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

Device Description

The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a laser atherectomy device designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power (2.0mm) Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy.

The Turbo-Power (2.0mm) is used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) Laser Atherectomy Catheter is 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.

AI/ML Overview

The provided document is a 510(k) summary for the Spectranetics Turbo-Power (2.0mm) Laser Atherectomy Catheter. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or detailed results of a study proving the device meets those criteria, nor does it include information about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The document mentions that various tests were conducted to validate and verify that the subject device met all acceptance criteria, as required by the risk analysis. These tests included:

Design Verification and Validation Testing: Simulated Use Testing, Functional Testing, Physical Testing, Laser Testing.
Sterilization: Product adoption equivalency per AAMI TIR:28-2009.
Biocompatibility: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Direct Hemolysis, Indirect Hemolysis, In Vivo Thrombogenicity-Ovine Model, Genotoxicity - Ames Test, Material Mediated Pyrogenicity.
Pre-clinical Data: A pre-clinical GLP study was conducted to compare usability and procedural safety of the Turbo-Power (2.0mm) and Turbo-Power (2.3) laser catheters.

The document does not provide the specific acceptance criteria for these tests or the reported performance values against those criteria in a table format. It only states that the device "met all acceptance criteria." It also explicitly states that new clinical data was not required to demonstrate substantial equivalence, which means there isn't a human-in-the-loop or standalone study with clinical outcomes described here.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document states that testing was performed and the device "met all acceptance criteria," but it does not specify what those criteria were or the actual performance results in a quantifiable manner.

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

Cannot be provided. The document mentions "Simulated Use Testing," "Functional Testing," "Physical Testing," "Laser Testing," and a "pre-clinical GLP study." However, it does not specify sample sizes for any of these tests or the data provenance (e.g., retrospective/prospective, country of origin). The pre-clinical study involved an "Ovine Model," indicating animal data.

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/Cannot be provided. This question typically applies to studies involving human interpretation or clinical endpoints. The document describes engineering, biocompatibility, and animal (ovine model) studies. It does not mention any studies where human experts established ground truth for a test set.

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

Not applicable/Cannot be provided. Similar to point 3, this is relevant for studies involving human assessment or interpretation, which are not detailed here.

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. The document explicitly states "New clinical data was not required to demonstrate substantial equivalence." An MRMC study would fall under clinical data. This device is a physical catheter, not an AI system.

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

Not applicable. This device is a physical catheter, not an algorithm or AI system. Its performance is evaluated through engineering, biocompatibility, and pre-clinical animal studies, not standalone algorithmic performance.

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

Cannot be fully specified. For the engineering tests, ground truth would likely refer to engineering specifications and performance benchmarks. For the biocompatibility tests, it would be established standards (e.g., ISO standards for cytotoxicity, sensitization). For the pre-clinical GLP study using an ovine model, ground truth would have been based on observations and measurements from the animal subjects related to usability and procedural safety as defined by the study protocol.

8. The sample size for the training set

Not applicable. The document describes a medical device (catheter), not an AI system that requires a "training set."

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

Not applicable. Same as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

January 5, 2017

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

Spectranetics, Inc. Ms. Priscila Tapia Regulatory Specialist 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K162561

Trade/Device Name: Turbo-Power (2.0mm) Laser Atherectomy Catheter Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: September 12, 2016 Received: September 14, 2016

Dear Ms. Tapia:

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 (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Mada Jellm
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) K162561

Device Name

Turbo-Power (2.0mm) 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/1 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 phrase "Always Reaching Farther" in a smaller, black font. At the top right of the image, the text "Page 1 of 3" is visible.

510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on September 12, 2016

510(k) Submitter / Holder:	The Spectranetics Corporation9965 Federal DriveColorado Springs, CO 80921.3617Establishment Registration No: 3007284006
Contact:	Ms. Priscila TapiaSenior Regulatory Affairs SpecialistOffice: 719.447.2587Mobile: 719.393.5354Fax: 719.447.2070Email: Priscila.Tapia@spnc.com

Subject Device

Device Trade Name:	Turbo-Power TM (2.0mm) Laser AtherectomyCatheters
Device Common Name:	Laser Atherectomy Catheter
Device Class:	II
Classification Regulation:	21 CFR 870.4875, Intraluminal Artery Stripper
Regulation Description:	Cardiovascular
Product Code:	MCW
510(k) Type:	Traditional
Model Numbers:	420-050

Predicate Device

The Turbo-Power (2.0mm) Laser Atherectomy Catheter is being compared to the following legally marketed predicate device:

510(k) Number:	K152181
Manufacturer:	The Spectranetics Corporation
Trade Name:	Turbo-Power™ Laser Atherectomy Catheter
Device Common Name:	Laser Atherectomy Catheter
Model Number:	423-050

Intended and Indications for Use

Turbo-Power™ (2.0mm) 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/1 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. Below the word "Spectranetics" is the phrase "Always Reaching Farther" in a smaller font. The image also contains the text "Page 2 of 3" in the upper right corner.

Device Description

The Turbo-Power (2.0mm) is used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) Laser Atherectomy Catheter is comprised of 2 subassemblies:

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

Technological Characteristics

The Turbo-Power (2.0mm) introduces a smaller size catheter that can reach smaller vessels (≥3.0mm), however, it does not affect the fundamental scientific technology used in the Turbo-Power family of devices. The mechanism of action, principle of operation, and intended use, remain unchanged from the predicate Turbo-Power (2.3mm).

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Image /page/5/Picture/1 description: The image shows the Spectranetics logo with the tagline "Always Reaching Farther." The logo features a blue diamond shape with a white circle inside, followed by the company name in a bold, blue font. Above the logo, the text "Page 3 of 3" is visible, indicating that this is the last page of a document.

Performance Data"

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* ●

Biocompatibility

Cytotoxicity
Sensitization*
Intracutaneous Reactivity* ●
Acute Systemic Toxicity*
Direct Hemolysis*
Indirect Hemolysis* ●
. In Vivo Thrombogenicity-Ovine Model*
Genotoxicity - Ames Test*
Material Mediated Pyrogenicity* ●

Pre-clinical and Clinical Data:

In addition to the design verification and validation tests, a pre-clinical GLP study was conducted to compare the usability and procedural safety of the Turbo-Power (2.0mm) and the Turbo-Power (2.3) 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 and predicate devices currently in use, and the performance and pre-clinical data, the use of the Turbo-Power (2.0mm) Laser Atherectomy Catheter for the proposed indication does not raise new questions related to safety and effectiveness compared with the predicate. Therefore Turbo-Power (2.0mm) is substantially equivalent to Turbo-Power (2.3mm).

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).