(127 days)
The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
The Medtronic® Zuma™ Guiding Catheters will be available in a 6F outer diameter size. The catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The inner lumen of the catheter has a thin lubricious coating. The Zuma™ Guiding Catheter has a larger inner lumen diameter and a stiffer shaft.
The provided text is a 510(k) summary for the Medtronic® Zuma™ Guiding Catheter. It outlines the device's intended use, construction, and provides a statement of substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results, or the comprehensive information required to fill in all aspects of your request.
Here's a breakdown of what can be extracted and what is missing:
The document states:
"Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use."
This confirms that some testing was done to meet specifications, but it doesn't provide the specifications themselves (the acceptance criteria) or the detailed results.
Assuming a hypothetical scenario for a medical device cleared via 510(k) and drawing common practices from such submissions, the following table and explanations are constructed. Please note these are inferred or placeholders where the original text lacks details.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| All materials pass ISO 10993 series tests for cytotoxicity, sensitization, irritation. | All appropriate Biocompatibility tests were successfully performed on the materials used. |
| Physical Performance: | |
| Inner Lumen Diameter: Minimum inner lumen diameter to accommodate therapeutic devices (e.g., 0.070 inches for a 6F catheter). | A larger inner lumen diameter (compared to existing catheters, implied by "Zuma™ Guiding Catheter has a larger inner lumen diameter"). Actual value not specified. |
| Shaft Stiffness/Pushability: Sufficient stiffness for guided advancement while maintaining flexibility to navigate tortuous anatomy (e.g., quantified by pushability (gf) and deflection angle). | A stiffer shaft (implied by "Zuma™ Guiding Catheter has... a stiffer shaft"). Specific metrics not provided. |
| Trackability/Torquability: Ability to accurately transmit torque and navigate vessel anatomy (e.g., torque response angle and force to advance through tortuous model). | Implied by "designed to provide a pathway... in the coronary or peripheral vascular system." Specific metrics not provided. |
| Distal Tip Softness/Atraumaticity: Distal tip atraumaticity to minimize vessel injury (e.g., durometer reading, force to cause vessel damage in a model). | A soft distal tip. Specific metrics not provided. |
| Lubricity (Inner Lumen): Low friction to facilitate device passage (e.g., coefficient of friction, force to advance device through lumen). | The inner lumen of the catheter has a thin lubricious coating. Specific metrics not provided. |
| Burst Pressure: Withstand internal pressure from contrast injection (e.g., >1200 psi). | Not specified, but implied by successful performance testing. |
| Kink Resistance: Maintain patency during navigation (e.g., angle of kink at defined force). | Not specified, but implied by successful performance testing. |
| Radiopacity: Clear visibility under fluoroscopy. | Not specified, but generally a requirement for guiding catheters. |
| Functional Equivalence: Performance comparable to predicate devices in relevant in-vivo/in-vitro models. | Deemed substantially equivalent to Medtronic® Vector™ X Guiding Catheter and Cordis® Brite Tip® Guiding Catheter. |
(The following sections will contain "Not mentioned in the provided text" for most points, as the 510(k) summary does not include this level of detail. Such information is typically found in the full 510(k) submission, not the public summary.)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned in the provided text. For physical properties, this would typically be a statistical sample of manufactured units (e.g., n=30 per test). For biocompatibility, it refers to the material samples tested.
- Data Provenance: Not mentioned in the provided text. Most likely laboratory testing (in-vitro) and animal studies (if required for certain biocompatibility or preclinical performance aspects), generally conducted in the country of manufacture or a certified lab. The summary implies the data is prospective, generated specifically for this submission.
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/Not mentioned. This device is a guiding catheter, a physical medical device, not an AI diagnostic tool. Ground truth in this context refers to established engineering specifications and performance benchmarks, not expert consensus on interpretations. Physical tests are carried out by engineers and technicians according to established protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. Adjudication methods are relevant for subjective diagnostic tasks, not for objective physical performance testing of a catheter. Testing follows pre-defined pass/fail criteria.
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 a physical medical device (guiding catheter), not an AI diagnostic system. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this submission.
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 (expert consensus, pathology, outcomes data, etc.)
- The ground truth for this type of device is established engineering specifications, mechanical test standards (e.g., ISO, ASTM), and clinical performance criteria derived from predicate devices and intended use. For biocompatibility, the ground truth is the pass/fail criteria of ISO 10993 tests.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/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 a physical device, this question is not relevant.
Summary of Device Clearance:
The Medtronic® Zuma™ Guiding Catheter was cleared through the 510(k) pathway by demonstrating substantial equivalence to existing legally marketed predicate devices (Medtronic® Vector™ X Guiding Catheter and Cordis® Brite Tip® Guiding Catheter). This means the FDA determined that the new device is as safe and effective as the predicate devices, based on its technological characteristics, intended use, and performance data. The review focuses on demonstrating that the new device does not raise different questions of safety and effectiveness compared to the predicate. The document confirms that "Test results verified that the Medtronic® Zuma™ Guiding Catheters meets all of the applicable specifications and is deemed adequate for the intended use." indicating successful performance testing, though the specifics of those tests and their acceptance criteria are not detailed in this public summary.
§ 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).