(161 days)
No
The description focuses on the physical characteristics and intended use of a guidewire, with no mention of AI or ML capabilities. The performance studies are standard biocompatibility and physical property tests.
No
The device is a guidewire used to introduce and position catheters, which are tools for diagnostic and interventional procedures, rather than directly treating a condition itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the guidewire is "intended for use to introduce and position catheters during diagnostic and interventional procedures." This indicates that one of its primary uses is in diagnostic procedures.
No
The device description explicitly states it is comprised of a stainless steel wire with a PTFE coating, indicating it is a physical hardware device, not software only.
Based on the provided information, the Medtronic ConfidaTM Brecker Guidewire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart". This describes a device used within the body for procedural guidance, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical guidewire used for navigation within the circulatory system. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Medtronic ConfidaTM Brecker Guidewire does not fit this definition.
N/A
Intended Use / Indications for Use
The Medtronic ConfidaTM Brecker Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI).
Product codes
DQX
Device Description
The Medtronic Confida™ Brecker Guidewire was developed for use in diagnostic and interventional procedures including transcatheter aortic valve implantation (TAVI) procedures for the treatment of aortic valve disease. The Medtronic ConfidaTM Brecker Guidewire (model number GWBC30) is available in one size and is comprised of a stainless steel wire, 0.035" in diameter, and 260cm in length. The distal end of the Medtronic Confida™ Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic Confida™ Brecker Guidewire is an external communicating device having limited (
§ 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2015
Medtronic CoreValve, LLC. Matthew Lobeck Regulatory Affairs Specialist 3576 Unocal Place Santa Rosa, California 95403
Re: K150465
Trade/Device Name: Medtronic Confida™ Brecker Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 4, 2015 Received: Mav 6. 2015
Dear Matthew Lobeck:
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.
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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Medtronic ConfidaTM Brecker Guidewire
Indications for Use (Describe)
The Medtronic ConfidaTM Brecker Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 C.ER 801 Subnart D) | Over-The-Counter Use (21 CER 801 Subnart C) |
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7.0 510(k) Summary in Accordance with 21 CFR § 807.92(c)
As required by the Safe Medical Devices Act of 1990, coded under Section 513, part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
| Date Prepared: | July 21, 2015 |
|---|---|
| Applicant: | Medtronic CoreValve, LLC |
| 1851 E. Deere Ave. | |
| Santa Ana, CA 92705 | |
| U.S.A. | |
| Establishment Registration No. 2025587 | |
| Contact Person: | Matthew Lobeck |
| Regulatory Affairs Specialist | |
| Medtronic Heart Valves | |
| Phone: (763) 514-9515 | |
| Fax: (763) 514-9521 | |
| Email: matthew.lobeck@medtronic.com | |
| Subject Device Name: | Medtronic Confida™ Brecker Guidewire |
| Model Number: | GWBC30 |
| Common Name: | Guidewire |
| Classification Name: | Wire, Guide, Catheter |
| Product Code: | DQX |
| Predicate Device(s): | Medtronic Confida™ Brecker Guidewire (K132623; cleared |
| December 19, 2013) | |
| Device Description: | The Medtronic Confida™ Brecker Guidewire was developed |
| for use in diagnostic and interventional procedures including | |
| transcatheter aortic valve implantation (TAVI) procedures for | |
| the treatment of aortic valve disease. The Medtronic ConfidaTM | |
| Brecker Guidewire (model number GWBC30) is available in | |
| one size and is comprised of a stainless steel wire, 0.035" in | |
| diameter, and 260cm in length. The distal end of the Medtronic | |
| Confida™ Brecker Guidewire is comprised of a preformed 360° | |
| curved tip. |
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| | The Medtronic Confida™ Brecker Guidewire is an external
communicating device having limited (