(30 days)
The Envoy Distal Access Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
The ENVOY® Distal Access (DA) Guiding Catheter is a variable stiffness, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The distal segment is flexible for navigation into distal vasculature. The outer surface has a hydrophilic coating that reduces friction during manipulation in the vasculature. The lubricious PTFE lined inner lumen is designed to facilitate the passage of guide wires and other devices. A luer fitting located on the end of the catheter hub can be used to attach accessories. The distal section of the catheter is radiopaque to aid visualization under fluoroscopy, and the catheter has a radiopaque marker. The catheter is available with preshaped tips to facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ENVOY® Distal Access Guiding Catheter:
Summary of Device Performance and Acceptance Criteria:
The provided document describes a special 510(k) submission, which means the device is substantially equivalent to a previously cleared device and does not introduce new technological characteristics. As such, the acceptance criteria are primarily focused on demonstrating that the new device performs as designed and is equivalent to the predicate devices in terms of safety and effectiveness, without raising new issues.
The device's performance is demonstrated through a battery of preclinical tests. Since this is a substantial equivalence claim for a new iteration of an existing device, the "acceptance criteria" are implied to be that the new device meets the same performance standards and safety profiles as the predicate devices in these tests. The document doesn't provide specific numerical thresholds for acceptance criteria, but rather states that the device "met all" requirements or "performs as designed."
Here's a table summarizing the tests, which serve as the de facto acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Aseptic removal of the guiding catheter from the packaging | Performed as designed / Met requirements (Implied by overall conclusion) |
| Visual Inspection/ Hub Transition | Performed as designed / Met requirements (Implied by overall conclusion) |
| Catheter Shape (post sterilization) | Performed as designed / Met requirements (Implied by overall conclusion) |
| Catheter Dimensional Verification | Performed as designed / Met requirements (Implied by overall conclusion) |
| Coating Length Verification | Performed as designed / Met requirements (Implied by overall conclusion) |
| Torque Testing | Performed as designed / Met requirements (Implied by overall conclusion) |
| Proximal Lateral Stiffness Test | Performed as designed / Met requirements (Implied by overall conclusion) |
| Back up Support | Performed as designed / Met requirements (Implied by overall conclusion) |
| Distal Tip lateral and Linear Stiffness Test | Performed as designed / Met requirements (Implied by overall conclusion) |
| Catheter Shaft Tensile Strength | Performed as designed / Met requirements (Implied by overall conclusion) |
| Catheter Tip Tensile Strength | Performed as designed / Met requirements (Implied by overall conclusion) |
| Hub Attachment Tensile Strength | Performed as designed / Met requirements (Implied by overall conclusion) |
| Coating Integrity | Performed as designed / Met requirements (Implied by overall conclusion) |
| Compatibility with Guidewires | Performed as designed / Met requirements (Implied by overall conclusion) |
| Trackability | Performed as designed / Met requirements (Implied by overall conclusion) |
| Kink Resistance (Distal & Proximal Shaft) | Performed as designed / Met requirements (Implied by overall conclusion) |
| Ovalization Testing | Performed as designed / Met requirements (Implied by overall conclusion) |
| System Liquid Leakage | Performed as designed / Met requirements (Implied by overall conclusion) |
| System Air Leakage | Performed as designed / Met requirements (Implied by overall conclusion) |
| Stability with Access Devices | Performed as designed / Met requirements (Implied by overall conclusion) |
| Hub Luer Taper | Performed as designed / Met requirements (Implied by overall conclusion) |
| Compatibility with REVIVE Intermediate Catheter | Performed as designed / Met requirements (Implied by overall conclusion) |
| Delamination of PTFE liner | Performed as designed / Met requirements (Implied by overall conclusion) |
| Peel Away Introducer Tests: | |
| Visual Inspection (Introducer) | Performed as designed / Met requirements (Implied by overall conclusion) |
| Dimensional Verification (Introducer) | Performed as designed / Met requirements (Implied by overall conclusion) |
| Shaft Peel Strength (Introducer) | Performed as designed / Met requirements (Implied by overall conclusion) |
| Hub detachment from the shaft (Introducer) | Performed as designed / Met requirements (Implied by overall conclusion) |
| Biocompatibility Requirements (ISO 10993 Part I & G95-1): | |
| Cytotoxicity | Met all biocompatibility requirements (Explicitly stated) |
| Sensitization | Met all biocompatibility requirements (Explicitly stated) |
| Irritation | Met all biocompatibility requirements (Explicitly stated) |
| Systemic Toxicity | Met all biocompatibility requirements (Explicitly stated) |
| Hemocompatibility | Met all biocompatibility requirements (Explicitly stated) |
| Thrombogenicity | Met all biocompatibility requirements (Explicitly stated) |
| Genotoxicity | Met all biocompatibility requirements (Explicitly stated) |
| Physicochemical | Met all biocompatibility requirements (Explicitly stated) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "preclinical testing data" and "results of verification and validation." These are typically conducted on a sample of manufactured devices, but the exact number isn't quantified in this summary.
- Data Provenance: The tests are "preclinical testing data" and "verification and validation" conducted by Codman & Shurtleff, Inc. This indicates it's retrospective data gathered from tests performed on prototypes or early production samples during the device development and manufacturing process. The country of origin for the data is implicitly the United States, where Codman & Shurtleff, Inc. is located.
- Clinical Testing: The document explicitly states: "Clinical testing was not required to establish substantial equivalence."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This is a special 510(k) for a medical device (catheter) based on substantial equivalence and preclinical testing. There is no mention of human expert evaluation or a "ground truth" derived from expert consensus in the context of clinical images or patient data to establish the device's basic functional and safety characteristics. The "ground truth" here is the pass/fail criteria for the engineering and biocompatibility tests themselves.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, there was no expert evaluation requiring adjudication. The tests conducted are objective, pass/fail engineering and biocompatibility evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study is a type of clinical study often used for imaging diagnostic devices or AI algorithms evaluating human performance. This document explicitly states that "Clinical testing was not required to establish substantial equivalence" for this device. Therefore, no MRMC study was conducted, and no effect size for human reader improvement with AI assistance is provided.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This device is a physical medical instrument (a catheter), not an artificial intelligence (AI) algorithm. Therefore, the concept of a "standalone algorithm" performance study is not relevant.
7. The Type of Ground Truth Used:
- The "ground truth" in this context refers to the specified engineering and biocompatibility requirements and standards (e.g., ISO 10993 Part I, General Program Memorandum # G95-1, internal design specifications for dimensions, strength, flexibility, etc.). The device was tested against these predetermined objective criteria.
8. The Sample Size for the Training Set:
- Not Applicable. The device is not an AI algorithm, so there is no "training set." The development of the device would involve engineering design and iterative prototyping, but not in the same sense as training a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set, this question is not applicable. The "ground truth" for the device's design and manufacturing is established through established engineering principles, material science, clinical needs for similar devices, and regulatory standards.
§ 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).