(82 days)
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 AI or ML capabilities.
No
This device is a guide wire used to facilitate the placement of other devices (balloon dilatation catheters and stent devices) during angioplasty procedures, rather than directly treating a condition itself.
No
The intended use is to facilitate the placement of other devices during procedures, not to diagnose a condition.
No
The device description clearly describes a physical guide wire with specific materials, coatings, and lengths, 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description and intended use of the HI-TORQUE PILOT™ Guide Wire clearly indicate it is a device used within the body to facilitate a medical procedure (angioplasty and stent placement). It is a tool for navigating blood vessels, not for analyzing biological samples.
The device is an invasive medical device used in interventional cardiology and peripheral vascular procedures.
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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The HI-TORQUE PILOT™ Guide Wire with Hydrocoat Hydrophilic Coating is a guide wire with a maximum diameter of 0.0140" and is available in 175 cm and 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TORQUE PILOT™ 200 Guide Wires). The distal tip of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference; the J shapes provide the physician the convenience of a J shape without manual shaping. Brachial and femoral markers are located on the proximal segment of the 190 cm and 300 cm guide wires to indicate when the tip of the guide wire is about to exit the guide catheter. The proximal section of the wire is coated with polytetrafluroethylene (PTFE). The distal, polyurethane-covered area, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of the verification testing demonstrate that the HI-TORQUE PILOT™ 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): 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.
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
Appendix A – 510(k) Summary
| Submitter | Guidant Corporation, Vascular Intervention |
|---|---|
| Submitter's | |
| Address | 26351 Ynez Road |
| Temecula, CA 92591 | |
| Telephone | (909) 914-4527 |
| Fax | (909) 914-0339 |
| Contact Person | Stacey Brown |
| Date Prepared | February 20, 2003 |
| Device Trade | |
| Name | HI-TORQUE PILOT™ 50 Guide Wire with Hydrocoat Hydrophilic Coating |
| HI-TORQUE PILOT™ 150 Guide Wire with Hydrocoat Hydrophilic Coating | |
| HI-TORQUE PILOT™ 200 Guide Wire with Hydrocoat Hydrophilic Coating | |
| 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 PILOT™ Guide Wires with Hydrocoat Hydrophilic Coating are | |
| substantially equivalent with regard to these features in the predicate device, | |
| the HI-TORQUE WHISPER™ MS Guide Wire with Hydrocoat Hydrophilic | |
| Coating (K002206, August 24, 2000; K013092, December 13, 2001; and | |
| K020340, March 1, 2002). |
1
| Device
description | The HI-TORQUE PILOT™ Guide Wire with Hydrocoat Hydrophilic
Coating is a guide wire with a maximum diameter of 0.0140" and is available
in 175 cm and 190cm extendable lengths and a 300 cm exchange length. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | There are three HI-TORQUE PILOT™ Guide Wire designs with varying
tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150,
and HI-TORQUE PILOT™ 200 Guide Wires). |
| | The distal tip of the guide wire is available either as a straight tip that is
shapeable, or as a pre-shaped "J". The straight shape allows the physician
to shape the tip according to his/her preference; the J shapes provide the
physician the convenience of a J shape without manual shaping. Brachial
and femoral markers are located on the proximal segment of the 190 cm
and 300 cm guide wires to indicate when the tip of the guide wire is about
to exit the guide catheter. |
| | The proximal section of the wire is coated with polytetrafluroethylene
(PTFE). The distal, polyurethane-covered area, 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) and compatible stent devices. |
| Technological
characteristics | The HI-TORQUE PILOT™ Guide Wire incorporates the same fundamental
scientific technology as the predicate device. |
| Performance
data | The results of the verification testing demonstrate that the HI-TORQUE
PILOT™ 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. |
・・・・・・・・・
ﻳ
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2003
Guidant Corporation Ms. Stacey Brown Regulatory Affairs Associate 26531 Ynez Road Temecula, CA 92591-4628
Re: K030549
Trade/Device Name: HI-TOROUE PILOT™ Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: April 15, 2003 Received: April 16, 2003
Dear Ms. Brown:
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. Stacey Brown
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), please contact the Office of Compliance at (301) 594-4646. 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) you may obtain. 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,
Bram D. Zuckerman, M.D.
am D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
,
Appendix B – Indications for Use Statement
| 510(k) number (if known) | K030549 |
|---|---|
| Device name | HI-TORQUE PILOT TM 50 Guide Wire with Hydrocoat Hydrophilic Coating |
| HI-TORQUE PILOT TM 150 Guide Wire with Hydrocoat Hydrophilic Coating | |
| HI-TORQUE PILOT TM 200 Guide Wire 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) and compatible stent devices. |
PLEASE DÓ NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | ||||
| (Division Sign-Off) | ||||
| Division of Cardiovascular Devices | ||||
| 510(k) Number | K030549 |