Search Results

The Medtronic guide catheter is designed to provide a pathway through which therapeutic devices are introduced. The guide catheter is intended to be used in the coronary or peripheral vascular system.

Launcher Guide Catheters are comprised of a cylindrical catheter having a proximal and distal end. A single lumen extends from the proximal to the distal end of the catheter. The distal end is the section of the catheter towards the tip and the proximal end is towards the hub and strain relief. The guide catheter is comprised of a luer hub, strain relief, shaft, segments, tungsten marker band, sleeve, and soft tip. The catheter shaft is made of three distinct layers. The guide catheter is available in various lengths ranging from 45 cm to 130 cm and four French sizes [5F, 6F, 7F, and 8F]. Launcher Guide Catheters have a lubricious inner lumen that runs from the proximal to the distal end of the catheter via a lubricious liner material or coating on the inner lumen.

The provided document is a 510(k) summary for the Medtronic Launcher Guide Catheter. It outlines the product's description, intended use, and substantial equivalence to a predicate device based on non-clinical performance and biocompatibility testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance/Conclusion |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility Assessment | 1) Cytotoxicity2) Sensitization3) Intracutaneous Reactivity4) Material-Mediated Pyrogenicity5) Hemocompatibility6) Acute Systemic Toxicity | Performed in accordance with FDA Guidance "Use of International Standard ISO 10993-1" and demonstrated no safety or effectiveness concerns. |
| Product Performance Evaluation (Dimensional & Performance) | 1) Inner Diameters (shaft, tip, & hub)2) Outer Diameters (shaft, segment, soft tip sleeve, & segment/shaft overlap)3) Total Segment Length4) Effective Length5) Exposed Tip Length6) Luer Connector Performance*7) Leak Resistance*8) Draw-through stiffness of primary and secondary curve9) Shaft bending stiffness & bending kink resistance (Body temperature and room temperature)10) Arch bending stiffness & bending kink resistance (Body temperature and room temperature)11) Shaft & distal segment crush resistance12) Torsional Stiffness, Rotational Kink Angle, and Rotations to Separation13) Curve retention after simulated seating14) Peak shaft & segment tensile load15) Peak soft tip tensile load16) Soft tip stiffness17) Peak hub/shaft tensile load*18) Internal lubricity | Necessary tests performed met the acceptance criteria and demonstrated that there are no safety or effectiveness concerns. The performance testing, along with biocompatibility testing, demonstrated substantial equivalence to the predicate device. Specific standards used for some tests are noted: ISO 594-1, ISO 594-2, EN ISO 80369-7 for Luer Connector Performance; ISO 10555-1 for Leak Resistance and Peak Hub/Shaft Tensile Load. |

Note: Tests marked with an asterisk () were specifically highlighted as being performed on the subject device to demonstrate substantial equivalence for modifications in this premarket notification.*

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

The document does not explicitly state the sample sizes used for the non-clinical and biocompatibility tests. It broadly mentions "Summary of Nonclinical Data/Performance Testing" and "Product Performance Evaluation". Given the nature of these tests for medical devices, they would typically involve a statistically relevant number of samples to ensure robust results, but the exact numbers are not provided in this summary.

The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer, Medtronic Vascular. No information regarding country of origin of the data or whether it was retrospective or prospective is mentioned (as these terms usually apply to clinical studies).

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

This information is not applicable to this submission. The "ground truth" concept usually applies to clinical studies where expert consensus or pathological findings are used to establish a definitive diagnosis or outcome. For non-clinical performance and biocompatibility testing, the "ground truth" is established by adherence to recognized international standards and engineering principles, with results evaluated against predefined acceptance criteria derived from these standards or predicate device performance. Experts involved would be engineers, scientists, and toxicologists specializing in medical device testing and regulatory compliance, but their specific numbers or detailed qualifications are not typically included in a 510(k) summary (beyond general statements about adherence to guidance documents like ISO 10993-1).

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials where multiple experts assess cases and their disagreements need to be resolved to establish a ground truth. For the non-clinical tests described, the "adjudication" is inherent in the test methodology and adherence to international standards and acceptance criteria. Any deviations or failures would be investigated and resolved according to quality system procedures.

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 comparative effectiveness study was done. This device is a physical medical device (catheter), not an AI-powered diagnostic or imaging tool that would involve human readers.

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

The ground truth for the non-clinical performance and biocompatibility testing is established by:

• Adherence to International/Recognized Standards: Such as ISO 594-1, ISO 594-2, EN ISO 80369-7, ISO 10555-1, and FDA Guidance "Use of International Standard ISO 10993-1".
• Predicate Device Performance: The subject device's performance is compared to the predicate device, aiming to demonstrate substantial equivalence by showing that any differences in characteristics do not raise different questions of safety and effectiveness.
• Engineering Specifications and Design Requirements: The tests verify that the device meets its own engineering specifications for parameters like dimensions, strength, flexibility, and resistance to various stresses.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this device. Training sets are used in machine learning and AI model development.

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

Not Applicable. As there is no training set for this physical medical device, there is no ground truth to be established for it.

Ask a specific question about this device

The Medtronic Guide Catheters are intended to be used in the coronary or the peripheral system; and are designed to provide a pathway through which therapeutic devices are introduced.

The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a lubricious coating. The inner lumen of the Sherpa Guide Catheters is an HDPE liner.

This document is a 510(k) summary for Medtronic's 5F and 6F Launcher® Guide Catheters and 5F and 6F Sherpa® Guide Catheters. It describes the device, its intended use, and its substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No clinical investigation has been performed on the modified device." This indicates that there was no "test set" in the traditional sense for clinical performance. The evaluation for this 510(k) was based on non-clinical data and a comparison of technological characteristics to predicate devices. The data provenance is not applicable as no human-subject testing occurred.

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

Not applicable. As stated above, no clinical investigation was performed, and therefore no ground truth was established by human experts for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical investigation or test set requiring adjudication occurred.

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 device is a guiding catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related improvement metrics are irrelevant.

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

Not applicable. This device is a medical instrument, not a software algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering testing and established standards, primarily demonstrating that the modified device's characteristics and performance are substantially equivalent to existing, legally marketed predicate devices. This includes:

• Non-clinical performance data: Indicating no new safety or effectiveness issues.
• Biocompatibility testing: Compliance to ISO 10993.
• Technological characteristics comparison: Verification that features like the Luer hub, outer jacket, wire braided shaft, distal segments, and soft tip are identical to predicate devices.

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."

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

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

Ask a specific question about this device

The 5F Dignity® Midsize CT Titanium Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

Not Found

This document is a 510(k) clearance letter from the FDA for the 5F Dignity® Midsize CT Titanium Port. It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, the provided text DOES NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• The FDA's decision regarding the 510(k) submission (K130923).
• The device name: 5F Dignity® Midsize CT Titanium Port.
• The device's regulation number, name, and class.
• General controls provisions of the Act that apply to the device.
• Indications for Use for the device.

To answer your request, I would need a different document, likely a section from the 510(k) submission itself (e.g., a "Performance Data" or "Clinical Study" section), which would detail the specific tests conducted, their acceptance criteria, and the results.

Ask a specific question about this device

The Medtronic 5F Sherpa Active NX Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. The 5F Sherpa Active NX Guiding Catheter is intended for use in the coronary or peripheral vascular system.

The 5F Sherpa Active NX Guiding Catheter consists of a luer hub, strain relief, a shaft (outer jacket, braid wire, an intermediate layer, and inner liner), a secondary segment, a primary segment, tungsten marker band, a segment sleeve and a soft tip.

The 5F Sherpa Active NX Guide Catheter design is based on a four layer design with an inner liner of polyethylene.

The provided text is related to a 510(k) submission for the Medtronic 5F Sherpa Active NX Guide Catheter, a medical device. This document describes the device, its intended use, and its substantial equivalence to predicate devices based on technological characteristics and performance testing.

However, the provided text does not contain any information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or the results of comparative effectiveness studies (MRMC) or standalone algorithm performance.

The document is a regulatory submission for a physical medical device (a catheter), not a software or AI-based device that would typically have the kind of performance metrics you are asking about (e.g., accuracy, sensitivity, specificity, expert adjudication).

Therefore, I cannot fulfill your request with the input provided. The requested information pertains to studies typically conducted for AI/machine learning medical devices, which this document is not about.

Ask a specific question about this device

The Medtronic® Launcher™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.

The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a thin lubricious coating.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medtronic 5F Launcher™ Guide Catheter:

Summary of Acceptance Criteria and Device Performance

The Medtronic 5F Launcher™ Guide Catheter was evaluated against a set of biocompatibility tests and functional engineering specifications. The documentation states that the device successfully met all these criteria.

This information indicates that the device's acceptance was based on a combination of biological safety assessments and mechanical performance tests, ensuring it is safe for its intended use and performs as expected.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each of the biocompatibility and functional tests. It mentions "test results reports have been received," implying data was collected.

• Sample Size: Not explicitly stated for individual tests.
• Data Provenance: The study was conducted by Medtronic AVE, Inc., suggesting internal testing. The country of origin of the data is not specified, but Medtronic AVE, Inc. is located in Danvers, MA, USA, which implies the testing was likely conducted in the USA or supervised by US-based personnel. The study appears to be a prospective assessment of newly manufactured devices against established performance specifications.

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

This type of information is not applicable to this submission. The "ground truth" in this context refers to engineering specifications and ISO standards, not clinical interpretations by medical experts. The "experts" would be the engineers and quality assurance personnel who designed the tests, interpreted the results, and determined compliance with the specifications and standards (e.g., ISO 10993). Their specific number and qualifications are not detailed in this regulatory summary.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable here. Adjudication processes are typically used in clinical trials or studies where subjective interpretations (e.g., by human readers of medical images) need to be reconciled. In this case, the results of the biocompatibility and functional engineering tests are objective and assessed against predefined pass/fail criteria.

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

No, an MRMC comparative effectiveness study was not done.

This type of study is relevant for evaluating the performance of AI algorithms in assisting human readers with diagnostic tasks. The Medtronic 5F Launcher™ Guide Catheter is a physical medical device, not an AI diagnostic tool, so such a study would not be relevant.

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

No, a standalone performance study (in the context of an algorithm) was not done.

Similar to point 5, this question pertains to AI algorithms. The "standalone performance" of the catheter refers to its ability to meet its functional specifications and biocompatibility requirements, which were indeed evaluated without human intervention in the operational performance of the device itself (e.g., the catheter's material strength is an intrinsic property, not dependent on a human operator's judgment during the test). However, it is not an "algorithm only" study.

7. The Type of Ground Truth Used

The "ground truth" against which the device was evaluated consists of:

• Established engineering specifications: These are internal Medtronic standards detailing acceptable ranges for mechanical properties (e.g., tensile strength, burst pressure, lubricity, torque response, radiopacity, tip softness).
• International standards for biocompatibility: Specifically, ISO 10993 series for medical devices (categorized as external-communicating, circulating blood, limited exposure ≤24 hours).
• Predicate device characteristics: The current device's performance was also compared to the characteristics of the legally marketed predicate devices (Medtronic 6F Launcher™ Guide Catheter and Medtronic 5F Genius™ Guide Catheter) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable.

A "training set" is used for machine learning algorithms. The Medtronic 5F Launcher™ Guide Catheter is a physical medical device, not an AI algorithm, so there is no training set in this context. The manufacturing processes and materials were established based on existing knowledge and experience with predicate devices.

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

Not applicable.

As there is no training set for a machine learning algorithm, the process of establishing its ground truth is irrelevant to this device. The "ground truth" for the device's design and manufacturing was established through established engineering practices, material science, and regulatory standards for medical device development based on extensive prior experience with similar devices.

Ask a specific question about this device

Ask a specific question about this device