(88 days)
The HI-TORQUE STEELCORE™18 Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.
The HI-TORQUE STEELCORE™ 18 Guide Wire is a steerable guide wire with a nominal diameter of 0.018 inches and three lengths: a 130 cm, a 190 cm and a 300 cm exchange length.
The provided text describes the performance testing for the HI-TORQUE STEELCORE™ 18 Guide Wire.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Distal Tip Pull Test | Met acceptance criteria and performed similar to predicate guide wires. |
| Turns-to-Failure Test | Met acceptance criteria and performed similar to predicate guide wires. |
| Rotational Accuracy Test | Met acceptance criteria and performed similar to predicate guide wires. |
| Tip Flexibility Test | Met acceptance criteria and performed similar to predicate guide wires. |
2. Sample size used for the test set and the data provenance:
The document mentions "bench testing" but does not specify the sample size for the test sets used for each test. Furthermore, there is no information provided regarding the country of origin of the data or whether the tests were retrospective or prospective. Given that this is bench testing, it is generally considered prospective, as the tests are conducted for the specific purpose of evaluating the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The performance data is based on physical bench tests, not on expert interpretations of medical images or data requiring ground truth established by medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not in physical bench testing.
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:
This information is not applicable. This device is a guide wire, and the study involves bench testing of its physical properties, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a medical instrument, not an algorithm. The "standalone" performance here refers to the device's inherent physical properties as tested in the bench environment, without human interaction during the test itself (though humans operate the testing equipment).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the bench tests would be the established engineering specifications and performance standards for guide wires, along with comparative data from predicate devices. The tests directly measure physical properties against these predefined criteria.
8. The sample size for the training set:
This information is not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set.
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NOV 10 1998
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76
APPENDIX VI
510(k) SUMMARY
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77
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: | Susan Silavin, Ph.D. | |
| Date Prepared: | August 13, 1998 |
- Device Trade Name: HI-TORQUE STEELCORE™ 18 Guide Wire
Device Common Name: Guide Wire
Device Classification Name: Catheter Guide Wire (74DQX)
-
- Device Description:
The HI-TORQUE STEELCORE™ 18 Guide Wire is a steerable guide wire with a nominal diameter of 0.018 inches and three lengths: a 130 cm, a 190 cm and a 300 cm exchange length.
- న్. Intended Use:
The HI-TORQUE STEELCORE™ 18 Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.
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-
- Technological Characteristics:
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties (see below), sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate devices.
- Technological Characteristics:
-
- Performance Data:
Bench testing was performed to demonstrate that the HI-TORQUE STEELCORE™ 18 Guide Wire met the acceptance criteria and performed similar to the predicate guide wires. The following tests were performed:
- Performance Data:
-
. Distal Tip Pull Test
-
Turns-to-Failure Test .
-
Rotational Accuracy Test ●
-
Tip Flexibility Test .
The results from the bench tests showed that the new HI-TORQUE STEELCORE™ 18 Guide Wire met acceptance criteria and performed in a manner equivalent to the predicate guide wires. No new safety or effectiveness issues were raised during the testing program.
-
- Conclusions:
Since the new guide wire has the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the HI-TORQUE STEELCORE™ 18 Guide Wire may be considered substantially equivalent to the predicates, ACS Hi-Torque IRON MAN™ and the Medi-tech Platinum Plus™ Guide Wires.
- Conclusions:
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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" written around it.
NOV 1 0 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Susan Silavin, Ph.D. Senior Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95054
K982876 Re: HI-TORQUE STEELCORE™ 18 Guide Wire Trade Name: Regulatory Class: II Product Code: DQX Dated: August 13, 1998 Received: August 14, 1998
Dear Dr. Silavin:
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 leqally 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. Existinq major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 Please note: this response to your premarket Federal_Reqister. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices
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Paqe 2 - Dr. Susan Silavin
under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 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 regulation 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. Callahon
Thomas J. Callahan, 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: HI-TORQUE STEELCORE™ 18 Guide Wire
Indications for Use:
The HI-TORQUE STEELCORE™18 Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.
(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)
TT Callahan
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices K982876
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.