(28 days)
This guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infrapopliteal arteries. This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
The HI-TORQUE (HT) Proceed Guide Wire Family includes steerable guide wires offered in several tip load and guide wire length configurations.
The HT Proceed Guide Wire Family will be available with the features as listed below:
- 2 tip loads: 11g and 14g
- 1 coating length: Uncoated Tip ●
- 1 tip shape: Pre-shaped, micro-J ●
- 2 lengths: 190 cm, 300cm
The HT Proceed Guide Wires are designed to be compatible with devices designed for use with 0.014" guide wires. The HT Proceed Guide Wire Family has a maximum diameter of 0.0144". The distal tip has a radiopaque length of 3.0 cm.
The provided text describes a 510(k) submission for a medical device, the HI-TORQUE PROCEED Guide Wire Family. This submission focuses on establishing substantial equivalence to a predicate device, the HT InfilTrac Guide Wire.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the subject device (HI-TORQUE PROCEED Guide Wire Family) is "technologically identical" to the predicate device (HT InfilTrac). Therefore, the performance data for the predicate device is leveraged.
| Acceptance Criteria Category | Reported Device Performance (Leveraged from Predicate Device) | Supporting Information in Text |
|---|---|---|
| Functional Specifications | Met functional acceptance criteria requirements as specified in product specification and external guidance documents. | "Results of these tests demonstrated that the HT InfilTrac Guide Wire Family...met the functional...acceptance criteria requirements..." |
| Dimensional Specifications | Met dimensional acceptance criteria requirements as specified in product specification and external guidance documents. | "...met the...dimensional...acceptance criteria requirements..." |
| Simulated Use Testing | Met simulated use testing acceptance criteria requirements as specified in product specification and external guidance documents. | "...met the...simulated use testing acceptance criteria requirements..." |
| Operating Principle | Identical to predicate device. | "both the subject and predicate devices use identical...operating principle..." |
| Materials | Identical to predicate device. | "...identical...materials..." |
| Design | Identical to predicate device. | "...identical...design..." |
| Sterilization Method | Identical to predicate device. | "...identical sterilization method..." |
| Shelf Life | Identical to predicate device. | "...identical...shelf life..." |
| Packaging Components-Materials | Identical to predicate device. | "...identical...packaging components-materials." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set. Instead, it refers to "in vitro bench testing and simulated use testing" performed on the predicate device (HT InfilTrac). The provenance of this data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be laboratory-based testing conducted by the manufacturer (Abbott Vascular).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. As this is a 510(k) submission primarily focused on mechanical and functional equivalence for a guide wire, the "ground truth" is established through engineering and performance testing against predefined specifications, rather than expert medical interpretation of clinical data.
4. Adjudication Method for the Test Set:
An adjudication method (e.g., 2+1, 3+1) is not applicable or mentioned in this context. The "ground truth" for this type of device is determined by the objective results of bench and simulated use testing against a set of engineering and performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices or AI algorithms where human interpretation is a key component. The HI-TORQUE PROCEED Guide Wire is a physical medical device, and its performance is evaluated through engineering tests, not human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is a physical guide wire, not a software algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. The Type of Ground Truth Used:
The ground truth for this device's performance is based on predefined engineering and performance specifications derived from industry standards, internal product requirements, and external guidance documents. The text explicitly states: "demonstrate that HT Proceed meets all acceptance criteria requirements as specified in the product specification and external guidance documents."
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or software-based device that requires a "training set" in the machine learning sense. The performance data is derived from testing the physical properties and functional capabilities of the device (or its identical predicate).
9. How the Ground Truth for the Training Set was Established:
Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth establishment process in the context of AI or machine learning. The "ground truth" for the device's performance is established through the engineering specifications and acceptance criteria it must meet, which are determined through design, risk analysis, and regulatory requirements.
§ 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.