(30 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.
The HI-TORQUE BALANCE Guide Wires are available in a 0.014" outer diameter, in 175 cm and 190 cm extendable lengths, and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.
The HI-TORQUE BALANCE TREK Guide Wires are available in a 0.014" outer diameter, and in an 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.
The HI-TORQUE BALANCE HEAVYWEIGHT Guide Wires are available in a 0.014" outer diameter, in 175 cm and 190 cm extendable lengths, and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of the adhesive that is used to adhere two core subassemblies.
The HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wires are available in a 0.014" outer diameter, 175 cm and 190 cm extendable lengths, and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of the adhesive that is used to adhere two core subassemblies.
The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire is a steerable guide wire available in a maximum outer diameter of 0.0137" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The BMW Universal Guide Wire is DOC® extendable in the 190 cm lengths. The change being made is to the formulation of an adhesive that is used to adhere two core subassemblies.
The HI-TOROUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is a steerable guide wire available in a diameter of 0.0140" and in lengths of 190 cm DOC extendable length and a 300 cm exchange length. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The distal segment of the guide wire is coated with a new lubricious coating to improve guide wire movement in the catheter. The proximal end of the guide wire utilizes SMOOTHGLIDE coating technology. The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.
The HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Guide Wire is a steerable guide wire available in a maximum outer diameter of 0.014" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0145". The proximal end of the guide wire is coated with hydrophobic coating, which reduces friction of the wire within a catheter. The ELITE Guide Wire is DOC® extendable in the 190 cm lengths. The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.
The provided text describes the 510(k) summary for various HI-TORQUE BALANCE Guide Wires by Abbott Vascular. The device is a guide wire used in percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The specific subject of this 510(k) is a change in the formulation of an adhesive used to adhere two core subassemblies within the guide wires.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for the Modified Adhesive Formulation:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Tensile strength of distal to proximal core joint must be sufficient to withstand normal tensile loading during clinical use. | The tensile strength to join the distal core with the proximal core of the guidewire was conducted. The hypotube pull test verified that the hypotube joint is sufficiently strong to withstand normal tensile loading during the use of the Guide Wire in a clinical procedure. |
| Adhesive Functionality | Functionality of the modified adhesive formulation must maintain appropriate performance for intended use. | Bench testing and biocompatibility testing confirmed that the device with the modified adhesive formulation remains appropriate for its intended use. |
| Biocompatibility (General Safety) | The modified adhesive formulation must pass a battery of specified biocompatibility tests. | The modified adhesive formulation was tested and results are reported to confirm biocompatibility. |
| Overall Safety & Effectiveness | No new safety or effectiveness issues should be raised compared to predicate devices. | No new safety or effectiveness issues were raised during the testing, and the devices are considered substantially equivalent to predicate devices. |
Biocompatibility Specific Tests:
| Biocompatibility Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| a. Cytotoxicity | Must be non-toxic | Tested, results confirm appropriate for use |
| b. Hemolysis, direct | Must not cause direct hemolysis | Tested, results confirm appropriate for use |
| c. Hemolysis, indirect | Must not cause indirect hemolysis | Tested, results confirm appropriate for use |
| d. Complement Activation | Must not activate complement | Tested, results confirm appropriate for use |
| e. Coagulation (PT and PTT) | Must not interfere with coagulation | Tested, results confirm appropriate for use |
| f. Sensitization | Must not cause sensitization | Tested, results confirm appropriate for use |
| g. Intracutaneous Toxicity (Irritation) | Must not cause irritation | Tested, results confirm appropriate for use |
| h. Acute Systemic Toxicity | Must not cause acute systemic toxicity | Tested, results confirm appropriate for use |
| i. Pyrogenicity Material Mediated (Rabbit) | Must not be pyrogenic | Tested, results confirm appropriate for use |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for the mechanical performance tests or the biocompatibility tests. It only mentions that "In vitro bench testing performance evaluations demonstrated..." and "Bench testing and Biocompatibility testing was conducted...".
- Data Provenance: The studies were retrospective in the sense that they were conducted for the purpose of demonstrating substantial equivalence for a specific change (adhesive formulation) to existing, legally marketed devices. The origin of the data is Abbott Vascular's internal testing facilities, as implied by the submission on behalf of Abbott Vascular. No country of origin for the data (beyond the applicant's location, USA/Germany for contact) is specified, but it's standard industry practice for such testing to be conducted in-house or by accredited labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts and Qualifications: This information is not provided in the document. For bench and biocompatibility testing, ground truth is typically established by adhering to recognized international standards (e.g., ISO for biocompatibility) and internal company specifications, rather than expert consensus on individual test outcomes. The "experts" would be the engineers, scientists, and toxicologists conducting and interpreting these tests, but their specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not discussed. Since the studies described are bench tests and biocompatibility assessments, not clinical studies or image interpretations, there is no mention of an adjudication method like 2+1 or 3+1. Performance is assessed against pre-defined engineering specifications and standardized biological response criteria.
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: No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (guide wire), specifically addressing a material change (adhesive formulation). It does not involve AI or human readers, so an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, a standalone algorithm-only study was not done. This submission is for a physical medical device, not an algorithm or AI product.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- For mechanical integrity (tensile strength, hypotube pull test): The ground truth is defined by engineering specifications and performance criteria designed to ensure the device can withstand normal tensile loading during clinical procedures. This is typically established through risk analysis and functional requirements.
- For biocompatibility: The ground truth is established by international standards and regulatory guidelines (e.g., ISO 10993 series) for evaluating the biological effects of medical devices. Passing these standardized tests establishes the material's safety for biological contact.
8. The Sample Size for the Training Set
- Sample Size for Training Set: This is not applicable as there is no mention of a training set. This submission is for a physical medical device and its material change, not an AI/machine learning model that requires training data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: This is not applicable as there is no training set involved.
§ 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.