(19 days)
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.
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.
The provided document is a 510(k) Summary for the Nitrex™ Nitinol Guidewire, which details its substantial equivalence to predicate devices. It does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study as typically understood for AI/ML-based medical devices.
Instead, the "Testing" section states: "Verification/validation testing demonstrated that devices utilizing the new coating formulation meet the original verification and validation requirements." This implies that the device (a guidewire) was evaluated against established engineering and performance specifications for medical guidewires, not against a clinical test set to assess AI diagnostic or prognostic accuracy.
Therefore, I cannot provide the requested information in the format of acceptance criteria and study details for an AI/ML device because the document describes a traditional medical device (a guidewire) approval process based on substantial equivalence and engineering verification/validation, not an AI/ML performance study.
If there were a different document related to an AI/ML device, I would be able to extract and present that information.
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KO40345
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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 | EV34600 Nathan Lane NorthPlymouth, MN 55442 | |||
|---|---|---|---|---|
| TRADE NAME | Nitrex™ Nitinol Guidewire | |||
| GENERIC CLASS | Guide wire | |||
| CLASSIFICATION | Class II (21 CFR 870.1330) | |||
| SUBMITTED BY | ev3 Inc4600 Nathan LaneMinneapolis, MN 55442 | |||
| CONTACT | Carolyn AndersonRegulatory Affairs Specialist763-398-7487 | |||
| PREDICATE | FlexFinder Guidewire (K893626, K943390)Nitrex Nitinol Guidewire (K024021, K031864)Lake Region Manufacturing, Inc. (K022813) | |||
| DEVICEDESCRIPTION | The guidewire is constructed of nitinol (nickel-titanium alloy).The nitinol core extends from the distal tip of the guidewire to theproximal shaft end. The distal tip is a helically coiled coil goldplated tungsten wire. The guidewire is coated with a coating(s)tohelp facilitate smooth passage. | |||
| INDICATION FORUSE | The 0.035" and 0.025" Guidewires are indicated for use in theperipheral vasculature. The 0.014", 0.016", and 0.018" guidewiresare indicated for use in the peripheral and coronary vasculature. | |||
| TESTING | Verification/validation testing demonstrated that devices utilizingthe new coating formulation meet the original verification andvalidation requirements. | |||
| SUMMARY OFSUBSTANTIALEQUIVALENCE | The Nitrex™ Nitinol Guidewire is substantially equivalent to thepredicate device in intended use, materials, labeling and principlesof operation. |
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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.
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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
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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
:
Page 1 of 1
§ 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.