ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.

K990639 · Guidant Corp. · DQX · Mar 25, 1999 · Cardiovascular

Device Facts

• Record ID: K990639
• Device Name: ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.
• Applicant: Guidant Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Device Story

Steerable guide wire used by physicians during PTCA/PTA procedures to facilitate balloon dilatation catheter placement. Device consists of stainless steel core wire (0.014" diameter) with distal radiopaque tip (straight or J-shape) and hydrophilic coating; proximal section coated with polytetrafluoroethylene. Available in 175 cm, 190 cm, and 300 cm lengths. 190 cm models feature tapered proximal end for compatibility with ACS DOC® Guide Wire Extension. 300XT model utilizes gold solder. Device functions as mechanical guide for catheter navigation through vasculature. Clinical benefit derived from improved steerability and trackability during interventional procedures.

Clinical Evidence

Bench testing only. Functional testing included Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test, and Tip Flexibility Test. Results demonstrated that the subject devices met all acceptance criteria and performed equivalently to the predicate devices.

Technological Characteristics

Stainless steel core wire; distal radiopaque tip; hydrophilic coating on distal portion; polytetrafluoroethylene coating on proximal section; 0.014" diameter; 175 cm, 190 cm, and 300 cm lengths; gold solder used in 300XT model; steerable design.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) to facilitate the placement of balloon dilatation catheters.

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 CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K981381)
• ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K982083)
• Commander, Standard, Steerable Guide Wire; C.R. Bard, Inc. (K961271)

Submission Summary (Full Text)

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3/25/99

K990639

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# 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<br>Advanced Cardiovascular Systems, Inc. |
|-----------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter's<br>Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95054 |
| | 3. Telephone: | 408-235-3995 |
| 4. | Fax: | 408-235-3743 |
| 5. | Contact Person: | Margaret Anderson |
| 6. | Date Prepared: | February 25, 1999 |
| 7. | Device Trade<br>Name: | • ACS HI-TORQUE CROSS-IT™ 100XT Guide Wire with<br>HYDROCOAT™ Hydrophilic Coating<br>• ACS HI-TORQUE CROSS-IT™ 200XT Guide Wire with<br>HYDROCOAT™ Hydrophilic Coating<br>• ACS HI-TORQUE CROSS-IT™ 300 XT Guide Wire with<br>HYDROCOAT™ Hydrophilic Coating |
| 8. | Device Common<br>Name: | Guide Wire |
| 9. | Device<br>Classification<br>Name: | Catheter Guide Wire (74DQX) |
| 10. Predicate Device: | | ACS HI-TORQUE CROSS-IT™ Guide Wire with<br>HYDROCOAT™ Hydrophilic Coating (K981381) |
| | | ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide<br>Wire with HYDROCOAT™ Hydrophilic Coating (K982083) |
| | | Commander, Standard, Steerable Guide Wire; C.R. Bard, Inc.<br>(K961271) |

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- 11. Device Description:
The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires 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 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The wire is constructed from a stainless steel core wire, with varying core lengths and diameters for each design. 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.

- 12. Intended Use:
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

- 13. 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 devices. The design modifications of the new guide wires compared to that of the predicate wire are the lengths and diameters of the core wire sections. The 300XT design is manufactured with a gold solder.

14. Performance Data:

In vitro bench testing and in vivo performance evaluations were performed to demonstrate that the ACS HI-TORQUE CROSS-IT™ XT family of guide wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate devices. 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 ACS HI-TORQUE CROSS-IT™ XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE CROSS-IT™ and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program.

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#### 15. Conclusions

Since the new guide wires have the same intended use, technological characteristics, performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the ACS HI-TORQUE CROSS-IT™ 100XT, 200XT and 300XT Guide Wires with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE CROSS-IT™ Guide Wires with HYDROCOAT™ Hydrophilic Coating, the ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the Commander, Standard, Steerable Guide Wire.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

Ms. Marqaret Anderson Requlatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 3200 Lakeside Drive Santa Clara, CA 95054

Re: K990639

> ACS HI-TORQUE CROSS-IT™ 100XT, 200XT and 300XT Guide Trade Name: Wires with HYDROCOAT™ Hydrophilic Coating Requlatory Class: II Product Code: DOX Dated: February 25, 1999 Received: February 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 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. Existing major regulations 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 requlation (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

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Page 2 - Ms. Margaret Anderson

your device in the Federal Register. Please note: this response to 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 vour 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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### ATTACHMENT 2

## Indications for Use Statement 510(k) Number (if known) ACS HI-TORQUE CROSS-IT™ 100XT Guide Wire with HYDROCOAT™ Device Name Hydrophilic Coating ACS HI-TORQUE CROSS-IT™ 200XT Guide Wire with HYDROCOAT™ Hydrophilic Coating ACS HI-TORQUE CROSS-IT™ 300XT Guide Wire with HYDROCOAT™ Hydrophilic Coating The ACS HI-TORQUE CROSS-IT™ 100XT, 200XT and 300XT Guide Wire Indications for with HYDROCOAT™ Hydrophilic Coating family of guide wires' intended Use use is: To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

المل المستمبر المسلم المستمبر المسلمين والمسلمين المستقل المستقل المستوى المستوى المستوى المستوى المستقل المستقل المستقل المستوى المستوى المستوى المستقل المستقل المستقل المس Prescription Use __

Use (Per 21 CFR 801.109)

OR Over-The-Counter

(Division Sign-Off)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K990639 510(k) Number_

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