(88 days)
The HI-TORQUE BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating have the following intended uses:
- To facilitate the placement of balloon dilatation catheters during percutaneous . transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
- The wire is also intended to facilitate the placement of equipment such as . atherectomy, IVUS and compatible stent devices during other diagnostic and therapeutic intravascular procedures.
The HI-TOROUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are steerable guide wires with a nominal diameters of 0.014" and two lengths: a 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 ACS DOC Guide Wire Extension (K902755, approved September 4, 1990).
The wires are constructed from a stainless steel proximal shaft and a distal superelastic ELASTINITE Shaft for flexibility and performance. The distal end of this guide wires have radiopaque tips that are available either as a straight, shapeable configuration or as a preshaped J configuration. The guide wires have proximal markers at 90 and 100 cm from the distal tip. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal shaft of the guide wire is coated with polytetrafluoroethylene.
The provided 510(k) summary (K973494) describes the performance testing for the HI-TORQUE BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating.
Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Bench testing was performed to demonstrate that the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE BALANCE® Guide Wire." Similarly, for in vivo testing, it states "The results showed that the new wires performed in an equivalent manner to the predicate devices." And finally, "The results from the bench tests plus the animal testing showed that the new HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the predicate HI-TORQUE BALANCE® Guide Wire and the HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire."
However, the specific quantitative acceptance criteria or detailed numerical performance results for each test were not explicitly provided in the summary. The acceptance criterion appears to be general equivalence or similarity to the predicate device.
| Test Performed | Acceptance Criteria (as implied) | Reported Device Performance (as stated) |
|---|---|---|
| Accelerated Aging | Equivalent to predicate device | Met acceptance criteria and performed similar/equivalent to the predicate device. |
| Distal Tip Pull Test | Equivalent to predicate device | Met acceptance criteria and performed similar/equivalent to the predicate device. |
| Distal Tip Turns-to-Failure Test | Equivalent to predicate device | Met acceptance criteria and performed similar/equivalent to the predicate device. |
| Rotational Accuracy Test | Equivalent to predicate device | Met acceptance criteria and performed similar/equivalent to the predicate device. |
| Tip Flexibility Test | Equivalent to predicate device | Met acceptance criteria and performed similar/equivalent to the predicate device. |
| Hypotube Junction Pull Test | Equivalent to predicate device | Met acceptance criteria and performed similar/equivalent to the predicate device. |
| Hypotube Junction Maximum Torque test | Equivalent to predicate device | Met acceptance criteria and performed similar/equivalent to the predicate device. |
| Coating Adherence/Integrity | Equivalent to predicate device | Met acceptance criteria and performed similar/equivalent to the predicate device. |
| In vivo animal testing | Equivalent to predicate device | Performed in an equivalent manner to the predicate devices. |
2. Sample size used for the test set and the data provenance
Test Set Sample Size: The document does not specify the exact number of units or animals used in the bench tests or the in vivo animal testing. It generally refers to "bench testing" and "in vivo animal testing in a canine model."
Data Provenance:
- Bench tests: Not explicitly stated, but typically conducted internally by the manufacturer.
- In vivo animal testing: Performed in a "canine model," which implies an experimental, prospective study. The country of origin is not specified but is presumably where the manufacturer (Guidant Corporation) is based or where their testing facilities are located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided document. The performance testing described (bench tests and animal studies) involves physical and mechanical properties, not interpretation or diagnosis requiring human experts or ground truth in the context of diagnostic accuracy. The "ground truth" here is the objective measurement of physical properties or observed physiological responses in the animal model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) to establish a consensus ground truth. The device's performance was evaluated through objective bench tests and animal studies, not through human interpretation requiring adjudication.
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 question is not applicable. The device is a medical guidewire, not an AI or imaging device that would be subject to MRMC studies or human reader comparisons. Performance was assessed through physical testing and animal models, not human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical guidewire, not an algorithm, so standalone algorithm performance is not relevant. The performance tests described (bench and animal) are inherently "standalone" in the sense that they evaluate the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" would be the objectively measured physical properties and performance characteristics against predefined engineering specifications (implied to be equivalent to the predicate device). For the in vivo animal testing, the "ground truth" would be the observed physiological responses, device maneuverability, and safety outcomes within the healthy coronary arteries of the canine model, compared to the predicate device.
8. The sample size for the training set
This question is not applicable. The device is a physical guidewire, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for a physical medical device.
§ 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.