(72 days)
The ACUITY Break-Away™ Lead Delivery System is intended to access the coronary venous system and may be used alone (8F) or in dual catheter delivery (8F with 6F). The system serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.
The ACUITY Break-Away™ Delivery System consists of two guide catheters plus the following accessories: torque device, guidewire introducer and cutter. The system is designed to provide venous access and to aid with the selective placement of implantable venous leads in the left cardiac vasculature. The catheters, provided in a 8F size and 6F size models, are packaged separately. The 8F catheter package also contains the torque device and guidewire introducer accessories, which assist with implanting the lead, and the cutter, which is used to facilitate removal of the catheters after implant. The 6F catheter is packaged alone. The 8F catheter may be used by itself or in conjunction with the 6F catheter in a telescoping manner to improve the access and delivery capabilities of the system. The ACUITY Break-Away catheter models feature a hub that is manually split apart rather than cut, and also incorporate a hemostasis valve to eliminate the need for an external accessory valve. The catheter is designed with a flexible distal segment and a soft tip to atraumatically enter the main coronary sinus and branch veins. The 6F ACUITY Break-Away catheter must be used with an 8F ACUITY Break-Away guide catheter to gain access to the main coronary sinus.
The provided text describes a 510(k) submission for the ACUITY Break-Away™ Delivery System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving effectiveness through clinical trials with specific acceptance criteria and performance metrics.
Therefore, the input does not contain the information needed to answer the questions about acceptance criteria and a study proving a device meets them. The document explicitly states: "Summary of Clinical Testing: Clinical evaluation was not required."
The request asks for:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance study details.
- Type of ground truth used.
- Training set sample size.
- Ground truth establishment for the training set.
None of this information is present in the provided 510(k) summary because a clinical study (which would generate such data) was not required for this device's regulatory pathway.
Instead, the document details a "Summary of Non-Clinical Testing" which involved:
- Design verification testing, including mechanical bench testing, animal testing, and heart modeling.
- Biocompatibility, packaging, and sterility testing.
These tests were conducted to verify that the performance of the ACUITY Break-Away catheters remains substantially equivalent to the predicate devices. The results confirmed that the modified catheters continue to meet all design and performance specifications and conform to relevant ISO standards (10993-1 for biocompatibility, 11137 for sterilization, and 11135 for EtO residual).
The basis for this 510(k) clearance is substantial equivalence, not a clinical study demonstrating specific performance metrics against hard 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).