(97 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The Brivant guidewire is used to navigate the vasculature, but it does not treat a disease or condition itself; it facilitates a diagnostic or interventional procedure.
No
The Brivant guidewire is an interventional device used to guide other medical instruments within the coronary and peripheral vasculature, not to diagnose a condition.
No
The device description clearly outlines a physical guidewire made of stainless steel with specific dimensions and coatings, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for use in the coronary and peripheral vasculature. This indicates a device used within the body for a procedural purpose (guiding other devices).
- Device Description: The description details a physical guidewire used for navigation within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal structures in the way a guidewire does.
N/A
Intended Use / Indications for Use
The Brivant guide wires are intended for use in the coronary and peripheral vasculature.
Product codes
DQX
Device Description
The Brivant Guidewire is a disposable medical device designed for single use only. It consists of a 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over the distal coil segment in a progressive fashion. The Brivant Guidewire is produced in lengths of 175, 195 and 300cm and is available in either silicone or hydrophilic coatings. The profile of the reduced section is varied to provide a range of products of mixed stiffness.
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
Performance testing involving the following testing has been completed tensile strength, torque strength, torque response, coating performance, radiopacity, packaging qualification (including accelerated aging), sterilization, tip flexibility, catheter compatibility testing and biocompatibility testing in compliance with ISO 10993-1 has been successfully completed. The successful tests demonstrated the Brivant Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for Brivant Medical Engineering. The text "BRIVANT" is in large, bold, sans-serif font. Below that, in a smaller font, is the text "MEDICAL ENGINEERING". The logo is simple and professional.
Brivant Guidewire Premarket Notification 510(k)
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
(1) Submitter's Name / Contact Person: Brivant Limited,
4 Westlink Commercial Park, Oranmore, Galway, Ireland
JUN - 7 2006
| Contact Person: | Tomas Furey,
Vice President Regulatory Affairs
Tel: (011) 35391 788960
Fax: (011) 35391 788961 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------|
| (2) Summary Preparation Date: | February 17, 2006 |
| (3) Device Name and Classification: | |
| Trade Name: | Brivant Guidewire |
|---|---|
| Common Name: | Guidewire |
| Classification Name: | Catheter, Guidewire |
| Device Classification: | Class II, 21 CFR §870.133- |
(4) Identification of Predicate Devices:
| # | Manufacturer | Device | 510(k) No. |
|---|---|---|---|
| 1 | Invatec Innovative | ||
| Technologies | SKIPPER and SKIPPER RACE | ||
| Guidewires | K050756 | ||
| 2 | Biosphere Medical Inc. | Segway GT SEG1812 | K011287 |
| K032129 |
This summary is provided in compliance with section 513(i)(3)(a) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission.
(5) Description of the Device:
The Brivant Guidewire is a disposable medical device designed for single use only. It consists of a 0.014" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over the distal coil segment in a progressive fashion. The Brivant Guidewire is produced in lengths of 175, 195 and 300cm and is available in either silicone or hydrophilic coatings. The profile of the reduced section is varied to provide a range of products of mixed stiffness.
1
Image /page/1/Picture/1 description: The image shows the logo for Brivant Medical Engineering. The word "BRIVANT" is in large, bold, sans-serif font. Below the word "BRIVANT" is the phrase "MEDICAL ENGINEERING" in a smaller, sans-serif font. A horizontal line separates the two phrases.
Brivant Guidewire Premarket Notification 510(k)
(6) Statement of Intended Use:
The Brivant guide wires are intended for use in the coronary and peripheral vasculature
(7) Predicate Device Comparison:
Brivant Guidewires are substantially equivalent to the SKIPPER and SKIPPER RACE guidewires, Invatec Innovative Technologies (K050756 cleared for marketing on May 5, 2005) and Segway GT SEG1812 Guidewire, Biosphere Medical Inc.(K011287, K032129) in terms of the indications for use, functional effectiveness, technological characteristics, materials and principles of operation. Brivant Guidewires shall be manufactured according to specified process controls and in compliance with an ISO 9001:2000/ISO 13485:2003/FDA QSR 820 Quality Assurance Program. The devices will undergo packaging and sterilization procedures in compliance with internationally recognized standards.
(8) Summary of Testing:
Performance testing involving the following testing has been completed tensile strength, torque strength, torque response, coating performance, radiopacity, packaging qualification (including accelerated aging), sterilization, tip flexibility, catheter compatibility testing and biocompatibility testing in compliance with ISO 10993-1 has been successfully completed. The successful tests demonstrated the Brivant Guidewires consistently performed within their design parameters, are safe and effective and perform as well as the predicate devices.
(9) Statement of Equivalence:
Brivant Guidewires are substantially equivalent to the SKIPPER and SKIPPER RACE guidewires (K050756) and Segway GT SEG1812 Guidewire (K011287, K032129) in intended use, materials, principle of operation, technological characteristics and performance.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2006
Brivant Medical Engineering c/o Mr. Tomas Furey Vice President, Regulatory Affairs 4 Westlink Commercial Park Oranmore, Galway, Ireland
Re: K060551
Brivant Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DQX Dated: May 15, 2006 Received: May 18, 2006
Dear Mr. Furey:
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.
3
Page 2 - Mr. Tomas Furey
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
una R. Launer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows a logo for Brivant Medical Engineering. The word "BRIVANT" is in large, bold, sans-serif font at the top. Below it, in a smaller font, are the words "MEDICAL ENGINEERING". There is a line above the words "MEDICAL ENGINEERING" and a line below the words "MEDICAL ENGINEERING".
Brivant Guidewire Premarket Notification 510(k)
Indications for Use
510(k) Number (if known):
Device Name: Brivant Guidewire
Indications for Use: Brivant guidewires are intended for use in the coronary and peripheral vasculature.
Prescription Use_ × (Per 21 CFR 801 Subpart D)
ಕ್ಕೆ ಹಿಡೆಯ
AND/OR
Over the Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna P. Vachner
Division Sign-O Division of Cardiovascular Devices
510(k) Number K060551
Page 4-2