SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028

K022138 · Spectranetics Corp. · DQY · Sep 23, 2002 · Cardiovascular

Device Facts

• Record ID: K022138
• Device Name: SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
• Applicant: Spectranetics Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Spectranetics Support Catheters are designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Story

Intravascular catheter; supports guidewire during vascular access; facilitates guidewire exchange; provides conduit for saline or diagnostic contrast agent delivery. Features 135 cm working length; radiopaque marker 2-3 mm from tapered distal tip; standard female luer proximal end; hydrophilic coating on distal 40 cm. Available in 3.0 Fr (0.014" guidewire compatible), 3.4 Fr (0.018" guidewire compatible), and 4.8 Fr (0.035" guidewire compatible) models. Used by clinicians in vascular procedures to navigate vasculature and deliver fluids.

Clinical Evidence

Bench testing only. Validation protocols addressed tensile strength, functionality, visibility, flow rate, sterility, and biocompatibility. No clinical data presented.

Technological Characteristics

Intravascular catheter; 135 cm length; hydrophilic coating on distal 40 cm; radiopaque marker; female luer connector. Materials and construction similar to predicate devices. No energy source or software.

Indications for Use

Indicated for patients requiring vascular access, guidewire support, guidewire exchange, or delivery of saline/contrast agents within the vascular system.

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

• Spectranetics Support Catheter (K991059)
• Medtronic Buchbinder Transfer Catheter (K935425)

Submission Summary (Full Text)

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## SEP 2 3 2002

**Spectranetics**

we get vour hlood flowing

## Premarket Notification 510(k) Summary

Submitted By: Michael J. Ryan RA Manager Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907 Signature and Date:

Michael J. Jr. 1 July 2002

Device Trade Name: Common Name: Classification Name:

Device Description:

Indications for Use:

Substantial Equivalence:

Spectranetics 0.035" Support Catheter. Intravascular Catheter Percutaneous Catheter, CFR 870.1250

The Spectranetics Support Catheters are intravascular catheters, available in 3 models. Model 518-016 is a 0.014 inch guidewire compatible, 3.0 French (Fr.) outside diameter catheter. Model 518-017 is a 0.018 inch guidewire compatible. 3.4 Fr. outer diameter catheter. The new device, Model 518-028 is a 0.035 inch guidewire compatible, 4.8 Fr. outer diameter catheter. All models have a working length of 135 centimeters. All models have a radiopaque marker 2-3 mm from its tapered distal tip. A standard female luer is placed on the proximal end of each model. The distal 40 cm of each model is coated with a lubricious, hydrophilic coating. Predicate devices of this type with similar intended uses have been classified into Class II.

The Spectranetics Support Catheters are designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

This product is substantially equivalent in design, composition, function, and intended use to the Spectranetics Support Catheter, 510(k) K991059, November 6, 1999, and the Medtronic Buchbinder Transfer Catheter, 510(k) K935425.

Coronary Arten Disease Therans

Cardian Lead Removal Systems

Peripheral Vascular
Disease Therapy

CVX-300 Excimer Technology TRANETICS CORPORATION 96 Talamine Court CO 80907-5186 Tel. [phone] Fax: [phone]

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## 1622138

Technological Characteristics & Nonclinical Testing Summary:

The Spectranetics Support Catheters are similar in design, construction, indications, target population, risk analysis, performance and materials to the predicate devices, the Spectranetics 0.014" and 0.018" Support Catheters, K991059. Spectranetics New Production Introduction procedure has been used in concert with the Quality System Regulations for the introduction of the 0.035" Support Catheter. The design validation protocols and risk analysis addressed all known aspects of the device including tensile strength, functionality, visibility, flow rate, sterility, and biocompatibility. Testing performed for the Spectranetics Support Catheter provides reasonable assurance that the device will perform in a safe and effective manner when used as indicated

The Spectranetics 0.014", 0.018", and the new 0.035" Support Catheters are similar in the indications for use as the Medtronic Buchbinder Catheter (K935425), the previous predicate device for the Spectranetics 0.014" and 0.018" Support Catheter, K991059.

The results of the testing demonstrate that the Spectranetics 0,035" Conclusions: Support Catheter is substantially equivalent to the predicate devices and it will perform in a safe and effective manner when used as indicated.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with wavy lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 3 2002

Mr. Michael J. Ryan RA Manager Spectranetics Corporation 96 Talamine Court Colorado Springs, CO 80907

Re: K022138

> Spectranetics 0.035" Support Catheter, Model 518-028 Regulation Number: 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: Class II (two) Product Code: 74 DQY Dated: July 1, 2002 Received: July 2, 2002

Dear Mr. Ryan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael J. Ryan

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

D. Z. , M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Applicant: | Spectranetics Corporation<br>96 Talamine Court<br>Colorado Springs, CO 80907 |
|--------------|------------------------------------------------------------------------------|
| 510(k): | |
| Device Name: | Spectranetics 0.014", 0.018", and 0.035" Support Catheters |

Statement of Indications for Use

The Spectranetics Support Catheters are designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Division of Cardiovascular & Respiratory Devices
510(k) Number K022138