(88 days)
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 and compatible stent devices during other diagnostic and therapeutic procedures.
The ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a guide with a 200 cm exchange length and lengths of 175 cm and 190 cm and 190 and lengths of 175 cm and 190 cm extendation of the are a soland tapered so that it has The proximal end of the 175 cm and 190 cm models and one Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges.
The ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is constructed from astable wire consists of an HYDROCOAT™ Hydropinne Coating is course in consists of the wire consists of an ewith a nominal oute with a nominal outer diameter of 0.017 . The wire is coated with polytetrafluoroethylene (PTFE) and the distal, segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.
The distal tip coil has a radiopaque length of 4.5 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The 190 cm and 300 cm guide wires have markers located 90cm and 100 cm from the distal tip.
The provided 510(k) summary for the ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating describes the performance data and conclusions based on bench testing. However, it does not include information related to human user studies, expert involvement, or training data for an AI/algorithm-based device. This is because the device described is a physical medical device (a guidewire), not an AI/software-as-a-medical-device (SaMD).
Therefore, the requested information elements related to AI/SaMD studies (sections 2, 3, 4, 5, 6, 7, 8, 9) are not applicable to this submission.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Distal Tip Pull Test | Not explicitly stated, but implied to be sufficient for intended use. | Met acceptance criteria and performed similar to the predicate device. |
| Distal Tip Turns-to-Failure Test | Not explicitly stated, but implied to be sufficient for intended use. | Met acceptance criteria and performed similar to the predicate device. |
| Rotational Accuracy Test | Not explicitly stated, but implied to be sufficient for intended use. | Met acceptance criteria and performed similar to the predicate device. |
| Tip Flexibility Test | Not explicitly stated, but implied to be sufficient for intended use. | Met acceptance criteria and performed similar to the predicate device. |
The document states: "The results from the bench tests showed that the new ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a physical medical device. The "test set" refers to the guidewire samples used in the bench tests. The document does not specify the number of guidewires tested for each bench test.
3. 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)
This information is not applicable. Ground truth is not established by human experts for the performance evaluation of this physical device in bench testing. Performance is measured against engineering specifications and comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for human interpretation tasks, not for bench testing of a physical device.
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 as this is a physical medical device and not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical device and not an AI/SaMD.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering specifications and performance equivalence to a legally marketed predicate device as demonstrated through bench testing. There is no biological or clinical "ground truth" as would be found in diagnostic AI studies (e.g., pathology, outcomes).
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/SaMD based on machine learning.
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" in the context of this 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.