(182 days)
No
The description focuses on the physical characteristics and intended use of a guide wire, with no mention of AI or ML capabilities.
No.
The device facilitates the placement of other interventional devices but does not perform a therapeutic function itself.
No
Explanation: The device description states that the guide wires are intended to guide the placement of intravascular catheters during therapeutic or diagnostic procedures. While it can be used in diagnostic procedures, its primary function is facilitation/guidance, not diagnosis itself. The Intended Use also focused on "facilitate the placement of balloon dilation catheters or other interventional devices," which are therapeutic tools.
No
The device description clearly describes a physical guide wire made of materials like platinum, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the placement of balloon dilation catheters or other interventional devices" during an interventional procedure. This describes a device used in vivo (within the body) for a therapeutic or diagnostic procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a "steerable coronary guide wire" with features like radiopaque marker bands and a platinum coil. These are components of a device designed for insertion into the coronary arteries, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in those specimens
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
The device described is a medical device used in interventional cardiology procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Galeo coronary guide wires are indicated to facilitate the placement of balloon dilation catheters or other interventional devices with compatible guide wire lumen during an interventional procedure.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
BIOTRONIK's Galeo Focus family of guide wires includes steerable coronary guide wires with various tip flexibilities and configurations that are intended to guide the placement of intravascular catheters with compatible guide wire lumens during PTCA or other therapeutic or diagnostic procedures. The Galeo Focus guide wires are identical in design and functionally equivalent to the Galeo and Galeo Hydro Guide Wires already cleared for distribution, with the guide wire consists of 3 radiopaque marker bands on the distal tip for lesion length assessment starting at 37 mm proximal to the quide wire tip. Additionally, the distal 27 mm of the quide wire are covered with a highly radiopage platinum coil. The number, dimensions and spacing of the markers on the distal tip of the Galeo Focus are the same as the legally marketed ATW Marker Wire from Cordis Corporation (#K994358, cleared 01-13-00) with the exception that the first distal marker is located 37 mm proximally from the tip versus 45 mm for Cordis' ATW.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary
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)
Not Found
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Galeo Focus Coronary Guide Wire Additional Information for 510(k) #K042373
| 1. 510(k) Summary | |
|---|---|
| Name and Address of Sponsor: | BIOTRONIK, Inc. |
| 6024 Jean Road | |
| Lake Oswego, OR 97035 | |
| Establishment Registration Number: | 1028232 |
| Device Name: | Proprietary Name Galeo Focus Guide Wire |
| Classification Class II (21 CFR 870.1330) | |
| Classification Name Catheter Guide Wire | |
| Product Code DQX | |
| General Description and Predicate Devices: |
BIOTRONIK's Galeo Focus family of guide wires includes steerable coronary guide wires with various tip flexibilities and configurations that are intended to guide the placement of intravascular catheters with compatible guide wire lumens during PTCA or other therapeutic or diagnostic procedures. The Galeo Focus guide wires are substantially equivalent to BIOTRONIK's GALEO Guide Wires (#K982272, cleared 01-08-99) and Galeo Hydro Guide Wires (#K001736, cleared 08-02-00).
The Galeo Focus Guide Wires are identical in design and functionally equivalent to the Galeo and Galeo Hydro Guide Wires already cleared for distribution, with the guide wire consists of 3 radiopaque marker bands on the distal tip for lesion length assessment starting at 37 mm proximal to the quide wire tip. Additionally, the distal 27 mm of the quide wire are covered with a highly radiopage platinum coil. The number, dimensions and spacing of the markers on the distal tip of the Galeo Focus are the same as the legally marketed ATW Marker Wire from Cordis Corporation (#K994358, cleared 01-13-00) with the exception that the first distal marker is located 37 mm proximally from the tip versus 45 mm for Cordis' ATW.
Indications for Use:
Galeo coronary guide wires are indicated to facilitate the placement of balloon dilation catheters or other interventional devices with compatible guide wire lumen during an interventional procedure.
Name and Address of Manufacturing Site:
BIOTRONIK GmbH & Co. KG (reg. no. 9610139) Woermannkehre 1, 12359 Berlin, Germany 011-49-30-689-05-304
Contact Person and Phone Number:
Jon Brumbaugh Director, Requlatory Affairs and Compliance Phone (888) 345-0374 Fax (503) 635-9936 jon.brumbaugh@biotronikusa.com
Name and Address of Contract Manufacturing Site:
BIOTRONIK AG (reg. no. 8043892) Ackerstrasse 6 8180 Bülach. Switzerland 011-41-1-864-5247
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MAR 2 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jon Brumbaugh Director, Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Re: K042373
Trade/Device Name: Galeo Focus Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: February 22, 2005 Received: February 23, 2005
Dear Mr. Brumbaugh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bood the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to trg. 35 the Medical Device Amendments, or to econiner of the United in accordance with the provisions of the Federal Food, Drug, devices that have been read to 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 r ou may, ateres provisions of the Act include requirements for annual registration, listing of general controls proficturing 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.
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
2
Page 2 -- Mr. Jon Brumbaugh
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dauna D. Vochner
- Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K042373
Device Name: Galeo Focus Guide Wire
Indications For Use:
Galeo coronary guide wires are indicated to facilitate the placement of balloon dilation Oalco coronary galler interventional devices with compatible guide wire lumen during an interventional procedure.
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)
Duna R. Vachner
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_K04_2373
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