(50 days)
Not Found
No
The description focuses on the material and physical properties of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guidewire, used to facilitate the passage of other devices, not to treat a medical condition directly. Its indicated uses are for navigation within vasculature.
No
The provided text describes a guidewire, which is an interventional device used to help navigate catheters in blood vessels. Its indications for use and performance studies focus on its physical properties and intended delivery function, not on diagnosing medical conditions.
No
The device description clearly states it is a guidewire constructed of physical materials (nitinol, tungsten) and includes performance studies related to physical properties (tensile strength, torque strength, coating performance). This indicates it is a hardware 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 taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a guidewire used within the body (in the peripheral and coronary vasculature) to facilitate the passage of other devices. It is an invasive device used for interventional procedures, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, based on the provided information, this guidewire is a medical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / 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.
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
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 was verified in accordance with ISO 10993-1, Biological Evaluation of the Medical Devices. In-vitro performance testing of the guidewire included dimensional inspection, tensile strength tests, torque strength tests, coating performance test, and performance under simulated conditions. All testing of the product yielded acceptable results.
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.
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
510(k) Summary
JAN 2 4 2003
| 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, 74 DQX) |
| SUBMITTED BY | ev3 Inc |
| 4600 Nathan Lane | |
| Minneapolis, MN 55442 | |
| CONTACT | Phil Neururer |
| Regulatory Affairs | |
| 763-398-7094 | |
| PREDICATE | Ultra-Select guidewire (K910280) |
| FlexFinder guidewire (K893626, K943390) | |
| 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" 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. | |
| TESTING | Biocompatibility of the guidewire was verified in accordance |
| with ISO 10993-1, Biological Evaluation of the Medical | |
| Devices. |
In-vitro performance testing of the guidewire included
dimensional inspection, tensile strength tests, torque strength
tests, coating performance test, and performance under
simulated conditions. All testing of the product yielded
acceptable results. |
| SUMMARY OF
SUBSTANTIAL
EQUIVALENCE | The Nitrex™ Nitinol Guidewire is substantially equivalent to
the predicate device in intended use and principles of
operation. |
Image /page/0/Picture/4 description: The image shows the logo for EV3, an endovascular company. The logo consists of the letters "ev3" in a sans-serif font, with three circles arranged in a triangular formation above the letters. Below the letters, there is some text that is too small to read.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2003
EV3 Corporation c/o Mr. Phil Neururer Regulatory Affairs Associate 4600 Nathan Lane North Plymouth, MN 55442
Re: K024021
Trade Name: Nitrex™ Nitinol Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 2, 2003 Received: January 3, 2003
Dear Mr. Neururer:
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.
2
Page 2 - Mr. Phil Neururer
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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) 594-4646. 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 (k) Number (if known): __ KO2 4 OZI
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.
(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 | K024021 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-the-Counter |
|---|---|---|
| ------------------------------------------ | ---- | ------------------ |