Search Results

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

Medtronic Tubing Packs are used in cardiopulmonary bypass procedures for connecting the primary devices of the bypass circuit. Medtronic Tubing Packs consist of coated and uncoated tubing, connectors and various medical devices that are pre-assembled into user-specified extracorporeal cardiopulmonary bypass perfusion circuits. Tubing Packs are intended for use within the extracorporeal blood pathway during cardiopulmonary bypass surgical procedures. Medtronic Tubing Packs are currently packaged into qualified clear tray and sterile packaging systems. This submission is to add additional tubing and connectors for use in Tubing Pack and is changing as part of continual process improvement efforts. The component additions include tubing and connectors that may be coated or uncoated. The coating types include: Cortiva, Trillium and Balance and these three types of coatings are identical to the cleared existing components for Tubing Packs (K891687, K012538 and K122811). The components being added do not have any changes in materials, technology or labeling than previously cleared components for Tubing Packs. These additional components are representative of currently cleared components and do not add any additional risk to patients therefore, Medtronic believes these components may be added to the Tubing Packs. All packaging components remain unchanged (peel pouches, ties, bands, trays, lids and shipper). There is no change to the sterile barrier, sterilization and test methods used for these components.

This looks like information for a regulatory submission for a medical device. Based on the provided text, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set in quantitative terms (e.g., number of units tested). Instead, it mentions that "worse case testing for tubing and connectors" was performed and "verification results were leveraged based on most challenging components." This suggests that a subset of components representing the most challenging scenarios was selected for testing.

The data provenance is from Medtronic, Inc.'s internal testing. It is prospective in the sense that the testing was conducted specifically for this submission to verify the performance of the added components. The country of origin of the data is implicitly the United States, as Medtronic is based there and submitting to the FDA.

3. Number of Experts and Qualifications for Ground Truth

This device (Medtronic Tubing Pack) is a Class II medical device, specifically "Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing." The "ground truth" in this context refers to established engineering and biocompatibility standards and performance requirements for such medical components, rather than clinical interpretation by medical experts (like radiologists for imaging devices).

The document does not mention the use of experts to establish a "ground truth" for a test set in the way one would for an AI-powered diagnostic device. The "ground truth" for this device's performance is derived from established industry standards, internal product specifications, and regulatory requirements that define acceptable limits for pressure integrity, biocompatibility, etc. The document refers to "product specification" and "rationalization documentation" as the basis for evaluation.

4. Adjudication Method

An adjudication method (like 2+1, 3+1) is typically used in clinical studies where there's a need to resolve discrepancies in expert opinions on imaging or clinical assessments. For this type of device (tubing and connectors), the "adjudication" is based on objective measurement against predefined specifications and standards. There is no mention of human adjudication in the traditional sense for reconciling expert interpretations for a test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation, particularly in diagnostic imaging, to assess improvements in reader performance with AI assistance. This device is a passive component for cardiopulmonary bypass and does not involve human interpretation in a diagnostic capacity or AI assistance.

6. Standalone Performance Study

The studies described are essentially standalone performance studies for the device components. The verification and validation testing assesses the "algorithm only" (if one considers the manufacturing process and design as the "algorithm" for a physical device) against predetermined performance specifications. The tests for pressure integrity, spallation, kink resistance, pull force, tubing life, and biocompatibility are all evaluations of the device's inherent performance characteristics without human interaction being part of the primary performance metric.

7. Type of Ground Truth Used

The ground truth used is primarily engineering specifications, material science standards, and biocompatibility standards, as outlined in the "product specification" and various "rationalization documentation" (e.g., Mechanical Requirements, Coating Requirements, Biocompatibility per product specifications). Essentially, the "ground truth" is established industry and regulatory benchmarks for the safety and efficacy of cardiopulmonary bypass components.

8. Sample Size for the Training Set

This document does not mention a "training set" as this is not an AI/machine learning device. The "training" for a physical medical device typically refers to the design, manufacturing process, and quality control procedures, which are developed and refined over time based on engineering principles and previous device iterations. There isn't a "training data" set in the context of an algorithm.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/machine learning sense, there is no ground truth established for it. The development and refinement of the device's design and manufacturing processes (analogous to "training" for a physical product) would be based on:

• Engineering design principles
• Material science knowledge
• Previous iterations of similar devices (predicates)
• User feedback
• Regulatory requirements and standards for medical devices.

Ask a specific question about this device

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

Medtronic Tubing Packs are used in cardiopulmonary bypass for connecting the primary devices of the bypass circuit. The functionality and intended use of these devices are the same as those for the coated (Cortiva - Coated Tubing Packs(K891687), Trillium BioPassive Surface Coated Tubing Packs (K012538), and Balance BioSurface Coated Tubing Packs(K122811) and uncoated tubing, connectors, and accessories that are FDA cleared.

Medtronic Tubing Packs consist of coated and uncoated tubing, connectors and various medical devices that are pre-assembled into user-specified extracorporeal cardiopulmonary bypass perfusion circuits. Tubing Packs are intended for use within the extracorporeal blood pathway during cardiopulmonary bypass surgical procedures.

The provided text describes a 510(k) premarket notification for a medical device called "Tubing Pack" by Medtronic, Inc. This submission focuses on a packaging change and does not involve the development or evaluation of an AI/ML powered device. Therefore, many of the requested elements for describing the acceptance criteria and study proving an AI device meets them are not applicable to this document.

However, I can extract and present the information that is relevant to the device and its testing as described in the document, even though it's not specific to AI.

Here's a breakdown based on the information available:

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

The document does not explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance" in the context of an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). Instead, it discusses demonstrating equivalence to a predicate device through various tests, implying that the acceptance criterion is successful completion of these tests without adverse outcomes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on sample sizes for these tests, nor does it specify data provenance in terms of country of origin or retrospective/prospective nature. These kinds of details are typically provided for clinical studies involving patient data, not for engineering and material testing of packaging components.

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. The tests performed are engineering and material science evaluations, not clinical assessments requiring expert human interpretation of data for ground truth.

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

Not applicable. Adjudication methods are typically use for resolving discrepancies in expert interpretations in clinical studies.

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. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for these tests would be established through scientific and engineering standards and validated test methods. For example:

• Shelf Life: Stability of the product over time, measured through established degradation testing.
• Sterilization: Achievement of a specified Sterility Assurance Level (SAL) confirmed by validated biological indicators and methods.
• Biocompatibility: Absence of adverse biological reactions as per ISO 10993 standards and associated testing.
• Packaging Performance: Adherence to ISO or ASTM packaging integrity test standards.

8. The sample size for the training set

Not applicable. There is no AI/ML model involved, and thus no training set.

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

Not applicable. There is no AI/ML model involved.

In summary, the provided document details a regulatory submission for a packaging change to a medical device. It thoroughly outlines the scope of the change (material, supplier, mold, and slight dimension changes to the tray) and the types of tests performed to ensure that these changes do not negatively impact the device's safety and effectiveness, and that it remains substantially equivalent to its predicate. However, it does not involve an AI/ML component and therefore lacks the information requested for AI device validation.

Ask a specific question about this device

These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

The Select 3D™ and Select CAP™ Arterial Cannulae both have clear flexible, thin w.ill wire-wound PVC bodies with angled, beveled tips. The proximal end of each cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line.

The Select 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicate direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). It is available in 22 and 24 Fr sizes.

The Select CAP™ Arterial Cannula tips have an integrated pressure monitoring port. The pressure monitoring port on the tip of the cannulae provides the real time capability of accurately measuring central arterial pressure within the aorta. Overall cannula length is 12" (30.5 cm). It is available in 18, 20, 22, and 24 Fr. sizes.

The devices may include a Carmeda® BioActive Surface.

This submission describes device modifications, specifically adding a Carmeda® BioActive Surface coating to existing Select 3D™ and Select CAP™ Arterial Cannulae. Therefore, the "study" is focused on demonstrating that the coated devices maintain the performance characteristics of the uncoated predicate devices and that the coating itself is safe and effective.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document does not explicitly present a table of quantitative acceptance criteria (e.g., minimum flow rates, burst pressures, specific leach limits) that were met. Instead, it refers to "functional testing," "coverage, bioactivity, and leach testing" as having been performed and the results supporting substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The description mentions "in vitro visual and functional testing" and "coverage, bioactivity, and leach testing" performed on "Carmeda® coated devices," implying a sample of such devices, but the exact number is not provided.
• Data Provenance: The testing was "in vitro," meaning laboratory-based testing. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human subjects.

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

This is not applicable as the study did not involve human subjects or expert assessment for ground truth establishment. The testing described is entirely in vitro (laboratory-based chemical and physical performance testing).

4. Adjudication Method for the Test Set:

This is not applicable as the study did not involve human subjects, diagnostic assessments, or a need for adjudication among experts.

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 is not applicable. This submission is for a medical device (arterial cannulae), not an AI/imaging diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

This is not applicable as this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on:

• In vitro measurements and observations: This includes visual inspections, functional tests (e.g., flow characteristics, mechanical integrity), and chemical analyses (e.g., coverage, bioactivity, leach testing) conducted in a laboratory setting.
• Comparison to predicate devices: The "ground truth" for performance is effectively defined by the established performance characteristics of the prior, uncoated, predicate devices, which the new coated devices must match or exceed.

8. The Sample Size for the Training Set:

This is not applicable as this is not an AI/algorithm-based device, so there is no "training set."

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

This is not applicable as this is not an AI/algorithm-based device, so there is no "training set" or ground truth establishment for it.

Ask a specific question about this device

The Medtronic CardioTherm™ Blood Cardioplegia System, with or without Carmeda® BioActive Surface, is intended for use in procedures requiring the mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

The Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface is coated with a non-leaching bioactive heparin surface which provides thromboresistant blood contact surfaces. The Carmeda® BioActive Surface is present on blood path materials.

Each Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios depending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient.

The Medtronic CardioTherm™ Blood Cardioplegia Heat Exchanger with Carmeda BioActive Surface consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or non-vented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery.

The heat exchanger housing contains non-porous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.

The flow of solution through the Medtronic CardioTherm™ Blood Cardioplegia Heat Exchanger with Carmeda® BioActive Surface is as follows:

Blood/Cardioplegia

The blood and/or cardioplegia solution enters the bottom of the device, flows up through the polypropylene hollow fibers, flows back down a center collecting tube, and exits the from the bottom of the device.

Water

The cooling/warming water enters a side port, passes around the outside walls of the polypropylene fibers, then exits through a parallel side port.

Heat exchange occurs as the blood/cardioplegia solution passes through the hollow fibers, while the temperature regulated cooling/warming water passes around the outside walls of the same fibers. The blood/cardioplegia solution is cooled/ warmed as it flows through the heat exchanger.

By connecting tubing of specific inner diameters to the heat exchanger, a predetermined approximate ratio of blood to cardioplegia solution may be delivered to the patient. The tubing sets are equivalent to the tubing sets which are currently used for the CardioTherm™ Blood Cardioplegia System (K960755)

Four of the various delivery ratios available are:

• a tubing set for 1:1 ratio of blood to asanguineous cardioplegia. 1.
• a tubing set for 2:1 ratio of blood to asanguineous cardioplegia. 2.
• a tubing set for 4:1 ratio of blood to asanguineous cardioplegia.
• a tubing set for 9:1 ratio of blood to asanguineous cardioplegia. 4.

These tubing ratios are identical to the commercially available CardioTherm™ Blood Cardioplegia Systems.

The provided text describes a 510(k) premarket notification for the Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove that the device meets specific acceptance criteria through a clinical study with real-world patient data, as would typically be the case for novel AI/ML medical devices.

Instead, the submission focuses on comparing the modified device (with the Carmeda® coating) to existing predicate devices already approved for market, primarily through in-vitro bench testing and biocompatibility testing. The "acceptance criteria" here are implicitly related to demonstrating that the new technological characteristic (the Carmeda® coating) does not negatively affect safety or effectiveness and that the modified device remains substantially equivalent to its predicates.

Therefore, the requested information elements related to clinical studies, human readers, ground truth establishment, and training/test set sample sizes (common for AI/ML device evaluations) are not directly applicable or available in the provided document, as this is a modification to an existing device rather than a de novo submission for a new AI/ML diagnostic or therapeutic device.

Here's an interpretation based on the provided text's context:

Acceptance Criteria and Study Details for Medtronic CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface

The "acceptance criteria" in this context are not explicit numerical thresholds from a clinical trial, but rather the demonstration of substantial equivalence to predicate devices through various tests. The device is considered to meet these criteria if the performance data from in-vitro bench testing and biocompatibility testing show that the addition of the Carmeda® BioActive Surface does not significantly affect safety and effectiveness compared to the predicate devices.

1. Table of "Acceptance Criteria" and Reported Device Performance

Given that this is a 510(k) for a device modification, the "acceptance criteria" are implied to be comparable performance to the predicate device across key characteristics, and absence of new safety/effectiveness questions. The "reported device performance" refers to the results of the in-vitro bench testing and biocompatibility studies conducted on the CardioTherm™ Blood Cardioplegia System with Carmeda® BioActive Surface.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of clinical patient data. The "test set" here refers to the in-vitro bench tests and biocompatibility tests conducted on the modified device and compared to the predicate. The specific number of devices or test runs for these in-vitro tests is not provided in the summary.
• Data Provenance: The data primarily comes from in-vitro bench testing and biocompatibility testing performed by Medtronic, Inc. It is not patient data from a specific country or retrospective/prospective study in the clinical sense.

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

• Number of Experts: Not applicable. For this type of device modification submission, "ground truth" is established through engineering and scientific test methods (e.g., measuring pressure, analyzing coating, biological compatibility assessments), not through expert clinical consensus on patient cases.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept applies to expert review of ambiguous clinical cases, which is not relevant for this engineering and biocompatibility assessment.

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

• MRMC Study: No. This type of study assesses the impact of an AI algorithm on human reader performance, which is not relevant for a blood cardioplegia system with a bioactive surface coating.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: No. This device is not an algorithm, and the concept of standalone performance does not apply to a physical medical device in this context. The closest analogy would be the in-vitro bench testing evaluating the device's physical and functional characteristics.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is based on established scientific and engineering measurement standards for device performance (e.g., pressure drop, heat exchange efficiency) and biocompatibility assessment protocols. It is not pathology, expert consensus on patient outcomes, or clinical outcomes data. The acceptance is based on demonstrating that the new coating does not alter these "ground truths" of established performance and safety compared to the predicate.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that undergoes a training phase.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device