(73 days)
The ENVOY® Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
The ENVOY® Guiding Catheter is a single lumen, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional/diagnostic devices. The guiding catheter is pre-shaped to facilitate positioning.
The provided document, K140307, describes a 510(k) submission for a line extension of the ENVOY® Guiding Catheter to include a new 7 French (Fr) diameter size. The submission asserts substantial equivalence to the predicate ENVOY® 6 French (Fr) Guiding Catheter (K093184).
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical catheter. For such devices, acceptance criteria are typically defined by compliance with recognized performance standards and successful execution of specific bench tests designed to ensure safety and effectiveness. The document lists the tests performed, which inherently serve as the performance criteria. The "reported device performance" in this context is the successful completion of these tests, demonstrating that the 7Fr Guiding Catheter meets the design requirements and is substantially equivalent to the predicate.
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Visual Inspection | Passed |
| Catheter Shape | Passed |
| Catheter Dimensional Verification | Passed |
| Tensile Strength Testing | Passed |
| System Liquid Leakage Testing | Passed |
| Lateral Stiffness Testing | Passed |
| Linear Stiffness Testing | Passed |
| Back-Up Support | Passed |
| Track Testing | Passed |
| Sheath Introducer Compatibility | Passed |
| Multiple In-dwelling device | Passed |
| Cytotoxicity (MEM Elution) | Passed |
| Hemocompatibility (In vitro Hemolysis) | Passed |
| USP Physicochemical Aqueous Extraction Test | Passed |
| Compliance with BS EN ISO 11607-1 | Documented Compliance |
| Compliance with BS EN ISO 11135-1 | Documented Compliance |
| Compliance with BS EN ISO 10993-7 | Documented Compliance |
| Compliance with BS EN ISO 10555-1 | Documented Compliance |
| Compliance with ISO 594-1 | Documented Compliance |
| Compliance with ISO 594-2 | Documented Compliance |
| Compliance with AAMI / ANSI HE75 | Documented Compliance |
| Compliance with BS EN ISO 10993-1 | Documented Compliance |
| Compliance with BS EN ISO 10993-5 | Documented Compliance |
| Compliance with BS EN ISO 10993-4 | Documented Compliance |
| Compliance with USP | Documented Compliance |
| Compliance with ISO 14971 | Documented Compliance |
| Compliance with BS EN ISO 15223-1 | Documented Compliance |
Study Proving Acceptance Criteria Met:
The study that proves the device meets the acceptance criteria is a non-clinical bench testing program combined with biocompatibility testing.
The document states: "Results of verification and validation testing that was conducted on the proposed ENVOY® Guiding Catheter demonstrates that it performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new questions of safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the performed bench tests. It only lists the types of tests.
Regarding data provenance, the testing was conducted by Codman & Shurtleff, Inc., the device submitter. The document does not explicitly state the country of origin for the testing, but the submitter's address is in Raynham, MA, USA, suggesting the testing was likely conducted in the US. The study is retrospective in the sense that the testing was performed on manufactured devices after their design, as part of the verification and validation process for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to this type of submission. This 510(k) is for a medical device (catheter) based on substantial equivalence to an existing predicate. The "ground truth" for these types of submissions is established through engineering specifications, recognized standards, and the performance characteristics of the predicate device. Expert human interpretation of data for "ground truth" (like in AI/diagnostic device studies) is not relevant here.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, such as clinical trials or studies establishing ground truth from multiple expert opinions. The testing described here is objective bench testing and standard compliance.
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
No, an MRMC comparative effectiveness study was not done. This device is a guiding catheter, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This refers to AI algorithm performance without human intervention, which is not relevant for a physical medical catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, recognized national and international performance standards (e.g., ISO, AAMI, USP), and the established performance and safety profile of the predicate device. The tests conducted (e.g., dimensional verification, tensile strength, leakage, biocompatibility) are designed to verify that the device meets these pre-defined, objectively measurable criteria.
8. The Sample Size for the Training Set
This information is not applicable as this is not an AI/machine learning device. There is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as this is not an AI/machine learning 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).