ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

K980294 · Guidant Corp. · DQX · Apr 24, 1998 · Cardiovascular

Device Facts

• Record ID: K980294
• Device Name: ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Applicant: Guidant Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is steerable wire intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is also intended to facilitate the placement of equipment, such as atherectomy and stent devices, during other diagnostic and therapeutic intravascular procedures.

Device Story

Steerable guide wire; 0.014" diameter; 190 cm or 300 cm lengths. Features radiopaque tip; available in straight or pre-shaped 'J' configurations. Proximal shaft coated with PTFE; distal portion features HYDROCOAT™ hydrophilic coating to facilitate movement within 0.014" devices. Used by physicians in clinical settings during intravascular procedures to navigate and position interventional equipment (catheters, stents, atherectomy devices). Facilitates access to target vasculature; aids in successful placement of therapeutic devices. Proximal end of 190 cm model compatible with ACS DOC® Guide Wire Extension.

Clinical Evidence

No human clinical data. Evidence consists of bench testing (accelerated aging, tip pull, turns-to-failure, rotational accuracy, tip flexibility, coating adherence) and in vivo animal testing (canine model, healthy coronary arteries). Results demonstrated performance equivalent to predicate devices.

Technological Characteristics

Steerable guide wire; 0.014" nominal diameter. Materials: radiopaque tip, PTFE-coated proximal shaft, hydrophilic coating. Energy source: manual manipulation. Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA), or other diagnostic and therapeutic intravascular procedures requiring placement of balloon dilatation catheters, atherectomy, or stent devices. Contraindicated for use in the 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)
• ACS HI-TORQUE®BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K973494)

Reference Devices

• ACS DOC® Guide Wire Extension (K902755)

Submission Summary (Full Text)

{0}------------------------------------------------

# APR 2 4 1998

4980294

# 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 95052 | |
| | Telephone: | 408-235-3480 | |
| | Fax: | 408-235-3743 | |
| | Contact Person: | David Kolesar | |
| | Date Prepared: | January 26, 1998 | |
| 2. | Device Trade Name: | ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with<br>HYDROCOAT™ Hydrophilic Coating ACS HI-TORQUE® | |
| | Device Common Name: | Guide Wire | |
| | Device Classification Name: | Catheter Guide Wire (74DQX) | |
| 3. | Predicate Device: | ACS HI-TORQUE® IRON MAN™ Guide Wire (K963702) | |
| | | ACS HI-TORQUE®BALANCE™ Guide Wire with<br>HYDROCOAT™ Hydrophilic Coating (K973494) | |

#### 4. Device Description:

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire with a nominal diameters of 0.014" and two lengths: a 190 cm extendable length 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 (K902755, September 4, 1990).

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating has a radiopaque tip and is are available with either a straight tip configuration, which allows the physician to shape the guide wire tip in a preferred shape, or a pre-shaped "J" tip configuration, which allows the physician the convenience using a guide wire with the tip pre-shaped.

The hydrophilic coating is intended to facilitate wire movement within 0.014" diameter devices. The proximal shaft of the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is coated with polytetrafluoroethylene (PTFE).

131

{1}------------------------------------------------

- న. Intended Use:
The the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating have the following intended uses:

- To facilitate the placement of balloon dilatation catheters during percutaneous . transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
- The wire is also intended to facilitate the placement of equipment such as . atherectomy and compatible stent devices during other diagnostic and therapeutic intravascular procedures.
- Technological Characteristics: 6.

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 device

- 7. Performance Data:
Bench testing was performed to demonstrate that the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate ACS HI-TORQUE® IRON MAN™ Guide Wire. The following tests were performed:

- Accelerated Aging .
- . Distal Tip Pull Test
- . Distal Tip Turns-to-Failure Test
- . Rotational Accuracy Test
- . Tip Flexibility Test
- Coating Adherence/Integrity .

{2}------------------------------------------------

In vivo animal testing in a canine model with healthy coronary arteries was performed to demonstrate performance properties of the the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating in comparison to the predicate guide wire. The results showed that the new wires performed in an equivalent manner to the predicate devices.

The results from the bench tests plus the animal testing showed that the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the ACS HI-TORQUE® IRON MAN™ Guide Wire. No new safety or effectiveness issues were raised during the testing program.

#### 8. Conclusions:

Since the new guide wires have the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the the ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the ACS HI-TORQUE® IRON MAN™ Guide Wire.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 1998

Mr. David Kolesar Senior Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95052

Re: K980294 ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Trade Name: Hydrocoat™ Hydrophilic Coating Requlatory Class: II Product Code: DQX January 26, 1998 Dated: Received: January 27, 1998

Dear Mr. Kolesar:

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 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 reqistration, 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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

{4}------------------------------------------------

#### Page 2 - Mr. Melinyshyn

concerning 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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. Callahon

Thomas J. Callaman, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### INDICATION FOR USE STATEMENT

### DEVICE NAME:

ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating

#### INDICATIONS FOR USE:

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is steerable wire intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating is also intended to facilitate the placement of equipment, such as atherectomy and stent devices, during other diagnostic and therapeutic intravascular procedures.

# CONTRAINDICATIONS:

The ACS HI-TORQUE® SUPER S'PORT™ Guide Wire with Hydrocoat™ Hydrophilic Coating 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)

| (Division Sign-Off) | <div style="text-align:center;"> <img alt="signature" height="30" src="signature.png" width="100"/> </div> |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Div. of Cardiovascular, Respiratory,<br>and Neurological Devices | |
| 510(k) Number | K980294 |

| Prescription Use<br>(Per 21 CFR 801.109 | OR | Over-The-Counter<br>(Optional Format 1-1-96) |
|----------------------------------------------------------------------------------|----|----------------------------------------------|
| <div> <img alt="check mark" height="20" src="check_mark.png" width="20"/> </div> | | |