(150 days)
The Medtronic 7F and 8F Launcher Biopsy guide Catheters provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used to for the percutaneous introduction of biopsy devices.
Medtronic Launcher Biopsy Guide Catheter is designed to provide a pathway through which therapeutic devices are introduced. This includes the introduction of biopsy forcep devices. The guiding catheter is intended to be used in accessing the coronary or peripheral system.
The Medtronic 7F and 8F Launcher Right Ventricular Biopsy Guiding Catheters are intended to be used for the percutaneous introduction of biopsy forceps into the right ventricle of the heart.
Medtronic® 7F and 8F Launcher Biopsy Guide Catheter
The Medtronic® Launcher Biopsy Guide Catheters are constructed with a braided proximal shaft with an inner liner a secondary segment (8F only), primary segment, a sleeve and a soft distal tip. The inner lumen of the catheter has a thin lubricious coating.
This document is a 510(k) summary for the Medtronic 7F and 8F Launcher Biopsy Guide Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might find for, say, an AI-powered diagnostic device.
Here's an analysis based on the provided text, addressing your points as much as possible given the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of medical device (guide catheter), the "acceptance criteria" are not reported as numerical performance metrics like sensitivity/specificity. Instead, they relate to meeting safety and efficacy standards and demonstrating substantial equivalence to pre-existing, legally marketed devices. The "performance" is implicitly demonstrated by meeting these standards and showing that the new device shares fundamental characteristics with its predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics: Substantial equivalence in materials, components, design, packaging, and sterilization to predicate devices. | "The Medtronic 7F and 8F Launcher Biopsy Guide Catheters are identical to the Medtronic 7F and 8F Launcher Guide Catheters regarding materials, components, design, packaging and sterilization." |
| Indications for Use: Equivalence to predicate devices. | "The indications for use are identical to the Medtronic SHERPA II (commercialized as Vector) regarding the percutaneous introduction of biopsy forceps and the Medtronic Launcher Guide Catheters regarding coronary and peripheral access. They are all indicated to provide a pathway through which therapeutic devices are introduced." |
| Biocompatibility: Meet appropriate biocompatibility standards. | "All appropriate biocompatibility tests were successfully performed on the materials used for the Medtronic Launcher Biopsy Guide Catheter." |
| Performance Standards/Specifications: Meet all applicable standards and specifications for intended use. | "Results of testing verified that the Medtronic Launcher Biopsy Guide Catheters meet all applicable standards and specifications and are deemed adequate for the intended use." |
| Substantial Equivalence: Deemed substantially equivalent to legally marketed predicate devices. | The device was deemed "substantially equivalent" to: |
- 7F Launcher Guide Catheter (K022764)
- 8F Launcher Guide Catheter (K023402)
- SHERPA, SHERPA II (commercialized as Vector) and ASCENT biopsy Guide Catheters (K944668) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the context of diagnostic device performance. The testing mentioned ("biocompatibility tests" and "testing verified that... meet all applicable standards") refers to engineering and bench testing, likely involving material samples or prototypes, not patient data in the typical sense of a diagnostic algorithm. Therefore, no specific sample size for a "test set" or data provenance (country, retrospective/prospective) is applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As there is no clinical "test set" with ground truth to be established in this submission, this information is not applicable and not provided.
4. Adjudication Method for the Test Set
Again, given the nature of a 510(k) for a guide catheter, adjudication methods for a test set are not applicable or provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC study was done or mentioned. This type of study is typically relevant for diagnostic imaging devices where human interpretation is involved, often with AI assistance. This submission is for a physical medical device (catheter), not a diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or mentioned. This device is a physical tool for medical procedures, not a software algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically used in AI/diagnostic device evaluation does not apply to this submission. The "ground truth" in this context is adherence to engineering specifications, material safety standards, and functional equivalence to predicate devices, verified through physical and chemical testing.
8. The Sample Size for the Training Set
There is no "training set" mentioned or applicable to this type of device submission. Training sets are used for machine learning algorithms, which are not relevant here.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set," this information is not applicable.
§ 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).