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These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.

The Medtronic DLP Malleable Single Stage Venous Cannulae represent modified versions of existing Medtronic Single Stage Venous Cannulae. The proposed change involves the incorporation of a malleable wire/tube assembly embedded within the wall of the cannula. This malleable wire/tube assembly allows the cannula body to be shaped into a surgeon preferred position.

The provided document, KO22272 for the Medtronic DLP Malleable Single Stage Venous Cannula, is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing completely new performance criteria. Therefore, the document does not contain detailed acceptance criteria in the form of specific performance metrics or a study that rigorously "proves" the device meets them in the same way a de novo or PMA submission might.

Instead, the acceptance criteria are implicitly met by demonstrating that the new device is as safe and effective as the predicate device, which is already on the market. The study described focuses on non-clinical tests to support this substantial equivalence.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The Medtronic DLP Arterial Cannulae with 3D Tip represent modified versions of existing Medtronic DLP Arterial Cannulae. The proposed change involves the incorporation of a baffled tip design into the 22 Fr. cannula. This baffled tip imparts a more diffuse pattern of blood flow exiting from the cannula tip than exists with the existing open tip cannula design.

The provided document is a 510(k) Summary for a medical device (Medtronic DLP Arterial Cannulae with 3D Tip - 22 Fr.) and describes non-clinical performance data rather than a study with acceptance criteria and device performance in the context of human data or AI algorithms. As such, many of the requested categories are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for use in venting the left heart during cardiopulmonary bypass surgery.

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is designed for use in venting the left heart during cardiopulmonary bypass surgery.

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is equipped with a pressure monitoring line, which allows measurement of left ventricular pressure.

This submission package does not contain the level of detail required to complete the requested table and provide specific information on acceptance criteria and study design elements like sample sizes, ground truth establishment, or expert qualifications. The provided document is a 510(k) summary for a medical device (24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line) seeking substantial equivalence to predicate devices.

Here's why and what can be pieced together:

Key Takeaways from the Document:

• Substantial Equivalence: The primary goal of this submission is to demonstrate that the new device is substantially equivalent to already legally marketed predicate devices. This means it has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.
• No Clinical Trials: 510(k) submissions, especially for devices seeking substantial equivalence based on minor modifications, often rely heavily on bench testing and comparison to predicates rather than extensive clinical studies with human participants. This is evident as no mention of human subject data, clinical trials, or expert reader studies (MRMC, standalone AI performance) is present.
• Bench Testing: The document explicitly states: "The biocompatibility rationale and in vitro bench testing demonstrated that when compared to the predicate devices, the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed devices. The in vitro bench testing included analysis of: kink testing, clamp testing, flexibility testing, burst, leak testing, pull testing and pressure monitoring capability."

Therefore, many sections of your request cannot be directly answered from this document.

Here's an attempt to populate the table and answer the questions based on the available information, noting where information is absent:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified for any of the bench tests.
• Data Provenance: The tests are in-vitro bench tests, not involving human or animal subjects. The location of the testing is not specified, but it was conducted by Medtronic, Inc. in the USA. Given the nature of a 510(k) for device modifications, these would be considered retrospective in the sense that the new device's performance is compared against known characteristics or specifications of existing predicate devices and general standards.

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 (N/A) as the study involved in-vitro bench testing, not expert interpretation or clinical assessment.

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

• This information is not applicable (N/A) as the study involved in-vitro bench testing, not subjective assessment requiring 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 MRMC study was done. This is a 510(k) for a physical medical device (catheter), not an AI-enabled diagnostic tool. Therefore, concerns about human reader improvement with AI are not applicable (N/A).

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

• No standalone algorithm performance study was done. This is a 510(k) for a physical medical device, not an AI algorithm. Therefore, concerns about standalone algorithm performance are not applicable (N/A).

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

• The "ground truth" for the bench tests would be the pre-defined engineering specifications, material standards, and performance characteristics of the predicate devices. For instance, the "ground truth" for burst pressure would be a certain pressure threshold the device must withstand, derived from safety standards and predicate device performance. It is based on engineering specifications and established material/device performance standards.

8. The sample size for the training set

• This is not applicable (N/A). This device is not an AI algorithm, and thus, there is no AI "training set."

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

• This is not applicable (N/A) as there is no AI training set.

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These devices are intended for the perfusion of anticoagulated arterial blood to an ischemic area of the heart.
These devices are intended for the perfusion of anticoagulated arterial blood from the aorta to coronary vessels to supply an ischemic area of the heart during beating heart CABG procedures.

The Medtronic AortoCoronary Shunt includes an Aortic Root Cannula Assembly, a Y-Tubing Connector Assembly and a set of Arteriotomy Cannulae (2 mm, 3 mm and 4 mm sizes). The Arteriotomy Cannula Assemblies are also available separately for user convenience. The user assembles the components into the final product configuration immediately prior to use. The assembled device diverts oxygenated, arterial blood from the patient's aorta directly to one or two coronary arteries, thereby providing perfusion of an ischemic area of the heart during cardiac surgical procedures

The Medtronic AortoCoronary Shunt and Arteriotomy Cannulae are medical devices intended for the perfusion of anticoagulated arterial blood to an ischemic area of the heart during cardiac surgical procedures. The provided 510(k) summary outlines the non-clinical performance data used to assert substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Sensitization (Guinea Pig Maximization Method): Negative results
• Intracutaneous Reactivity (in rabbits): Negative results
• Acute Systemic Toxicity (in mice): Negative results
• Genotoxicity (Ames Salmonella typhimurium / Escherichia coli Mutation Reversion Method): Negative results
• Hemocompatibility (material-mediated Hemolysis and Thrombogenicity): Negative results |
  | Tensile and Hydrostatic Burst Testing | Acceptable strength and integrity of all device segments. | Yielded acceptable results on all segments of the fully assembled AortoCoronary Shunt. |
  | Resistance to Fluid Flow | Capable of delivering blood to target coronary arteries at flow rates higher than normally observed. | Demonstrated that the product is capable of delivering blood to target coronary arteries at flow rates that are higher than are normally observed in those coronary arteries. Evaluated for both Arteriotomy Cannulae alone and the fully assembled AortoCoronary Shunt. |
  | Resistance to Kinking and Damage due to Clamping | Acceptable resistance to kinking and damage. | Yielded acceptable results. |

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

The provided document describes non-clinical performance data, meaning these are laboratory or bench tests, not tests on human subjects. Therefore, the concept of a "test set" with human data is not applicable in this context.

• Sample Size: Not explicitly stated for each test (e.g., number of devices tested for tensile strength). However, the document implies that a sufficient number of samples were tested to demonstrate acceptable performance for each criterion.
• Data Provenance: The tests are explicitly described as "non-clinical" performance data, conducted in a laboratory setting. Country of origin of data is not specified but is implicitly associated with the submitter, Medtronic Cardiac Surgical Products, Grand Rapids, MI, USA. The data is prospective in the sense that the tests were conducted specifically to evaluate the new device.

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

Not applicable. As this involves non-clinical bench testing, the concept of "ground truth" established by medical experts (e.g., radiologists) for a test set is not relevant. The "ground truth" here is the physical and biological characteristics measured by the laboratory tests against established scientific and regulatory standards (e.g., ISO 10993-1).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies or clinical trials to resolve discrepancies in expert opinions. For non-clinical bench testing, the results are typically quantitative measurements or qualitative observations directly compared against pre-defined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices, not on comparing the effectiveness of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This submission is for a physical medical device (AortoCoronary Shunt and Arteriotomy Cannulae), not for an artificial intelligence/machine learning algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these non-clinical tests is based on:

• International Standards: Specifically, ISO 10993-1 for biocompatibility.
• Engineering Principles and Benchmarks: For functional tests like tensile strength, burst pressure, fluid flow resistance, and kinking resistance, the ground truth is established by physical measurements and comparison against expected physiological performance (e.g., flow rates higher than normally observed in coronary arteries) and engineering specifications for device integrity.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device. The tests described are for a physical medical device.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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