(516 days)
The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.
The D·Kaptain™ PTA High Pressure Balloon Dilatation Catheter is an over-the-wire balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fillings. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 150 mm and with shaft lengths of 50 cm, 75 cm, and 130 cm.
This is a medical device submission, specifically for a balloon dilatation catheter, not an AI/ML powered device. As such, the typical acceptance criteria and study designs for AI/ML devices (e.g., test set sample size, data provenance, expert adjudication, MRMC studies, standalone performance) are not applicable here.
The document describes the performance criteria for the physical medical device and the studies conducted to demonstrate that the device meets those criteria, ensuring its substantial equivalence to a legally marketed predicate device.
Here's the information extracted based on your request, adapted for a medical device:
1. A table of acceptance criteria and the reported device performance
The document lists various in-vitro performance tests that were conducted and states that "The test results met all acceptance criteria" and "ensure the design and construction are suitable for its intended use." Specific numerical acceptance criteria are not detailed in this summary, but the successful outcome is reported. Some of these performance characteristics are implied comparisons to the predicate device, where "SE" (Substantial Equivalence) indicates the performance is considered comparable.
| Acceptance Criteria (Implied / Tested) | Reported Device Performance |
|---|---|
| In vitro performance tests: | All met acceptance criteria and ensure design suitability. |
| Visual inspection | Met |
| Dimensional verification | Met |
| Crossing profile | Met |
| Guidewire compatibility | Met |
| Simulated use | Met |
| Air/liquid leak | Met |
| Flexibility and kink | Met |
| Torque strength | Met |
| Particulate release | Met |
| Coating integrity | Met |
| Lubricity | Met |
| Balloon rated burst pressure | Met |
| Balloon fatigue | Met |
| Balloon compliance | Met |
| Balloon inflation and deflation time | Met |
| Catheter bond strength | Met |
| Tip pull strength | Met |
| Trackability | Met |
| Radiopacity | Met |
| Biocompatibility testing: | Met all acceptance criteria; Device is biocompatible. |
| Cytotoxicity | Met |
| Sensitization test | Met |
| Intracutaneous reactivity test | Met |
| Systemic Toxicity test (Acute) | Met |
| Material-mediated pyrogenicity | Met |
| Hemocompatibility (hemolysis, complement activation, PTT, in vivo thrombo resistance) | Met |
| Sterility: | Sterile with SAL of 10-6 via EO sterilization. |
| Packaging/Shelf Life: | Shelf life of 2 years. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses in-vitro testing for the device. It does not mention a "test set" in the context of clinical data for AI/ML. The performance data is derived from laboratory tests on the physical device prototypes. No mention of country of origin or retrospective/prospective nature is given for these laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the evaluation of a physical medical device like a balloon catheter. "Ground truth" established by experts is relevant for diagnostic AI/ML models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is not applicable to the evaluation of a physical medical device.
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
No such study was conducted or mentioned, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to AI/ML algorithm performance. The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical performance tests, the "ground truth" would be established engineering specifications, industry standards (like ISO 10993-1), and FDA guidance for Class II Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submission. Device performance against these established criteria forms the basis of proving suitability.
8. The sample size for the training set
This is not applicable to a physical medical device.
9. How the ground truth for the training set was established
This is not applicable to a physical medical device.
§ 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).