(19 days)
Not Found
No
The description focuses on the material and physical construction of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A guidewire is an accessory used to facilitate the placement of another therapeutic device (e.g., a catheter) or for diagnostic purposes; it is not a therapeutic device itself.
No
Explanation: The provided text describes a guidewire, which is an interventional device used to facilitate the passage of other catheters in the vasculature. Its intended use focuses on navigation and support, not on identifying a disease or condition, which is the purpose of a diagnostic device.
No
The device description clearly states it is a guidewire constructed of physical materials (nitinol, tungsten wire) and has a coating. This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states this is a guidewire used in the peripheral and coronary vasculature. This is a device that is inserted into the body for a procedural purpose (guiding other devices).
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens.
This device is an invasive medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The 0.035" and 0.025" Guidewires are indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s) to help facilitate smooth passage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Verification/validation testing demonstrated that devices utilizing the new coating formulation meet the original verification and validation requirements.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K893626, K943390, K024021, K031864, K022813
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KO40345
Image /page/0/Picture/2 description: The image shows a date written in a simple, sans-serif font. The date reads "MAR - 2 2004". The month is abbreviated to "MAR", followed by a hyphen, the number 2, and the year 2004.
PH 763.398.7000
FX 763.398.7200
4600 Nathan Lane North, Plymouth, MN 55442-2920
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter | EV3
4600 Nathan Lane North
Plymouth, MN 55442 | | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| TRADE NAME | Nitrex™ Nitinol Guidewire | | | |
| GENERIC CLASS | Guide wire | | | |
| CLASSIFICATION | Class II (21 CFR 870.1330) | | | |
| SUBMITTED BY | ev3 Inc
4600 Nathan Lane
Minneapolis, MN 55442 | | | |
| CONTACT | Carolyn Anderson
Regulatory Affairs Specialist
763-398-7487 | | | |
| PREDICATE | FlexFinder Guidewire (K893626, K943390)
Nitrex Nitinol Guidewire (K024021, K031864)
Lake Region Manufacturing, Inc. (K022813) | | | |
| DEVICE
DESCRIPTION | The guidewire is constructed of nitinol (nickel-titanium alloy).
The nitinol core extends from the distal tip of the guidewire to the
proximal shaft end. The distal tip is a helically coiled coil gold
plated tungsten wire. The guidewire is coated with a coating(s)to
help facilitate smooth passage. | | | |
| INDICATION FOR
USE | The 0.035" and 0.025" Guidewires are indicated for use in the
peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires
are indicated for use in the peripheral and coronary vasculature. | | | |
| TESTING | Verification/validation testing demonstrated that devices utilizing
the new coating formulation meet the original verification and
validation requirements. | | | |
| SUMMARY OF
SUBSTANTIAL
EQUIVALENCE | The Nitrex™ Nitinol Guidewire is substantially equivalent to the
predicate device in intended use, materials, labeling and principles
of operation. | | | |
Image /page/0/Picture/9 description: The image shows the text "ev3" in a sans-serif font. Above the text are three solid black circles arranged in a triangular pattern. The circles are slightly overlapping each other. The text is in lowercase.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2004
Carolyn Anderson Regulatory Affairs Specialist ev3 Incorporated 4600 Nathan Lane North Plymouth, Minnesota 55442
Re: K040345
Trade/Device Name: Nitrex™ Nitinol Guidewire Regulatory Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: February 11, 2004 Received: February 12, 2004
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
$\sqrt{}$
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | K040345 |
|---|---|
| Device Name: | Nitrex™ Nitinol Guidewire |
| Indications For Use: | The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature. |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K040 345
:
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