(85 days)
Not Found
No
The document describes a physical medical device (guidewires) and its intended use and physical characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are limited to bench testing and biocompatibility.
No
Explanation: The device is described as a steerable guidewire used for the introduction and placement of diagnostic or interventional devices, facilitating the delivery of other devices for treatment, rather than providing therapy itself.
No
The device description clearly states that these guidewires "serve as a guide for other diagnostic or interventional devices" and are used "for the introduction and placement of diagnostic or interventional devices." This indicates they are tools assisting in diagnostic procedures, not performing the diagnosis themselves.
No
The device description clearly outlines a physical guidewire with a corewire, spring coils, a variable tip, coating, and marker bands. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these guide wires are used for the "introduction and placement of diagnostic or interventional devices" and to "facilitate the placement of balloon dilatation catheters." This describes a device used within the body to guide other medical instruments, not a device used to test samples outside the body for diagnostic purposes.
- Device Description: The description details the physical components of the guide wires (corewire, spring coils, tip design, coating, marker bands) and their function in navigating the vasculature. This aligns with an invasive medical device used for procedural guidance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is a medical device used for interventional procedures within the cardiovascular system.
N/A
Intended Use / Indications for Use
Medtronic ProVia™ and Intuition™ Guidewires: Medtronic [ProVia™ and Intuition™] GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Thunder™ Guidewires: Medtronic [Thunder™] PTCA guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.
Zinger™ Guidewires: Medtronic [Zinger™] guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. [Zinger™] guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Cougar™ Guidewires: Medtronic Cougar™ wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.
Product codes
DOX
Device Description
Medtronic PTCA Guidewires are steerable guidewires that are used during the Percutaneous Coronary Intervention (PCI) to reach a lesion or vessel segment by serving as a guide for other diagnostic or interventional devices in the coronary and peripheral vasculature. The guidewires may also be used to reach and cross a target lesion within the coronary and peripheral vasculature excluding the cerebral vasculature. Once the tip of the guidewires arrive at a target destination within the vasculature, it acts as a guide that larger catheter can rapidly follow for easier delivery to the treatment site in the coronary and peripheral vasculature.
Medtronic Guidewires consist of a corewire covered with spring coils and terminated in a variable tip design to impart varied characteristic to the distal section of the wire, such as tip stiffness. Medtronic guidewires are coated to impart sufficient lubricity to reach and cross target lesions. There are marker bands on few Medtronic Guidewires to help in gauging guidewire position in the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral 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)
Performance/ Bench Testing: The following bench tests were performed to demonstrate the substantial equivalence to the predicate PTCA Guidewires:
i. Coating Integrity
ii. Particulate evaluation
iii. Outer Diameter Measurement.
Biocompatibility Testing: Pursuant to the ISO 10993-1: 2009- Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process; the biocompatibility testing for the modified PTCA Guidewires.
No new safety or effectiveness concerns were raised during the testing on the modified device. The performance testing along with biocompatibility testing demonstrated that the modified PTCA Guidewires is safe, effective and performs as well or better than the predicate device.
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.
K091582, K100470, K970466, K983927, K032899
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
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.
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Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circle with a stylized image of a person carrying another person on their shoulders. Below the image is the word "Medtronic" in a bold, sans-serif font.
JUN 1 2 2014
K140695 510(k) Summary Page 1 of 3
Traditional 510(k) Summary
Submitter:
ﻟﺤﺴﺮ
Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923, USA
Contact Person:
Nisarg Shah Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923 USA Phone: (978)-739-6632 Fax: (978)-750-8204 Email: nisarg.g.shah(@medtronic.com
Date Prepared:
June 6, 2014
Trade Name:
Cougar™ Guidewires Zinger™ Guidewires
Thunder™ Guidewires ProVia™ Guidewires Intuition™ Guidewires
Common Name:
PTCA Guidewire
Classification Name:
Catheter guide wire Class II per 21 CFR §870.1330, Product Code DOX.
Predicate Device:
The following commercialized Medtronic PTCA Guidewires were used as predicate devices in the 510(k) submission:
-
- K091582 (ProVia 3, 6, 9 and Intuition)
-
- K100470 (ProVia 12)
-
- K970466 (Thunder)
-
- K983927 (Zinger)
-
- K032899 (Cougar)
Device Description : Medtronic PTCA Guidewires are steerable guidewires that are used during the Percutaneous Coronary Intervention (PCI) to reach a lesion or vessel segment by serving as a guide for other diagnostic or interventional devices in the coronary and
1
Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of the word "Medtronic" in a bold, sans-serif font. Above the word is a circular emblem containing a stylized representation of a person in motion. The person appears to be rotating or moving dynamically within the circle.
K140695 510(k) Summary Page 2 of 3
peripheral vasculature. The guidewires may also be used to reach and cross a target lesion within the coronary and peripheral vasculature excluding the cerebral vasculature. Once the tip of the guidewires arrive at a target destination within the vasculature, it acts as a guide that larger catheter can rapidly follow for easier delivery to the treatment site in the coronary and peripheral vasculature.
Statement of Intended Use:
Medtronic ProVia™ and Intuition™ Guidewires:
Medtronic [ProVia™ and Intuition™] GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Thunder™ Guidewires:
Medtronic [Thunder™] PTCA guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.
Zinger™ Guidewires:
Medtronic [Zinger™] guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. [Zinger™] guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Cougar™ Guidewires:
Medtronic Cougar™ wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.
Summary of Technological Characteristics: Medtronic Guidewires consist of a corewire covered with spring coils and terminated in a variable tip design to impart varied characteristic to the distal section of the wire, such as tip stiffness. Medtronic guidewires are coated to impart sufficient lubricity to reach and cross target lesions. There are
2
Image /page/2/Picture/0 description: The image shows the Medtronic logo. The logo consists of the word "Medtronic" in a bold, sans-serif font. Above the word is a circular emblem with a stylized human figure inside. The figure appears to be in motion, possibly representing activity or movement.
K140695 510(k) Summary Page 3 of 3
marker bands on few Medtronic Guidewires to help in gauging guidewire position in the vasculature. The technological characteristics of the Medtronic PTCA Guidewires are identical to the predicate devices legally marketed by Medtronic.
Summary of Nonclinical Data:
The device performance/ bench tests and biocompatibility tests were conducted in accordance to the relevant FDA guidance to demonstrate substantial equivalence to the legally marketed predicate devices.
Performance/ Bench Testing: The following bench tests were performed to demonstrate the substantial equivalence to the predicate PTCA Guidewires:
- i. Coating Integrity
- ii. Particulate evaluation
- iii. Outer Diameter Measurement.
Biocompatibility Testing: Pursuant to the ISO 10993-1: 2009- Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process; the biocompatibility testing for the modified PTCA Guidewires.
No new safety or effectiveness concerns were raised during the testing on the modified device. The performance testing along with biocompatibility testing demonstrated that the modified PTCA Guidewires is safe, effective and performs as well or better than the predicate device.
No clinical investigation has been performed on the modified device.
Conclusion from Data:
Summary of
Clinical Data:
Medtronic Vascular has demonstrated that the modified PTCA Guidewires are substantially equivalent to the legally marketed predicate devices based on its intended use and technological characteristics.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem with a stylized caduceus-like symbol. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2014
Medtronic Vascular Inc. % Nisarg Shah, Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923 US
Re: K140695
Trade/Device Name: Cougar™ Guidewires, Zinger™ Guidewires, Thunder™ Guidewires, ProVia™ Guidewires, Intuition™ Guidewires Regulation Number: -21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: April 3, 2014 Received: April 4, 2014
Dear Mr. Shah.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Mr. Nisarg Shah
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
M. Lellem
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K140695
Device Name: Medtronic PTCA Guidewires (Cougar™, Zinger™, Thunder™, ProVia™ and Intuition™).
Indications for Use:
Medtronic ProVia™ and Intuition™ Guidewires:
Medtronic [ProVia™ and Intuition™] GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Thunder™ Guidewires:
Medtronic [Thunder™] PTCA guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA.
Zinger™ Guidewires:
Medtronic [Zinger™] guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. [Zinger™] guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Cougar™ Guidewires:
Medtronic Cougar™ wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.
Prescription Use > (Part 21 CFR 801 Subpart D) 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)
PAGE 1 OF
M. A. Hillman