ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE

K992169 · Advanced Cardiovascular Systems, Inc. · DQX · Oct 28, 1999 · Cardiovascular

Device Facts

• Record ID: K992169
• Device Name: ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
• Applicant: Advanced Cardiovascular Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 28, 1999
• 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 percutancous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Device Story

Steerable guide wire; 0.014" diameter; 175 cm, 190 cm, or 300 cm lengths. Stainless steel core wire; radiopaque distal tip (straight or J-shape); distal hydrophilic coating; proximal PTFE coating. Used by physicians in clinical settings (e.g., cath lab) to navigate vasculature and guide balloon dilatation catheters during PTCA/PTA procedures. Facilitates catheter placement; improves procedural efficiency. No software or electronic components.

Clinical Evidence

Bench testing and in vivo performance evaluations. Functional tests included tensile strength, torque strength, torqueability, and tip flexibility. Results demonstrated performance equivalent to predicate devices.

Technological Characteristics

Stainless steel core wire; 0.014" nominal diameter; distal hydrophilic coating; proximal PTFE coating. Radiopaque tip. Sterilized. Mechanical device; no software or electronic components.

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

• HI-TORQUE CROSS-IT™ 300XT Guide Wire with HYDROCOAT™ Hydrophilic Coating
• Wholey Hi-Torque Standard® 0.035" Guide Wire
• Commander, Standard, Steerable Guide Wire

Submission Summary (Full Text)

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# 1992169

OCT 28 1999

63

## 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: | 408-845-3995 |
| | Fax: | 408-845-3743 |
| | Contact Person: | Margaret Anderson |
| | Date Prepared: | July 20, 1999 |
| 2. | Device Trade Name: | HI-TORQUE CROSS-IT™ 400XT Guide Wire<br>with HYDROCOAT™ Hydrophilic Coating |
| | Device Common Name: | Guide Wire |
| | Device Classification Name: | Catheter Guide Wire (74DQX) |
| 3. | Predicate Device: | HI-TORQUE CROSS-IT™ 300XT Guide Wire<br>with HYDROCOAT™ Hydrophilic Coating |
| | | Wholey Hi-Torque Standard® 0.035" Guide Wire |
| | | Commander, Standard, Steerable Guide Wire |

#### 4. Device Description:

The ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a nominal diameter of 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 tapcred to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The wire is constructed from a stainless steel core wire. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. A hydrophilic coating is applied to the distal portion of the guide wire and the proximal section is coated with polytetrafluoroethylene.

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

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- 6. 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 wire compared to that of the predicate wire arc the coils and the dimensions of the core wire sections.

- 7. Performance Data:
In vitro bench testing and in vivo performance evaluations were performed to demonstrate that the ACS HI-TORQUE CROSS-IT™ 400XT Guide Wires with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate devices. The following functional tests were performed: Tensile Strength, Torque Strength, Torqueability and Tip Flexibility Test.

The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire. No new safety or effectiveness issues were raised during the testing program.

- 8. Conclusions:
Since the new guide wire has 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™ 400XT Guiler Guiler with HYDROCOAT™ Hydrophilic Coating may be considered substantially equivalent to the predicate ACS HI-TORQUE CROSS-IT™ 300XT Guide Wire with IIYDROCOAT™ Hydrophilic Coating, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the three branches of government.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 28 1999

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

K992169 Re :

R Frade Name: HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating Requlatory Class: II Product Code: DQX Dated: September 13, 1999 Received: September 14, 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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device commerce prior of har ee that have been reclassified in accordance with rhe 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 A substantially equivalent determination assumes compliance with 895. 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 concerning your device in the

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Page 2 - Ms. Margaret Anderson

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,

Arthur A. Ciarlusli.

Jo, Wolf Sapirstein, M.D. Acting 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:

ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating

### Indications for Use:

To facilitate the placement of balloon dilatation catheters during percutancous angin To facilitate the placement of banoon chalaton catherers and in all angloplasty
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)

*Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992169

X Prescription Use (Per 21 CFR 801.109)

OR

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