(50 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.
This document is a 510(k) summary for the Nitrex™ Nitinol Guidewire, submitted to the FDA in 2003. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for new device performance metrics in the way a modern AI/ML device submission would.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test / Verification | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 Compliance | Device meets ISO 10993-1 standards for biological evaluation. | "Biocompatibility of the guidewire was verified in accordance with ISO 10993-1, Biological Evaluation of the Medical Devices." |
| In-vitro Performance | Dimensional Inspection | Dimensions are within specified tolerances. | "All testing of the product yielded acceptable results." |
| Tensile Strength Tests | Tensile strength meets specifications for intended use. | "All testing of the product yielded acceptable results." | |
| Torque Strength Tests | Torque strength meets specifications for intended use. | "All testing of the product yielded acceptable results." | |
| Coating Performance Test | Coating adheres and functions as intended, facilitating smooth passage. | "All testing of the product yielded acceptable results." | |
| Performance under Simulated Conditions | Device performs as expected under simulated use conditions. | "All testing of the product yielded acceptable results." |
Explanation: The document states that "All testing of the product yielded acceptable results." However, it does not explicitly list quantitative acceptance criteria for each specific test (e.g., "tensile strength > X N," "coating adhesion > Y score"). The acceptance criteria are implied to be adherence to internal specifications and relevant standards. This is common for predicate-based medical device submissions that focus on substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the performance tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective nature). The testing appears to be conducted in a laboratory setting (in-vitro and simulated conditions).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in this type of submission. This document describes the testing of a physical medical device (guidewire), not an AI/ML algorithm that requires expert-established ground truth from a dataset.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, this is for a physical device, not an AI/ML algorithm requiring expert adjudication of data.
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
There was no MRMC comparative effectiveness study done. This type of study is relevant for AI/ML devices that assist human readers (e.g., radiologists, pathologists). The Nitrex™ Nitinol Guidewire is a physical interventional device, not an AI diagnostic or assistance tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm only) performance study done. This is not an AI/ML device. The "standalone performance" here refers to the guidewire's physical characteristics and functionality.
7. The Type of Ground Truth Used
The "ground truth" for this device's testing would be defined by engineering specifications, material science standards, and established in-vitro performance test methods. For example, the "ground truth" for tensile strength would be the measured force at which the guidewire breaks, compared against a pre-defined acceptable range. For biocompatibility, the ground truth is adherence to ISO 10993-1 guidelines and testing results.
8. The Sample Size for the Training Set
There is no training set for this device. This is a physical medical device, not an AI/ML algorithm that undergoes training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set mentioned for this physical medical device.
{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 | ev34600 NATHAN LANE NORTHPLYMOUTH, MN 55442 |
| TRADE NAME | Nitrex™ Nitinol Guidewire |
| GENERIC CLASS | Guide wire |
| CLASSIFICATION | Class II (21 CFR 870.1330, 74 DQX) |
| SUBMITTED BY | ev3 Inc4600 Nathan LaneMinneapolis, MN 55442 |
| CONTACT | Phil NeururerRegulatory Affairs763-398-7094 |
| PREDICATE | Ultra-Select guidewire (K910280)FlexFinder guidewire (K893626, K943390) |
| DEVICEDESCRIPTION | The guidewire is constructed of nitinol (nickel-titaniumalloy). The nitinol core extends from the distal tip of theguidewire to the proximal shaft end. The distal tip is ahelically coiled coil gold plated tungsten wire. Theguidewire is coated with a coating(s)to help facilitate smoothpassage. |
| INDICATION FORUSE | The 0.035" and 0.025" Guidewire is indicated for use in theperipheral vasculature. The 0.014", 0.016", and 0.018"guidewires are indicated for use in the peripheral andcoronary vasculature. |
| TESTING | Biocompatibility of the guidewire was verified in accordancewith ISO 10993-1, Biological Evaluation of the MedicalDevices.In-vitro performance testing of the guidewire includeddimensional inspection, tensile strength tests, torque strengthtests, coating performance test, and performance undersimulated conditions. All testing of the product yieldedacceptable results. |
| SUMMARY OFSUBSTANTIALEQUIVALENCE | The Nitrex™ Nitinol Guidewire is substantially equivalent tothe predicate device in intended use and principles ofoperation. |
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 |
|---|---|---|
| ------------------------------------------ | ---- | ------------------ |
§ 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.