(185 days)
The Medtronic Model 10600 Deflectable Catheter System is indicated to provide a pathway through which diagnostic and therapeutic devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
The Medtronic Model 10600 Deflectable Catheter System features a percutaneous needle and syringe to access the venous insertion site, a guide wire to access the vein, an adjustable hemostasis valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a deflectable catheter dilator to facilitate deflectable catheter passage, and slitters to remove the deflectable catheter.
The Model 10600 Deflectable Catheter System is provided STERILE and is intended for single use only.
The Model 10600 Deflectable Catheter System combines devices that are either cleared for market distribution via 510(k) or are exempt from Premarket notification because of Class I designation.
The provided text describes a 510(k) Premarket Notification for the Medtronic Model 10600 Deflectable Catheter System. This notification focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria in the way a new, novel AI or diagnostic device would.
Therefore, many of the typical acceptance criteria and study details requested (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission. The submission relies on engineering and integrity testing to show that the new device performs comparably to established devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Test Type | Reported Device Performance / Outcome |
|---|---|---|
| Device Integrity | Environmental Conditioning | Met specified requirements |
| Mechanical Testing | Met specified requirements | |
| Compatibility Testing | Met specified requirements | |
| Package/Shelf Life Testing | Met specified requirements | |
| Biocompatibility | ISO 10993-1 | All blood-contacting materials found to be biocompatible |
| Sterilization | 100% Ethylene Oxide (EtO) sterilization process | Validated process used |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests. The "Summary of Studies" indicates that "Device integrity testing was conducted," but does not provide details on the number of units tested.
- Data Provenance: Not applicable in the context of clinical data for a diagnostic/AI device. The testing described is laboratory-based engineering and material testing performed by the manufacturer, Medtronic, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission is for a medical catheter system, not a diagnostic or AI device that requires expert-established ground truth from clinical data. The "ground truth" for this device relates to meeting engineering specifications and biocompatibility standards.
4. Adjudication Method for the Test Set
- Not Applicable. As there is no clinical data or expert interpretation involved, no adjudication method would be used.
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 hardware medical device (catheter system), not an AI or diagnostic imaging device. Therefore, no MRMC study would be performed, nor would there be human readers, AI assistance, or an effect size for improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device; there is no algorithm or AI component to test in a standalone manner.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by engineering specifications, recognized standards (like ISO 10993-1 for biocompatibility), and validated processes (for sterilization). The device is deemed acceptable if it meets these predetermined technical and safety requirements.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).