(199 days)
The DuoFlo™ Catheter is intended for general intravascular use in the perioheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.
The Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries.
The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.
The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.
The provided text is a 510(k) summary for the ThermopeutiX DuoFlo™ Catheter, and it does not contain the level of detail typically found in a study report for an AI/ML-based medical device. Therefore, I cannot extract all the requested information. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and basic performance/safety validation for a physical medical device (a catheter), not a software algorithm.
However, I can provide information based on what is available in the document regarding the performance and safety aspects of the physical device.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions Performance and Safety validation but does not provide specific quantitative acceptance criteria or detailed reported performance in a tabular format as would be expected for an AI/ML study. It generally states that the device meets safety and integrity requirements.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated through biocompatibility studies of materials in accordance with ISO 10993-1. |
| Physical Integrity | Physical testing was performed to assure catheter integrity, including verification of catheter body and balloon burst pressure. |
| Sterility | Device is supplied sterile with a Sterility Assurance Level (SAL) of 10⁻⁶. |
| Safety/Effectiveness | There are no new safety or effectiveness issues related to this device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the document describes validation for a physical catheter through biocompatibility and physical integrity testing, not a clinical study on a test set of data.
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)
This information is not applicable/provided. The validation described does not involve establishing ground truth by human experts for a test set, as it's not a diagnostic or AI/ML device requiring such evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the same reasons as item 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
This information is not applicable/provided. The device is a physical catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided. There is no algorithm for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. The "ground truth" for a physical device like a catheter would be its physical properties, material safety, and functional performance metrics, not clinical outcomes derived from expert assessment or pathology.
8. The sample size for the training set
This information is not applicable/provided. There is no training set for a physical catheter.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no training set for a physical catheter.
Summary of Study (Based on available information):
The "study" described in the 510(k) summary is primarily comprised of:
- Biocompatibility studies: Conducted on the raw materials in accordance with ISO 10993-1 to demonstrate the safety of materials in contact with the body.
- Physical testing: Performed to assure the integrity of the catheter, including verification of catheter body and balloon burst pressure. The document states that these tests were done to "assure catheter integrity."
- Sterility validation: The device is supplied with a Sterility Assurance Level (SAL) of 10⁻⁶.
The overall approach for this device relies on demonstrating substantial equivalence to already legally marketed predicate devices in terms of general indications, design, features, construction materials, and safety profile. The validation tests (biocompatibility, physical integrity, sterility) confirm that the DuoFlo™ Catheter meets established safety and performance standards for its type.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).