(193 days)
Not Found
No
The description focuses on the physical characteristics and materials of a guidewire, with no mention of AI or ML capabilities.
No
The device is described as a guidewire intended to facilitate the placement of catheters. It does not perform any therapeutic function itself, but rather aids in a diagnostic or interventional procedure.
No
The device description and intended use indicate it is a guide wire used to facilitate the placement of catheters, which is an interventional procedure tool, not a diagnostic one.
No
The device description clearly details a physical guide wire made of metal with coatings, intended for use in vascular procedures, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Galeo Guidewires are for "use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries." This describes a device used within the body for a procedural purpose, not a device used outside the body to examine specimens from the body.
- Device Description: The description details a physical wire designed to be inserted into blood vessels. It talks about materials, coatings, flexibility, and radioopacity – all characteristics of an invasive medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Galeo Guidewires are an invasive medical device used for guiding catheters within the coronary arteries, not an in vitro diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
Galeo Guidewires are intended for use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
74 DQX
Device Description
BIOTRONIK Galeo Guide Wires are coronary vascular guide wires with a nominal diameter of 0.014"/0.36 mm and a nominal length of 175 cm. The BIOTRONIK Galeo Guide Wire Family consists of nine coronary guide wires of various flexibilities and one extension wire. Galeo has a straight configuration with five levels of stiffness: Highly Stiff (HS), Stiff (S), Medium (M), Flexible (F), and Highly Flexible (HF). There are also three stiffness variations available with a pre-formed J-tip: Floppy (F), Medium (M), and Stiff (S). Galeo ES (Extra Support) offers enhanced support during intracoronary vascular procedures. All Galeo Guide Wires (175 cm) are extendable to over-the-wire exchange length using the Galeo Extension Wire (EW). The distal coil areas of the BIOTRONIK Galeo guide wires are treated with a siliconebased coating that makes the distal section of the guide wire more lubricious than the bare metal surface. The proximal wire section is coated with PTFE. The distal 3.0 cm of the Galeo Guide Wire responds easily to manual forming or shaping. The Galeo Guide Wire offers different grades of radioopacity over its distal stainless steel and platinum coil section. The 27 cm stainless steel coil section (27 cm in length) is radiolucent; the platinum coil section (3.0 cm) is highly radioopaque. The proximal end of the guide wire is slightly tapered and allows the attachment of the extension wire Galeo EW. The combination of Galeo EW results in an overall wire length of 325 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary arteries
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.
Not Found
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
11. 510(k) Summary
- 11.1 Submitter Information
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 (800) 547-0394 Contact: David Makanani, Vice President, Clinical and Regulatory Affairs Notification Prepared June 26, 1998
11.2 Device Name
| Trade Name: | Galeo HS 014 |
|---|---|
| Galeo S 014 | |
| Galeo M 014 | |
| Galeo F 014 | |
| Galeo HF 014 | |
| Galeo S/J 014 | |
| Galeo M/J 014 | |
| Galeo F/J 014 | |
| Galeo ES 014 | |
| Galeo EW 014 | |
| Common Name: | guide wire |
| Classification Name: | catheter guide wire |
11.3 Predicate Devices
The Galeo guide wire is substantially equivalent in material, design, function, and intended use to the following devices: Guidant ACS Hi-Torque guide wire
Medtronic Mustang guide wire
11.4 Device Description
BIOTRONIK Galeo Guide Wires are coronary vascular guide wires with a nominal diameter of 0.014"/0.36 mm and a nominal length of 175 cm. The BIOTRONIK Galeo Guide Wire Family consists of nine coronary guide wires of various flexibilities and one extension wire. Galeo has a straight configuration with five levels of stiffness: Highly Stiff (HS), Stiff (S), Medium (M), Flexible (F), and Highly Flexible (HF). There are also three stiffness variations available with a pre-formed J-tip: Floppy (F), Medium (M), and Stiff (S). Galeo ES (Extra Support) offers enhanced support during intracoronary vascular procedures.
1
All Galeo Guide Wires (175 cm) are extendable to over-the-wire exchange length using the Galeo Extension Wire (EW).
The distal coil areas of the BIOTRONIK Galeo guide wires are treated with a siliconebased coating that makes the distal section of the guide wire more lubricious than the bare metal surface. The proximal wire section is coated with PTFE.
The distal 3.0 cm of the Galeo Guide Wire responds easily to manual forming or shaping. The Galeo Guide Wire offers different grades of radioopacity over its distal stainless steel and platinum coil section. The 27 cm stainless steel coil section (27 cm in length) is radiolucent; the platinum coil section (3.0 cm) is highly radioopaque.
The proximal end of the guide wire is slightly tapered and allows the attachment of the extension wire Galeo EW. The combination of Galeo EW results in an overall wire length of 325 cm.
11.5 Intended Use
Galeo guidewires are intended for use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries.
11.6 Comparison to Predicate Devices
The Galeo guide wires are functionally equivalent to market-released guide wires. In specific, the materials used and design are similar to the Guidant ACS Hi-Torque (K973494, Dec. 12, 1997) series with the exception of the coating of the distal coil region. This coating is similar between the Galeo series and the Medtronic Mustang guide wire (K961917, Nov. 20, 1996).
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 JAN
Mr. David M. Makanani Biotronik, Inc. 6024 Jean Road 97035-5369 Lake Oswego, OR
Re: K982272 Biotronik Galeo Guide Wire Requlatory Class: II (two) Product Code: 74 DQX Dated: November 20, 1998 Received: November 23, 1998
Dear Mr. Makanani:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. David M. Makanani
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page Page of
510(k) Number (if known): K982272
BIOTRONIK GALEO GUIDE WIRES Device Name:
Indications For Use:
Galeo Guidewires are intended for use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chaturbun Hon
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 9822 72
510(k) Number K982272
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)