(228 days)
The Extroducer Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the perivascular area of the peripheral vasculature. The Extroducer Infusion Catheter System is also intended for the infusion of diagnostic and therapeutic solutions intraluminally.
The Extroducer™ Infusion Catheter System is a minimally invasive device for administering diagnostic or therapeutic solutions through the vascular wall directly to perivascular tissue of adult patients. At the selected site, the device is used to penetrate through the vascular wall into the tissue requiring treatment. The diagnostic or therapeutic solution is then delivered through the device. The device is sterile and designed for single patient use only. The device is to be used in hospital operating theaters and catheterization labs under normal clinical conditions, only by physicians trained in its use. The duration of use is no more than 60 minutes. The Extroducer™ Infusion catheter system consists of two main parts: An infusion needle with a needle hub and radiopaque marker and An outer protective sheath to protect the needle during positioning of the device, with a haemostatic valve to secure the infusion needle during use.
The provided text is a 510(k) premarket notification for a medical device called the "Extroducer Infusion Catheter System." It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data and an animal study.
The request asks for information regarding acceptance criteria, study details, and ground truth establishment, which are typical for an AI/ML-based device submission, especially those involving diagnostic image analysis. However, the provided text describes a physical medical device (an infusion catheter system) and its non-clinical and animal testing. It does not involve any AI/ML components, image analysis, or human reader studies.
Therefore, many of the requested details, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "standalone (algorithm only) performance," are not applicable to this type of device and submission.
The document focuses on demonstrating that the new device has similar technological characteristics, indications for use, and performance to a legally marketed predicate device, thereby proving "substantial equivalence."
Based on the provided text, here is the information that is available or can be inferred, and an explanation of why other requested information is not present:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a formal table of acceptance criteria with specific quantitative thresholds. Instead, it lists the types of non-clinical tests performed to demonstrate functionality and safety, implying that the device met the expected performance for each test to claim substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-clinical Performance: | |
| Dimensional verification (e.g., Catheter length, Needle length, Outer diameter, Needle diameter) | Catheter length: 179cm (from needle hub) |
| Needle length: 5-15 mm from radiopaque marker/depth limiting collar (Three models: 5, 10, 15 mm) | |
| Outer diameter: 0.5 mm (Sheath) | |
| Needle diameter (OD): 0.19 mm | |
| Simulated use (including trackability) | Successfully navigated to all intended target arteries (Animal Study). Tested for functionality and safety. |
| Catheter bond strength | Tested |
| Flexibility and kinking | Tested |
| Torque strength | Tested |
| Radiopacity | Yes, radiopaque marker band included. Tested. |
| Particulate evaluation | Tested |
| Catheter body burst pressure | Tested |
| Infusion flow rate | Tested |
| Visual inspection | Tested |
| Needle characteristics (tensile strength, tip strength etc.) | Tested |
| Functional testing of Thumb wheel/haemostatic valve | Tested |
| Leakage testing | Tested |
| Infusion force | Tested |
| Biocompatibility (ISO 10993) | Successfully tested for: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity (Acute Systemic Toxicity, Material Mediated Pyrogenicity), Hemocompatibility (direct and indirect hemolysis, Complement activation assay, In vivo thrombogenicity). |
| Sterilization validation | Validated. Provided sterile. |
| Transport testing | Tested |
| Package testing (sterile barrier) | Tested |
| Stability studies (selected bench tests and package tests) | Tested. Shelf Life: 1 year. |
| Animal Study: | |
| Evaluation of device safety and performance compared to predicate | Concluded that the Extroducer™ Infusion Catheter System was able to be navigated to all intended target arteries. Results from treatment procedures, performance assessments, thrombosis evaluation, gross pathology, histopathology, and clinical pathology assessments support the conclusions of safety for intended clinical use. |
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 exact sample sizes for the individual non-clinical (bench) tests. For the animal study, a specific sample size is not mentioned, but it is implied to be a prospective study conducted for the purpose of this submission.
- Data Provenance: The Smartwise Sweden AB is based in Tullinge, Sweden. The non-clinical tests would have been performed in a laboratory setting, likely in Sweden or a contracted test facility. The animal study would have been performed as part of the pre-clinical development process. The exact country of origin for the data is not specified beyond the applicant's location. The studies are prospective as they were conducted specifically for this application.
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 question is not applicable. This is a physical medical device. Ground truth as typically understood for AI/ML diagnostic devices (e.g., based on expert image review) is not relevant here. The "ground truth" for the performance of this device is established through the physical and biological testing conducted (e.g., measured dimensions, observed mechanical performance, histological findings from animal studies).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (e.g., radiologists) provide independent assessments that need to be reconciled for ground truth establishment. This is not a human reader study. The "adjudication" for the non-clinical tests would be adherence to pre-defined test protocols and pass/fail criteria. For the animal study, it would involve standard veterinary and pathology assessments.
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 question is not applicable. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers. This device is a physical infusion catheter; it does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device does not have an algorithm component for diagnostic performance. Its "standalone" performance is measured by its physical, mechanical, and biological properties through non-clinical and animal testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through:
- Engineering/Bench Test Measurements: Direct physical measurements (e.g., dimensions, flow rates, strengths).
- Observed Performance in Bench Tests: Qualitative and quantitative observations of mechanical function (e.g., trackability, leakage, kinking).
- Pathology and Clinical Pathology from Animal Models: Histological analysis, gross pathology findings, and blood work from the animal study to confirm safety (e.g., absence of thrombosis, tissue damage).
8. The sample size for the training set
This question is not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as there is no AI/ML training set for this device.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).