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The delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus and into the right ventricle.

The Attain Select II + SureValvery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus, left-heart venous anatomy, and the right ventricle. For left heart use, the delivery catheter system is indicated for use with outer guide catheters. For right ventricle use, the delivery catheter system is indicated for use without an outer guide catheter.

The Attain Command + SureValve Delivery System outer guide catheters are designed to facilitate lead implantation in the left heart, via the coronary sinus and lead implantation in the right ventricle.

The Attain Command + SureValve Delivery System 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 Delivery System is available in 12 models: 6250V-45S, 6250V-50S, 6250V-57S, 6250V-AM, 6250V-EH, 6250V-EHXL, 6250V-MB2, 6250V-MB2X, 6250V-MP, 6250V-MPR, 6250V-MPX, and 6250V-3D. Each model is different with respect to the guide catheter shape and length and dilator length.

The Attain Command + SureValve Delivery System kits each contain two outer guide catheters with an integrated hemostasis valve (SureValve), up to two valve tools, one dilator, one guide wire, and one slitter. The Attain Command + SureValve Delivery System kit is available in two models: 6250VC and 6250VS. 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.

Attain Select II + SureValve Delivery System

The Attain Select II + SureValve delivery system is designed to facilitate left-heart lead delivery to a desired cardiac vein or right-heart lead delivery to the right ventricle. The delivery system includes a delivery catheter and an inner catheter. The delivery catheter aids in subselection and provides a pathway for the delivery of transvenous devices such as leads, inner catheters, and guide wires. It has a radiopaque flexible tip to facilitate viewing during fluoroscopy. The inner catheter supports the delivery catheter and aids in subselection. The inner catheter has a radiopaque tip and allows delivery of a guide wire or contrast solution. For left-heart use, the delivery catheter system is used with an outer guide catheter, which is the sheath used to gain coronary sinus access. Together, the catheters function as a telescoping system that can provide additional subselecting capabilities. For right-heart use, the delivery catheter system is used without an outer guide catheter.

The Attain Select II + SureValve delivery 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 + Sure Valve delivery system is available in 8 models: 6248V-90S. 6248V-90L. 6248V-130. 6248V-130L. 6248V-90P. 6248V-90SP. and 6248V-130P. 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 is an FDA 510(k) clearance letter for two medical device delivery systems: "Attain Command + SureValve" and "Attain Select II + SureValve." It indicates that these devices are substantially equivalent to previously cleared predicate devices.

However, the provided document DOES NOT contain information about acceptance criteria, specific study designs (like sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML devices). This is because the devices are catheter delivery systems, mechanical medical devices, not AI/ML-driven diagnostics. The "study" mentioned refers to design verification and validation testing, which are standard engineering and quality assurance tests for physical devices, not clinical studies involving AI performance metrics.

Therefore, I cannot provide a detailed response to your request, as it pertains to AI/ML device evaluation criteria, which are not present in this document.

In summary, the document states:

• Acceptance Criteria & Device Performance: The document generally states, "The results of the above verification and validation testing met the specified acceptance criteria and did not raise new or different questions of safety or effectiveness." It does not provide specific numerical acceptance criteria or performance metrics in the format requested for an AI/ML device.
• Study Type: The "studies" mentioned are "design verification and design validation activities," which are typically bench testing, material compatibility, and functional performance tests for mechanical devices, not clinical trials or AI performance evaluations.
• Reason for Limited Detail: The devices are delivery catheter systems, which are physical medical instruments, not AI/ML software. Therefore, the detailed criteria for AI/ML performance (like expert consensus, sample sizes for AI training/test sets, MRMC studies, etc.) are not applicable and are not included in this type of FDA submission summary.

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