Search Results

The Dual Lumen Short Term Hemodialysis and Extra Flow (EF) Short Term Hemodialysis catheters are indicated for use in hemodialysis, hemoperfusion and apheresis for short-term duration of less than 30 days via the subclavian, femoral or jugular vein.

The Joline D-Line Catheter ST family of catheters, consisting of the Dual Lumen Short Term Hemodialysis and Extra Flow (EF) Short Term Hemodialysis catheters are a polyurethane radiopaque catheter which allows for hemodialysis, hemoperfusion and apheresis. A crosssectional view of the shaft of the Joline D-Line Catheter ST catheters reveals a double "D" configuration -one "D" for the arterial lumen and the other for the venous lumen. In the Extra Flow (EF) Short Term design the venous lumen extends beyond the arterial lumen and terminates in a round tip. The Dual Lumen Short Term catheter has both lumens exiting together and incorporates side-holes along the shaft of the catheter body in its design. Two color-coded safety clamps, red and blue, identify arterial and venous extensions. lmportant information such as priming volume and catheter length is printed on both sides of the clamp. A swiveling suture ring is available to secure the catheter after placement. Two extensions merge into a tapered bifurcation joint or hub molded to the catheter body. These extensions can be straight, curved or curved-to-one-side. The finished kit consists of either the Dual Lumen Short Term Hemodialysis or Extra Flow ITIc Timenta Kit of Childers packaged with various accessory components. These components include: guidewire, introducer needle, dilator, and luer lock caps.

This document describes the 510(k) summary for the Joline D-Line Catheter ST family of catheters. The submission focuses on demonstrating substantial equivalence to predicate devices through engineering bench testing, rather than clinical performance based on metrics like sensitivity, specificity, or AUC. Therefore, many of the requested criteria related to clinical study design (sample size, expert ground truth, adjudication) are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. The study was based on engineering bench testing, not clinical data with a "test set" of patients.
• Data Provenance: Not applicable. The data came from engineering laboratory tests, not patient data from specific countries or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. The study did not involve expert review of clinical cases to establish ground truth. Compliance was based on engineering data and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No "test set" or clinical adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC comparative effectiveness study was not performed. The submission is for a medical device (catheter), not an AI/imaging diagnostic tool that would typically involve human reader performance.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

• Engineering Specifications and Predicate Device Performance: The "ground truth" for this submission refers to established engineering standards (e.g., ISO 10555, ISO 10993) and the known performance characteristics of the legally marketed predicate devices. The new device's performance was compared against these established benchmarks.

8. Sample Size for the Training Set

• Not applicable. There was no "training set" as this was not an AI/machine learning study.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

Ask a specific question about this device

The NovoSci ™ Ready System® is indicated for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.

The NovoSci" Ready System® is a closed loop extracorporeal system providing circulatory, thermal and gas-exchange support for extracorporeal perfusion. The NovoSci" Ready System® is provided as a sterile system with a non-pyrogenic fluid pathway for single use only and is not to be re-sterilized by the user.

The provided text describes a 510(k) premarket notification for the NovoSci™ Ready System®, an extracorporeal system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new, innovative device. Therefore, much of the requested information regarding AI model performance, human reader studies, and detailed ground truth establishment is not applicable to this submission.

Here's a breakdown of the information that can be extracted and explanations for what cannot:

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly list "acceptance criteria" in the way one would for an AI algorithm's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.

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 in the given text. Non-clinical testing typically involves bench-top tests, simulations, and material analyses rather than patient-derived "test sets" in the context of an AI device.

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/not provided. Ground truth establishment by experts is relevant for diagnostic AI devices where human interpretation is being benchmarked. For an extracorporeal circulation system, "ground truth" is typically defined by engineering specifications, validated test methods, and compliance with industry standards.

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

This information is not applicable/not provided. Adjudication methods are used in studies involving human interpretation or agreement, typically for diagnostic accuracy studies of AI.

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/not provided. The NovoSci™ Ready System® is a medical device for extracorporeal circulation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance metrics are not relevant.

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

This information is not applicable/not provided. As explained above, this is not an AI device.

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

For this type of device, the "ground truth" for non-clinical testing would involve:

• Engineering specifications and standards: Performance parameters like flow rate, pressure drop, and blood damage are compared against pre-defined, acceptable ranges established through engineering principles and regulatory guidelines for similar devices.
• Predicate device performance data: The NovoSci™ Ready System®'s performance is compared against the known, established performance of the legally marketed predicate devices (Jostra MECC System, V-bag, V-box). This acts as a de-facto "ground truth" for what constitutes safe and effective performance.

8. The sample size for the training set

This information is not applicable/not provided. This is not an AI device, so there is no "training set."

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

This information is not applicable/not provided. As not an AI device, there is no "training set" or ground truth established for it in that context.

Ask a specific question about this device

The NovoSci™ NovoCoat™ treated tubing and connectors are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.

The NovoSci ™ tubing and connectors treated with NovoCoat™ are sterile, single use only, disposable devices. They are used to connect cardiopulmonary bypass components used during surgery procedures requiring extracorporeal support. When used on devices for cardiopulmonary surgery, the NovoCoat™ treatment improves blood compatibility of non-biological surfaces in the extracorporeal circuit.

NovoSci™ tubing is polyvinyl chloride (PVC) tubing available in various sizes. The NovoSci™ connectors are polycarbonate in various configurations such as straight, reducing, "Y", with or without luer ports.

Acceptance Criteria and Study for NovoSci™ Tubing and Connectors with NovoCoat™

This 510(k) summary focuses on demonstrating that the NovoSci™ Tubing and Connectors with NovoCoat™ are substantially equivalent to the predicate device, NovoSci™ Duraflo treated tubing and connectors. The acceptance criteria and supporting study are therefore based on non-clinical performance and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each non-clinical test. However, it indicates that "Non-clinical testing" was performed. Given the nature of medical device testing (especially for substantial equivalence), it is assumed that appropriate, statistically valid sample sizes were used for each test to demonstrate equivalence to the predicate device.

The data provenance is not explicitly stated in terms of country of origin. The study is a non-clinical, in-vitro, bench-top testing assessment, therefore the concept of "retrospective or prospective" doesn't directly apply in the same way as a clinical trial. The testing was conducted to support the 510(k) submission, suggesting it was purpose-designed (prospective) to gather data for regulatory review.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This section is not applicable to this 510(k) submission. The device is a medical accessory (tubing and connectors), and its performance assessment is based on objective, measurable physical and chemical properties through non-clinical testing rather than human interpretation of data where "ground truth" would be established by experts.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical endpoints that require expert consensus, which is not the case for these non-clinical tests. The tests performed are objective measurements.

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 section is not applicable. This is a 510(k) submission for a physical medical device (tubing and connectors), not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies are irrelevant.

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

This section is not applicable. This submission is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria in this submission is the established performance characteristics of the predicate device, NovoSci™ Duraflo treated tubing and connectors. The tests (biocompatibility, blood damage, bond strength, hardness, leak test, pump life) were designed to demonstrate that the new device performs equivalently to this well-established predicate. This would involve comparing quantitative or qualitative results of the new device against the known and accepted performance range/values of the predicate device.

8. The Sample Size for the Training Set

This section is not applicable as this is a non-AI medical device and does not involve a "training set" in the context of machine learning or algorithms.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reasons as point 8.

Ask a specific question about this device