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' 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.

AI/ML Overview

The provided text describes the Spectranetics 2.5 mm Turbo CLiRpath Excimer Laser Catheter and its substantial equivalence to a predicate device. However, it does not explicitly define acceptance criteria in a table format or present a comparative study with numerical performance metrics against those criteria. The study described focuses on safety and performance in a porcine model rather than a detailed, quantitative analysis against pre-defined acceptance criteria for efficacy in humans.

Here's an attempt to extract the relevant information based on the typical content of a 510(k) summary, acknowledging the limitations of the provided document in explicitly defining "acceptance criteria" and "device performance" in a quantitative, human-centric way:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit, quantitative acceptance criteria for efficacy in the manner of a clinical trial. Instead, the "acceptance criteria" are implied by the demonstration of safety and equivalent functionality to a predicate device. The "device performance" is described qualitatively.

Acceptance Criteria (Implied)	Reported Device Performance (Qualitative)
Safety: No deleterious tissue damage, no complications.	Confirmed safety in a porcine model. No complications were noted during treatment of the illiac and femoral arteries. Histological evaluation of harvested arterial segments showed no deleterious tissue damage after exposure to maximum energy parameters.
Functionality/Efficacy (Equivalence to Predicate): Ablates or debulks lesion material, re-establishes blood flow, facilitates placement of other devices, equivalent to the predicate device.	The device disrupts occlusive material plaque, permitting its removal and re-establishing blood flow within the diseased vessel. The pathway opened facilitates subsequent placement of other devices. Comparisons to the predicate device indicated that the 2.5 mm Turbo catheter was equivalent with respect to both safety and functionality. In vitro laboratory tests, qualification and validation studies confirmed manufacturing and design specifications met.
Biocompatibility: Meets ISO 10993 standards.	Confirmed in accord with the ISO 10993 series of standards.
Sterilization: Meets ISO 11135 standards.	Conducts and maintains valid ethylene oxide sterilization processes in accord with ISO 11135.
Packaging: Validated and visually verified for integrity.	Initially validated and visually verified for 100% of devices.
Device Integrity and Functionality: Meets Spectranetics in-house and ISO 10555-1 requirements.	Qualified and/or validated using samples produced under routine manufacturing conditions. Meets or exceeds both Spectranetics in-house requirements and requirements listed in ISO 10555-1.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of animals, but refers to "a porcine model."
Data Provenance: The study was conducted on a porcine model (animals), making it pre-clinical and prospective (conducted specifically for this submission). The country of origin of the data is not specified, but the company is based in Colorado Springs, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study was a pre-clinical animal study, and while a GLP (Good Laboratory Practices) compliant protocol was followed, there's no mention of experts establishing a "ground truth" in the diagnostic sense (e.g., radiologists interpreting images). Histological evaluation would typically be performed by veterinary pathologists, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given it was an animal study focused on safety (complications, tissue damage observed histologically) and device functionality, formal adjudication by a panel of experts for diagnostic accuracy (as might be seen in a clinical trial for an imaging device) is unlikely to have been applied in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical catheter, not an AI-powered diagnostic tool, so the concept of human readers improving with or without AI assistance is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study of an algorithm was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the animal study was based on:

Direct observation of complications during the procedure in the porcine model.
Histological evaluation of harvested arterial segments (pathology) to assess tissue damage.
Functional assessment of the device's ability to "disrupt occlusive material plaque" and "re-establish blood flow," implicitly compared to the predicate device's known performance.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not a machine learning model requiring a training set. The device design and manufacturing processes were likely developed and refined through engineering tests and validation, but these are not "training sets" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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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: 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: 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

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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).