(193 days)
Galeo Guidewires are intended for use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries.
BIOTRONIK Galeo Guide Wires are coronary vascular guide wires with a nominal diameter of 0.014"/0.36 mm and a nominal length of 175 cm. The BIOTRONIK Galeo Guide Wire Family consists of nine coronary guide wires of various flexibilities and one extension wire. Galeo has a straight configuration with five levels of stiffness: Highly Stiff (HS), Stiff (S), Medium (M), Flexible (F), and Highly Flexible (HF). There are also three stiffness variations available with a pre-formed J-tip: Floppy (F), Medium (M), and Stiff (S). Galeo ES (Extra Support) offers enhanced support during intracoronary vascular procedures. All Galeo Guide Wires (175 cm) are extendable to over-the-wire exchange length using the Galeo Extension Wire (EW). The distal coil areas of the BIOTRONIK Galeo guide wires are treated with a siliconebased coating that makes the distal section of the guide wire more lubricious than the bare metal surface. The proximal wire section is coated with PTFE. The distal 3.0 cm of the Galeo Guide Wire responds easily to manual forming or shaping. The Galeo Guide Wire offers different grades of radioopacity over its distal stainless steel and platinum coil section. The 27 cm stainless steel coil section (27 cm in length) is radiolucent; the platinum coil section (3.0 cm) is highly radioopaque. The proximal end of the guide wire is slightly tapered and allows the attachment of the extension wire Galeo EW. The combination of Galeo EW results in an overall wire length of 325 cm.
The provided text is a 510(k) summary for the BIOTRONIK Galeo Guide Wire. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance are not present in the provided document.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on the concept of substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs comparably or in a manner that does not raise new questions of safety or effectiveness compared to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Material Equivalence: Materials used are comparable to predicate devices. | Materials used and design are similar to Guidant ACS Hi-Torque, with the coating similar to Medtronic Mustang. |
| Design Equivalence: Device design is comparable to predicate devices. | Design and various flexibilities (HS, S, M, F, HF, J-tip variations, ES) are described. Nominal diameter and length are 0.014"/0.36 mm and 175 cm. |
| Function Equivalence: Device functions are comparable to predicate devices. | Functionally equivalent to market-released guide wires. Distal coil treated with silicone-based coating for lubricity. Proximal wire section coated with PTFE. Distal 3.0 cm responds to manual forming. Different grades of radioopacity. |
| Intended Use Equivalence: Intended use is the same as predicate devices. | Intended for use in vascular interventional procedures to facilitate the placement of catheters within coronary arteries, consistent with current guidewires. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific "test set" or a clinical study with human subjects that would involve a sample size. The review is based on a comparison to predicate devices, material specifications, and design features.
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)
Not applicable. No ground truth establishment by experts for a test set is described in this regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication process is described.
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
Not applicable. This is a medical device (guide wire) submission, not an AI-enabled diagnostic device, so MRMC studies involving human readers and AI assistance are not relevant here and are not mentioned.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No specific ground truth determination is mentioned as this is a substantial equivalence submission based on physical and functional comparisons.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth establishment for it.
In summary, the provided 510(k) summary for the BIOTRONIK Galeo Guide Wire is a regulatory document focused on demonstrating substantial equivalence to existing predicate devices based on material, design, function, and intended use. It does not describe a clinical study with detailed performance metrics, acceptance criteria, or ground truth establishment in the manner typically associated with studies for novel diagnostic or treatment algorithms.
§ 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.