(28 days)
Not Found
No
The device description details a physical guide wire with coatings and a core wire, and the summary explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as training and test sets.
No.
The 'Intended Use' clearly states its purpose is "To facilitate the placement of balloon dilatation catheters... and compatible stent devices during therapeutic intravascular procedures," indicating it is an accessory tool rather than a therapeutic device itself.
No
The device description and intended use indicate that the device is a guidewire used to facilitate the placement of catheters and stent devices during therapeutic intravascular procedures. It does not perform any diagnostic function.
No
The device description clearly details a physical guide wire constructed of stainless steel, polyurethane, and PTFE, with a tip coil for radiopacity. It is a hardware device used in interventional procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placement of catheters and stent devices during therapeutic intravascular procedures. This is a procedural device used in vivo (within the body) to aid in a medical intervention.
- 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 compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is a tool used directly within the body during a medical procedure.
N/A
Intended Use / Indications for Use
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.
Product codes
DQX
Device Description
The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic Coating are guide wires with a 0.014" diameter and available in 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The wires are constructed with a stainless steel core wire. The proximal section of the core wire has a constant diameter and the distal core segment tapers in diameter to the tip. Attached to the distal core is a tip coil that provides radiopacity. The distal 30 cm of the core wire is jacketed with a polyurethane coating that is coated with a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of the verification testing demonstrate that the HI-TORQE WHISPER™ LS and MS Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
MAR 1 2002
K02D340
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Guidant Corporation
Vascular Intervention |
|-----------------------------|----------------------------------------------|
| Submitter's Address: | 26531 Ynez Road
Temecula, CA 92591 |
| Telephone:
Fax: | (909) 914-4581
(909) 914-0339 |
| Contact Person: | Jennifer Pae Riggs |
| Date Prepared: | January 25, 2002 |
| Device Trade Name: | HI-TORQUE WHISPER™ LS and MS |
| Device Common Name: | Guide Wire |
| Device Classification Name: | Guide Wire Catheter |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The design, materials, method of delivery and intended use features of the HI-TORQUE WHISPER™ LS and MS Guide Wires are substantially equivalent with regard to these features in their predicate device, the HI-TORQUE WHISPER™ LS and MS Guide Wires (K002206, August 24, 2000 and K013092, December 13, 2001).
Device Description:
The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic Coating are guide wires with a 0.014" diameter and available in 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The wires are constructed with a stainless steel core wire. The proximal section of the core wire has a constant diameter and the distal core
A3-2
1
segment tapers in diameter to the tip. Attached to the distal core is a tip coil that provides radiopacity. The distal 30 cm of the core wire is jacketed with a polyurethane coating that is coated with a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".
Intended Use:
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.
Technological Characteristics:
Comparisons of the proposed and predicate device show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate device. The only change is the new tungsten material.
Performance Data:
The results of the verification testing demonstrate that the HI-TORQE WHISPER™ LS and MS Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program.
Conclusions:
The HI-TOROUE WHISPER™ LS and MS Guide Wires with the new material has the same intended use, technological characteristics, performance properties, identical sterilization and substantially equivalent materials. Therefore, there are no new safety or effectiveness issues. The HI-TORQUE WHISPER™ LS and MS Guide Wires with the new material are substantially equivalent to the predicate device.
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 with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2002
Ms. Jennifer Pae Riggs Guidant Corporation 26531 Ynez Road Temecula, CA 92591-4628
Re: K020340
HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrophilic Coating Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: January 31, 2002 Received: February 1, 2002
Dear Ms. Riggs:
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
3
Page 2 - Ms. Jennifer Pae Riggs
comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Hot Crequirements (1); good manufacturing practice requirements as set CI N Far 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quind) byovisions (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) This letter wification. The FDA finding of substantial equivalence of your device to a legally premated notificated wice 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 11 you doelly 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Compinatee at (301) 594-666 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 Ource goneral 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,
Lhe
Bram 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 K020340 (if known) HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrophilic Device Name Coating To facilitate the placement of balloon dilatation catheters during percutaneous Indications for transluminal coronary angioplasty (PTCA) and percutaneous transluminal Use 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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Over-The-Counter Use_ Prescription Use OR (Per 21 CFR 801.109) Division of Cardiovascular & Respiratory Devices
510(k) Number _ 1/202 C C 340 510(k) Number