Search Results

The SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.

The SureFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through drainage holes near the catheter's bullet shaped tip. Similar to the predicate, the catheter is barium- sulfate- impregnated to provide radiopacity. Black stripes are located every 1 cm between 5 cm and 15 cm from the catheter tip to assist the surgeon in catheter placement. Double stripes and numerical markings are located at 10 cm and 15 cm. (All dimensions are nominal).

The SureFlo EVD Catheter is provided with a stainless steel Stylette, stainless steel Trocar, Barbed Luer Connecter, Male Luer Cap and silicone Suture Clip. The stainless-steel Stylet facilitates catheter placement for introduction of the catheter into the ventricle or other ventricular target site. A Trocar is supplied with the catheter to facilitate subcutaneous tunneling away from the burr hole. The external portion of the catheter may be secured to the scalp by the radiopaque Suture Clip. The Barbed Luer Connector supplied with each SureFlo EVD Catheter will connect the catheter to external drainage systems. The included Male Luer Cap may be used to close (cap) the barbed luer connector until the catheter is connected to a drainage or monitoring device.

The SureFlo EVD Catheter and its accessories are provided sterile.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Arkis SureFlo EVD Catheter:

The document describes pre-market testing primarily focused on bench performance, sterility, shelf life, package integrity, and biocompatibility. It does not involve a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it present standalone algorithm performance. The device is a physical medical device (catheter), not AI software. Therefore, the questions related to AI-specific criteria (human reader improvement with AI, standalone AI performance, training set details) are not applicable.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with recognized consensus standards (ISO 7197:2006, ASTM F647-94(2014) for performance; ISO 11135:2014, ISO 10993-7:2008, ANSI ST72:2011 for sterility; ASTM F1980-16, ASTM D4169-16, ASTM F2096-11, F88/F88M-15, ASTM F1608-16 for shelf life/package integrity; and ISO 10993-1:2009/(R)2013, ISO 10993-5, -10, -11, -3, -4, -6 for biocompatibility). The reported device performance indicates that the SureFlo EVD Catheter met or exceeded all specified requirements and demonstrated equivalence or superiority to the predicate devices in these areas.

Additional Information:

2. Sample sizes used for the test set and data provenance:

   • The document describes bench testing, sterility testing, shelf life/package integrity testing, and biocompatibility testing. Specific sample sizes for each test are not explicitly provided in this summary document.
   • Data provenance: All testing appears to be prospective laboratory/bench testing conducted by the manufacturer or contract labs, rather than clinical patient data. The origin of the data would be the respective testing facilities.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable. This device relies on objective measurements against engineering and biological standards, not expert interpretation of cases or images.

4. Adjudication method for the test set:

   • Not applicable. Ground truth is established by objective measurements and standardized test methods, not expert adjudication.

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 physical medical device (catheter) and not an AI/software device. Therefore, MRMC studies and AI assistance metrics are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

   • Standardized measurements against industry consensus standards and predicate device performance. For biocompatibility, it involved biological responses measured in in vitro and in vivo (animal) studies compared against established safety limits.

8. The sample size for the training set:

   • Not applicable. There is no AI algorithm being "trained" for this physical device.

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

Ask a specific question about this device

The NMI Dialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis in adults. Catheters greater than 40 cm are intended for femoral vein insertion.

The NMI Dialysis Catheter (NMI DC) is a Carbothane, double lumen catheter used to remove and return blood during hemodialysis and apheresis. The catheter lumens are 'D' shaped, open at the distal tip with a total of 4 side holes (two at venous tip, two at arterial tip). The distal venous tip extends beyond the arterial lumen to reduce recirculation. The distal tip is tapered and curved to facilitate insertion. The distal tip also includes a guidewire lumen to facilitate insertion by the optional guidewire placement technique. The proximal section of the device contains a fixed polyester cuff that allows for tissue ingrowth for long term placement, an integrated bifurcation hub, suture wing, and extension leg set with colorcoded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the clamps. The procedure kit includes the necessary accessories to correctly insert the catheter. The catheters are intended to be inserted percutaneously and are primarily placed in the right internal jugular vein of an adult patient. This implantation procedure is recommended to be carried out under direct fluoroscopic guidance. The catheter shaft, bifurcation, and extension legs incorporate Endexo polymer for improved resistance to thrombus formation on the surfaces of the catheter.

Here's an analysis of the provided text regarding the NMI Dialysis Catheter, focused on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary, which is a premarket notification to the FDA demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report. Therefore, many of the specific details requested, particularly for clinical trials (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, ground truth for training set), are not present in this type of document. The focus here is on demonstrating performance against established standards and internal specifications, and often leverages in vitro and in vivo animal or simulated studies.

However, I will extract what is available and explain where information is missing due to the nature of the document.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance." Instead, it lists the types of performance tests conducted and concludes that the device "successfully passed relevant testing per the above Guidance and standards." This implies the acceptance criteria for each test were met, even if the specific numerical thresholds aren't provided.

Here's an interpreted table based on the information given:

Additional Requested Information:

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 specified. This document focuses on bench testing and in vitro/animal in vivo studies, not human clinical trials. Sample sizes for these types of tests would be determined by the specific test protocols and standards (e.g., a certain number of catheters for tensile testing).
• Data Provenance: Not specified. Given it's a submission to the US FDA, the tests were likely conducted in the US or in labs compliant with US regulations, but no country of origin is explicitly stated.
• Retrospective or Prospective: Not applicable in the context of human data. The tests described are laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a study requiring expert readers to establish ground truth for interpreted data (e.g., medical images). The ground truth in these types of studies is the objective measurement from the bench or in vitro test.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This is not a study requiring human adjudication for diagnostic outcomes.

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 medical device (catheter) and not an AI-powered diagnostic tool. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The ground truth for the performance evaluations (e.g., tensile strength, recirculation, hemolysis) would be the objective measurements derived from the standardized test methods themselves. For example, for tensile testing, the ground truth is the breaking force measured by the testing equipment. For thromboresistance, it would be the observed thrombus formation in vitro or in vivo (animal model), compared to a control or predicate.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable for the same reason as above.

Summary of Study:

The studies conducted for the NMI Dialysis Catheter were primarily benchtop performance tests ("in vitro") and some in vivo animal studies (for thromboresistance), as indicated by the mention of "In-Vitro and In-Vivo Thromboresistance Testing." These tests were designed to evaluate the catheter's physical properties, functional performance (e.g., recirculation), biocompatibility, and resistance to thrombus formation against recognized international standards (ISO, EN ISO) and FDA guidance documents.

The conclusion of the submission is that "Based on successful results of testing... the proposed device is determined to be substantially equivalent to the predicate devices." This means the device met the performance expectations set by the applicable standards and guidance, demonstrating it is as safe and effective as the predicate devices.

Ask a specific question about this device