(8 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.
Here's an analysis of the provided text regarding the EV3 Nitrex™ Nitinol Guidewire.
Important Note: The provided document is a 510(k) summary for a medical device (guidewire). For this type of device, the "acceptance criteria" and "device performance" usually refer to engineering specifications and physical testing, not clinical performance metrics like sensitivity, specificity, or accuracy which are common for AI/diagnostic devices. Similarly, concepts like "ground truth," "experts," "adjudication," and "MRMC studies" are typically not applicable to guidewires.
The document describes a submission for substantial equivalence based on physical and dimensional testing, comparing it to predicate devices. It does not contain information about studies involving AI, human readers, or clinical outcomes that would typically have the metrics and study design elements requested in the prompt.
Given this context, I will extract the information that is present and indicate where the requested information is not applicable to this type of device submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Testing" section) | Reported Device Performance |
|---|---|
| Dimensional inspection of the guidewire yielded acceptable results. | "All testing of the product yielded acceptable results." |
| Verification/validation testing performed on the original device determined that the modification would not affect the original results. | (Implicitly, the modification did not affect the original results, leading to the substantial equivalence determination.) |
| Device is substantially equivalent to predicate devices in intended use, materials, labeling, and principles of operation. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for dimensional or verification/validation testing.
- Data Provenance: Not specified, but likely internal testing by EV3 in the USA, as per their address. This is not a clinical study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device, and "ground truth" in the diagnostic sense is not relevant. The "ground truth" for manufacturing would be adherence to engineering specifications and successful functional testing, typically performed by engineers/technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is not relevant for dimensional and functional testing of a guidewire.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device relates to its physical properties meeting design specifications and its functional performance during testing (e.g., ability to advance smoothly, tip flexibility, etc.) compared to predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI or learning-based system.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI or learning-based system.
Summary of Device and Study (Based on 510(k) Summary):
The EV3 Nitrex™ Nitinol Guidewire is a Class II medical device used in peripheral and coronary vasculature. The submission (K031864) is for substantial equivalence to existing predicate guidewires. The "study" mentioned is internal "dimensional inspection" and "verification/validation testing" performed by the manufacturer, EV3. The stated outcome is that "All testing of the product yielded acceptable results" and modifications did not affect original results, leading to the FDA's finding of substantial equivalence based on intended use, materials, labeling, and principles of operation being similar to predicate devices. No clinical trial, AI component, or human reader study is described in this document.
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Image /page/0/Picture/0 description: The image shows the logo for EV3. The logo consists of three circles arranged in a triangular pattern above the letters "ev3" in a stylized font. The circles are solid black, and the letters are also black.
PH 763 398 7000
FX 763.398.7200
4600 Nathan Lane North, Plymouth, MN 55442-2920
10(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter | EV3 |
|---|---|
| 4600 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 | Ultra-Select guidewire (K910280)FlexFinder guidewire (K893626, K943390)Nitrex Nitinol Guidewire (K024021) |
| 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" Guidewire is 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 | Dimensional inspection of the guidewire has been conducted. Alltesting of the product yielded acceptable results. A review of theverification/validation testing performed on the original devicedetermined that the modification would not affect the originalresults. |
| SUMMARY OFSUBSTANTIALEQUIVALENCE | The Nitrex™ Nitinol Guidewire is substantially equivalent to thepredicate device in intended use, materials, labeling and principlesof operation |
Image /page/0/Picture/9 description: The image shows the logo for EV3, which is a robotics kit. The logo consists of the letters "ev3" in lowercase, with three circles arranged in a triangular pattern above the letters. The letters and circles are all in black, and the background is white.
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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2003
EV3 Corporation c/o Ms. Carolyn Anderson Regulatory Affairs Specialist 4600 Nathan Lane Plymouth, MN 55442
Re: K031864 Nitrex™ Nitinol Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: June 13, 2003 Received: June 16, 2003
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.
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Page 2 - Ms. Carolyn Anderson
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. 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) 594-4648. 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 vours.
C. Mefcal mayn
Bram Zuckerman. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510 (k) Number (if known): K031864
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)
Mella Mynl for B. Zuckerman
510(k) Number K031864
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter_
§ 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.