SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038

K033678 · Spectranetics Corp. · DQY · Feb 23, 2004 · Cardiovascular

Device Facts

• Record ID: K033678
• Device Name: SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038
• Applicant: Spectranetics Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Spectranetics Quick-Cross 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

The Spectranetics Quick-Cross Support Catheter is an intravascular device used to support guidewire access, facilitate guidewire exchange, and deliver fluids (saline or contrast agents) within the vascular system. The device consists of a catheter shaft with varying stiffness, a proximal female luer, and three radiopaque markers at the tapered distal tip for visualization. The distal 40 cm of the shaft features a lubricious, hydrophilic coating to aid navigation. It is intended for use by clinicians in a vascular setting. The device functions as a conduit and support tool, assisting the physician in navigating the vasculature during interventional procedures.

Clinical Evidence

Bench testing only. Validation protocols addressed tensile strength, functionality, radiopacity (visibility), flow rate, sterility, and biocompatibility.

Technological Characteristics

Intravascular catheter with varying shaft stiffness; proximal female luer; three radiopaque markers at distal tip; hydrophilic coating on distal 40 cm. Available in 0.014", 0.018", and 0.035" diameters. Class II device (21 CFR 870.1250).

Indications for Use

Indicated for use in the vascular system to support guidewire access, facilitate guidewire exchange, and deliver saline or 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

• Spectranetics Support Catheters (K991059)
• Spectranetics Support Catheter (K022138)

Submission Summary (Full Text)

{0}------------------------------------------------

FEB 2 3 2004

## Premarket Notification 510(k) Summary

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

7 Michael J. Ba 21 Nov 03

Device Trade Name: Common Name: Classification Name:

Device Description:

Intravascular Catheter Percutaneous Catheter, CFR 870.1250

Spectranetics Quick-Cross Support Catheter.

The Spectranetics Quick-Cross Support Catheters are intravascular catheters, available in seven (7) models:

| 518-032 | 0.014" diameter catheter, | 135cm length |
|---------|---------------------------|---------------|
| 518-033 | 0.018" diameter catheter | 90 cm length |
| 518-034 | 0.018" diameter catheter | 135 cm length |
| 518-035 | 0.018" diameter catheter | 150 cm length |
| 518-036 | 0.035" diameter catheter | 90 cm length |
| 518-037 | 0.035" diameter catheter | 135 cm length |
| 518-038 | 0.035" diameter catheter | 150 cm length |

Model number 518-032 has a shaft of varying stiffness with a proximal shaft diameter of 3.0 Fr. tapering to a distal shaft diameter of 1.9 Fr.

Model numbers 518-033, 518-034, and 518-035 have a shaft of varying stiffness with a proximal shaft diameter of 3.4 Fr. tapering to a distal shaft diameter of 2.2 Fr.

Model numbers 518-036, 518-037, and 518-038 have a shaft of varying stiffness with a proximal shaft diameter of 4.8 Fr. tapering to a distal shaft diameter of 3.7 Fr.

{1}------------------------------------------------

| | All models have three (3) radiopaque markers located at their 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. |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Spectranetics Quick-Cross 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. |
| Substantial Equivalence: | This product is substantially equivalent in design, composition, function, and intended use to the Spectranetics Support Catheters, 510(k) K991059 and K022138. |
| Technological Characteristics & Nonclinical Testing Summary: | The Spectranetics Quick-Cross 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, and the Spectranetics 0.035" Support Catheter, K022138. Spectranetics New Production Introduction procedure has been used in concert with the Quality System Regulations for the introduction of the Quick Cross 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 Quick-Cross Support Catheters are similar in the indications for use as the Spectranetics Support Catheters K991059 and K022138. |
| Conclusions: | The results of the bench testing demonstrate that the Spectranetics Quick-Cross Support Catheters are substantially equivalent to the predicate devices and they will perform in a safe and effective manner when used as indicated. |

:

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2004

Spectranetics Corporation c/o Mr. Michael J. Ryan Regulatory Affairs Manager 96 Talamine Court Colorado Springs, CO 80907

Re: K033678

Spectranetics Quick-Cross Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: November 21, 2003 Received: November 25, 2003

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 (sec 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

{3}------------------------------------------------

## Page 2 - Mr. Michael J. Ryan

or any Federal statutes and regulations administered by other Federal agencies. You must of any Federal statutes and regulations and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) regulations 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (overies (overies as described in your Section 510(k) This letter whil anow you to begin manteg of substantial equivalence of your device to a legally premarket nothleation: "The PDA miding of basification 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), please If you desire specific advice ion 100 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address

[phone] 01 at 10 no 10 m / ds mamain . html

Sincerely yours,

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

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:___Spectranetics Quick-Cross Support Catheter

Indications For Use:

The Spectranetics Quick-Cross Support Catheters are a guidewire exchange and infusion device designed for use in the vascular system. The catheters are intended to influsion action acolgins for access of the vasculature, allow for exchange of guidewires, support a galownio dainly dooses on of saline solutions or diagnostic contrast agents.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hatal Sign Off

510(k) Numb