(22 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of AI or ML capabilities.
No
The device aids in the selective placement of catheters during diagnostic and/or therapeutic procedures, but it is not described as directly performing a therapeutic function itself.
Yes
The "Intended Use / Indications for Use" states that the guidewire is used "to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures," directly mentioning "diagnostic procedures."
No
The device description clearly describes a physical guidewire made of stainless steel with a platinum coil, a torque device, and a guidewire introducer. These are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guidewire is used "to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body for procedural guidance, not for testing samples outside the body.
- Device Description: The description details a physical guidewire with a coating and accessories for manipulation and introduction into the body. This aligns with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: An IVD would typically involve:
- Testing of biological samples (blood, urine, tissue, etc.).
- Reagents or assays to detect specific substances or conditions.
- An output that provides diagnostic information based on the sample analysis.
This device is an invasive medical device used for guiding other instruments within the body.
N/A
Intended Use / Indications for Use
The SilverSpeed Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The SilverSpeed™ Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque platinum distal coil. The guidewire is hydrophilically coated from the shapeable platinum coil up to the proximal 30cm of the guidewire. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introducer to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, visceral and cerebral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility of the guidewire has been verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the guidewire when tested as an external communicating, blood contact, short duration (
§ 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
OCT 21 1999
Image /page/0/Picture/2 description: The image shows the logo for MicroTherapeutics, Inc. The logo consists of the letters "MTI" in a bold, sans-serif font. To the left of the letters, there is a graphic of small squares that appear to be disintegrating. Below the letters, the words "MicroTherapeutics, Inc." are written in a smaller, sans-serif font.
510(k) Summary of Safety and Effectiveness SilverSpeed™ Hydrophilic Guidewire
Prepared September 23, 1999
| Trade Name: | SilverSpeed TM Hydrophilic Guidewire (.014", .016" and .018") | ||
|---|---|---|---|
| Generic Name: | Guidewire, Catheter | Classification: | Class II |
| Submitted By: | Micro Therapeutics, Inc. | ||
| 2 Goodyear | |||
| Irvine, CA 92618 | Contact: | Tom Daughters | |
| Regulatory Affairs | |||
| (949) 837-3700 |
Predicate Devices
Micro Therapeutics, Inc. . 010" SilverSpeed™ Hydrophilic Guidewire B. Braun Guidewire Introducer & Guidewire Torque Device
Device Description
The SilverSpeed™ Hydrophilic Guidewire is a stainless steel guidewire with a radiopaque platinum distal coil. The guidewire is hydrophilically coated from the shapeable platinum coil up to the proximal 30cm of the guidewire. Included within the sterile pouch is a torque device to assist in guidewire manipulation and a guidewire introducer to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
Intended Use
The guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
Testing
Biocompatibility of the guidewire has been verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. Test results confirmed biocompatibility of the guidewire when tested as an external communicating, blood contact, short duration (