(27 days)
Not Found
Not Found
No
The summary describes a guide wire, a mechanical device, and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: The device is described as a "guide wire" used to "facilitate the placement of balloon dilatation catheters" and "compatible stent devices." It does not directly provide therapy but rather aids in the delivery of other therapeutic devices.
No
The device is a guide wire used to facilitate the placement of other medical devices during therapeutic procedures, not to diagnose a condition.
No
The device description clearly describes physical guide wires, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a guide wire used to facilitate the placement of catheters and stents during therapeutic intravascular procedures (PTCA and PTA). This is an invasive medical device used directly within the patient's body, not for testing samples outside the body.
The information provided focuses on the physical characteristics and function of the guide wire for guiding other devices within the vasculature, which is consistent with an interventional medical device, not an IVD.
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
74 DQX
Device Description
The HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVESAL™ Guide Wires 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 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-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ 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)
Not Found
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
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: | April 17, 2002 |
| Device Trade Name: | HI-TORQUE BALANCE®
HI-TORQUE BALANCE MIDDLEWEIGHTTM
HI-TORQUE BALANCE HEAVYWEIGHT™
HI-TORQUE BALANCE TREKTM
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSALTM |
| 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 BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires are substantially equivalent with regard to these features in their predicate device.
Device Description:
The HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVESAL™ Guide Wires guide wires with a 0.014'' diameter and available in 175 cm and
1
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 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 devices show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate devices.
Performance Data:
The results of the verification testing demonstrate that the HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ 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-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires have the same intended use, technological characteristics, performance properties, identical sterilization and substantially equivalent materials. Therefore, there are no new safety or effectiveness issues. HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires are 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 & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2002
Ms. Jennifer Pae Riggs, RAC Sr. Regulatory Affairs Associate Guidant Corporation 26531 Ynez Road Temecula, CA 92591-4628
K021228 Re:
HI-TORQUE Balance® Balance Middleweight™, Balance Heavyweight™, Balance TrekTM and Balance Middleweight Universal™ Guide Wires Regulation Number: 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II (two) Product Code: 74 DQX Dated: April 17, 2002 Received: April 18, 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 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. 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,
NOahtill
Donna-Bea Tillman, Ph.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) | K021228 |
|---|---|
| Device Name | HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and the BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires |
| 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. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺎ Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Division of Cardiovascular & Respiratory Devices
510(k) Number K021225