(178 days)
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No
The description focuses on a mechanical device for shaping and steering guidewires, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a steering mechanism for guidewires and a tool for shaping guidewire tips, which are functions related to the manipulation and preparation of medical instruments rather than directly treating a disease or condition.
No
The device is described as a "steering mechanism for guidewires" and has a "shaping bar which allows for shaping the distal tip of guidewires." Its stated purpose is mechanical manipulation, not diagnosis. The performance studies also focus on its mechanical function (shaping, visual, functional, and tensile strength tests).
No
The device description clearly indicates a physical device used for steering and shaping guidewires, which are hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the CRICKET™ is a "steering mechanism for guidewires" and has a "shaping bar which allows for shaping the distal tip of guidewires." This describes a mechanical tool used in vivo (within the body) to manipulate medical devices.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The CRICKET™ does not perform any such tests.
- Device Description: The description reinforces the mechanical nature of the device for shaping and steering guidewires.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the CRICKET™ is a medical device used for procedural support, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires (revised February 13, 1996)
Product codes
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Device Description
The CRICKET™ is intended to be used as a steering mechanism for guidewires. The opposite end of the CRICKET™ has a shaping bar which allows for shaping the distal tip of guidewires (revised February 13, 1996)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Functional/Safety Testing: All current MICROVENA guidewires were successfully shaped with the CRICKET™ and the guidewires successfully passed visual, functional and tensile strength tests. (revised February 13, 1996)
Key Metrics
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Predicate Device(s)
ACS Wire Shaper (K862567), MICROVENA Microtorquer pin vise (K922060)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Microvena Corporation. The logo consists of a stylized "M" made of two overlapping zig-zag lines. To the right of the "M" is the word "MICROVENA" in a sans-serif font, with the word "CORPORATION" in a smaller font below it.
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K955304'. The characters are written in a bold, handwritten style, with some smudging or blurring around the edges. The sequence appears to be a code or identifier of some kind.
510(k) SUMMARY
4166
| Contact/Submitter: | Jodi Locher, Manager, Regulatory Affairs |
|---|---|
| Date Prepared: | November 10, 1995 |
| Trade Name: | CRICKET™ Multipurpose Steering Device and Tip Shaper |
| Common Name: | Steering Device and Guide Wire Shaping Device |
| Classification Name: | Steering Device and Wire Shaper |
| Predicate Devices: | ACS Wire Shaper (K862567) |
| MICROVENA Microtorquer pin vise (K922060) | |
| Device Description: | |
| Intended Use | The CRICKET™ is intended to be used as a steering mechanism |
| for guidewires. The opposite end of the CRICKET™ has a | |
| shaping bar which allows for shaping the distal tip of guidewires | |
| (revised February 13, 1996) | |
| Comparative Analysis: | The CRICKET™ has the same intended use as the ACS Wire |
| Shaper and the MICROVENA Microtorquer pin vise. | |
| Functional/Safety | |
| Testing: | All current MICROVENA guidewires were successfully shaped |
| with the CRICKET™ and the guidewires successfully passed | |
| visual, functional and tensile strength tests. | |
| (revised February 13, 1996) | |
| Conclusion: | The CRICKET™ is substantionally equivalent to the predicate |
| devices based on intended use and the results of functional | |
| testing. |