(53 days)
The Hi-Torque Versacore Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels.
The Hi-Torque Versacore Guide Wire is not intended for use in coronary or neurovasculature.
The Hi-Torque Versacore Guide Wire is a core-to-tip designed wire which consists of a stainless steel core, Polytetrafluoroethylene (PTFE) coated stainless steel coils on the distal 100 cm of the core, and a polyethylene coating on the remainder of the core. The core is tapered from the tip over 35cm in three successive steps in diameter until it reaches its full diameter for the Modified J Guide Wire and in two successive steps for the Floppy and the Standard Guide Wires. The coil covers the grinds and is brazed to the core at the tip and 7.5 cm (nominal) from the tip. The distal tip is radiopaque with a nominal diameter of 0.035" or 0.025". The distal tip is also shapeable or has a preshaped "J". Polyethylene coating covers the proximal end and is attached to the coil with medical grade glue (Cyanoacrylate Ester) to ensure a smooth transition from coil to coating. Silicon is used to coat the entire length of the polyethylene tubing. The Hi-Torque Versacore Guide Wire comes in lengths of 145 cm, 175 cm, 260 cm and 300 cm. The 0.035" diameter wires that are 145 cm and 175 cm in length are extendable using the Loc® Guide Wire Extension. Each Hi-Torque Versacore Guide Wire is packaged with a 0.025"-0.038" Torque Device.
This document is a 510(k) summary for the Hi-Torque Versacore Guide Wire. It is a submission for substantial equivalence to a predicate device, not a study proving a device meets acceptance criteria for novel performance. Therefore, most of the requested information regarding acceptance criteria and a study demonstrating performance is not applicable or not present in this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
Because this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily based on demonstrating equivalence to the predicate device, not on specific performance metrics against a defined threshold. The "reported device performance" is implicitly that it performs as well as the predicate because it is virtually the same device.
| Acceptance Criteria Category | Description (Based on 510(k) Summary) | Reported Device Performance (Implied) |
|---|---|---|
| Intended Use | Same as predicate device | The device has the same intended use. |
| Operating Principle | Same as predicate device | The device has the same operating principle. |
| Guide Wire Design | Same as predicate device | The device has the same guide wire design. |
| Manufacturing Processes | Same as predicate device | The device uses the same manufacturing processes. |
| Materials | Same as predicate device | The device uses the same materials (excluding packaging/labeling). |
| Shelf Life | Same as predicate device | The device has the same shelf life. |
| Sterilization Method | Same as predicate device | The device uses the same sterilization method. |
| Branding/Labeling | Branding and labeling changes only (IFU, label, chipboard box, Scotch Tape) | Changes made are cosmetic and do not impact product performance. |
Study Information (Not Applicable or Not Provided)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document is a 510(k) for substantial equivalence, not a clinical or performance study demonstrating the primary performance of the device against acceptance criteria. The basis for equivalence relies on comparing the new device to an existing, legally marketed predicate device. No new "test set" in the context of a performance study is described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No ground truth establishment for a test set is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
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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:
- Not Applicable. This is not an AI-assisted device. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No ground truth for a performance study is described. The "ground truth" in this context is the performance and safety established for the predicate device.
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The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. No training set is involved.
Conclusion:
The provided 510(k) summary focuses on demonstrating that the Hi-Torque Versacore Guide Wire is "substantially equivalent" to an existing predicate device (Mallinckrodt branded Wholey Hi-Torque Guide Wire). The basis for this claim is the device's identical intended use, operating principle, design, manufacturing processes, materials, shelf life, and sterilization method. Essentially, it is stated to be the same device with only branding, packaging, and labeling changes. Therefore, a separate study to prove the device meets acceptance criteria distinct from the predicate device's established performance is not presented or required for this type of submission.
§ 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.