AGILITY STEERABLE GUIDEWIRE

K991646 · Cordis Neurovascular, Inc. · DQX · Sep 23, 1999 · Cardiovascular

Device Facts

• Record ID: K991646
• Device Name: AGILITY STEERABLE GUIDEWIRE
• Applicant: Cordis Neurovascular, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Cordis AGILITY™ Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

Device Story

AGILITY Steerable Guidewires are medical devices used to facilitate the placement of microcatheters and other interventional devices within the neuro and peripheral vasculature. The device consists of a stainless steel wire core and a radiopaque platinum/tungsten distal tip coil, featuring a hydrophilic coating to enhance navigation. It is supplied with a steering/torquing device and a guidewire introducer. The device is operated by a physician in a clinical setting (e.g., interventional suite) to navigate complex vascular anatomy. By providing steerability and torque response, the guidewire allows for precise positioning of therapeutic or diagnostic devices, potentially improving procedural outcomes and reducing trauma to the vasculature.

Clinical Evidence

No clinical data. Evidence consists of in-vitro bench testing (tensile, torque strength, torque response, tip flexibility, lubricity, kink resistance) and animal study testing, which confirmed the device functions as intended. Biocompatibility testing was successfully completed.

Technological Characteristics

Stainless steel wire core; radiopaque platinum/tungsten distal tip coil; hydrophilic coating. Includes steering/torquing device and guidewire introducer. Mechanical device; no energy source or software.

Indications for Use

Indicated for selective placement of microcatheters and other devices within the neuro and peripheral vasculature in patients requiring endovascular procedures.

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

• Dasher® - 10 (Target Therapeutics)
• TRANSEND™ Guidewire (Target Therapeutics (BSC))
• INSTINCT™ Guidewire (Cordis Corporation)
• ESSENCE™ Guidewire (Cordis Endovascular Systems, Inc. (CES))

Submission Summary (Full Text)

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SEP 2 3 1999

K991646
0-000032

## 510(k) Summary of Safety and Effectiveness

| Submitter's Name/Contact Person | Alina Caraballo<br>Regulatory Affairs Manager<br>Cordis Endovascular Systems<br>14000 NW 57 Court<br>Miami Lakes, FL 33014<br>Tel: [phone] |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | The trade name is :<br><ul><li>AGILITY™ Steerable Guidewires.</li></ul> |
| Classification | This is a Class II Device. |
| Performance Standard | The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this device. |
| Device Description | The hydrophilically coated AGILITY Steerable Guidewires consist of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. Guidewire length, diameter, and distal tip configuration are indicated on the product label. A steering/torquing device and a guidewire introducer are packaged with the AGILITY Guidewire. |
| Intended Use | The Cordis AGILITY™ Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature. |

Continued on next page

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## 510(k) Summary of Safety and Effectiveness, Continued

| Device | Company | Product Code | Predicate for: |
|------------------------|--------------------------------------------|--------------|-----------------------------------------------------------------------------------------------------------------|
| Dasher® - 10 | Target Therapeutics | DQX | • Intended use<br>• Sterilization<br>• method<br>• Design<br>• Corewire and coil<br>• material<br>• Performance |
| TRANSEND™<br>Guidewire | Target Therapeutics<br>(BSC) | DQX | • Hydrophilic<br>• coating |
| INSTINCT™<br>Guidewire | Cordis Corporation | DQX | • Intended Use<br>• Sterilization<br>• Packaging |
| ESSENCE™<br>Guidewire | Cordis Endovascular<br>Systems, Inc. (CES) | DQX | • Intended Use<br>• Sterilization<br>• Manufacturing |

The predicate devices are listed in the table below: Predicate Devices

In-vitro testing showed that the Agility Guidewire performs as well or better than the Summary of predicate devices tested. No new questions of safety and effectiveness were raised. Studies Comparative testing included:

- Tensile Test
- Torque Strength .
- . Torque Response
- . Tip Flexibility
- . Lubricity Testing
- Kink Resistance .

Animal study testing indicated that the device works as intended.

All appropriate biocompatibility tests were successfully performed on the materials used to manufacture the AGILITY™ Guidewire.

The AGILITY™ Steerable Guidewire is similar in its basic design, construction, indication Summary of for use, and performance characteristics to the predicate devices. Substantial Equivalence

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an abstract caduceus symbol with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.

Public Health Service

SEP 2 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Alina Caraballo Manager, Regulatory Affairs Cordis Endovascular Systems P.O. Box 025700 Miami, FL 33102-5700

K991646 Re : AGILITY™ Steerable Guidewires Trade Name: Requlatory Class: II Product Code: DOX September 13, 1999 Dated: Received: September 14, 1999

Dear Ms. Caraballo:

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 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 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 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 obliqation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Ms. Alina Caraballo

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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number: k991646

## Indications for Use Statement

The Cordis Endovascular AGILITY™ Steerable Guidewires are intended for selective placement of microcatheters and other devices within the neuro and peripheral vasculature.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use /
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Chtopm. A

Division Sign-Off)

ISIR Intravascular Respiratory,

S No & Devices

PMK Number K991646