(269 days)
The Reprocessed VersaCross Steerable Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The Reprocessed SureFlex Steerable Guiding Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The Reprocessed VersaCross Steerable Sheath consists of three components; a Reprocessed VersaCross Steerable Sheath, a Reprocessed VersaCross Transseptal Dilator, and a 0.035" J-tipped mechanical quidewire.
The Reprocessed VersaCross Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The Reprocessed VersaCross Transseptal Dilator provides support for the sheath, features a tapered tip and a shaft that can be reshaped manually. Radiopaque tips maximize visualization of the sheath the dilator during manipulation.
The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.
The Reprocessed SureFlex Steerable Guiding Sheath consists of three components: a reprocessed sheath, a reprocessed dilator and a J-tipped Mechanical Guidewire.
The Reprocessed SureFlex Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.
The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.
Note: Only the steerable sheaths and dilator are subject of this submission. The guidewires are purchased off-the shelf and packaged with the reprocessed devices.
The provided text is a 510(k) summary for the reprocessing of medical devices, specifically VersaCross Steerable Sheaths and SureFlex Steerable Guiding Sheaths. It describes the regulatory review process and confirms that the reprocessed devices are substantially equivalent to their predicate devices.
However, the document does not describe a study that proves a device meets acceptance criteria using an AI/algorithm-driven component. The entire document discusses the reprocessing of physical medical devices and their functional and safety testing to establish substantial equivalence, not the performance of an AI or software-based device.
Therefore, I cannot extract the information required to answer your prompt questions about acceptance criteria for an AI device, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, or training sets, because this information is not present in the provided text.
The closest relevant information relates to functional and safety testing of the reprocessed physical medical devices, which is presented as:
Functional and Safety Testing (of physical reprocessed catheters):
Bench and laboratory testing evaluated substantial equivalence to the predicate devices. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional Testing
- Visual Inspection
- Dimensional Inspection
- Tip Deflection
- Tip Buckling
- Valve/Joint leak
- Radiopacity
- Simulated Use
- Torque Testing
- Tensile Testing
- Corrosion Testing
- Packaging Validation
This list represents the acceptance criteria (or areas of testing) for the reprocessed physical device, not an AI or software device. The document does not provide specific numerical performance metrics for these tests, nor does it detail sample sizes, expert involvement, or adjudication methods for these physical device tests in the way your prompt requests for an AI study.
In summary, the provided text does not contain any information about an AI/algorithm-driven device or a study related to its performance against acceptance criteria.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).