(44 days)
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
| Acceptance Criteria Category | Specific Tests/Metrics | Reported Device Performance | Comments |
|---|---|---|---|
| Biocompatibility | Acute Intracutaneous Reactivity | Passed | Performed per ISO 10993 for external-communicating devices, circulating blood, limited exposure (≤24 hours). |
| Acute Systemic Toxicity | Passed | ||
| Cytotoxicity | Passed | ||
| Hemolysis | Passed | ||
| Sensitization | Passed | ||
| Functional Performance | Hub-to-Shaft Tensile | Meets applicable specifications | Ensures structural integrity at the connection point. |
| Shaft Tensile | Meets applicable specifications | Assesses the strength of the catheter shaft. | |
| Distal Tip-to-Shaft Tensile | Meets applicable specifications | Ensures the integrity of the flexible tip attachment. | |
| Torque Response | Meets applicable specifications | Evaluates the catheter's ability to transmit rotational forces for steering. | |
| Lumen Lubricity | Meets applicable specifications | Verifies smooth passage of therapeutic devices through the catheter. | |
| Radiopacity | Meets applicable specifications | Confirms visibility under fluoroscopy. | |
| Pressure Shaft Burst | Meets applicable specifications | Tests the catheter's resistance to internal pressure. | |
| Hub Leak | Meets applicable specifications | Ensures no fluid leakage at the hub connector. | |
| Tip Compression (Softness) | Meets applicable specifications | Assesses the flexibility and atraumatic nature of the distal tip. |
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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).