(220 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a guidewire, with no mention of AI or ML capabilities.
No
The device is a guidewire used to introduce and position other medical devices, not to treat a disease or condition itself.
No
This device is a guidewire used to introduce and position catheters and other interventional devices. It facilitates procedures but does not diagnose conditions.
No
The device description clearly describes a physical guidewire with a coil and markers, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature." This describes a device used within the body for medical procedures, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details a physical guidewire with a coil and markers, designed for navigation within blood vessels. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
Therefore, this device is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Cordis STABILIZER Marker Wire Steerable Guidewire and Cordis WIZDOM Marker Wire Steerable Guidewire are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Product codes
74DQX
Device Description
Cordis Marker Wire Steerable Guidewires have a soft, flexible, highly radiopaque platinum/tungsten coil on the distal tip and radiopaque markers along the length of the guidewire. Guidewire length, diameter, distal tip configuration and radiopaque marker configuration are indicated on the product label. A steering/torquing device may be attached to aid in steering/torquing the guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K952067, K953750, K953750, K941269
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
FEB 21 1997
00-00014
K962765
PREMARKET NOTIFICATION Cordis Corporation STABILIZER Marker Wire WIZDOM Marker Wire
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
Common or Usual Name: Catheter Guide Wire
Proprietary Name: Cordis STABILIZER Marker Wire Steerable Guidewire Cordis WIZDOM Marker Wire Steerable Guidewire
Name of Predicate Devices II.
Cordis STABILIZER with Radiopaque Markers (K952067 and K953750) Cordis WIZDOM with Radiopaque Markers (K953750) Gore SMOOTHER II (K941269) Rulers and Calipers
III. Classification
Catheter Guide Wire, Class II - 21 CFR 870.1330 74DQX - Cardiovascular
IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Cordis STABILIZER Marker Wire Steerable Guidewire and Cordis WIZDOM Marker Wire Steerable Guidewire are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Cordis Marker Wire Steerable Guidewires have a soft, flexible, highly radiopaque platinum/tungsten coil on the distal tip and radiopaque markers along the length of the guidewire. Guidewire length, diameter, distal tip configuration and radiopaque marker configuration are indicated on the product label. A steering/torquing device may be attached to aid in steering/torquing the guidewire.
1
PREMARKET NOTIFICATION Cordis Corporation STABILIZER Marker Wire WIZDOM Marker Wire
VI. Biocompatibility
All materials have been tested as specified by the 1986 Tripartite Biocompatibility Guidance or the FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1). All material demonstrated compatibility with biological tissue by meeting the acceptance requirements stipulated in the test protocols.
VII. Summary of Substantial Equivalence
The Cordis STABILIZER Marker Wire Steerable Guidewire and Cordis WIZDOM Marker Wire Steerable Guidewire are substantially equivalent in product design, indications for use, and packaging to the currently marketed Cordis Marker Wires. They are substantially equivalent in indications for use (as a measurement tool) and product design (incorporation of marker bands) to the Gore Smoother II. The Cordis STABILIZER and WIZDOM Marker Wire Steerable Guidewires are also similar to various rulers and calipers which are routinely used as measurement tools.
A statement of substantial equivalence to another product is required by 21CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seg. (1977).