(143 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.
Yes
The device is indicated for use during diagnostic and/or therapeutic procedures, meaning it can be used in therapeutic contexts.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the guidewire is "indicated for general intravascular use to aid in the selective placement of catheters in the mural, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures." The key word here is "diagnostic," indicating that the device can be used in procedures where diagnosis is being performed.
No
The device description clearly describes a physical guidewire made of stainless steel with a platinum coil and hydrophilic coating. It also includes physical accessories like a torque device and introducer. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SilverSpeed guidewire is used to "aid in the selective placement of catheters in the mural, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body to facilitate a medical procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a physical guidewire with specific materials and coatings, designed for insertion into blood vessels. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Reagents, calibrators, or controls
The SilverSpeed guidewire is an interventional medical device used to navigate within the vascular system.
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)
DOX
Device Description
The SilverSpeed™ Hydrophilic Guidewire is a .010" diameter 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 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 Eyaluation 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
Micro Therapeutics, Inc.
6254.3
DEC 1 1 1998
Image /page/0/Picture/4 description: The image shows the logo for Micro Therapeutics, Inc. The logo consists of the letters "MTI" in a bold, sans-serif font. To the left of the letters is a graphic of small squares that appear to be dispersing. Below the letters is the text "MICRO THERAPEUTICS, INC."
510(k) Summary of Safety and Effectiveness
SilverSpeed™ Hydrophilic Guidewire
Prepared December 9, 1998
| Trade Name: | SilverSpeed™ Hydrophilic Guidewire | ||
|---|---|---|---|
| Generic Name: | Guidewire, Catheter | Classification: | Class II |
| Submitted By: | Micro Therapeutics, Inc. | ||
| 1062-F Calle Negocio | |||
| San Clemente, CA 92673 | Contact: | Tom Daughters | |
| Regulatory Affairs | |||
| (949) 361-0616 | |||
| Predicate Devices |
Target Therapeutics, Inc. Dasher-10 Guidewire Target Therapeutics, Inc (BSC). Transend-10 Guidewire B. Braun Guidewire Introducer B. Braun Guidewire Torque Device
Device Description
The SilverSpeed™ Hydrophilic Guidewire is a .010" diameter 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 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 Eyaluation of Medical Devices. Test results confirmed biocompatibility of the guidewire when tested as an external communicating, blood contact, short duration (