(17 days)
Not Found
No
The description details a physical guidewire with a coating change and includes performance studies related to material properties and biocompatibility, with no mention of AI or ML.
No.
The device is a guidewire intended to facilitate the introduction and positioning of other catheters for diagnostic and interventional procedures, rather than directly treating a disease or condition itself.
Yes
The "Intended Use / Indications for Use" states that the guidewire is "intended for use to introduce and position catheters during diagnostic and interventional procedures." This explicitly includes diagnostic procedures as an intended use.
No
The device description clearly states it is a physical guidewire made of stainless steel with a PTFE coating, intended for use in diagnostic and interventional procedures. It is a tangible hardware device.
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 clearly states it's for "introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart". This describes a device used in vivo (within the body) for procedural guidance, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical guidewire used for navigation within the circulatory system. It mentions contact with circulating blood, which is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Medtronic ConfidaTM Brecker Guidewire is a medical device used for interventional procedures, not an IVD.
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 (comma separated list FDA assigned to the subject device)
DOX
Device Description
The Medtronic ConfidaTM 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 ConfidaTM Brecker Guidewire is comprised of a preformed 360° curved tip. The Medtronic ConfidaTM Brecker Guidewire is an external communicating device having limited contact (
§ 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.
0
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May 3, 2018
Medtronic Core Valve LLC % Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K181001
Trade/Device Name: Medtronic ConfidaTM Brecker Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: April 12, 2018 Received: April 16, 2018
Dear Mr. Job:
We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good
1
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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
for
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)
K181001
Device Name Medtronic Confida™ Brecker Guidewire
Indications for Use (Describe)
The Medtronic Confida™ 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 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5.0 510(k) Summary
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: | March 30, 2018 |
|---|---|
| Applicant: | Medtronic CoreValve LLC |
| 1851 E Deere Ave | |
| Santa Ana, CA 92705 | |
| USA | |
| Establishment Registration NO. 2025587 | |
| Contact Person: | Gerardine Drummond |
| Senior Regulatory Affairs Specialist | |
| Medtronic Ireland | |
| Parkmore Business Park West | |
| Galway, Ireland | |
| Phone: (+353-91)-708914 | |
| Fax: (+353-91)-708672 | |
| Email: Gerardine.drummond@medtronic.com | |
| Subject Device Name: | Medtronic ConfidaTM Brecker Guidewire |
| Model Number: | GWBC30 |
| Common Name: | Guidewire |
| Classification Name: | Wire, Guide, Catheter |
| Product Code: | DQX |
| Predicate Device(s): | Medtronic ConfidaTM Brecker Guidewire (K150465 cleared |
| August 03, 2015) | |
| Device Description: | The Medtronic ConfidaTM 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 ConfidaTM Brecker Guidewire is comprised of a | |
| preformed 360° curved tip. The Medtronic ConfidaTM Brecker | |
| Guidewire is an external communicating device having limited | |
| contact ( |