(45 days)
The 110cm V-18 Control Wire is intended for general intravascular usc including the placement of PTA balloon catheters requiring an 0.018" guide wire in hemodialysis AV access procedures. The wire can be torqued to facilitate placement of diagnostic or therapeutic catheters. This device is intended for peripheral vascular use only. A torque device is included with cach wire to facilitate directional manipulation of the guide wire.
The 110 cm V-18 Control Wire wire is for use in the percutaneous introduction of catheters including Hemodialysis Access Management procedures. The 110 cm V-18 Control Guide Wire is a sterile, single-use wire that is available in a 110cm nominal wire length, a nominal of 0.018" diameter, a nominal 8 cm taper length, and a shapeable tip. The core is a tapered stainless steel wire which provides the pushability, flexibility, torquability and steerability needed to maneuver into tortuous vessels. The most distal portion of the wire is shapeable. The distal end of the core is covered with a heat-flow polyurethane compounded with tungsten. The tungsten provides the radiopacity necded for visualization. The heatflow is coated with a hydrophillic polymer for ease of use and enhances appearance. A torque device, also cleared in the V-18 Strike 510(k) (K934359) is included in the package and is intended for use at the proximal end of the guide wire to allow manipulation of the wire during the percutaneous procedure.
The provided text describes a 510(k) premarket notification for the Boston Scientific V-18 Control Wire and does not contain the specific details required to fully address all aspects of your request regarding acceptance criteria and a definitive study proving the device meets those criteria.
However, based on the principle of substantial equivalence for 510(k) submissions, we can infer the "acceptance criteria" and the "study" by understanding how these types of devices are approved.
Here's an attempt to answer your questions based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a table. Instead, it relies on the concept of substantial equivalence to a predicate device. The primary "acceptance criterion" is that the new device (110cm V-18 Control Wire) performs equivalently or better than the predicate device (V-18 Strike Control Guide Wire, K934359) for its intended use, particularly for the new length and additional indication (hemodialysis AV access management).
The "reported device performance" is essentially that the new device met the performance characteristics of the predicate device.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Technological Characteristics: Equivalent design, manufacturing, sterilization, and fundamental technology to the predicate V-18 Strike Control Guide Wire (except for length). | The 110 cm V-18 Control Wire incorporates equivalent packaging, fundamental technology, manufacturing, and sterilization as the V-18 Strike Control Guide Wire. Its design is identical to the V-18 Strike Control Wire except for the 110cm length. This implies it meets the same performance benchmarks as the predicate in terms of materials, construction, and basic function. |
| Device Compatibility: Met minimum requirements for intended use. | Device compatibility testing was performed, and the results met minimum requirements and are adequate for its intended use. This suggests that the device interacts as expected with other components (e.g., catheters) and within the physiological environment. |
| Biocompatibility: Met minimum requirements for intended use. | Biocompatibility testing was performed, and the results met minimum requirements and are adequate for its intended use. This indicates the device is safe for contact with biological tissues and fluids, and does not pose unacceptable risks of toxicity or adverse reactions. |
| No new safety or performance issues raised. | No new safety or performance issues were raised during the testing regimen. This is a critical acceptance point, as any new issues would necessitate further investigation or design changes. |
| Performance characteristics of distal wire segments (e.g., Distal Tip Torsion, Combined Load Failure, Torque Response, Tip Flexibility, Polyurethane/PTFE Coating Adherence Test, Torque Slip Force, Pull Tensile Test, Collett Release Test, Deformation Test) are equivalent to the predicate. | Since the distal wire segments are identical to the V-18 Strike Control Wire, the previous test data for these characteristics are considered representative and applicable to the 110cm V-18 Control Wire. This implies the new device performs identically to the predicate in these crucial aspects. The Conclusion states it has been "shown to be adequate for its intended use and is considered to be substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that previous test data for the V-18 Strike Control Wire was not repeated for the 110cm V-18 Control Wire because the distal wire segments are identical. Therefore, the "test set" for the key performance characteristics (like distal tip torsion, torque response, etc.) would be the sample size used in the original V-18 Strike Control Wire testing (K934359).
- Sample Size: Not specified in this document. It would be detailed in the original K934359 submission.
- Data Provenance: Not specified in this document for the original predicate device data. The studies would have been retrospective in relation to this new 510(k) submission, as they were conducted on the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (for a guide wire) typically relies on in-vitro engineering testing rather than human expert interpretation of images or clinical outcomes to establish "ground truth." Therefore, the concept of "experts establishing ground truth" in the way it might apply to AI/imaging devices is not directly relevant here. The "ground truth" is established by the engineering specifications and validated testing methods measuring physical properties.
4. Adjudication Method for the Test Set
Again, for in-vitro engineering tests, adjudication methods like 2+1 or 3+1 are not typically used. The results are objective measurements against defined specifications (e.g., force, flexibility, adherence). Any discrepancies would be handled through repeat testing or investigation of the testing methodology.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images where AI assistance might improve reader performance. The V-18 Control Wire is a therapeutic/interventional device (catheter guide wire).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This device does not involve an algorithm or AI that operates independently. Its performance is evaluated based on its physical properties and interaction with the human body and other medical instruments.
7. Type of Ground Truth Used
The ground truth used for this type of device, as per the description, would be based on:
- In-vitro Engineering Test Data: Objective measurements of physical properties (e.g., tensile strength, torque response, flexibility, coating adherence) against established specifications.
- Biocompatibility Standards: Compliance with recognized international standards for biological evaluation of medical devices.
- Device Compatibility Data: Verification that the guide wire functions correctly with associated devices (e.g., catheters).
8. Sample Size for the Training Set
There is no explicit "training set" mentioned because this is not an AI/machine learning device. The "data" being referenced for substantial equivalence is the physical test data from the predicate device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the context of an AI/ML model, this question is not applicable. The "ground truth" for the predicate device's performance was established through rigorous engineering testing and adherence to established medical device standards and regulations at the time of its original 510(k) clearance (K934359).
§ 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.