2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011

K043465 · Spectranetics Corp. · PDU · Aug 18, 2005 · Cardiovascular

Device Facts

• Record ID: K043465
• Device Name: 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
• Applicant: Spectranetics Corp.
• Product Code: PDU · Cardiovascular
• Decision Date: Aug 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions can not be crossed with standard guide wires.

Device Story

The 2.5 mm Turbo CLiRpath Excimer Laser Catheter is an over-the-wire peripheral atherectomy device. It consists of a bundle of optical fibers encased in medical-grade tubing. The device connects to an excimer laser source to deliver 308 nm ultraviolet laser energy to the catheter tip. During endovascular procedures, a physician inserts the catheter over a guidewire to the site of a vascular lesion. Laser energy ablates and debulks occlusive plaque material, re-establishing blood flow and facilitating the placement of other interventional devices. The device is intended for use in the peripheral vasculature of the leg. It features increased lubricity and improved energy delivery efficiency compared to predicate models.

Clinical Evidence

No human clinical data provided. Safety and efficacy were established via GLP-compliant porcine model studies in iliac and femoral arteries. Histological evaluation showed no deleterious tissue damage at maximum energy parameters. Bench testing confirmed compliance with ISO 10555-1 and ISO 10993 standards.

Technological Characteristics

Catheter with optical fiber bundle; 2.5 mm diameter; 110 cm working length. Energy source: 308 nm excimer laser. Materials: medical grade tubing. Sterilization: ethylene oxide (ISO 11135). Standards: ISO 10993 (biocompatibility), ISO 10555-1 (catheter requirements).

Indications for Use

Indicated for patients with symptomatic infrainguinal lower extremity vascular disease presenting with total obstructions that cannot be crossed with standard guide wires.

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 CLiRpath excimer laser catheters (K040067)

Submission Summary (Full Text)

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K043465
p. 1 of 3

AUG 1 8 2005

## 510(k) SUMMARY

#### SUBMITTER INFORMATION

- A. Company Name: Spectranetics Corporation, Inc.
- B. Company Address: 96 Talamine Court Colorado Springs, Colorado 80907
- C. Company Phone: [phone]
- D. Company Facsimile: 719 442 2248
- E. Contact Person: Adrian Elfe Vice President Quality Assurance & Regulatory Affairs Compliance

## DEVICE IDENTIFICATION

- A. Device Trade Name: 2.5 mm Turbo CLiRpath Excimer Laser Catheter
- B. Device Common Name: Laser Catheter
- C. Classification Name: Catheter, Peripheral, Atherectomy
- D. Device Class: Class II (per 21 CFR 870.4875)
- E. Device Code: MCW

## IDENTIFICATION OF PREDICATE DEVICES

Spectranetics CLiRpath excimer laser catheters for peripheral use, cleared to market under 510(k) K040067, serve as predicate to the 2.5 mm Turbo CLRpath Excimer Laser Catheter.

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#### DEVICE DESCRIPTION

Spectranetics' laser atherectorny catheters, including the 2,5 mm Turbo CLiRoath catheter for peripheral use, consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. The 2.5 mm Turbo catheter is designed for "over-the-wire" interventional techniques. Laser energy impinged on a blockage ablates, or debulks, the lesion material re-establishing blood flow within the vessel, and permitting placement of devices used in vascular interventions.

The Spectranetics Turbo laser catheter is supplied with a tip diameter of 2.5 mm, appropriate for interventional use in the peripheral vasculature of the leg.

#### INTENDED USE

For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions can not be crossed with standard guide wires.

### COMPARISON TO PREDICATE DEVICES

The Spectranetics 2.5 mm Turbo Excimer Laser Catheter for peripheral use is substantially equivalent in form, fit, and function to other Spectranetics CLiRpath laser catheters, which received market clearance under section 510(k) rules. The 2.5 mm Turbo catheter is an addition to the CLiRpath line of catheters, with the following enhancements.

Increased lubricity Improved efficiency in energy delivery of 308 nm laser light Continuous "on" capability

The 2.5 mm Turbo laser catheter consists of a piece of tubing with a working length of approximately 110 cm, and a diameter of 2.5 mm. The catheters communicate excimer laser energy at 308 nm to an occlusion within a patient's targeted peripheral artery. Communicated energy disrupts occlusive material plaque, and permits its removal via the patient's endoreticular system. The pathway opened by either the predicate device or the Turbo catheter, facilitates subsequent placement of other devices and interventions, and re-establishes blood flow within the diseased vessel.

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# BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING

Biocompatibility of both component materials and the finished 2.5 mm Turbo catheter have been confirmed in accord with the ISO 10993 series of standards, Biological Evaluation of Medical Devices. Spectranetics conducts and maintains valid ethylene oxide sterilization processes in accord with ISO 11135, Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Package integrity is initially validated, and, in addition, visually verified for 100% of Spectranetics devices prior to transfer to finished goods inventory.

Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. All CLiRpath excimer laser catheter models meet or exceed both Spectranetics in-house requirements, and requirements listed in ISO 10555-1, Sterile, Single-use Intravascular Catheters - Part 1: General Requirements.

### NON-CLINICAL STUDIES

Spectranetics confirmed safety and equivalent efficacy in the peripheral anatomy for the 2.5 mm Turbo laser catheter using a porcine model, in accord with a protocol compliant with good laboratory practices (GLP's). No complications were noted during treatment of the illiac and femoral arteries in the animal model. Histological evaluation of harvested arterial segments showed no deleterious tissue damage after exposure to the 2.5 mm Turbo catheter operating at maximum energy parameters. Comparisous to treatment with CLiRpath laser catheters, the cited predicate device, indicated that he 2.5 mm Turbo catheter was equivalent with respect to both safety and functionality.

### CONCLUSION

A GLP-compliant study using a porcine model verified the safety and performance characteristics for the Spectranetics 2.5 mm Turbo laser catheter when deployed for use in the treatment of peripheral arterial disease. In vitro laboratory tests, as well as qualification and validation studies, have confirmed that 2.5 mm Turbo catheters meet manufacturing and design specifications. All of these data combined establish substantial equivalence to the CLiRpath predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing a human figure embracing or protecting something. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Spectranetics Corpation c/o Mr. Neil Burris Clinical Data Services 96 Talamine Court Colorado Springs, CO 80907

SEP 18 2013

Re: K043465

Trade/Device Name: 2.5 mm Turbo CLiRpath Excimer Laser Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: August 12, 2005 Received: August 15, 2005

Dear Mr. Burris:

This letter corrects our substantially equivalent letter of August 18, 2005.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Z.M.Z.

Sist

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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# 7. Statement of Indication for Use

# Device Name: Spectranetics 2.5 mm Turbo™ Excimer Laser Catheter

## Indications for Use

For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions can not be crossed with standard guide wires.

Prescription Use XXXX (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)

Arulen B. Bour

510(k) Numl