(78 days)
Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
The Hi-Torque Connect guidewire range are disposable medical devices designed for single use only. They consist of a PTFE coated 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support. Each of these 3 levels of support are provided in 3 different length options (145cm - 300cm)
This document is a 510(k) summary for the Hi Torque Connect Guidewire. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance Tests | Implicitly, the device must perform comparably to predicate devices and meet established product specifications for safe and effective use in its intended application. | |
| The results demonstrated that the Hi-Torque Connect Guidewire range met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s). | ||
| Specific tests included: |
- Tensile Strength
- Torque Strength
- Outer Diameter measurement
- Torque Response
- Catheter Compatibility
- Coating Adherence/Coating Integrity
- Particulate Testing
- Tip Flexibility |
| Biocompatibility Tests | No specific numerical acceptance criteria are given, but the device must demonstrate biological safety based on ISO 10993-1. | The device's biological safety has been established through biocompatibility testing carried out in compliance with ISO 10993-1.
Specific tests performed: - Cytotoxicity Study (Qualitative and Quantitative)
- Irritation Test (Intracutaneous Injection, ISO 10993-10)
- Sensitisation Test (Kligman Maximisation, ISO 10993-10)
- Acute Systemic Toxicity Test (Systemic Injection, ISO 10993-11; ISO-Rabbit-Pyrogen)
- Haemocompatibility Test (Haematology: Haemolysis, In-vitro Haemocompatiblity Assay; Coagulation: Prothrombin Time Assay (PT), Unactivated Partial Thromboplastin Time Assay (UPTT); Thrombosis: In Vivo Thrombogenicity in Dogs; Complement Activation; Lee & White Coagulation Assay) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the mechanical or biocompatibility testing. The data provenance is not specified beyond indicating "in vitro bench tests" and reference to FDA guidance. Given the nature of a 510(k) submission for a medical device of this type, the testing would generally be conducted in a controlled laboratory environment. This would be considered prospective testing for the purpose of regulatory submission. The country of origin for the testing itself is not stated, but the submitter is Lake Region Medical Limited, Ireland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a medical device (guidewire) premarket notification (510(k)) that focuses on engineering performance and biocompatibility rather than diagnostic accuracy or clinical outcomes that typically involve expert consensus on ground truth. The "ground truth" for these tests are the established scientific and engineering principles, and regulatory standards.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. Test results are compared against predefined specifications and regulatory standards, not expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic imaging device or an AI algorithm intended for interpretation, so MRMC studies are not relevant. This submission focuses on the safety and performance of a physical medical device.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical guidewire, not a standalone algorithm.
7. Type of Ground Truth Used
For the performance testing, the "ground truth" is based on:
- Established engineering specifications and standards: These define acceptable ranges for tensile strength, torque strength, dimensions, etc.
- Predicate device performance: The new device must perform "comparably" to legally marketed predicate devices.
- Regulatory guidance: Specifically, "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995" for mechanical tests, and ISO 10993-1 for biocompatibility.
8. Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as 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.