are not detailed in these overview documents.
§ 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).