(26 days)
The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.
• 6 French
• Single lumen catheter featuring a nylon body reinforced with a tightly wound stainless steel braid wire
• The transition segment is designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip.
This document describes safety and effectiveness for VISTA BRITE TIP and ENVOY Guiding Catheters. However, this submission to the FDA (K982632) is for a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria for AI/ML validation studies, such as sample size for test/training sets, experts for ground truth, adjudication methods, and MRMC studies, are not applicable to this type of submission.
The primary focus of this document is to establish substantial equivalence to previously cleared predicate devices, an approach common for medical device clearances that are not software algorithms.
Here's the information that can be extracted or inferred from the provided text:
1. Table of Acceptance Criteria (Inferred from Substantial Equivalence) and Reported Device Performance
Since this is a substantial equivalence claim for guiding catheters, the "acceptance criteria" are implicitly met by demonstrating that the new devices perform as intended and are as safe and effective as the predicate devices. The document does not describe a formal study with quantitative performance metrics against pre-defined acceptance criteria in the way an AI/ML study would. Instead, it relies on the comparison to established predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence Principles) | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use: Device is suitable for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature. | The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for this use, identical to predicate devices. |
| Design Characteristics: Maintained key features and specifications of predicate devices. | The new devices are 6 French, single lumen, with a nylon body reinforced with a tightly wound stainless steel braid wire, and a transition segment designed with nylons of different durometers. This description is consistent with the predicate devices. |
| Material Biocompatibility: Materials used are biocompatible. | "All materials used in the VISTA BRITE TIP and ENVOY Guiding Catheters are biocompatible." |
| Safety and Effectiveness: As safe and effective as the predicate devices. | The FDA found the device "substantially equivalent" to legally marketed predicate devices, implying comparable safety and effectiveness for the stated indications for use. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a medical device submission, not an AI/ML algorithm study involving a "test set" of data in the computational sense. The "test" is more about demonstrating that the physical device's characteristics (materials, design, function) are equivalent to existing cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth in this context would implicitly be the established safety and effectiveness of the predicate devices based on their prior clearance and clinical use, rather than expert annotation of a dataset.
4. Adjudication method
- Not Applicable. See point 2.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an artificial intelligence algorithm.
7. The type of ground truth used
- Predicate Device Performance/Clearance: The "ground truth" for this submission is essentially the established safety, effectiveness, and intended use of the predicate devices (Cordis Corporation VISTA BRITE TIP Guiding Catheter and Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter). The submission aims to prove the new device is "substantially equivalent" to these already cleared devices, meaning it performs as well and is as safe as those established devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML algorithm that requires a "training set" of data.
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).