ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

K982083 · Guidant Corp. · DQX · Sep 11, 1998 · Cardiovascular

Device Facts

• Record ID: K982083
• Device Name: ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Applicant: Guidant Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 11, 1998
• Decision: SESE
• Submission Type: Traditional
• 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). The wire is also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.

Device Story

Guide wire used to facilitate placement of interventional equipment (balloon catheters, atherectomy devices, stents) during coronary and peripheral angioplasty. Device consists of stainless steel proximal core (0.014" diameter) with PTFE coating and distal segment with HYDROCOAT™ hydrophilic coating. Features include 4.5 cm radiopaque distal tip coil, available in straight or pre-shaped 'J' configurations, with optional markers at 90 cm and 100 cm. Used in clinical settings (e.g., cath lab) by physicians to navigate vasculature. Provides mechanical support and trackability for interventional devices. Benefits include improved navigation and exchange of catheters during procedures.

Clinical Evidence

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

Technological Characteristics

Stainless steel proximal core; 0.014" nominal outer diameter; PTFE coating on proximal segment; HYDROCOAT™ hydrophilic coating on distal segment; 4.5 cm radiopaque distal tip coil; straight or pre-shaped 'J' tip options; available in 175 cm, 190 cm, and 300 cm lengths.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA), or other diagnostic and therapeutic procedures requiring the placement of balloon dilatation catheters, atherectomy devices, or stents.

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 BALANCE MIDDLEWEIGHT™ Guide Wire

Submission Summary (Full Text)

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K982083

SEP 1 1 1998

#### 510(k) SUMMARY

# This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

#### Prepared By:

Lorna Tsuda Regulatory Affairs Coordinator

#### Address:

## GUIDANT CORPORATION

Advanced Cardiovascular Systems, Inc. 3200 Lakeside Drive Santa Clara, CA 95054 408-235-3995 Telephone: [phone] Fax: June -- , 1998 Date Prepared:

| Device Trade Name: | ACS HI-TORQUE BALANCE HEAVYWEIGHT™ GuideWire with HYDROCOAT™ Hydrophilic Coating |
|-----------------------------|----------------------------------------------------------------------------------|
| Device Common Name: | Guide Wire |
| Device Classification Name: | Catheter Guide Wire, 74DQX |
| Predicate Device: | ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire |

#### Device Description:

The ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with The ACS HI-TORQUE BALANCE IIIEA + With a puice with a nominal diameter of 0.014"
HYDROCOAT™ Hydrophilic Coating is a guide with a 200 cm exchange length HYDROCOAT™ Hydrophilic Coating is a gelec while and a 300 cm exchange length.
and lengths of 175 cm and 190 cm and 190 and lengths of 175 cm and 190 cm extendation of the are a soland tapered so that it has The proximal end of the 175 cm and 190 cm models and one Wire Extension. This the ability to fit into the nypotube portion of the Fred D of this guide wire to facilitate catheter
enables the physician to extend the working length of this guide wire to exchanges.

The ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with The ACS HI-TORQUE BALAINCE IILA-T THEICH Tom stainless steel proximal core
HYDROCOAT™ Hydrophilic Coating is constructed from astable wire consists of an HYDROCOAT™ Hydropinne Coating is course in consists of the wire consists of an
with a nominal outer diameter of 0.014". The first wire is consists of an
ewith a nominal oute with a nominal outer diameter of 0.017 . The wire is coated with

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polytetrafluoroethylene (PTFE) and the distal, segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.

The distal tip coil has a radiopaque length of 4.5 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The 190 cm and 300 cm guide wires have markers located 90cm and 100 cm from the distal tip.

#### Intended Use:

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 procedures.

#### 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 feature that distinguishes the new guide wires from that of the predicate wires is the tapered distal coil.

#### Performance Data:

Bench testing was performed to demonstrate that the ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire. The following tests were performed: Distal Tip Pull Test, Distal Tip Turns-to-Failure Test, Rotational Accuracy Test and Tip Flexibility Test.

The results from the bench tests showed that the new ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire. No new safety or effectiveness issues were raised during the testing program.

#### 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 BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Ghide Wire.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### SED 11 1938

Ms. Lorna Tsuda Regulatory Affairs Coordinator Guidant Corporation Advanced Cardiovascular Systems, Inc. 3200 Lakeside Dr. P.O. Box 58167 Santa Clara, CA 95054-2807

Re: K982083

> Trade Name: ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating Regulatory Class: II Product Code: DQX Dated: June 12, 1998 Received: June 15, 1998

Dear Ms. Tsuda:

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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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

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Page 2 - Ms. Lorna Tsuda

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 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 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, Respirator 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:

ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating

#### Indications for Use:

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 procedures.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Punge
(Division Sign-Off)

(Division Sign-Off) Cardiovascular, Respiratory,
and Neurological Devices and Neurological Devices 510(k) Number

K982083

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter (Optional Format 1-1-96)