(14 days)
The Medtronic Attain Command" 6250 Left Heart Delivery Systems and the Medtronic Attain Command™ 6250 Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
The Attain Command™ 6250 Left Heart Delivery Systems contain two guide catheters, one guide catheter dilator, one guide wire, one valve and one slitter. It is designed to access the coronary sinus and the chambers of the heart using the guidewire to access the vein, the valve to reduce blood loss during the implant procedure, the guide catheter to introduce a transvenous device, the guide catheter dilator to facilitate catheter passage and the slitter to remove the guide catheter.
The Attain Command™ 6250 Left Heart Delivery Systems arc available in two models:
- · Attain Command™ 6250C Left Heart Delivery System
- · Attain Command™ 6250S Left Heart Delivery System.
All components with the exception of the two guide catheters are identical in both models. The guide catheters are different in each model with respect to the guide catheter shape and length.
The Attain Command™ 6250 Guide Catheters for Left Heart Delivery are individual packs, each containing one guide catheter and one guide catheter dilator. It is also designed to access the coronary sinus and the chambers of the heart using the guide catheter to introduce a transvenous device and the guide catheter dilator to facilitate catheter passage.
The Attain Command" 6250 Guide Catheters for Left Heart Delivery are available in eleven models as follows: - Attain Command" 6250-45S Guide Catheter for Left Heart Delivery
Attain Command™ 6250-50S Guide Catheter for Left Heart Delivery - · Attain Command™ 6250-57S Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-AM Guide Catheter for Left Heart Delivery
- · Attain Command" 6250 Fin Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-EHXL Guide Catheter for Left Heart Delivery
- · Atlain Command™ 6250-MB2 Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-MB2X Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-MP Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-MPR Guide Catheter for Left Heart Delivery
- · Attain Command™ 6250-MPX Guide Catheter for Left Heart Delivery
Each model is different with respect to the guide catheter shape and length and the dilator length
The provided document is a 510(k) summary for the Medtronic Attain Command™ 6250 Left Heart Delivery Systems and Guide Catheters. This document details the substantial equivalence of minor modifications to an existing device rather than presenting a study for a new device's performance against specific acceptance criteria in a clinical setting.
Therefore, much of the requested information regarding acceptance criteria and a study proving a device meets them (especially in the context of AI/standalone algorithm performance, multi-reader studies, and ground truth establishment) is not applicable to this particular 510(k) submission.
However, I can extract information related to the device integrity testing that was performed to support equivalency.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states: "The modified Attain Command™ 6250 product family met all specified design and performance requirements." It does not provide a specific table of quantitative acceptance criteria or detailed numerical performance metrics.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Device Integrity | Met all specified design and performance requirements. |
| Biocompatibility | Biocompatible, consistent with ISO10993-1:2003. |
| Sterilization | Sterilized using a validated Ethylene Oxide (EtO) process. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Device integrity testing was performed" but does not specify the sample size for this testing. It also does not specify data provenance in terms of country of origin or whether it was retrospective/prospective, as this was not a clinical study involving patient data. This testing would have been conducted on prototypes or production samples of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable. The "ground truth" for device integrity testing refers to engineering specifications and performance benchmarks, not clinical outcomes interpreted by experts.
4. Adjudication Method for the Test Set:
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical data interpretation, not for evaluating engineering device performance.
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 would be relevant for evaluating diagnostic or interpretive AI systems, not for a medical device such as a catheter delivery system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an AI algorithm.
7. The Type of Ground Truth Used:
The ground truth for this submission was based on engineering design specifications, performance requirements, and established industry standards (e.g., ISO10993-1:2003 for biocompatibility).
8. The Sample Size for the Training Set:
This is not applicable. There is no "training set" in the context of establishing substantial equivalence for a physical medical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as point 8.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a modified medical device to a predicate device, primarily through engineering and biocompatibility testing, rather than a clinical study evaluating the performance of an AI or diagnostic tool against specific acceptance criteria.
§ 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).