(28 days)
The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, 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 PTA Balloon Dilatation Catheters is now also available as an over-the-wire balloon catheter for peripheral indications. The balloon diameters range from 1.5mm to 6.0mm and balloon lengths range from 20mm to 240mm, with 90cm, 150cm and 200cm catheter lengths. The balloon material is made of a minimally compliant material with a rated burst pressure of 18 atmospheres for 5.0-6.0mm and 20atm for 1.5-4.0mm. Hydrophilic lubricious coatings are applied to the distal section of the catheter. The shaft of the catheter is composed of a proximal shaft and a distal shaft. The distal shaft is composed of a distal outer tube and tri-extrusion inner tube with a balloon welded to both tubes at the distal tip to aid in tracking through vasculature. The proximal shaft is composed of a proximal outer tube and tri-extrusion inner tube that are bonded to a female luer connector, with the proximal outer tube allowing for proximal pushability with a smooth transition to the distal shaft. The inner lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the hub guidewire lumen. Two radiopaque marker bands 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. One marked section, for the 90cm catheter working length, or two marked sections, for the 150cm and 200cm catheter working lengths, are located on the proximal shaft to indicate catheter position relative to the tip of the guiding catheter or introducer sheath. The Y-type hub is bonded on the proximal end of the catheter at the entrance to the inflation lumen and the guidewire lumen. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
The provided text describes the 510(k) summary for the Jade PTA Balloon Dilatation Catheter, which is a medical device. This type of submission is for proving "substantial equivalence" to a legally marketed predicate device, rather than proving that an AI/algorithm-based device meets specific performance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves an AI/algorithm device meets those criteria. The provided text details performance testing for a physical medical device (a balloon catheter) to demonstrate its safety and effectiveness, and its equivalence to a predicate catheter.
Specifically, the document does not address any of the following points relevant to an AI/algorithm-based device study:
- 1. A table of acceptance criteria and the reported device performance (for an AI/algorithm)
- 2. Sample sized used for the test set and the data provenance
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- 8. The sample size for the training set
- 9. How the ground truth for the training set was established
The performance data mentioned in the document (Visual Inspection, Marker Band Radiopacity, Dimensional Verification, etc.) are all related to the physical characteristics and functionality of the balloon catheter, not an AI algorithm.
§ 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).