(42 days)
The Guidant RAPIDO™ Cut- Away™ Guiding Catheter is intended to access the coronary venous system, and may be used as a dualcatheter assembly. The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.
The RAPIDO Cut-Away Guiding Catheter is similar to the approved RAPIDO Guiding Catheter. The Cut-Away Catheter is comprised of a flexible shaft, lucr (hub) and a soft tip. The catheter shaft is comprised of an inner liner of polytetrafluoroethylene (PTFE), an outer layer of radiopaque polyether block amide (PEBAX), with a reinforcing layer of 304V stainless steel braid sandwiched between the two. A blue PEBAX luer (sometimes referred to as a "hub") is attached to the proximal end of the shaft using a cyanoacrylate adhesive. A silicone coating is applied to the exterior of the shaft to improve device lubricity. The distal end of the catheter is formed into a variety of shapes as needed to access differing areas of the anatomy.
The provided document describes a 510(k) summary for the RAPIDO™ Cut-Away™ Guiding Catheter. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than providing detailed clinical study data with specific acceptance criteria as might be found for a novel device or one requiring a PMA.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided text. The document focuses on demonstrating substantial equivalence through technological characteristics and performance testing in comparison to a predicate.
However, I can extract and infer some information based on the typical content of a 510(k) and the statements made.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (RAPIDO Guiding Catheter K021455) in design and intended use | "Testing demonstrated that the RAPIDO Cut-Away Guiding Catheters met the acceptance criteria and performed similarly to the predicate device." |
| No new safety or effectiveness issues | "No new safety or effectiveness issues were raised during the testing program." |
| Functional equivalence in serving as a conduit for delivery of contrast medium and devices to the coronary venous system | Performed similarly to the predicate device, which is indicated for this use. |
| Similar technological characteristics to predicate device | "Comparisons of the RAPIDO Cut-Away Guiding Catheters and predicate devices show that the technological characteristics such as design and intended use are substantially equivalent to the currently marketed predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "testing" but does not provide details on the number of catheters or tests performed.
- Data Provenance: Not explicitly stated, but typically, performance testing for 510(k) submissions is conducted by the manufacturer (Guidant Corporation) in a controlled laboratory environment. It is retrospective in the sense that the data is generated to demonstrate equivalence of a new design to an existing one. No information on country of origin of data (e.g., patient data) is relevant or provided, as this is a device performance test, not a clinical trial with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable/not provided. The "ground truth" for this type of device (a guiding catheter) is typically established through engineering specifications, material testing, and functional performance benchmarks rather than expert consensus on medical images or clinical outcomes. The performance is compared to the predicate device, not against an "expert ground truth" in a diagnostic sense.
4. Adjudication method for the test set
- This is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where there might be disagreement in expert interpretation. For a medical device like a catheter, performance is assessed against engineering and functional specifications, not subjective interpretations requiring adjudication.
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 is not applicable. The RAPIDO™ Cut-Away™ Guiding Catheter is not an AI-powered diagnostic device, nor is it a device that enhances human reader performance in interpreting medical cases. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. This is a physical medical device (catheter), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission would be engineering specifications, material properties, and functional performance benchmarks that the predicate device (RAPIDO Guiding Catheter, K021455) was designed and cleared to meet. The new device is then tested to confirm it meets these same implicit standards.
8. The sample size for the training set
- Not applicable/not provided. This is a physical medical device, not a machine learning algorithm, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As stated above, there is no training set for this 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).