(41 days)
The Rival® PTA Dilatation Catheters are intended to dilate stenoses in the peripheral arteries, treat obstructive lesions of native or synthetic A-V fistulae, and/or re-expand endoluminal stent graft elements in the aorta and iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Rival® PTA Dilatation Catheter is a 0.035" guidewire compatible balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The hub of the catheter includes inflation and guidewire ports with female luer locks. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon.
Here's an analysis of the provided text regarding the Rival® PTA Dilatation Catheter, focusing on acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (510(k) Summary) states that the Rival® PTA Dilatation Catheter met all predetermined acceptance criteria. However, it does not explicitly list numerical acceptance criteria or specific performance values for the device in a comparative table a typical "acceptance criteria" table might present. Instead, it refers to comparable performance to predicate devices based on in vitro tests.
Here's an interpretation based on the available information:
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| General Performance | Comparable to predicate devices (Edwards Peripheral Dilation Catheter, Dorado® PTA Dilatation Catheter) in technological characteristics and performance criteria. | "The results from these tests demonstrate that the technological characteristics and performance criteria of the Rival® PTA Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use." |
| Puncture Resistance | To be comparable to predicate devices. | Performed an in vitro test. Results indicated comparability. |
| Robustness | To be comparable to predicate devices. | Performed an in vitro test. Results indicated comparability. |
| Safety & Effectiveness | No new issues of safety and effectiveness compared to predicate devices, based on risk analysis and proposed indications for use. | Demonstrated through risk analysis process. |
| Design Verification & Validation | Met all predetermined acceptance criteria as specified by applicable standards, guidance, test protocols and/or customer inputs. | Device "met all the predetermined acceptance criteria of design verification and validation." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data. The performance evaluation was based on in vitro tests. Therefore, the "sample size" would refer to the number of devices or iterations tested during the Puncture Resistance and Robustness in vitro studies. This specific number is not provided in the summary.
- Data Provenance: The data is from in vitro studies conducted by the manufacturer, Bard Peripheral Vascular, Inc. The document does not mention any clinical data, country of origin for clinical data, or whether it was retrospective or prospective, as no human studies were described for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable as the described performance evaluation relies solely on in vitro testing, not on human-based adjudication or ground truth establishment for a test set of data.
4. Adjudication Method for the Test Set
- This question is not applicable as the described performance evaluation relies solely on in vitro testing, not on human-based adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states the evaluation was based on in vitro tests to demonstrate substantial equivalence to predicate devices, not on human-in-the-loop performance or comparison of human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable as the device is a physical medical instrument (dilatation catheter), not an algorithm or AI system. The "standalone performance" here refers to the device's physical and mechanical properties. These were evaluated in vitro as described.
7. The Type of Ground Truth Used
- The concept of "ground truth" as typically used in AI/image analysis is not directly applicable here. For this physical device, the "ground truth" for its performance is established by the engineering specifications and performance metrics defined for Puncture Resistance and Robustness in the in vitro tests. The "truth" is that the device either meets these defined physical performance standards or it doesn't, relative to its predicate devices.
8. The Sample Size for the Training Set
- This question is not applicable as the device is a physical medical instrument and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as above – no training set was involved for this physical 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).