(181 days)
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No
The description focuses on the physical construction and performance characteristics of a guide wire, with no mention of AI or ML technologies.
No
The device is a guide wire intended to facilitate the placement of other devices, not to provide therapy itself.
No
Explanation: The device is a guide wire intended to facilitate the placement of diagnostic and therapeutic devices, but it is not itself a diagnostic device.
No
The device description clearly states it is a physical guide wire constructed from stainless steel, urethane resin, and a hydrophilic coating, and bench testing was performed on the physical properties of the wire.
Based on the provided information, the HYDROCORE™ Guide Wire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "facilitate the placement of diagnostic and therapeutic devices during intravascular procedures." This describes a device used within the body to aid in medical procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical guide wire used for navigation within blood vessels. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the HYDROCORE™ Guide Wire is an intravascular medical device, not an IVD.
N/A
Intended Use / Indications for Use
The HYDROCORE™ Guide Wire is intended to facilitate the placement of diagnostic and therapeutic devices during intravascular procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The HYDROCORE™ Guide Wire is a 150 cm length guide wire is available in nominal diameters of 0.025", 0.032", 0.035" and 0.038″, with shaft stiffness variations of: soft, standard, and extra stiff. The wires come in straight and angled tip configurations. The wire is constructed from a stainless steel core wire that is encased in a urethane resin and surfaced with a hydrophilic coating. The urethane casing contains radiopaque properties.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to demonstrate that the HYDROCORE™ Guide Wire met the acceptance criteria of the product specifications and performed similar to that of the predicate. The following bench tests were performed: tensile strength test, torque strength test, tip flexibility, torqueability and coating adhesion and integrity test.
The results from the bench tests showed that the new HYDROCORE™ Guide Wire met the acceptance criteria and performed in a manner equivalent the predicate device. No new safety or effectiveness issues were raised during the testing program.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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3/23/99
99
510(k) SUMMARY
This 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. |
|----|-----------------------------|--------------------------------------------------------------------------------------------|
| | Submitter's Address: | 3200 Lakeside Drive
Santa Clara, CA 95054 |
| | Telephone: | 408-235-3995 |
| | Fax: | 408-235-3743 |
| | Contact Person: | Margaret Anderson |
| | Date Prepared: | September 21, 1998 |
| 2. | Device Trade Name: | HYDROCORE™ Guide Wire |
| | Device Common Name: | Guide Wire |
| | Device Classification Name: | Catheter Guide Wire (74DQX) |
| 3. | Predicate Device: | ACS HI-TORQUE WHOLEY SUPRA CORE™
Guide Wire
Terumo® Radifocus® Glidewire® Guide Wire |
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- Device Description:
The HYDROCORE™ Guide Wire is a 150 cm length guide wire is available in nominal diameters of 0.025", 0.032", 0.035" and 0.038″, with shaft stiffness variations of: soft, standard, and extra stiff. The wires come in straight and angled tip configurations. The wire is constructed from a stainless steel core wire that is encased in a urethane resin and surfaced with a hydrophilic coating. The urethane casing contains radiopaque properties.
- Device Description:
-
న. Intended Use:
The HYDROCORE™ Guide Wire is intended to facilitate the placement of diagnostic and therapeutic devices during intravascular procedures. -
Q. Technological Characteristics:
Comparisons of the new and predicate devices show that the technological characteristics such as design, materials, functional performance properties, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate devices.
1
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- Performance Data:
Bench testing was performed to demonstrate that the HYDROCORE™ Guide Wire met the acceptance criteria of the product specifications and performed similar to that of the predicate. The following bench tests were performed: tensile strength test, torque strength test, tip flexibility, torqueability and coating adhesion and integrity test.
- Performance Data:
The results from the bench tests showed that the new HYDROCORE™ Guide Wire met the acceptance criteria and performed in a manner equivalent the predicate device. No new safety or effectiveness issues were raised during the testing program.
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- Conclusions:
The new guide wire has a similar intended use, and has the same technological characteristics, performance properties, identical sterilization and packaging as those of the predicate devices. Furthermore, the results from the bench tests showed that no new safety or effectiveness issues were raised during the testing program. Therefore, the HYDROCORE™ Guide Wire may be considered substantially equivalent to the predicate ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire and the Terumo® Radifocus® Glidewire® Guide Wire.
- Conclusions:
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. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1999
Ms. Margaret Anderson Regulatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 3200 Lakeside Drive Santa Clara, CA 95054
Re: K983346
Trade Name: HYDROCORE™ Guide Wire Requlatory Class: II Product Code: DQX Dated: January 25, 1999 Received: January 26, 1999
Dear Ms. 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 You may, therefore, market the device, subject to the Act (Act). 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 Regulations, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to
3
Paqe 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 regulations.
This letter will allow you to begin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. 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. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name:
HYDROCORE™ Guide Wire
Indications for Use:
The HYDROCORE™ Guide Wire is intended to facilitate the placement of diagnostic and therapeutic devices during intravascular 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)
OR
Over-The-Counter (Optional Format 1-1-96)
Oktoph Mthonlor TTC
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number