(23 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 technologies.
No
The device is a guide wire that facilitates the placement of other therapeutic devices (e.g., balloon dilatation catheters, atherectomy devices, stent devices) but does not itself provide a therapeutic effect.
No
The device is a guide wire intended to facilitate the placement of other medical devices (balloon dilatation catheters, atherectomy devices, stent devices) during therapeutic and some diagnostic procedures, but it does not diagnose conditions itself.
No
The device description clearly describes a physical guide wire with specific dimensions, materials (hydrophilic coating, PTFE), and features (radiopaque tip, tapered ends). This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a medical procedure (PTCA, PTA, atherectomy, stenting) to facilitate the placement of other devices. This is a procedural aid, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical guide wire with specific coatings and dimensions, designed to be inserted into the body. This aligns with a medical device used in a procedure, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used in interventional procedures, 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). The wire is also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.
Product codes
DQX
Device Description
The HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire with a maximum diameter of 0.014″ 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. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.
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 and in vivo performance evaluations were performed to demonstrate that the HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate device. The following functional tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test and Tip Flexibility Test.
The results from the tests demonstrated that the new The HI-TORQUE BALANCE TREK™ Guide Wires met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire. 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
4/29/99
K991152 31
ATTACHMENT 4
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: | 408-235-3995 |
| 4. | Fax: | 408-235-3743 |
| 5. | Contact Person: | Margaret Anderson |
| 6. | Date Prepared: | April 5, 1999 |
| 7. | Device Trade Name: | HI-TORQUE BALANCE TREKTM Guide Wires with
HYDROCOATTM Hydrophilic Coating |
| 8. | Device Common Name: | Guide Wire |
| 9. | Device Classification Name: | Catheter Guide Wire
(74DQX) |
| 10. | Predicate Device: | ACS HI-TORQUE BALANCE HEAVYWEIGHTTM Guide
Wire with HYDROCOATTM Hydrophilic Coating (K982083) |
1
-
- Device Description:
The HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire with a maximum diameter of 0.014″ 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. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.
- Device Description:
-
- 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 equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.
- Intended Use:
-
- Technological Characteristics:
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate device. The design modifications of the new guide wire compared to that of the predicate wire are the modified core and tip coils.
- Technological Characteristics:
-
- Performance Data:
In vitro bench testing and in vivo performance evaluations were performed to demonstrate that the HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate device. The following functional tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test and Tip Flexibility Test.
- Performance Data:
The results from the tests demonstrated that the new The HI-TORQUE BALANCE TREK™ Guide Wires met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire. No new safety or effectiveness issues were raised during the testing program.
2
15. Conclusions
Since the new guide wire has the same intended use, materials, technological characteristics, performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE BALANCE HEA VYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Ms. Marqaret Anderson Regulatory Affairs Guidant Corporation P.O. Box 58167 Santa Clara, CA 95052
Re: K991152
HI-TORQUE BALANCE TREK™ Guide Wires with Trade Name: HYDROCOAT™ Hydrophilic Coating Requlatory Class: II Product Code: DOX Dated: April 5, 1999 Received: April 6, 1999
Dear Mr. Anderson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to
4
Page 2 - Ms. Margaret Anderson
your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin marketing your device as described in your 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callah Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ATTACHMENT 2
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | HI-TORQUE BALANCE TREK™ Guide Wires with HYDROCOAT™ Hydrophilic Coating |
| Indications for Use | The intended use for the HI-TORQUE BALANCE TREK™ Guide Wires with HYDROCOAT™ Hydrophilic Coating is: 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 equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic 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)
Use
OR
Over-The-Counter
A. Wetteng
(Division Sign-Off) Division of Cardiovascular, Respirato and Neurological Device 510(k) Number