(21 days)
The Runthrough NS Extension Wire are used to facilitate the placement of balloon dilatation catheters for percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
The Runthrough NS is a coil-type guide wire. The main components of the wire include a core wire, a tip coil, a tip coil marker, and surface coating. The core wire is constructed of a Ni/Ti alloy wire and a stainless steel wire joined together. The tip coil marker, a Pt/Ni alloy, is radiopaque. The tip coil has lubricous coating (silicone coating) and/or hydrophilic coating on the surface depending on product code. The shaft is surfacecoated with silicone and PTFE. Tip flexibility can be selected among three types, Extra Floppy, Floppy, and Intermediate, flexibility decreasing in the named order. The wire is also available in a hyper-coating type which is more lubricous than the standard wire. The device may be accompanied by a torque device, inserter, and stylet accessories. An extension wire is available to connect to the proximal end of the 180cm wire when the physician wants to convert from a monorail catheter system to an over the wire system.
The provided text describes a 510(k) summary for the "Runthrough NS Extension Wire," a medical device used to facilitate the placement of balloon dilatation catheters. The document focuses on demonstrating the substantial equivalence of this modified device to a predicate device (Runthrough NS K063695).
Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Tests) | Reported Device Performance (as stated in the document) |
|---|---|
| Dimensional Inspection | Performed; "None of the data raises any new issues of safety and effectiveness." |
| Tensile strength of tip | Performed; "None of the data raises any new issues of safety and effectiveness." |
| Extension wire connection strength | Performed; "None of the data raises any new issues of safety and effectiveness." |
| Biological Evaluation (Biocompatibility) | Tested in accordance with ISO-10993; "Results of the testing demonstrate that the blood contacting materials are biocompatible." |
| Sterilization Validation | Validated in accordance with ANSI / AAMI / ISO 11135-1994 and EN 550; "The device is sterilized to a SAL of 10-6." |
Note: The document states, "The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Runthrough NS Extension Wire) to the unmodified device (Runthrough NS K063695)." The acceptance criteria are implicitly met if these tests show no new issues of safety or effectiveness and demonstrate substantial equivalence to the predicate device. The detailed quantitative acceptance limits for each test (e.g., specific tensile strength values, dimensional tolerances) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "Dimensional Inspection," "Tensile strength of tip," and "Extension wire connection strength" tests. These would typically be part of a design verification and validation report, not usually detailed in a 510(k) summary.
Data Provenance: The tests are described as "verification tests" performed to demonstrate substantial equivalence, implying they were conducted by the manufacturer (Terumo Corporation) as part of their design and development process. The data is created by the manufacturer's testing, not from patient data, and is thus prospective in nature in terms of device testing, not clinical data collection.
- Country of Origin of Data: Not explicitly stated, but given the company's address (Elkton, MD, USA), it's likely the testing was conducted in the US or by the manufacturer's global R&D/testing facilities.
- Retrospective or Prospective: Prospective (device testing).
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 device submission. The Runthrough NS Extension Wire is a physical medical device (guide wire), not an AI/software device that requires expert consensus for "ground truth" establishment regarding interpretations of data (e.g., medical images). The "ground truth" for this device's performance is objective measurements against engineering specifications and validated test methods.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, which is not relevant for the engineering performance tests of a guide wire.
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
This information is not applicable. An MRMC comparative effectiveness study is used to evaluate the performance of AI-assisted diagnostic systems. The Runthrough NS Extension Wire is a physical medical device and does not involve AI or human-in-the-loop performance in diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. This question pertains to AI/software performance. The device is a physical guide wire.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Runthrough NS Extension Wire is established through:
- Engineering Specifications: Objective measurements (e.g., dimensions, tensile strength, connection strength) are compared against predetermined, specified ranges and values that define acceptable performance.
- Biocompatibility Testing: Results of biological assays and tests in accordance with ISO-10993 standards.
- Sterilization Validation Standards: Compliance with validated sterilization cycles to achieve a specified sterility assurance level (SAL).
- Comparison to Predicate Device Performance: The primary ground for acceptance in a 510(k) is demonstrating "substantial equivalence" to a legally marketed predicate device, meaning the new device performs acceptably and no new safety or effectiveness issues are raised compared to the predicate.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical medical device, not an AI/machine learning algorithm requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
§ 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.