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

K172687 · Spectranetics, Inc. · MCW · Nov 27, 2017 · Cardiovascular

Device Facts

• Record ID: K172687
• 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: Nov 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Turbo-Power Laser Atherectomy Catheters are sterile, single-use devices used with the CVX-300 Excimer Laser System for peripheral atherectomy. The catheter features optical fibers arranged eccentrically around a 0.018" guidewire lumen, a hydrophilic-coated working length, and a radiopaque marker band. The device connects to a Motor Drive Unit (MDU). During operation, the system transmits ultraviolet energy from the CVX-300 laser to the distal tip to photoablate arterial obstructions (atheroma, fibrosis, calcium, thrombus) via molecular bond disruption. The device supports a 'jogging' mode and a continuous rotation mode (simultaneous lasing and rotation). Used by physicians in clinical settings to recanalize diseased vessels, the device helps restore blood flow. The output is the physical removal of obstructive material, which aids clinical decision-making by facilitating vessel recanalization and improving patient outcomes in peripheral artery disease.

Clinical Evidence

No clinical data was required. Evidence consists of bench testing (simulated use, functional, physical, and laser testing) and pre-clinical GLP studies comparing usability and procedural safety between the 2.0mm and 2.3mm catheter models.

Technological Characteristics

Catheter subassembly with optical fibers, 0.018" guidewire lumen, PTFE lumen tip, stainless steel torque wire, and hydrophilic coating. Radiopaque marker band for visibility. Energy source: CVX-300 Excimer Laser System (ultraviolet). Operation: simultaneous lasing and rotation or jogging mode. Sterilization: AAMI TIR:28-2009 product adoption. Dimensions: 2.0mm (6Fr) and 2.3mm (7Fr).

Indications for Use

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

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 (K152181)
• Turbo-Power Laser Atherectomy Catheter (K162561)

Submission Summary (Full Text)

{0}------------------------------------------------

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);

{1}------------------------------------------------

## 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 ([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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K172687

#### Device Name

Turbo-Power Laser Atherectomy Catheters

Indications for Use (Describe)

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).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <div style="float: left; margin-right: 5px;"> <img alt="Checked" height="12" src="checked.png" width="12"/> </div>Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;"> <div style="float: left; margin-right: 5px;"> <img alt="Unchecked" height="12" src="unchecked.png" width="12"/> </div>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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: [phone] |
| | Fax: [phone] |
| | 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) 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).

{4}------------------------------------------------

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 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.

#### 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.

{5}------------------------------------------------

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.