(71 days)
No
The summary describes a physical guide wire and its intended use and performance in an animal study. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
No.
The indications for use state that the device is intended to "aid in the selective placement of interventional devices, such as catheters, in the coronary, peripheral and visceral vasculature during diagnostic and/or therapeutic procedures," meaning it is used in therapeutic procedures but does not provide therapy itself.
No
The device is a guide wire, which is an interventional device used to aid in the placement of other devices. While it is used during "diagnostic and/or therapeutic procedures," its function is not to diagnose conditions but to facilitate procedures.
No
The device description clearly identifies the BMW Guide Wire as a physical, steerable guide wire, which is a hardware component used in medical procedures.
Based on the provided information, the BMW Guide Wire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the guide wire is for "general intravascular use to aid in the selective placement of interventional devices... in the coronary, peripheral and visceral vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body for procedural guidance, not for testing samples outside the body.
- Device Description: The description details a physical guide wire used for navigation within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. The BMW Guide Wire is an interventional device used in vivo.
N/A
Intended Use / Indications for Use
Current: All ACS HI-TORQUE® Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
Proposed: The HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices, such as catheters, in the coronary and peripheral vasculature during diagnostic and/or therapeutic procedures.
Product codes
DQX
Device Description
The BMW Guide Wire is a steerable guide wire available in a nominal diameter of 0.14" in two lengths: a 190 centimeter extendible length (extendible to 335cm using the DOC® Guide Wire Extension) and a 300-centimeter exchange length.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
An animal study was conducted to evaluate the performance of the ACS Hi-Torque Floppy II® (K887897) and the BMW (K971815) Guide Wire when the devices were used within the coronary vein. The results of the in vivo animal evaluation show that the BMW Guide Wire is acceptable within the coronary vein when used with a compatible lead system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
NOV I 0 1998 CONFIDENTIAL
K983033¹⁴
510(k) Summary
-
- Device Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire
-
- Intended Use: The BMW Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices, such as catheters, in the coronary, peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.
-
- Device Description: The BMW Guide Wire is a steerable guide wire available in a nominal diameter of 0.14" in two lengths: a 190 centimeter extendible length (extendible to 335cm using the DOC® Guide Wire Extension) and a 300-centimeter exchange length.
-
- Summary of Technological Characteristics: This notification concerns a labeling modification to modify the indications for a currently marketed device. There are no changes to the design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device.
-
- Summary of Substantial Equivalence: This notification concerns a labeling modification to modify the indications for the currently marketed device. The indications are equivalent to the currently marketed MicroVena Niner Nitinol Guide Wire (K952860, cleared December 3, 1995) and all other aspects of the proposed BMW Guide Wire are identical to the currently marketed BMW Guide Wire (K971815, cleared July9, 1997).
7. Testing Data:
In Vivo Testing
An animal study was conducted to evaluate the performance of the ACS Hi-Torque Floppy II® (K887897) and the BMW (K971815) Guide Wire when the devices were used within the coronary vein. The results of the in vivo animal evaluation show that the BMW Guide Wire is acceptable within the coronary vein when used with a compatible lead system. See Appendix B for the in vivo study.
1
-
- Conclusion: This BMW Guide Wire with the modified indication is substantially equivalent to the currently marketed MicroVena Niner Nitinol Guide Wire (K952860, cleared December 3, 1995) with regard to intended use and all other aspects of the proposed BMW Guide Wire are identical to the currently marketed BMW Guide Wire (K971815, cleared July 9, 1997).
2
Image /page/2/Picture/1 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 three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 10 1998
Ms. Jennifer Pae Riggs Sr. Regulatory Affairs Coordinator Guidant Corporation Advanced Cardiovascular Systems 26531 Ynez Road P.O. Box 9018 Temecula, CA 92591
K983033 Re : Trade Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire Requlatory Class: II Product Code: DQX Dated: August 28, 1998 Received: August 31, 1998
Dear Ms. Riggs:
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulatory In addition, FDA may publish further announcements concerning action.
3
Page 2 - Ms. Jennifer Pae Riggs
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.
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) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 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,
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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K983033
Device Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire
Indications for Use:
Current:
All ACS HI-TORQUE® Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
Proposed:
The HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices, such as catheters, in the coronary and peripheral vasculature during diagnostic and/or therapeutic procedures.
Ta lu fa
(Division Sign-Off) (Division Sign Oil)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ・
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use . (Per 21 CFR 801.109) OR
Over-The-Counter (Optional Format 1-1-96)