(107 days)
The 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature in the iliac, femoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) device with various shaft lengths. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold & strain relief that allows for the use of the 0.018" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide, EtO) and is intended for single use only.
The provided text describes a medical device, the "018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter," and its FDA 510(k) submission. This document is a premarket notification for a medical device and is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on its performance in a clinical study (like an AI/ML device would).
Therefore, there is no information present in the provided document to fulfill the request concerning:
- A table of acceptance criteria and reported device performance for a study directly proving the device meets the acceptance criteria. The document discusses design verification testing to demonstrate substantial equivalence to a predicate device, not necessarily performance against pre-defined clinical acceptance criteria.
- Sample size for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document explicitly states: "No clinical data is being submitted for the 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter." This confirms that there was no clinical study conducted to establish performance metrics against acceptance criteria in the way one would for an AI/ML diagnostic device.
The study that was done to support this device's submission focused on:
- Performance Bench Testing: This involved tests like Rated Burst Pressure, Balloon Diameter, Inflation/Deflation Time, Tensile Strength, etc., to ensure the device performs as intended in a non-clinical setting and is comparable to the predicate. These are engineering specifications and internal quality assurance metrics, not "acceptance criteria" in the context of clinical performance or AI/ML evaluation.
- Biocompatibility: Testing to ensure the device is safe for human contact.
- Sterilization: Verifying the sterilization process.
These tests were performed to demonstrate "substantial equivalence" to a predicate device (Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter, K132430), meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This is a common path for medical device clearance, especially for devices that are variations of existing technology.
§ 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).