The Turbo-Power Laser Atherectomy Catheter is indicated for laser atherectomy of de novo restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

Device Description

The 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System. The 2.0mm and 2.3mmTurbo-Power Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy. The 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are used to ablate lesions with reference vessel diameters of ≥3.0mm. 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are comprised of 2 subassemblies: 1. Catheter Subassembly 2. Motor Drive Unit (MDU) Subassembly The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) guidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system is used to photoablate multiple morphology lesions which mav be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

AI/ML Overview

The provided text is a 510(k) summary for the Spectranetics Turbo-Power Laser Atherectomy Catheters. The document states that "New clinical data was not required to demonstrate substantial equivalence," and much of the testing was "leveraged from the predicate Turbo-Power (2.3mm)" and summarized within this submission (which is not fully provided). Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and ground truth establishment for a new study are not available in the provided text because a new extensive clinical study for this specific 510(k) was not conducted.

However, based on the information provided, here's what can be inferred or directly stated:

1. A table of acceptance criteria and the reported device performance

The document lists types of performance data collected but does not provide specific acceptance criteria or quantitative performance results in a table format.

Acceptance Criteria Category	Reported Device Performance
Design Verification and Validation Testing	Met all acceptance criteria as required by the risk analysis.
Simulated Use Testing	Performed. Outcomes not detailed.
Functional Testing	Performed. Outcomes not detailed.
Physical Testing	Performed. Outcomes not detailed.
Laser Testing	Performed. Outcomes not detailed.
Sterilization	Product adoption equivalency per AAMI TIR:28-2009.
Pre-clinical GLP Studies	Compared usability and procedural safety to predicate devices. Supported premarket notification.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified for any new testing. Much of the data was leveraged from predicate devices. For pre-clinical GLP studies, the sample size is not disclosed.
Data Provenance: Not specified for any new testing. The phrase "pre-clinical GLP studies" suggests controlled laboratory or animal studies, not human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as new clinical data requiring expert-established ground truth was not explicitly detailed or required. The testing involved "Design Verification and Validation Testing" and "Pre-clinical GLP studies," which typically don't involve expert ground truth in the same way clinical imaging studies do.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as new clinical data requiring adjudication was not explicitly mentioned or required.

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

No MRMC study was mentioned. This device is a physical medical device (laser atherectomy catheter), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to a physical medical device like a laser atherectomy catheter. The device itself performs the intended function, often with human operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the pre-clinical GLP studies, the ground truth would likely be based on direct observations, measurements of tissue effects, and safety endpoints within the experimental setup, rather than expert consensus on diagnostic images or pathology. The document does not provide details.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this physical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 27, 2017

Spectranetics, Inc. Mr. Christopher McLellan Regulatory Affairs Manager 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K172687

Trade/Device Name: Turbo-Power Laser Atherectomy Catheters Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: September 5, 2017 Received: September 6, 2017

Dear Mr. McLellan:

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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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Page 2 - Mr. McLellan

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

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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Indications for Use

510(k) Number (if known) K172687

Device Name

Turbo-Power Laser Atherectomy Catheters

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape on the left, followed by the word "Spectranetics" in blue, bold font. Below the word "Spectranetics" is the tagline "Always Reaching Farther" in a smaller, lighter blue font. The logo is clean and modern, and the tagline suggests that the company is always striving to improve.

510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on September 06, 2017

510(k) Submitter / Holder:	The Spectranetics Corporation
	9965 Federal Drive
	Colorado Springs, CO 80921.3617
	Establishment Registration No: 3007284006
Contact:	Ms. Stephanie Byrum
	Regulatory Affairs Specialist
	Office: 719.447.2671
	Mobile: 719.482.4765
	Fax: 719.447.2070
	Email: Stephanie.Byrum@spnc.com

Subiect Device

Device Trade Name:

Device Common Name:
Device Class:
Classification Regulation:
Regulation Description:
Product Code:
510(k) Type:
Model Numbers:

Turbo-Power™ (2.0mm) and (2.3mm) Laser Atherectomy Catheters Laser Atherectomy Catheter = 21 CFR 870.4875, Intraluminal Artery Stripper Cardiovascular MCW Traditional 420-050, 423 .- 050

Predicate Device

The Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are being compared to the following legally marketed predicate device:

510(k) Number:	K152181 (cleared November 12, 2015) and K162561 (cleared January 5, 2017)
Manufacturer:	The Spectranetics Corporation
Trade Name:	Turbo-Power Laser Atherectomy Catheter
Device Common Name:	Laser Atherectomy Catheter
Model Number:	420-050, 423-050

Intended and Indications for Use

Turbo-Power™ (2.0mm) and (2.3mm)Laser Atherectomy Catheter is indicated for laser atherectomy of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA).

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Image /page/4/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white circle in the center, followed by the word "Spectranetics" in blue, bold font. Below the word "Spectranetics" is the tagline "Always Reaching Farther" in a smaller, regular font.

Device Description

The 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are used to ablate lesions with reference vessel diameters of ≥3.0mm. 2.0mm and 2.3mm Turbo-Power Laser Atherectomy Catheters are comprised of 2 subassemblies:

1. Catheter Subassembly
1. Motor Drive Unit (MDU) Subassembly

The working length of the Turbo Power Laser Atherectomy Catheter is constructed of multiple optical fibers arranged eccentrically around a 0.018" (0.46 mm) guidewirecompatible lumen. The PTFE quidewire lumen tip is attached to a stainless steel torque wire which is connected to the MDU at the proximal end of the working length. The multifiber laser catheter transmits ultraviolet energy from the Spectranetics CVX-300 Excimer Laser System through the tip of the laser to an obstruction in the patient's artery. The outer surface of the laser catheter working length is hydrophilic-coated, and the distal tip of the catheter contains a radiopaque marker band for in situ visibility. The ultraviolet energy transmitted from the CVX-300 laser system is used to photoablate multiple morphology lesions which mav be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

Technological Characteristics

The 2.0mm (6Fr) and 2.3mm (7Fr) Turbo-Power catheters introduce a new mode of operation of simultaneously pressing the two (2) jogging buttons for continuous distal tip rotation and allows for simultaneous lasing and rotation. The subject devices also contain the jogging mode feature, which currently exists for both predicate devices. This device iteration does not affect the fundamental scientific technology used in the Turbo-Power family of devices. The mechanism of action, and intended use, remain unchanged from the predicate devices, 2.0mm (6Fr) Turbo-Power and 2.3mm (7Fr) Turbo-Power Laser Atherectomy Systems.

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Image /page/5/Picture/0 description: The image shows the Spectranetics logo. The logo consists of a blue diamond shape with a white circle in the center, followed by the word "Spectranetics" in blue, bold letters. Below the word "Spectranetics" is the tagline "Always Reaching Farther" in a smaller, lighter font.

Performance Data1

The following testing was conducted to validate and verify that the subject device met all acceptance criteria as required by the risk analysis that was performed:

Design Verification and Validation Testing

Simulated Use Testing ●
. Functional Testing
Physical Testing ●
. Laser Testing

Sterilization

Product adoption equivalency per AAMI TIR:28-2009* ●

Pre-clinical and Clinical Data:

In addition to the design verification and validation tests, pre-clinical GLP studies were conducted to compare the usability and procedural safety of the 2.0mm (6Fr) Turbo-Power and the 2.3mm (7Fr) Turbo-Power laser catheters, and support this premarket notification.

New clinical data was not required to demonstrate substantial equivalence.

Substantial Equivalence

Based on the similarities in design between the subject devices and predicate devices which are currently in use, and the performance and pre-clinical data, the use of the 2.0mm (6Fr) Turbo-Power and the 2.3mm (7Fr) Laser Atherectomy Catheters for the proposed indication does not raise new questions related to safety and effectiveness compared with the predicate. Therefore the 2.0mm (6Fr) and 2.3mm (7Fr) Turbo-Power Laser Atherectomy Catheters with the continuous rotation and jogging mode features are substantially equivalent to the predicate 2.0mm (6Fr; K162561) and 2.3mm (7Fr; K152181) Turbo-Power Laser Atherectomy Catheters with the jogging mode feature.

1 All testing marked with an * is leveraged from the predicate Turbo-Power (2.3mm). Additional testing required is summarized within this submission.

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).