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Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.

Integra® Jarit® Heparin Cannulas, Injectors, and Needles are manual, stainless steel catheter cannulas provided in various sizes, shapes, and lengths for use during cardiovascular surgical procedures such as coronary artery bypass surgery. The cannulas are intended to be connected to a syringe filled with heparinized saline to confirm there is no leakage as well as ensure patency of harvested and/or grafted veins. The syringes are not being supplied with the cannulas nor are the syringes offered by Integra; therefore they are not part of this submission. These reusable devices are packaged non-sterile and are steam sterilizable.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Integra® Jarit® Heparin Cannulas, Injectors, and Needles:

Context: The provided text is a 510(k) Summary for a medical device seeking substantial equivalence to predicate devices, not an AI/ML medical device. Therefore, many of the typical acceptance criteria and study components associated with AI devices (like ground truth, expert consensus, MRMC studies, training/test sets, etc.) are not applicable here. This document focuses on demonstrating physical and material properties, and reusability.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The tests conducted are typically on a sample of the devices designed to be representative of production, but the specific number is not disclosed in this summary.
• Data Provenance: The tests are controlled bench tests performed on the physical devices manufactured by Integra York PA, Inc. The data is prospective for the purpose of this submission; it's generated specifically to demonstrate compliance for the 510(k). Country of origin for data generation is not specified beyond "Integra York PA, Inc." (USA).

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

This question is not directly applicable to this type of device submission. The "ground truth" for these tests is established by recognized industry standards (e.g., AAMI, ASTM, ISO) and the scientific principles behind them (e.g., measuring protein residue, assessing material integrity, verifying sterilization efficacy). These standards themselves are developed by committees of experts, but specific individual experts are not cited for establishing the ground truth for this particular test of this device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human interpretation or consensus. The tests performed yield objective, measurable results (e.g., "Pass" or "Fail" based on whether predefined thresholds from the standards are met).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a manual surgical instrument, not an AI/ML-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., Algorithm-Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical, manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used is defined by adherence to established national and international performance standards and test methods (e.g., ANSI/AAMI ST79, ASTM TIR 30, ISO 13402, ASTM F1089-02, ISO 7153-1). These standards specify acceptable levels for cleanliness, sterilization, corrosion resistance, and mechanical strength. In the case of biocompatibility, the ground truth is based on the recognized biocompatibility profiles of the specified stainless steel materials as per relevant material standards (ASTM F899-11 and ISO 7153-1) and their long history of safe use in medical devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.

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

Not applicable, as there is no training set for this type of device.

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The Edwards Lifesciences Arterial Perfusion Cannulae II are indicated for arterial perfusion in the extracorporeal circuit for

Edwards Arterial Perfusion Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood to a patient during cardiopulmonary bypass procedures.

The cannulae are available in a range of sizes and in a variety of tip configurations. Some cannulae are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking; other cannulae are non-reinforced. Some cannulae are provided with a movable suture ring, a fixed suture ring or a fixed suture bump or flange to facilitate the fixation of the cannula.

The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.

The provided 510(k) summary for the Edwards Lifesciences Arterial Perfusion Cannula II does not contain the kind of detailed information about acceptance criteria, study design, expert ground truth, or statistical analyses that would typically be found in a submission for a device that uses AI or machine learning.

This submission is for a medical device that is a physical product (an arterial perfusion cannula), and its safety and efficacy are demonstrated through comparative analysis and functional/safety testing against a predicate device, not through studies involving AI or complex data analysis with expert consensus.

Therefore, I cannot extract the requested information as it is not present in the provided document.

Here's why and what kind of information is available instead:

• Acceptance Criteria & Device Performance: The document states that the "functional data indicate that the subject devices perform in a substantially equivalent manner when compared with the predicate device." This implies the acceptance criteria were met if the new device's functional performance was deemed equivalent to the predicate. Specific numerical targets or performance metrics are not provided, as this is a traditional medical device submission focused on physical characteristics and performance.
• Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Functional/Safety Testing" and "Comparative Analysis." These studies demonstrate that the new APC II cannulae are "comparable to the predicate devices in intended use, fundamental scientific technology, material type, principles of operation and functional performance evaluations."
• Points 2-9 (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, training set, etc.): These points are specific to studies involving algorithms, data analysis, and expert interpretation (common in AI/ML submissions). They are entirely absent because this submission is for a physical medical device. The "ground truth" for a physical device like a cannula would be its physical integrity, material properties, flow rates, pressure resistance, etc., which are assessed through engineering and bench testing, not expert consensus on interpretations of data.

In summary, the provided text describes a 510(k) submission for a physical medical device, not an AI/ML-powered device. Therefore, the questions related to AI/ML study design and ground truth are not applicable and cannot be answered from the given information.

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The AngioDynamics, Inc. Micro Access Kit is indicated for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain information regarding acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications. It only states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot fulfill your request for the specific information outlined.

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The CardiacAssist Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to a suitable extracorporeal blood pump unit which returns blood to the patient via the femoral artery or other appropriate site.

The Transseptal Cannula Set consists of three components: (1) 21 Fr. Transseptal Cannula, (2) 13 Fr. Obturator, and (3) 14/21 Fr. Two-stage Dilator, that accept a 0.035 in. guidewire.

The 21 Fr. Transseptal Cannula (Figure 1) allows for drainage of the left atrium during ventricular bypass. It has 14 side holes in addition to the tip opening for inflow at the distal end, a barbed fitting at the proximal end, and insertion depth markings from 40 to 62 cm measured from the distal end. The Transseptal Cannula also includes a Suture Wing and 2 Suture Rings to provide a means for securing it to the patient.

The 13 Fr. Obturator (Figure 2) is used to advance the Cannula to the right atrium from the inguinal area and then across the atrial septum into the left atrium. It contains a luer hub and aspiration side holes at both the distal and proximal ends to facilitate de-airing and to allow for use of contrast material to facilitate final positioning of the Cannula. It also contains a radiopaque marker band proximal to the Cannula drainage holes when the Obturator is inserted in the Cannula.

The 14/21 Fr. Dilator (Figure 3) is provided for pre-dilation of the fossa ovalis once left atrial access is achieved via standard transseptal technique.

The provided text describes a 510(k) submission for the "CardiacAssist-Transseptal Cannula Set". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the device performance data provided is primarily based on bench testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes bench testing rather than human clinical trials. Therefore, information about human "test sets" or "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable in the context of this 510(k) submission for bench testing. The "test set" would consist of multiple units of the manufactured device subjected to various engineering and materials tests. The document does not specify the exact number of units tested for each criterion, but it implies a sufficient number were tested to draw conclusions.

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

This is not applicable as the data presented is from bench testing, not from human studies requiring expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for these tests are objective measurements against established engineering specifications and international standards (e.g., ISO 10993-1).

4. Adjudication Method for the Test Set:

This is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts provide interpretations that need to be reconciled. Bench tests rely on objective measurements and established protocols.

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. The device is a physical medical instrument (a cannula set), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness is irrelevant to this submission.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the bench tests described:

• Functional Performance (Flow vs. Pressure Drop, Kink Radius): The ground truth would be established by comparing the device's performance against the predicate device (Elecath cannula) and/or predetermined engineering specifications. The statement "substantially better than that of the Elecath cannula" indicates the predicate's performance served as a baseline or "ground truth" for comparison.
• Mechanical Strength (Tensile Strength) and Integrity (Leak Testing): The ground truth would be predefined engineering design requirements and specifications.
• Biocompatibility: The ground truth is compliance with recognized international standards and FDA guidance documents (FDA Blue Book Memorandum #G95-1 and ISO 10993-1).

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical instrument, and the testing described is bench testing, not machine learning or AI where "training sets" are used.

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

This is not applicable for the same reasons as #8.

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The RMI Internal Mammary Artery Cannula is composed of a chrome-plated brass female luer hub and 304 stainless steel tubing with smooth bulb tip.

The provided text describes a medical device, the RMI Internal Mammary Artery Cannula, and its comparison to a predicate device, the DLP I.M.A. Cannula, for the purpose of a 510(k) premarket notification. However, the information provided does not pertain to the performance of a software algorithm or AI-based device, but rather a physical medical instrument. Therefore, most of the requested categories related to AI/algorithm performance and study design are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The text explicitly states "Since the flowrate through a cannula indicated for flushing the internal mammary artery with a vasodilator is only an issue if the pressure needed to create the desired flow is too high, it may be concluded that in terms of flow rates, the RMI Internal Mammary Artery Cannula, IMA-001, is substantially equivalent to the DLP I.M.A. Cannula, I.M.A. 31001." This implies that a higher flow rate, as long as it doesn't lead to excessive pressure, is acceptable and contributes to substantial equivalence.

Study Details (as much as can be extracted or inferred for a physical device)

1. Sample size used for the test set and the data provenance:

   • Sample Size: The text mentions "A comparative performance test... was completed" but does not specify the number of cannulae tested (i.e., the sample size) for either the RMI or DLP devices.
   • Data Provenance: Not specified. It's an internal comparative performance test, likely conducted by the manufacturer or a contracted lab. Neither country of origin nor retrospective/prospective status is mentioned, but given it's a physical device performance test, these classifications are less standard than for clinical data.

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

   • Not Applicable. This is a performance test for a physical device (flow rate measurement), not an interpretative task requiring expert ground truth in the way medical imaging or diagnostic algorithms do. The "ground truth" would be the measured flow rates themselves, established by the testing methodology.

3. Adjudication method for the test set:

   • Not Applicable. No expert adjudication is described or needed for a physical performance test like a flow rate comparison.

4. 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/software device, and no MRMC study was conducted.

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

   • Not Applicable. This is not an algorithm.

6. The type of ground truth used:

   • For the flow rate comparison, the "ground truth" is the measured flow rate of each cannula, determined empirically through the specified performance test.

7. The sample size for the training set:

   • Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.

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

   • Not Applicable. No training set for an algorithm.

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