Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters

K180694 · Spectranetics, Inc. · MCW · Apr 5, 2018 · Cardiovascular

Device Facts

• Record ID: K180694
• Device Name: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
• Applicant: Spectranetics, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Apr 5, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Turbo-Power 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).

Device Story

Laser atherectomy catheter used with CVX-300 Excimer Laser System; transmits ultraviolet energy to ablate atheroma, fibrosis, calcium, and thrombus in peripheral arteries. Device consists of catheter subassembly with optical fibers and Motor Drive Unit (MDU). Used by physicians in clinical settings to recanalize diseased vessels via photoablation, disrupting molecular bonds at cellular level without thermal damage. Radiopaque marker band provides in situ visibility. Benefits include vessel recanalization for patients with infrainguinal arterial disease.

Clinical Evidence

No clinical data was required. Substantial equivalence was demonstrated through design verification and validation testing of the modified components (Motor Drive Unit lifetime, functionality, and pull tab isolation).

Technological Characteristics

Catheter with optical fibers arranged around 0.018" guidewire lumen; stainless steel torque wire; hydrophilic-coated outer surface; radiopaque marker band. Energy source: CVX-300 Excimer Laser System (ultraviolet). Sterile, single-use. Modifications include improved battery clip and pull tab.

Indications for Use

Indicated for patients with de novo or restenotic lesions in native infrainguinal arteries and femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, requiring adjunctive PTA.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Turbo-Power Laser Atherectomy Catheter (K172687)

Submission Summary (Full Text)

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April 5, 2018

Spectranetics, Inc. Travis Pittman Regulatory Affairs Specialist 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K180694

Trade/Device Name: Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheters Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: March 15, 2018 Received: March 16, 2018

Dear Mr. Travis Pittman:

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

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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 ([e-mail]) or phone [phone] 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) K180694

#### Device Name

Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheters

Indications for Use (Describe)

Turbo-Power is indicated for laser atherectorny 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).

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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K180694 pg 1 of 3

# 510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92(c) Prepared on March 23, 2018

| 510(k) Submitter / Holder: | The Spectranetics Corporation<br>9965 Federal Drive<br>Colorado Springs, CO 80921.3617<br>Establishment Registration No: 3007284006 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Travis Pittman<br>Regulatory Affairs Specialist<br>Office: 719.447.2470<br>Mobile: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

### 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, 2.3mm) Laser Atherectomy Catheters Laser Atherectomy Catheter . 21 CFR 870.4875, Intraluminal Artery Stripper Cardiovascular MCW Special 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: Manufacturer: Trade Name: Device Common Name: Model Number:

K172687 (cleared November 27, 2017) The Spectranetics Corporation Turbo-Power Laser Atherectomy Catheter Laser Atherectomy Catheter 420-050, 423-050

#### Intended and Indications for Use

Turbo-Power 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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## Device Description

The Turbo-Power (2.0mm, 2.3mm) Laser Atherectomy Catheter are laser atherectomy devices designed for use with the CVX-300™ Excimer Laser System. The Turbo-Power (2.0mm) and (2.3mm) Laser Atherectomy Catheters are sterile, single use, prescription only devices used for peripheral atherectomy.

The Turbo-Power (2.0mm) and (2.3mm) are used to ablate lesions with reference vessel diameters of ≥3.0mm. Turbo-Power (2.0mm) and (2.3mm) 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 guidewire 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 may 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

This submission introduces an improved battery clip and battery pull tab; however, it 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 Turbo- Power (2.0mm, 2.3mm).

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## Performance Data

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

## Design Verification and Validation Testing

- Motor Drive Unit Lifetime Test ●
- Motor Drive Unit Functionality Test ●
- . Pull Tab Isolation Test

## Sterilization

An assessment was conducted and concluded that additional sterilization testing was not required for the subject device to demonstrate substantial equivalence.

### Pre-clinical and Clinical Data

No new pre-clinical or clinical data was 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) and (2.3mm) Laser Atherectomy Catheter for the improved battery clip and pull tab does not raise new questions related to safety and effectiveness compared with the predicate. Therefore Turbo-Power (2.0mm) and (2.3mm) are substantially equivalent to Turbo- Power (2.3mm) and Turbo-Power (2.0mm) (K172687).