(171 days)
ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating, ACS HI-TORQUE TRA VERSE® Guide Wire
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guide wire used to facilitate the placement of other therapeutic devices (balloon dilatation catheters and stent devices); it does not directly provide therapy.
No
The device is a guide wire used to facilitate the placement of other catheters and stent devices during therapeutic procedures, not to diagnose a condition.
No
The device description clearly details a physical guide wire with specific materials, dimensions, and coatings, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a guide wire used during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) procedures. Its purpose is to facilitate the placement of other devices (balloon catheters and stents) within the body.
- No Specimen Analysis: There is no mention of this device being used to analyze any biological specimens.
Therefore, based on the intended use and device description, this guide wire is an invasive medical device used in interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.
Product codes
DQX
Device Description
The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is a guide wire with a nominal diameter of 0.012". Like the ACS HI-TORQUE TRA VERSE® Guide Wire, the HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire is constructed from a stainless steel core. The distal segment of the guide wire includes a series of tapers and a flat, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance. The distal tip coil has a radiopaque length of 3 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J".
The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is available in lengths of 190 cm and 300 cm exchange length. The 300 cm exchange length enables the physician ample working length of the guide wire to facilitate catheter exchanges. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal, coiled segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
In vitro bench testing and in vivo performance evaluations demonstrated that the HIm varo occión costains and .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similarly to the predicate devices. The Counting functional tests were performed: Distal Tip Pull (Tensile Strength), Distal Tip Tomowing Tailerial torque Strength), Rotational Accuracy (Torqueability), and Tip Flexibility. I unis-to I antare (Torque Buchgan), stons in an in vivo animal model were conducted. The In addition, two performed comparably to the predicate devices and no new safety or effectiveness issues were raised during the testing program Therefore, the HI-TORQUE MIDDLE ISUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating, HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire with HYDROCOAT™ Hydrophilic Coating
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
JAN 2 4 :
98
K012534
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| 1. Submitter's Name: | Guidant Corporation
Advanced Cardiovascular Systems, Inc. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter's Address: | 3200 Lakeside Drive
Santa Clara, CA 95054 |
| 3. Telephone: | 408-845-3956 |
| 4. Fax: | 408-845-3743 |
| 5. Contact Person: | Joanna Mroz |
| 6. Date Prepared: | July 6, 2001 |
| 7. Device Trade Name: | HI-TORQUE MIDDLE SUPPORT™ .012" Guide
Wire with HYDROCOAT™ Hydrophilic Coating |
| 8. Device Common Name: | Guide Wire |
| 9. Device Classification Name: | Catheter Guide Wire (74DQX) |
| 10. Predicate Devices: | • ACS HI-TORQUE TRAVERSE® Guide Wire with
HYDROCOAT™ Hydrophilic Coating
• HI-TORQUE BALANCE MIDDLEWEIGHT
Guide Wire with HYDROCOAT™ Hydrophilic |
Coating
- Device Description:
The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is a guide wire with a nominal diameter of 0.012". Like the ACS HI-TORQUE TRA VERSE® Guide Wire, the HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire is constructed from a stainless steel core. The distal segment of the guide wire includes a series of tapers and a flat, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance. The distal tip coil has a radiopaque length of 3 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J".
The HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating is available in lengths of 190 cm and 300 cm exchange length. The 300 cm exchange length enables the physician ample working length of the guide wire to facilitate catheter exchanges. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal, coiled segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.
-
- Intended Use:
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.
- Intended Use:
1
13. Technological Characteristics:
Comparisons of the new and predicate devices show that the technological characteristics compansons of the new and presign, and intended use are substantially equivalent to the currently marketed predicate devices.
14. Performance Data:
In vitro bench testing and in vivo performance evaluations demonstrated that the HIm varo occión costains and .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similarly to the predicate devices. The Counting functional tests were performed: Distal Tip Pull (Tensile Strength), Distal Tip Tomowing Tailerial torque Strength), Rotational Accuracy (Torqueability), and Tip Flexibility. I unis-to I antare (Torque Buchgan), stons in an in vivo animal model were conducted. The In addition, two performed comparably to the predicate devices and no new safety or effectiveness issues were raised during the testing program Therefore, the HI-TORQUE MIDDLE ISUPPORT™ .012" Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2002
Ms. Joanna Mroz Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95054-2807
Re: K012534
HI-TORQUE MIDDLE SUPPORT™ 0.012" Guide Wire with HYDROCOAT™ Hydrophilic Coating Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 29, 2001 Received: December 4, 2001
Dear Ms. Mroz:
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.
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
3
Page 2 - Ms. Joanna Mroz
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 premainer nedicate 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Dafe Tille
ram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K012534
HI-TORQUE MIDDLE SUPPORT™ .012" Guide Wire with Device Names: . HYDROCOAT™ Hydrophilic Coating
To facilitate the placement of balloon dilatation catheters during Indications percutaneous transluminal coronary angioplasty (PTCA), for Use: percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.
(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)
✓
Over-The-Counter (Optional Format 1-1-96)
Dalerteh
Division of Cardiovascular & Respiratory Devices
510(k) Number K012534
OR