(75 days)
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature.
The Vista Brite Tip Guiding Catheters are single lumen catheters which feature a nylon body with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane with a radiopaque filler; this is the softest material in the catheter.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the "Cordis Vista Brite Tip® Guiding Catheter":
It's important to note that this document is a Premarket Notification (510(k)) Summary of Safety and Effectiveness from 1997. At that time, the scope and requirements for demonstrating "acceptance criteria" and "study results" for medical devices, particularly regarding algorithmic performance (AI), were fundamentally different from today's standards. AI, as we understand it in medical devices now, did not exist in this context. The focus of this 510(k) is on demonstrating substantial equivalence to predicate devices through design, materials, and biocompatibility, rather than statistical performance against specific clinical endpoints derived from a study.
Therefore, many of the requested categories for AI/algorithm-based devices will not be directly applicable or present in this document. I will fill in the table and information based on what is provided and explain where information pertinent to AI/algorithm studies is missing due to the nature of the submission.
Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria here are interpreted as the successful completion of standard evaluations for medical devices of this type, primarily focusing on safety and equivalence. There are no quantifiable performance metrics in the way one would define for an AI algorithm (e.g., sensitivity, specificity, AUC).
| Acceptance Criteria Category | Specific Requirement (from document) | Reported Device Performance (from document) |
|---|---|---|
| Design & Construction | Similar in design and construction to commercially available Cordis guiding catheters. | "The Cordis Guiding Catheters are similar in design, construction, indication for use, and performance characteristics to other commercially available Cordis guiding catheters." (Implies successful comparison to predicates) |
| Indications for Use | Intended for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature. | "The Vista Brite Tip Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature." (Confirms alignment with stated indication) |
| Biocompatibility | All appropriate biocompatibility tests for guiding catheters. | "All appropriate biocompatibility tests for the guiding catheters were successfully completed." |
| Predicate Device Equivalence (Overall) | Substantially equivalent (for indications for use) to devices marketed prior to May 28, 1976, or reclassified devices. Similar in design, construction, indication for use, and performance characteristics to other commercially available Cordis guiding catheters (predicates listed: Cordis Vista Brite Tip, Cordis Endovascular Systems, ENVOY Guiding Catheters, DVI, Devices for Vascular Intervention). | "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)." |
| Material Properties (Implicitly met for equivalence) | Catheter features a nylon body with a tightly wound stainless braid wire and transition segments with nylons of different durometers. Brite Tip segment is polyurethane with a radiopaque filler (softest material). | Described features are part of the device description, implying they meet the engineering and design specifications that allow for equivalence. |
Study Information (as applicable to a 1997 510(k) for a physical device, NOT an AI algorithm)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This document is a 510(k) submission for a physical medical device (guiding catheter) and does not describe a "test set" in the context of an algorithm or clinical study with patient data. The 'testing' would have primarily been bench testing for mechanical properties and biocompatibility. No specific sample sizes for such tests are detailed in this summary.
- Data Provenance: Not applicable. No clinical data or patient data is referenced that would have a provenance like 'country of origin'.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. "Ground truth" in the context of expert consensus for imaging or clinical diagnosis is not relevant to this device submission. The primary "ground truth" for a device like this would be engineering specifications and predicate device characteristics, not expert interpretation of cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) submission.
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
- MRMC Study / AI Effect Size: Not applicable. This device is a physical guiding catheter, not an AI-powered diagnostic or assistive tool. No MRMC studies were performed, and AI was not a component of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For a 510(k) of this nature, the "ground truth" is primarily based on engineering specifications, material science standards, biocompatibility testing results, and the established characteristics and performance of the identified predicate devices. There is no clinical or diagnostic "ground truth" from patient data involved in this summary.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. As there's no training set, there's no ground truth for it.
In summary: This 1997 510(k) submission demonstrates the substantial equivalence of a physical medical device (a guiding catheter) to existing, legally marketed predicate devices. The "acceptance criteria" are based on meeting design, material, and biocompatibility standards comparable to those predicates, and successfully satisfying the FDA's regulatory requirements for a Class II device. The modern concepts of "acceptance criteria" and "study results" as they pertain to AI algorithms are not present or applicable in this historical document.
§ 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).