Who is the manufacturer of HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282?

Guidant Corp. filed the 510(k) submission for HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 (K982876).

What is the FDA product code for HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282?

ACS HI-TORQUE IRON MAN™ Guide Wire (K963702); Medi-tech Platinum Plus™ Guide Wire (K945379).

Who can help prepare an FDA 510(k) submission like HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282

K982876 · Guidant Corp. · DQX · Nov 10, 1998 · Cardiovascular

Device Facts

Record ID	K982876
Device Name	HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282
Applicant	Guidant Corp.
Product Code	DQX · Cardiovascular
Decision Date	Nov 10, 1998
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1330
Device Class	Class 2

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.

Device Story

Steerable guide wire; 0.018-inch diameter; 130 cm, 190 cm, and 300 cm lengths. Used by physicians during intravascular procedures to navigate and position diagnostic or therapeutic devices. Manual operation. Bench testing confirms performance equivalence to predicate wires regarding tip pull, turns-to-failure, rotational accuracy, and tip flexibility.

Clinical Evidence

Bench testing only. Tests included distal tip pull, turns-to-failure, rotational accuracy, and tip flexibility. Results met acceptance criteria and demonstrated equivalence to predicate devices.

Technological Characteristics

0.018-inch diameter steerable guide wire; available in 130 cm, 190 cm, and 300 cm lengths. Materials, biocompatibility, and performance properties are substantially equivalent to predicates. Sterilization and packaging identical to predicates.

Indications for Use

Indicated for facilitating placement and exchange of diagnostic and therapeutic devices during intravascular procedures. Contraindicated for use in cerebral vasculature.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

ACS HI-TORQUE IRON MAN™ Guide Wire (K963702)
Medi-tech Platinum Plus™ Guide Wire (K945379)

Related Devices

K980119 — ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE · Guidant Corp. · Mar 20, 1998
K200144 — HI-TORQUE Steelcore Bare Guide Wire · Abbott Vascular · Apr 8, 2020
K980360 — SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES · Scimed Life Systems, Inc. · Apr 29, 1998
K133155 — HYDROPHILIC COATED GUIDEWIRE · Lake Region Medical · Apr 7, 2014
K983033 — ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE · Guidant Corp. · Nov 10, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ K982876 NOV 10 1998 .. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 76 ## APPENDIX VI ## 510(k) SUMMARY {1}------------------------------------------------ K982876 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 Corporation<br>Advanced Cardiovascular Systems, Inc. | |----|----------------------|--------------------------------------------------------------| | | Submitter's Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95054 | | | Telephone: | 408-235-3995 | | | Fax: | 408-235-3743 | | | Contact Person: | Susan Silavin, Ph.D. | | | Date Prepared: | August 13, 1998 | 2. Device Trade Name: HI-TORQUE STEELCORE™ 18 Guide Wire > Device Common Name: Guide Wire Device Classification Name: Catheter Guide Wire (74DQX) - 3. Predicate Devices: ACS HI-TORQUE IRON MAN™ Guide Wire (K963702, approved January 22, 1997) Medi-tech Platinum Plus™ Guide Wire (K945379, approved June 5, 1995) - 4. 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. {2}------------------------------------------------ - 6. 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. - 7. 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: - . 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. - 8. 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. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line. The text is likely part of a document or sign. 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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.