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 Description

Spectranetics' CLiRpath excimer laser atherectomy catheters, including CLiRpath Turbo Plus™ models, 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 guidewire, allowing the operator to deliver laser energy targeted to a lesion (blockage) in the vasculature. CLiRpath laser catheters are provided in models designed for both "over-the-wire" and "rapid exchange" interventional techniques. Laser energy impinged on a blockage photoablales, or debulks, the lesion material re-establishing blood flow within the vessel, and permitting placement of devices used in vascular interventions.

Spectranetics brand CLiRpath Turbo Plus™ excimer laser catheters will add 80 Hz as a maximum repetition rate for pulsed laser energy to the peripheral atherectorny catheter models not already cleared for 80 Hz operation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CLiRpath Turbo Plus™ Excimer Laser Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove performance against specific acceptance criteria in the context of AI/ML-based medical devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from the provided text.

The document highlights:

Device Identification: CLiRpath Turbo Plus™ Excimer Laser Catheter, a peripheral atherectomy catheter.
Intended Use: For endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guidewires.
Comparison to Predicate Devices: The core of the submission is to establish substantial equivalence to existing CLiRpath Turbo excimer laser catheters. The primary enhancement of the "Plus" version is an increased pulse repetition rate from 40 Hz to 80 Hz, leading to faster ablation speeds.
Testing Mentioned: Biocompatibility, sterilization, packaging, and bench testing were performed. These tests confirmed that the device meets Spectranetics' in-house requirements and ISO 10555-1 standards. However, specific acceptance criteria or performance metrics for these tests are not detailed.

In summary, this submission is not a clinical study report or a performance validation for an AI/ML device, but rather a regulatory filing asserting substantial equivalence based on material and functional similarities, with an enhanced operational parameter (80 Hz pulse rate).

Summary

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K05 2514

ACT 1 4 700

510(k) SUMMARY

SUBMITTER INFORMATION

A. Company Name: Spectranetics Corporation, Inc.
B. Company Address: 96 Talamine Court Colorado Springs, Colorado 80907
C. Company Phone: 719-633-8333 / 1-800-633-0960
D. Company Facsimile: 719 442 2248
E. Contact Person: Adrian Elfe Vice President Quality Assurance & Regulatory Affairs Compliance

DEVICE IDENTIFICATION

A. Device Trade Name: CLiRpath Turbo Plus™ 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 Turbo excimer laser catheters with continuous-on functionality, [510(k) K052296], serve as predicates to the line of CLiRpath Turbo Plus™ excimer laser catheters with 80 Hz and continuous-on capability. The 2.5 mm CLiRpath Turbo excimer laser catheter and CLiRpath™ excimer laser catheters, cleared under 510(k)'s K043465 and K043465, respectively, likewise serves as a predicate devices.

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DEVICE DESCRIPTION

INTENDED USE

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

COMPARISON TO PREDICATE DEVICES

CLiRpath Turbo Plus™ excimer laser catheters for peripheral use are substantially equivalent in form, fit, and function to Spectranelics CLiRpath Turbo excimer laser catheters, including the 2.5 mm Turbo catheter, which has received market clearance under section 510(k) rules. Prior peripheral atherectomy laser catheters with lip sizes ranging from 1.4 to 2.5 mm, delivered photoablating laser energy at up to 40 pulses per second (40 Hz). CLiRpath Turbo Plus™ excimer laser catheters are enhanced versions of these catheters, providing the physician with faster ablation speeds due to a doubled pulse rate of 80 Hz.

CLiRpath Turbo Plus™ excimer laser catheters are fiber optic catheters with a selection of working lengths between 110 cm and 150 cm. Tip diameters range from 1.4 mm to 2.5 mm. The catheters deliver excimer laser energy at 308 nm to an occlusion within a patient's targeted peripheral artery. Delivered energy photoablates occlusive material, such as arterial plaque, and permits its removal via the patient's reticuloendothelial system. The arterial channel opened by either the predicate device or the Turbo catheler, facilitates subsequent placement of other devices and interventions, and reestablishes blood flow within the diseased vessel.

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BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING

CLiRpath Turbo Plus ™ excimer laser catheters are built from the same components and materials of construction as other, already-marketed, Spectranetics products, Therefore, biocompatibility of both component materials and the finished CLiRpath Turbo catheters have been previously 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 Turbo Plus™ 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.

CONCLUSION

The above statements establish substantial equivalence between the CLiRpath Turbo predicate devices, including 2.5 mm Turbo model, and the CLiRpath Turbo Plus™ excimer laser catheters.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing strength and freedom. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, indicating the organization's name and location.

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

Spectranetics c/o Mr. Neil Burris Clinical Data Services 96 Talamine Court Colorado Springs, CO 80907-5159

SEP 1 8 2013

Re: K052514

Trade/Device Name: CLiRpath Turbo Plus Excimer Laser Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: September 14, 2005 Received: September 14, 2005

Dear Mr. Burris:

This letter corrects our substantially equivalent letter of October 19, 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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Zin.M. Zin

For

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 CLiRpath Turbo Plus™ 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)

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K052514
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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).