Spectranetics Turbo-Elite Laser Atherectomy Catheters

K170059 · Spectranetics, Inc. · MCW · Apr 7, 2017 · Cardiovascular

Device Facts

• Record ID: K170059
• Device Name: Spectranetics Turbo-Elite Laser Atherectomy Catheters
• Applicant: Spectranetics, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Apr 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. The 0.014" and 0.018" Over-the-Wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Device Story

Percutaneous intravascular laser catheters; transmit ultraviolet energy from Spectranetics CVX-300 Excimer Laser System to arterial obstructions. Optical fibers arranged around guidewire lumen (OTW) or bundled (Rx) deliver energy to photoablate fibrous, calcific, and atheromatous lesions via molecular bond disruption. Used by physicians in clinical settings to recanalize diseased vessels. Output is physical removal of arterial plaque; enables vessel recanalization. Benefits include reduced stenosis and improved blood flow. No changes to device design or function from predicate; submission focuses on expanded indications.

Clinical Evidence

ABLATE clinical study evaluated safety and effectiveness in infrainguinal stenosis. Primary safety endpoint: freedom from major adverse events (death, major amputation, TLR) through 30 days. Primary effectiveness endpoint: mean reduction in percent stenosis via Angiographic Core Lab. Both endpoints met. Additional analysis showed ≤50% residual stenosis post-treatment and long-term freedom from TLR through 180 days (average reduction 42%).

Technological Characteristics

Percutaneous intravascular catheter; multiple optical fibers; OTW and RX configurations. Tip sizes: 0.9mm–2.5mm. Guidewire compatibility: 0.014", 0.018", 0.035". Energy source: Spectranetics CVX-300 Excimer Laser (ultraviolet). Sterilization: unchanged from predicate. No changes to materials of construction.

Indications for Use

Indicated for patients with infrainguinal stenoses and occlusions requiring atherectomy. 0.014" and 0.018" OTW models are indicated for femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents when used with the Turbo-Tandem System and 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

• Spectranetics Turbo-Elite® System (K140775)

Submission Summary (Full Text)

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

April 7, 2017

Spectranetics, Inc. Rebecca Spelich Regulatory Affairs Specialist 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K170059

Trade/Device Name: Spectranetics Turbo-Elite Laser Atherectomy Catheters Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: March 10, 2017 Received: March 13, 2017

Dear Ms. Spelich:

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Fernando Aguel
Fernando Aguel
-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) K170059

Device Name

Spectranetics Turbo Elite Laser Atherectomy Catheter

Indications for Use (Describe)

The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

The 0.014" and 0.018" Over-the-Wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/1 description: The image shows the Spectranetics logo. The logo features a blue diamond shape with a white circle in the center, followed by the word "Spectranetics" in blue, stylized font. Below the company name is the tagline "Always Reaching Farther" in a smaller, less bold font.

# 510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92

Updated on 6 April 2017

| 510(k) Submitter / Holder: | Spectranetics<br>9965 Federal Drive<br>Colorado Springs, CO 80921.3617 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration No: 3007284006 |
| Contact: | Ms. Rebecca Spelich<br>Regulatory Affairs Specialist<br>Office: [phone]<br>Mobile: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |

#### Subject Device

| Device Trade Name: | Spectranetics Turbo-Elite Laser Atherectomy Catheters |
|----------------------------|---------------------------------------------------------|
| Device Common Name: | Laser Atherectomy Catheters |
| Device Class: | II |
| Classification Regulation: | 21 CFR 870.4875, Intraluminal Artery Stripper |
| Regulation Description: | Cardiovascular |
| Product Code: | MCW |
| 510(k) Type: | Traditional |
| Model Numbers: | 410-152, 414-151, 417-152, 420-006, 423-001,<br>425-011 |

#### Predicate Device

The Turbo Elite Laser Catheters are being compared to the following legally marketed predicate device:

| 510(k) Number: | K140775 |
|---------------------|--------------------------------------|
| Manufacturer: | The Spectranetics Corporation |
| Trade Name: | Spectranetics Turbo-Elite® System |
| Device Common Name: | Percutaneous Laser Ablation Catheter |

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Image /page/4/Picture/1 description: The image shows the Spectranetics logo. The logo features 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, italicized font.

## Indications for Use

The devices are currently cleared under K140775 with the following IFUs:

- Turbo Elite: The Turbo Elite devices are indicated for use in the treatment of infrainguinal stenosis and occlusions. When used in conjunction with the Turbo Booster and/or as an accessory to the Turbo Tandem System, the devices are indicated for atherectomy of infrainguinal arteries.
The 0.014" and 0.018" Over-the-wire (OTW) Turbo Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

This 510(k) submission requested expansion of the IFU statements to:

Turbo Elite: The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

> The 0.014" and 0.018″ Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

#### Device Description

Spectranetics Turbo-Elite Laser Ablation Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen for Over-the-Wire (OTW) configurations, and bundled together for Rapid-Exchange (Rx) versions. Turbo Elite Laser Ablation Catheters are available in an Over the Wire (OTW) configuration and a Rapid Exchange (RX) configuration. The Turbo-Elite laser catheters in the OTW configuration are available in six different catheter tip sizes (0.9mm, 1.4mm, 1.7mm, 2.0mm, 2.3mm, and 2.5mm) and three different guide-wire compatibilities (0.014″, 0.018″, and 0.035"). New indication clearance is only being requested for the OTW configurations of Turbo-Elite catheters compatible with 0.014" and 0.018" guidewires.

The multifiber laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to an obstruction in the patient's artery. The ultraviolet energy is delivered to the laser catheter to photoablate fibrous, calcific, and atheromatous lesions, 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

There have been no changes to the design or function of the predicate devices. The only change being proposed is to the indication of use. The safety and effectiveness of the existing technological characteristics are being supported by clinical evidence.

#### Performance Data

The following testing was conducted to validate and verify that the subject device met all specifications and was substantially equivalent to the predicate device.

Design Verification and Validation Testing (submitted in support of prior 510(k)s)

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Image /page/5/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, bold font. Below the word "Spectranetics" is the tagline "Always Reaching Farther" in a smaller, non-bold font.

- Solarization
- . Tissue ablation efficiency
- Physical testing
- Trackability
- Torquability
- Tensile
- . Laser Lifetime
- Packaging stability

Bench testing submitted in support of IDE G140141 and this 510(k)

- Stent Fatigue testing (post lasing and visual inspection )
- Stent Axial, Bending, Torsion, and Fatigue Study (post - lasing and visual inspection)
- . Stent corrosion testing (post lasing, inspection and fatigue testing)

## Sterilization

- There have been no changes to the sterilization process for either the Spectranetics Turbo-Elite; therefore, the sterilization previously submitted under the existing 510(k) files is unchanged.
## Biocompatibility:

- . There have been no changes to the materials of construction, or manufacturing process for either the Spectranetics Turbo-Elite catheters, therefore the biocompatibility testing previously submitted under the existing 510(k) files is unchanged.
# Clinical Data:

- . The Atherectomy By Laser Ablation with Turbo-Elite (ABLATE) clinical study was performed to demonstrate the safety and effectiveness of the Turbo-Elite in the treatment of patients with infrainguinal stenosis. The primary safety endpoint is percent freedom from major adverse events (MAE) through day 30 follow-up, which included all-cause death, major amputation in the target limb, or target lesion revascularizations (TLR). The primary effectiveness endpoint was a mean reduction in percent stenosis at the time of the procedure by Angiographic Core Lab assessment. Both primary safety and effectiveness hypotheses were met. Additional analyses were conducted to prove lesions had ≤50% residual stenosis post Turbo-Elite treatment and longterm freedom from TLR through 180-days. Both of these analyses were successful, with an average reduction of 42%.
- . Procedural safety and effectiveness are clearly demonstrated for Turbo-Elite by the Primary Safety and Primary Effectiveness Endpoints, as well as the longer term data contained in this clinical study report. Based on the clinical data it is reasonable to conclude that Turbo-Elite performs atherectomy in accordance with the indicationss for use.