(84 days)
None
Not Found
No
The 510(k) summary describes a mechanical guide wire and does not mention any AI or ML components or functionalities.
No
The device is a guide wire used to introduce and place interventional catheters, not to directly treat a medical condition.
No
Explanation: The device is a steerable guide wire used for introducing and placing interventional catheters during angioplasty procedures. Its function is to facilitate the delivery of other instruments, not to diagnose a condition.
No
The device description clearly describes a physical guide wire with specific material properties, coatings, and a spring, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Mustang™ Steerable Guide Wire Function: The description clearly states the Mustang™ Steerable Guide Wire is used during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA). This is a procedure performed inside the body to introduce and place interventional catheters.
The device is a surgical/interventional tool used directly in a medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Mustang™ Steerable Guide Wire is indicated for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
Product codes (comma separated list FDA assigned to the subject device)
74 DQX
Device Description
The Medtronic® MUSTANG™ Steerable Guide Wire is a guide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).
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)
In vitro testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity and catheter compatibility. Testing was also performed to assess the biocompatibility of the device. Test results verified that the MUSTANG™ meets all of the applicable specifications and is deemed adequate for the intended use.
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.
Medtronic® Mustang TM Steerable Guide Wire, ACS® Hi-Torque Floppy II® Guide Wire, ACS® Hi-Torque Intermediate® Guide Wire, ACS® Hi-Torque Standard® Guide Wire, ACS® Hi-Torque Extra S'port™ Guide Wire, SciMed® Sceptor™ Floppy Guide Wire
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12. Safe Medical Devices Act of 1990)
NOV - 3 1997
-
- The trade or proprietary name of the device is the Medtronic® MUSTANG™ Steerable Guide Wire. Models offered in this product line include:
- Medtronic® MUSTANG™ Super Floppy Steerable Guide Wire ●
- Medtronic® MUSTANG™ Floppy Steerable Guide Wire .
- Medtronic® MUSTANG™ Intermediate Steerable Guide Wire .
- Medtronic® MUSTANG™ Standard Steerable Guide Wire ●
- Medtronic® MUSTANG™ Extra Support Steerable Guide Wire, .
The common or classification name is Coronary Guidewire.
-
- The Medtronic® MUSTANG™ Steerable Guide Wire is for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
-
- The Medtronic® MUSTANG™ Steerable Guide Wire is a quide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).
-
- In vitro testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity and catheter compatibility. Testing was also performed to assess the biocompatibility of the device.
-
- Test results verified that the MUSTANG™ meets all of the applicable specifications and is deemed adequate for the intended use. The MUSTANG™ line of guide wires is considered to be substantially equivalent to the following devices:
- Medtronic® Mustang TM Steerable Guide Wire ●
- ACS® Hi-Torque Floppy II® Guide Wire .
- ACS® Hi-Torque Intermediate® Guide Wire ●
- ACS® Hi-Torque Standard® Guide Wire ●
- ACS® Hi-Torque Extra S'port™ Guide Wire .
- SciMed® Sceptor™ Floppy Guide Wire .
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1997
Ms. Mary De Armond Medtronic Interventional Vascular 9410 Carroll Park Drive San Diego, California 92121-2256
Re: K972944 Medtronic® MUSTANG™ Steerable Guide Wire Requlatory Class: II (two) Product Code: 74 DQX Dated: August 7, 1997 Received: August 11, 1997
Dear Ms. Armond:
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 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 requirement, 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 Failure to comply with the GMP regulation may result in assumptions. regulatory 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.
2
Page 2 - Ms. Mary De Armond
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 requlation 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/dsmamain.html".
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
3
INDICATIONS FOR USE
| 510(k) Number: | To Be Assigned By FDA |
|---|---|
| Device Name: | Medtronic® Mustang™ Steerable Guide Wire™ |
| Indications For Use: | The Mustang™ Steerable Guide Wire is indicated for |
| use in introducing and placing interventional catheters | |
| during percutaneous transluminal coronary | |
| angioplasty (PTCA) and/or percutaneous transluminal | |
| angioplasty (PTA). |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K972944 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| ------------------ | ---------------------------------- | ---- | ---------------------- |
(Per 21 CFR 801.109)