(112 days)
The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
A guide wire is a flexible wire of a small diameter that serves as a track for directing or passing a device to a vessel, organ or cavity, by threading the device over its length.
The provided document is a 510(k) premarket notification for a medical device called the "Attain Hybrid Guide Wire." It describes the device, its intended use, and the studies performed to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, specifically focusing on what is available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "The results of the above verification tests met the specified acceptance criteria." However, it does not provide a detailed table outlining specific numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the types of tests performed.
| Test Type | Acceptance Criteria (Not Detailed in Document) | Reported Device Performance (Not Detailed in Document) |
|---|---|---|
| Coating adhesion | Met specified criteria | Met specified criteria |
| Dimensional verification | Met specified criteria | Met specified criteria |
| Particulate PTFE coating adhesion | Met specified criteria | Met specified criteria |
| Tip integrity | Met specified criteria | Met specified criteria |
| Tip deflection force | Met specified criteria | Met specified criteria |
| Distal tip stiffness | Met specified criteria | Met specified criteria |
| Guide Wire Perforation | Met specified criteria | Met specified criteria |
| Guide Wire Passage/Seal Integrity | Met specified criteria | Met specified criteria |
| Silicone lubricity and durability | Met specified criteria | Met specified criteria |
| Guide wire torque response | Met specified criteria | Met specified criteria |
| Sterilization validation | Met specified criteria | Met specified criteria |
| Shelf life evaluation | Met specified criteria | Met specified criteria |
| Biocompatibility tests (ISO 10993-1) | Met specified criteria | Met specified criteria |
| - Cytotoxicity | Met specified criteria | Met specified criteria |
| - Irritation or Intracutaneous Reactivity | Met specified criteria | Met specified criteria |
| - Systemic Toxicity | Met specified criteria | Met specified criteria |
| - Hemocompatibility / Hematology | Met specified criteria | Met specified criteria |
| - Hemocompatibility / Thrombosis | Met specified criteria | Met specified criteria |
| - Pyrogen Test | Met specified criteria | Met specified criteria |
| - Complement Activation Assay | Met specified criteria | Met specified criteria |
| - Sensitization Test | Met specified criteria | Met specified criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for any of the bench/performance tests or biocompatibility tests. It also does not mention any human clinical test set for this device; the testing is focused on demonstrating substantial equivalence through bench and biocompatibility testing. Therefore, there is no data provenance (e.g., country of origin, retrospective/prospective) described for a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Since the testing described is primarily bench and biocompatibility testing, there is no "ground truth" established by human experts in the context of clinical interpretation or diagnosis. The ground truth for these tests would be derived from the experimental parameters, validated methods, and material characterization.
4. Adjudication Method for the Test Set:
Not applicable, as there is no clinical test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document describes bench and biocompatibility testing, not a clinical study involving human readers or comparative effectiveness with or without AI assistance. This device is a guide wire, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No. This question is also not applicable. The device is a physical medical instrument, not an algorithm, and therefore does not have "algorithm only" performance.
7. Type of Ground Truth Used:
The ground truth for the studies described would be based on:
- Engineering specifications and standards: For dimensional verification, coating adhesion, tip integrity, deflection force, stiffness, perforation, passage/seal integrity, lubricity, durability, and torque response. These are objective measurements against defined criteria.
- Validated laboratory methods and international standards (e.g., ISO 10993-1): For biocompatibility tests. The "ground truth" here is the adherence to these standards and the established biological responses that indicate safety.
- Validated sterilization and shelf-life protocols: For sterilization validation and shelf life evaluation.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set. The substantial equivalence is based on physical and biological testing against a predicate device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As established, there is no training set for this device.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.