(182 days)
The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ 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 Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer quide catheters.
The Attain Command™ + SureValve™ Left Heart Delivery System and Attain Command™ + SureValve™ 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™ + SureValve™ Left-Heart Delivery System kits each contain two outer quide catheters with an integrated hemostasis valve (SureValve™), up to two valve tools, one dilator, one guide wire, and one slitter. The Attain Command™ + SureValve™ Left-Heart Delivery System is available in two models: Attain Command TM + SureValve ™ 6250VC Left Heart Delivery System and Attain Command™ + SureValve™ 6250VS Left Heart Delivery System. With the exception of the two guide catheters, all system components packaged in each kit are identical. Each guide catheter model is different with respect to the guide catheter shape and length.
The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery individual packs each contain one guide catheter with an integrated hemostasis valve (SureValve™), up to two valve tools, and one dilator. The Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery are available in 12 models. Each model is different with respect to the guide catheter shape and length and dilator length.
The Attain Select™ II + SureValve™ delivery catheter system is designed to facilitate leftheart lead delivery to a desired cardiac vein. The Attain Select™ II + SureValve™ delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer quide catheters. Together, the catheters function as a telescoping system that can provide additional subselecting capabilities.
The delivery catheter system consists of a delivery catheter with an integrated hemostasis valve (SureValve™), an inner catheter, and up to two valve tools. The Attain Select™ II + SureValve™ delivery catheter system is available in 8 models. The Attain Select™ II + SureValve™ inner catheter is identical for all configurations. Each model is different with respect to delivery catheter shape and length.
The provided text describes the 510(k) summary for several Medtronic devices: Attain Command™ + SureValve™ Left Heart Delivery System, Attain Command™ + SureValve™ Guide Catheters for Left Heart Delivery, and Attain Select™ II + SureValve™ Delivery Catheter System.
Based on the document, these devices did not undergo a study involving AI or algorithm performance. The acceptance criteria and "study" that proves the device meets them are entirely based on non-clinical performance data, comparing the new devices to existing predicate devices.
Here's the breakdown of the information requested, as it applies to this submission:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly list "acceptance criteria" for each test with numerical thresholds. Instead, it states that the devices "met all specified design and performance requirements" and that biocompatibility tests "indicate that the devices are biocompatible for their intended use."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In Vitro Bench Tests | Devices met all specified design and performance requirements. |
| Dimensional Testing | Met all specified design and performance requirements. |
| Catheter Safety & Performance Testing | Met all specified design and performance requirements. |
| Component/Accessory Safety & Performance Testing | Met all specified design and performance requirements. |
| Interface Safety & Performance Testing (compatibility with transvenous devices) | Met all specified design and performance requirements. |
| Packaging Qualifications | Met all specified design and performance requirements. |
| Shelf Life Testing | Met all specified design and performance requirements. |
| Biocompatibility | Devices are biocompatible for their intended use. |
| Cytotoxicity | Passed |
| Sensitization | Passed |
| Intracutaneous Reactivity | Passed |
| Acute Systemic Toxicity | Passed |
| Material Mediated Pyrogen | Passed |
| In-vitro Hemolysis | Passed |
| Partial Thromboplastin Time (PTT) Coagulation Testing | Passed |
| C3a Complement Activation Assay | Passed |
| Sc5b-9 Complement Activation Assay | Passed |
| In Vivo Thromboresistance | Passed |
| Physicochemical Tests (Aqueous) | Passed |
| Physicochemical Tests (Non-Aqueous) | Passed |
| Sterilization | Achieved a minimum Sterility Assurance Level (SAL) of 10-6. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not specified for each individual non-clinical test. The document refers to "testing" and "validations" but does not provide specific numbers of units tested.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Non-clinical tests were conducted by Medtronic Ireland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for this device, in the context of the 510(k) submission, is established through the results of non-clinical, laboratory-based tests (bench tests, biocompatibility tests, sterilization validations) against pre-defined engineering and safety specifications, and compliance with relevant ISO standards. There were no human experts evaluating performance in this context, nor was there a "ground truth" established by experts in the way it would be for an AI diagnostic device (e.g., radiologists interpreting images).
4. Adjudication Method for the Test Set
Not applicable. This submission relies entirely on objective non-clinical test results rather than human judgments that would require adjudication.
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 submission does not involve AI or algorithms, nor does it include a clinical study (MRMC or otherwise).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission does not involve AI or algorithms.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Engineering specifications and design requirements: For in vitro bench tests.
- International Standards (e.g., ISO 10993-1:2009 for biocompatibility, ISO 11135-1 and EN556-1 for sterilization): These standards define the acceptable methodologies and criteria for evaluating device properties.
- FDA Good Laboratory Practice (GLP) regulations (21 CFR, Part 58): For biocompatibility testing methodology.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 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).