(116 days)
The Crosperio OTW PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infrapoplited and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Crosperio OTW PTA Balloon Dilatation Catheter (Crosperio OTW) is an over-the-wire type of balloon dilatation catheter, which consists of an outer tube, inner tube, balloon, radiopaque markers, manifold, outer reinforcement tube 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 manifold at the proximal end. Crosperio OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the inner tube to the guidewire port of the manifold for the introduction of a guidewire.
The maximum compatible diameter of a guidewire used together with Crosperio OTW in a PTA procedure is 0.014 inches. Additionally, the compatible size of a sheath introducer is 4 Fr. The nominal inflated balloon diameters range from 1.5 mm to 4.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1500 mm.
The provided text is a 510(k) summary for the Crosperio OTW PTA Balloon Dilatation Catheter, a medical device. It describes the device, its intended use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The Crosperio OTW 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 explicitly list the quantitative acceptance criteria for each test or the specific reported device performance values in a table format. It lists the types of tests performed.
Types of In Vitro Tests Performed:
- 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
Types of Biocompatibility Tests Performed:
- 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 (General Statement):
"The results from these tests demonstrate that the technological characteristics and performance criteria of the Crosperio OTW 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."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test sets used in the in vitro or biocompatibility tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as these were bench and lab tests on the device itself, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable and therefore not provided in the document. The tests performed are engineering and biological evaluations of the device's physical properties and material safety, not diagnostic imaging or clinical performance requiring expert interpretation of results for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert assessment of data, not for bench testing of medical devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and therefore not provided. The Crosperio OTW PTA Balloon Dilatation Catheter is a physical medical device, not an AI software/algorithm. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and therefore not provided. As stated above, this is a physical medical device, not an algorithm, so standalone AI performance is not relevant.
7. The type of ground truth used:
The "ground truth" for the performance and biocompatibility tests was established by engineering specifications, recognized standards, guidance documents (like the FDA's "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and established biological safety testing protocols (like ISO 10993). It is based on objective, measurable criteria inherent to the device's design and manufacturing, rather than expert consensus, pathology, or outcomes data from patients.
8. The sample size for the training set:
This information is not applicable and therefore not provided. Training sets are relevant for machine learning algorithms, not for physical medical devices being evaluated through bench testing.
9. How the ground truth for the training set was established:
This information is not applicable and therefore not provided. As there is no training set for a machine learning algorithm, there is no ground truth establishment method for it.
§ 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).