(114 days)
The Crosperio RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Crosperio RX PTA Balloon Dilatation Catheter (Crosperio RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Crosperio RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire.
The maximum compatible diameter of a guidewire used together with Crosperio RX in a PTA procedure is 0.014 inches; hence, sheath introducers with a minimum diameter of 4 Fr have been deemed to be compatible with Crosperio RX. The nominal inflated balloon diameters range from 1.5 mm to 4.0 mm with balloon working lengths of 20 mm to 200 mm. Two different catheter working lengths will be provided: 900 and 1500 mm.
The Crosperio RX is provided with the following accessory device:
- Flushing Needle: provided per one catheter device for the purpose of flushing and filling . of the guidewire lumen with heparinized saline before use.
This document describes the Crosperio RX PTA Balloon Dilatation Catheter, a medical device, and provides a summary of its performance testing to demonstrate substantial equivalence to legally marketed predicate devices.
Here's the breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Crosperio RX "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not provide specific quantitative acceptance criteria or a detailed table of reported device performance values against those criteria. It only lists the types of tests performed and a general conclusion.
Types of Performance Tests Performed:
| Category | Specific Tests |
|---|---|
| Physical Performance | Dimensional Verification |
| Balloon Preparation, Deployment and Retraction | |
| Balloon Rated Burst Pressure | |
| Balloon Fatigue (Repeat Balloon Inflations) | |
| Balloon Compliance | |
| Balloon Inflation and Deflation Time | |
| Catheter Bond Strength | |
| Flexibility and Kink Test | |
| Torque Strength | |
| Radiopacity | |
| Coating Integrity | |
| Particulate Evaluation | |
| Balloon Rated Burst Pressure (in Stent) | |
| Balloon Fatigue (Repeat Balloon Inflations; in Stent) | |
| Shelf Life Testing | |
| Biocompatibility | Cytotoxicity |
| Sensitization | |
| Intracutaneous reactivity (irritation) | |
| Systemic toxicity (acute) | |
| Pyrogenicity | |
| Hemocompatibility (thrombogenicity, hemolysis, and immunology) | |
| Genotoxicity (bacterial gene mutation assay, in vitro mammalian genotoxicity assay, and in vivo cytogenetics assay) |
Reported Device Performance:
"The results from these tests demonstrate that the technological characteristics and performance criteria of the Crosperio RX are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use."
"The Crosperio RX met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
2. Sample Size Used for the Test Set and Data Provenance
The document describes in vitro (bench) and biocompatibility testing. It does not specify the sample sizes used for each test. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but as these are bench tests and biocompatibility tests, they would be conducted in a laboratory setting. There is no indication of human subject data involved in these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the tests described are primarily physical and chemical performance tests conducted in vitro and biocompatibility assessments, not diagnostic or clinical accuracy studies requiring human expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the in vitro and biocompatibility testing described. Adjudication methods are typically relevant for clinical studies where multiple human readers or experts assess cases.
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
This information is not applicable. The document describes a medical device (balloon catheter) for angioplasty, not an AI-powered diagnostic tool requiring MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
For the in vitro performance tests, the "ground truth" would be the engineering specifications, established standards (e.g., ISO), and guidance documents (e.g., FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters").
For biocompatibility testing, the "ground truth" relies on established biological safety standards (ISO 10993-1), which defines acceptable biological responses to medical devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not a machine learning model, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated above.
§ 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).