(81 days)
The TomCat™ Guide Wire is intended to facilitate the placement of interventional catheters during therapeutic intravascular procedures.
The TomCat Extender™ Wire is used to facilitate exchange of one therapeutic device for another, while still maintaining the guide wire position in the coronary vasculature.
The guide wire extension tool is a device used to facilitate the joining of a guide wire with an extension wire.
There are three guide wire designs: Coil, Tube and Fighter. Accessories include an extension wire and extension tool.
Coil Design: Consists of a coated core wire gradually tapered by grinding in a multi-step process at the distal end over a 30 cm length. The distal tip is flattened. A radiopaque helically wound coil 30 cm in length is soldered in three places to the core wire. The distal 30 cm is coated to reduce friction. Manufactured in two tip configurations: pre-shaped J-Tip or unmodified straight tip. For 175 cm wires, the proximal end is tapered to accommodate attachment to the Merit TomCat™ Extender™ Wire.
Tube Design: The coated core wire is tapered and shaped in the same manner as the coil design. A 3 cm radiopaque helically wound coil is soldered in two places to the core wire instead of the 30 cm coil. A tube is then bonded in two places over the remainder of the exposed area of the core wire. The distal 30 cm is coated to reduce friction. Manufactured in two tip configurations: pre shaped J-tip or unmodified straight tip. For 175 cm wires, the proximal end is tapered to accommodate attachment to the Merit TomCat™ Extender™ Wire.
Fighter Design: A modification of the coil design. The coated core wire is tapered and shaped in the same manner as the coil design. A 3 cm long radiopaque helically wound coil is soldered to the ground core wire in 2 places, instead of a 30 cm coil. The remainder of the tapered portion of the core wire is left bare. The distal 30 cm is coated to reduce friction. Manufactured in two tip configurations: pre shaped J-tip or unmodified straight tip. For 175 cm wires, the proximal end is ground to accommodate attachment to the Merit TomCat™ Extender™ Wire.
Extender Wire: A coated core wire, 150 cm long and has a 0.014 inch diameter. It is tapered at the distal end, where a nickel/titanium hypotube is bonded to the core wire. This hypotube mates with the proximal tapered section of the Merit TomCat™ Guide Wire.
Extension Tool: Provides for axial alignment between the TomCat Extender Wire and a TomCat guide wire. The tool is a flat molded piece with two tabs. One tab holds the guide wire in place in the alignment channel. An embossed arrow shows where the end of the wire needs to be placed. The extension wire is placed in the alignment channel on the other side and the other tab holds it in place. The guide wire is then slid along the alignment channel until it is inserted into the extension wire's hypotube.
This submission, K973708, is a 510(k) premarket notification for the TomCat™ PTCA Guide Wire, Extender™ Wire, and Extension Tool. These are medical devices used for facilitating the placement of interventional catheters and the exchange of therapeutic devices during intravascular procedures.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" or present a table of device performance against such criteria. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria for a novel device. The implicit acceptance criteria are that the device performs similarly to or better than predicate devices in relevant functional aspects, addressing safety and effectiveness concerns for an intravascular guide wire system.
However, based on the device description and the nature of guide wires, essential performance characteristics (and therefore implicit acceptance criteria) would include:
| Characteristic/Implicit Acceptance Criteria | Reported Device Performance/Design Attributes (from document) |
|---|---|
| Biocompatibility (non-pyrogenic) | "Non-Pyrogenic: Yes" (Page 3) |
| Sterility | "Sterile: Yes" (Page 3) |
| Tip Flexibility & Shapeability (for navigation and placement) | Coil Design: Gradual taper over 30 cm, flattened tip, flexibility determined by tip dimension and taper pattern (Floppy, Intermediate, Standard, X-Support). Pre-shaped J-Tip or unmodified straight tip for custom shaping. (Page 1) |
| Tube Design: Tapered and shaped same as coil design; 3cm radiopaque coil, bonding of tube over core wire. Pre-shaped J-tip or unmodified straight tip. (Page 1) | |
| Fighter Design: Tapered and shaped same as coil design; 3 cm radiopaque coil, remainder of tapered portion bare. Pre-shaped J-tip or unmodified straight tip. (Page 2) | |
| Radiopacity (for visualization during procedure) | Coil Design: Radiopaque helically wound coil 30 cm in length. (Page 1) |
| Tube Design: 3 cm radiopaque helically wound coil. (Page 1) | |
| Fighter Design: 3 cm long radiopaque helically wound coil. (Page 2) | |
| (Also implied in catalog descriptions like "3 cm Opaque," "30 cm Opaque" on page 3) | |
| Friction Reduction (for smooth device advancement) | Distal 30 cm of wire is coated to reduce friction. (Pages 1 & 2) |
| Guide Wire Diameter (standardization) | "0.014 inches (0.36 mm)" (Page 3) |
| Guide Wire Lengths | "175 cm; 300 cm" (Page 3) |
| Compatibility with Extender Wire System | Proximal end of 175 cm wires tapered to accommodate attachment to TomCat™ Extender™ Wire. (Page 1 & 2) |
| Extender Wire: 150 cm long, 0.014 inch diameter, tapered distal end with nickel/titanium hypotube to mate with guide wire. (Page 2) | |
| Extension Tool: provides axial alignment for joining guide wire and extension wire. (Page 2) | |
| Shelf Life | "2 Years" (Page 3) |
| Single Use | "Single Use: Yes" (Page 3) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This 510(k) summary does not contain information about a specific "test set" and its sample size for evaluating the device's performance through a clinical study or specific performance testing data (e.g., in vitro or bench testing results like tensile strength, tortional integrity, etc.).
The entire submission is focused on demonstrating "substantial equivalence" to legally marketed predicate devices based on design and intended use similarities. No specific study data is presented. Therefore, no information on data provenance (country, retrospective/prospective) is available.
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. As no specific test set or study data is presented, there is no mention of experts or ground truth establishment in this document for the device itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or related adjudication method 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 device is a physical medical instrument (guide wire, extender wire, and extension tool), not an AI-based system. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe the use of ground truth data for performance evaluation of the device in the context of a study. The basis of this submission is substantial equivalence to predicate devices, meaning the established safety and effectiveness of the existing devices serve as the benchmark.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is a physical medical device and not an AI/machine learning system.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for it is mentioned.
§ 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.