SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017

K991059 · Spectranetics Corp. · DQY · Nov 16, 1999 · Cardiovascular

Device Facts

• Record ID: K991059
• Device Name: SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017
• Applicant: Spectranetics Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed for patients needing vascular intervention.

Device Story

Coronary intravascular catheter; used to support guidewire, assist in guidewire exchange/placement in distal vessels, and deliver saline or diagnostic contrast agents. Used in clinical settings by physicians during vascular interventions. Device provides mechanical support and conduit functionality. Benefits include improved guidewire navigation and delivery of diagnostic media to target vessels.

Clinical Evidence

Bench testing only. No clinical data provided. Validation included FMECA and testing for tensile strength, bond joints, tracking, visibility, flow rate, wire movement, sterility, and biocompatibility.

Technological Characteristics

Coronary intravascular catheter. Materials evaluated for biocompatibility (hemolysis, MEM cytotoxicity, dermal sensitization). Mechanical characteristics include tensile strength, bond joint integrity, tracking, and flow rate performance. Sterility maintained per standard requirements.

Indications for Use

Indicated for patients requiring vascular intervention who need coronary intravascular catheter support for guidewire exchange, guidewire placement in distal vessels, or delivery of saline/diagnostic contrast agents.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Medtronic Buchbinder Transfer Catheters (K935425)

Submission Summary (Full Text)

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NOV I 6 1999

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K99 1059
BRILLIANCE IN INTERVENTIONAL THERAPY

Submitted By: Adrian E. Elfe. CQM, RAC Vice President, Quality Assurance and Regulatory Affairs Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907 Signature and Date:

510(k) Summary

Device Trade Name:

The device trade name is Spectranetics Support Catheter. The generic name for this device is percutaneous catheter.

The Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed for patients needing vascular intervention. Predicate devices of this type with similar intended uses have been classified into Class II.

Substantial Equivalence:

This product is similar in design, composition, and function to the Medtronic Buchbinder Transfer Catheters, 510(k) K935425.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990 and 21 CFR 807.92.

The Spectranetics Support Catheters are similar in basic design, construction, mechanical safety, indications, target population, risk analysis, performance and materials to the predicate device. Spectranetics New Product Introduction procedure has been faithfully followed in concert with the quality systems regulations for new production. The design validation protocols and the Design Failure Mode, Effect and Criticality Analysis (FMECA), addressed all known risks associated with the device including tensile strength, bond joints. tracking, visibility, flow rate, wire movement, sterility and biocompatibility including hemolysis, MEM cytotoxicity and dermal sensitization. Testing performed for the Spectranetics Support Catheter provides reasonable assurance that the devices will perform in a safe and effective manner when used as indicated.

> THE SPECTRANETICS CORPORATION 96 TALAMINE COURT • COLORADO SPRINGS, COLORADO 80907-5186 TEL [phone] · 800.6333.0960 · FAX [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 6 1999

Mr. Michael J. Quinn Director of Requlatory Affairs Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907-5186

Re: K991059 Spectranetics Support Catheter Trade Name: Regulatory Class: II Product Code: DQY Dated: October 21, 1999 October 22, 1999 Received:

Dear Mr. Quinn:

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 Regulation (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

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Page 2 - Mr. Michael J. Quinn

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 requlations.

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]. 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,

Christopher Martin

Celia M. Witten, Ph.D., 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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## BRILLIANCE IN INTERVENTIONAL THERAPY

| Applicant: | Spectranetics Corporation |
|------------|----------------------------|
| | 96 Talamine Court |
| | Colorado Springs, CO 80907 |

510(k):

Spectranetics Support Catheter Device Name:

> Statement of Indications for Use Spectranetics Support Catheter

The Spectranetics Support Catheter is a coronary intravascular catheter used to support a guidewire, to assist in guidewire exchange or placement in distal vessels, and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. It is designed for patients needing vascular intervention.

Christopher Arthur Witten

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 199117 510(k) Number

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