(87 days)
Not Found
No
The device description and summary of performance studies focus on the physical characteristics and mechanical performance of a guide wire, with no mention of AI or ML.
No
The device is a guide wire used to facilitate the placement of other therapeutic devices (balloon catheters, stents), but it does not directly provide therapy.
No
Explanation: The device description and intended use clearly indicate that this is a guide wire used to facilitate the placement of other devices (balloon dilatation catheters, stent devices) during angioplasty procedures. It does not perform any diagnostic function.
No
The device description clearly details physical components like stainless steel core wire, tip coil, polyurethane coating, and hydrophilic coating, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the placement of catheters and stents during percutaneous procedures (PTCA and PTA). This is an in vivo procedure, meaning it is performed within the living body.
- Device Description: The description details a physical guide wire used for navigation within blood vessels. This is a surgical/interventional tool, not a device used to examine specimens outside the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such examinations.
The device described is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
To facilitate the placement of balloon dilatation catheters during percutaneous ro raomate the pracement of one of CA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.
Product codes
DQX
Device Description
The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic The II - Ore Quide 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 extendable lengths and a 500 em enemange compression 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 tapes in diamover to the up. Thathew re- wire is jacketed with a polyurethane coating that is coated with a hyrophilic coating. The proximal section of the wire is coated with 13 couted with a hyropinias countal 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)
In vitro bench testing demonstrated that the HI-TORQUE WHISPER™ Guide Wires met
the acceptance criteria and is acceptable for clinical use.
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
DEC 1 3 2001
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the SMDA of 1990.
| 1. Submitter's Name: | Guidant Corporation
Vascular Intervention |
|--------------------------------|------------------------------------------------------------------------------------------|
| 2. Submitter's Address: | 26531 Ynez Road |
| 3. Telephone: | (909) 914-4581 |
| 4. Fax: | (909) 914-0339 |
| 5. Contact Person: | Jennifer Pae Riggs |
| 6. Date Prepared: | September 14, 2001 |
| 7. Device Trade Name: | HI-TORQUE WHISPER™ LS and MS Guide Wires
with Hydrocoat Hydrophilic Coating |
| 8. Device Common Name: | Guide Wire |
| 9. Device Classification Name: | Catheter Guide Wire (74DQX) |
| 10. Predicate Device: | HI-TORQUE WHISPER™ LS and MS Guide Wires
with Hydrocoat Hydrophilic Coating (K002206) |
11. Device Description:
The HI-TORQUE WHISPER™ LS and MS Guide Wires with Hydrocoat Hydrophilic The II - Ore Quide 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 extendable lengths and a 500 em enemange compression 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 tapes in diamover to the up. Thathew re- wire is jacketed with a polyurethane coating that is coated with a hyrophilic coating. The proximal section of the wire is coated with 13 couted with a hyropinias countal tips of the guide wires are available either as a straight tip that is shapeable, or as a pre-shaped "J".
12. Intended Use:
To facilitate the placement of balloon dilatation catheters during percutaneous ro raomate the pracement of one of CA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.
1
13. Technological Characteristics:
There are no changes to the technological characteristics.
- Performance Data:
In vitro bench testing demonstrated that the HI-TORQUE WHISPER™ Guide Wires met
the acceptance criteria and is acceptable for clinical use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Ms. Jennifer Pae Riggs Sr. Regulatory Affairs Coordinator Guidant Corporation 26531 Ynez Road Temecula, CA 92589-9018
K013092 Re:
K013092
HI-TORQUE™ WHISPER LS and MS Guide Wires with Hydrocoat Hydrophilic Coating Regulation Number: 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: September 14, 2001 Received: September 17, 2001
Dear Ms. Riggs:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(x) premained is substantially equivalent (for the indications felerenced above and nave determined the arredicate devices marketed in interstate for use stated in the ciclosure) to regally names of the Medical Device Amendments, or to commence prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been icclassified in acceraanse was a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA and Cosment Act (Act) that to not requent of the general controls provisions of the Act. The I ou may, merciolo, market the act include requirements for annual registration, listing of general controls provisions of the reviles, 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 IT your device is classified (500 a0010) als. Existing major regulations affecting your device can inay be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may or found in the Oous cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least of advised that I Dris issualites our device complies with other requirements of the Act that I DT has made a active and regulations administered by other Federal agencies. You must of any I cacial statutes and regaranents, including, but not limited to: registration and listing (21 compy with an tale 110 (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Ms. Jennifer Pae Riggs
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 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 21 CFR Part 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) 594-4639. 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,
K. Donka Telle
am Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
KO13092 510(k) Number (if known): _ HI-TORQUE WHISPER™ LS (Light Support) Guide Wire with Device Names: . Hydrocoat Hydrophilic Coating
- HI-TORQUE WHISPER™ MS (Middle Support) Guide Wire . with Hydrocoat Hydrophilic Coating
To facilitate the placement of balloon dilatation catheters during Indications PTCA), 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)
Division of Cardiovascular & Respiratory Devices
510(k) Number K015092
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter_ (Optional Format 1-1-96)