(195 days)
The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access in femoral, popliteal and infrapopliteal arteries.
The product is also intended for injection of radiopaque contrast media for the purpose of angiography.
The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable quide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm.
The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers.
The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014" (Oscar 4F) and 0.018" (Oscar 6F) guide wires.
The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately.
The provided text is a 510(k) summary for the Oscar Peripheral Multifunctional Catheter system. This type of regulatory document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about clinical studies involving human readers, AI assistance, or detailed ground truth establishment that would typically be found in algorithms designed for diagnostic or prognostic purposes.
Therefore, many of the requested fields are not applicable to the information provided in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states, "All necessary performance testing was conducted on the Oscar Peripheral Multifunctional Catheter System to ensure that the device conforms to the design specification and to support a determination of substantial equivalence to the predicate device." It lists several performance tests, indicating that the device met these specifications, but it does not explicitly state the quantitative acceptance criteria for each test or the exact reported performance values. It generally concludes that the device's performance meets specifications.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Balloon compliance | Conforms to design specification | Meets design specification |
| Balloon nominal diameter | Conforms to design specification | Meets design specification |
| Balloon length | Conforms to design specification | Meets design specification |
| Balloon Fatigue | Conforms to design specification | Meets design specification |
| Marker band visibility | Conforms to design specification | Meets design specification |
| Inflation/deflation time | Conforms to design specification | Meets design specification |
| Device tracking/delivery | Conforms to design specification | Meets design specification |
| Torque strength | Conforms to design specification | Meets design specification |
| Kink resistance | Conforms to design specification | Meets design specification |
| Joint strength testing | Conforms to design specification | Meets design specification |
| Rated burst pressure | Conforms to design specification | Meets design specification |
| Biocompatibility | Meets biocompatibility standards | Meets biocompatibility standards |
| Sterilization | Validated for sterility | Validated for sterility |
| Shelf life | Validated shelf life | Validated shelf life |
| Packaging | Validated for packaging integrity and protection | Validated |
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 describes non-clinical bench testing. It does not specify sample sizes for each test in the provided text, nor does it refer to "data provenance" in the context of clinical data (e.g., country of origin, retrospective/prospective). These are engineering tests performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document describes a medical device (catheter system) and its non-clinical performance testing, not an AI/diagnostic algorithm that requires expert-established ground truth from medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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
Not applicable. This is a medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to an algorithm's performance. The submission is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench tests (e.g., balloon compliance, burst pressure), the "ground truth" would be established by engineering standards, material specifications, and validated measurement techniques. For example, a burst pressure test would compare the actual burst pressure to a pre-defined engineering specification. It is not expert consensus, pathology, or outcomes data as these are not clinical tests.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).