(125 days)
The JADE PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.
The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications and include both Rapid Exchange (RX) and Over-The-Wire (OTW) designs. The over-the-wire design permits the use of standard 0.018 inch and 0.035 inch guidewires respectively (hereafter referred to as 18 OTW version and 35 OTW version), and the rapid exchange design permits the use of standard 0.018 inch guidewires (hereafter referred to as 18 RX version) as shown in Table 1 below. The JADE PTA balloon dilatation catheter is made of a minimally compliant material with a rated burst pressure of 16 atmospheres for 7.0mm diameters, 18 atmospheres for 4.5-6.0mm diameters and 20 atmospheres for 1.5-4.0mm diameter. Two radiopaque marker bands (Platinum/Iridium) are positioned within the balloon shoulder, and for balloons of working length 180-240mm, two more marker bands (four marker bands in total) are positioned in the middle of the balloon. A hydrophilic lubricious coating is applied to the outside surface of distal section of the catheter. A Silicone coating is applied to wire lumen surface.
The provided text describes a 510(k) submission for a medical device, the JADE PTA Balloon Dilatation Catheter, and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not pertain to an Artificial Intelligence/Machine Learning (AI/ML) device.
Therefore, the information required to answer the question about the acceptance criteria and study proving an AI/ML device meets those criteria, specifically concerning data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, is not present in the provided document.
The document focuses on in vitro performance tests and biocompatibility tests for a physical medical device (a balloon catheter), not a software-driven diagnostic or AI-assisted system.
Specifically, the document lists performance tests such as:
- Visual Inspection
- Dimensional Verification
- Balloon Preparation, Deployment, and Retraction
- Balloon Rated Burst Pressure (including in-stent)
- Balloon Fatigue (including in-stent)
- Balloon Compliance
- Balloon Inflation and Deflation Time
- Catheter Bond Strength
- Tip Pull Strength
- Flexibility and Kink
- Torque Strength
- Marker Band Radiopacity
- Coating Integrity
- Particulate Evaluation
And biocompatibility tests:
- Cytotoxicity
- Intracutaneous reactivity
- Sensitization
- Acute systemic toxicity
- Hemocompatibility (Hemolysis, Complement activation, Partial thromboplastin time, Platelet and leukocyte counts, In vivo thromboresistance)
- Pyrogenicity
- Genotoxicity (bacterial mutagenicity test, in vitro mouse lymphoma Assay)
It concludes that "The test results met all acceptance criteria," but it does not specify what those numerical criteria were, only the types of tests performed. It certainly does not provide any details related to AI/ML device validation.
§ 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).