(181 days)
The HYDROCORE™ Guide Wire is intended to facilitate the placement of diagnostic and therapeutic devices during intravascular procedures
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HYDROCORE™ Guide Wire:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Tensile Strength Test | Met acceptance criteria and performed similar to predicate devices. |
| Torque Strength Test | Met acceptance criteria and performed similar to predicate devices. |
| Tip Flexibility Test | Met acceptance criteria and performed similar to predicate devices. |
| Torqueability Test | Met acceptance criteria and performed similar to predicate devices. |
| Coating Adhesion and Integrity Test | Met acceptance criteria and performed similar to predicate devices. |
| No New Safety/Effectiveness Issues | "No new safety or effectiveness issues were raised during the testing program." |
| Substantial Equivalence to Predicate Devices | The device was found to have "similar intended use, and has the same technological characteristics, performance properties, identical sterilization and packaging as those of the predicate devices." Based on bench tests, it was concluded to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "bench testing," implying a set of physical devices were tested, but the number of guide wires used for each test is not provided.
- Data Provenance: The study was a bench test, meaning it was conducted in a laboratory setting, not on patient data. Therefore, concepts like "country of origin" or "retrospective/prospective" don't apply in the traditional clinical trial sense for this type of testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of information is not applicable to this study. Bench tests rely on objective physical measurements against predefined engineering specifications (acceptance criteria) rather than expert interpretation of complex data (like medical images).
4. Adjudication Method for the Test Set
- None. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple experts when establishing ground truth from subjective data. Since this study involved objective bench testing against pre-defined specifications, no human adjudication was required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This was a bench test of a medical device (guide wire), not an AI-powered diagnostic tool. Therefore, an MRMC study or any assessment of human reader improvement with AI assistance is not relevant and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. The device is a physical guide wire, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for this study was established using predefined engineering specifications and performance characteristics for guide wires. The device's performance in tensile strength, torque strength, tip flexibility, torqueability, and coating adhesion/integrity was measured and compared against these objective criteria and the performance of predicate devices.
8. The Sample Size for the Training Set
- This concept is not applicable to this study. Bench testing of a physical medical device does not involve "training sets" in the context of machine learning or AI models. The device itself is not an algorithm that learns from data.
9. How the Ground Truth for the Training Set was Established
- This concept is not applicable for the reasons stated above.
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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 CorporationAdvanced Cardiovascular Systems, Inc. |
|---|---|---|
| Submitter's Address: | 3200 Lakeside DriveSanta 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 WireTerumo® Radifocus® Glidewire® Guide Wire |
-
- 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.
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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.
-
- 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:
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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
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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
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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
§ 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.