1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System

K172386 · Volcano Atheromed, Inc. · MCW · Aug 24, 2017 · Cardiovascular

Device Facts

• Record ID: K172386
• Device Name: 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
• Applicant: Volcano Atheromed, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Aug 24, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phoenix® Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Device Story

Phoenix Atherectomy System is a sterile, single-use, over-the-wire peripheral atherectomy device. It consists of a catheter and a battery-powered handle. The handle drives a rotating front-cutting catheter tip to debulk plaque. Excised debris is continuously captured and conveyed proximally through the catheter into an external collection reservoir. Used in clinical settings by physicians; the device is inserted into the peripheral vasculature over a 0.014" guidewire. The physician activates the cutter via a handle-mounted switch. The system provides mechanical plaque removal, potentially improving vessel patency. Modifications include improved catheter pushability, enhanced internal debris maceration, and the addition of a 2.4 mm tip diameter model.

Clinical Evidence

Bench testing only. No clinical data presented. Performance evaluated via dimensional/visual inspection, simulated use, cutter/chain torque-to-failure, functional outer shaft torque, knob-to-shaft testing, drive train stress, cutter stall, temperature rise, kink bend radius, trackability, sheath flow rate, and sheath compatibility.

Technological Characteristics

Materials: Multi-strand stainless steel torque shaft, stainless steel outer shaft, Teflon sheath, DLC-coated distal tip. Energy: Battery-powered motor (10,000-12,000 RPM). Form factor: Over-the-wire catheter (130 cm or 149 cm lengths), 1.8 mm to 2.4 mm tip diameters. Connectivity: None. Sterilization: Ethylene Oxide. Single-use.

Indications for Use

Indicated for atherectomy of peripheral vasculature. Not for use in coronary, carotid, iliac, or renal vasculature.

Regulatory Classification

Identification

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

Predicate Devices

• Phoenix Atherectomy System (K140944)
• Phoenix Atherectomy System (K143328)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 24, 2017

Volcano AtheroMed, Inc. Ms. Jean Chang Senior Director. Operations 1530 O'Brien Drive. Suite A Menlo Park, California 94025

Re: K172386

Trade/Device Name: Phoenix Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: August 7, 2017 Received: August 8, 2017

Dear Ms. Chang:

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 device

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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.

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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

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) K172386

Device Name Phoenix Atherectomy System

Indications for Use (Describe)

The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

### Submitter Information:

| Date of 510(k) Summary Preparation: | August 22, 2017 |
|-------------------------------------|---------------------------------------------------------------------------------|
| Name and Address of Manufacturer: | Volcano AtheroMed, Inc.<br>1530 O'Brien Drive, Suite A.<br>Menlo Park, CA 94025 |
| Contact Person: | Jean Chang<br>Sr Director, Operations<br>Phone: [phone] |

#### Subject Device:

| Device Trade Name: | Phoenix® Atherectomy System |
|-------------------------|---------------------------------|
| Common Name: | Peripheral Atherectomy Catheter |
| Regulation Description: | Intraluminal Artery Stripper |
| Regulation Number: | 21 CFR 870.4875 |
| Product Code: | MCW |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |

#### Predicate Device:

Trade Name: 510(k) Numbers: Manufacturer:

Phoenix Atherectomy System Primary: Secondary: K140944 Volcano AtheroMed, Inc.

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#### Device Description:

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle.

The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle. The Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold a guidewire in a fixed position relative to the Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System.

There are multiple models of the Phoenix Catheter. The Phoenix Tracking Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8 mm and 2.2 mm tip diameter sizes; a 2.4 mm tip diameter size (identical in design to the currently marketed 2.4 mm Phoenix Deflecting Catheter) has been added under this 510(k). The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle.

This 510(k) includes modifications to the 1.8 mm and 2.2 mm tip diameter 149 cm Phoenix Tracking Catheter models to improve the overall catheter pushability and internal debris maceration of the longer length catheter models and (as just noted previously) to also add a 2.4 mm tip diameter 130 cm Phoenix Tracking Catheter to the Phoenix Catheter product family. Tables 9-1 and 9-2 summarize the subject modifications relative to the predicate devices.

#### Indications for Use:

The Phoenix® Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

#### Testing Summary:

To demonstrate the substantial equivalence of the modified Phoenix Atherectomy System to the predicate Phoenix Atherectomy System, the performance and technological characteristics were evaluated by completion of the following testing:

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- Dimensional and Visual Inspection .
- Simulated Use
- Cutter Torque Chain Torque-to-Failure Test
- Functional Outer Shaft Torque Test
- Knob to Shaft Testing
- . Catheter Drive Train Stress Test
- Cutter Stall Test
- . Temperature Rise of Catheter During Simulated Use
- Kink Bend Radius Test
- Catheter Trackability in Below-the-Knee Anatomy ●
- . Sheath Flow Rate (2.4mm X 130 cm Phoenix Catheter only)
- Sheath Compatibility (2.4mm X 130 cm Phoenix Catheter only)

The results from this testing demonstrate that the performance and technological characteristics of the modified Phoenix Atherectomy System meet pre-defined design requirements and that the modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System with the identical intended use.

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| Table 9-1: Technological Characteristics Comparison Summary of the Predicate to the Modified | | |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 130 cm Phoenix Atherectomy System | | |
| Technological<br>Characteristic | Predicate Phoenix Atherectomy System<br>(K140944),<br>5F (FG1847) and 6F (FG1984) Phoenix<br>Catheters | Modified Phoenix<br>Atherectomy System,<br>(Subject Device),<br>7F (FG2938) |
| Rotational Speed | 10,000-12,000 RPM | Identical |
| Guidewire Exchange | Over-the-wire | Identical |
| Guidewire Compatibility | 0.014" | Identical |
| Sheath Compatibility | 5F - 6F | 7F |
| Catheter Working Length | 130 cm | Identical |
| Catheter Torque Shaft | Multi-Strand Stainless Steel (SS) | Identical |
| Catheter Outer Shaft | Stainless Steel Outer Shaft and Teflon<br>sheath | Identical |
| Catheter Shaft Diameter | 1.7mm | Identical |
| Distal Cutter Flute Maximum<br>Diameter | 1.8 mm (FG1847)<br>2.2 mm (FG1984) | 2.4 mm |
| Tip Diameter and Crossing<br>Profile | 1.8 mm (FG1847)<br>2.2 mm (FG1984) | 2.4 mm |
| Cutting Tip Port | Single exit port conveys excised debris from<br>the inner guidewire lumen into the Distal<br>Cutting Flute channel | Identical |
| Second Stage Maceration<br>within Housing | Yes | Yes |
| Cutter Housing | No Coating | Identical |
| Distal Tip Assembly Coating | DLC Coating | Identical |
| Minimum Vessel Size for<br>Device Use | 2.5 mm (FG1847)<br>3.0 mm (FG1984) | Identical to FG1984 (3.0 mm) |
| Debris Collection & Removal | Continuous collection and removal of<br>excised debris by mechanical conveyance | Identical |
| Steering (Directional)<br>mechanism | Rotation of knob on handle steers distal tip<br>and cutter by torqueing catheter shaft | Identical |
| Catheter Coating | No | Identical |
| Sterilization | Ethylene Oxide | Identical |
| Single-use only | Yes | Identical |

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| Table 9-2: Technological Characteristics Comparison Summary of the Predicate to the Modified<br>149 cm Phoenix Atherectomy System | | |
|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristic | Predicate Phoenix Atherectomy<br>System (K143328),<br>5F (FG2160) and 6F (FG2162)<br>Phoenix Catheters | Modified Phoenix Atherectomy<br>System, (Subject Device),<br>5F (FG2160) and 6F (FG2162)<br>Phoenix Catheters) |
| Rotational Speed | 10,000-12,000 RPM | Identical |
| Guidewire Exchange | Over-the-wire | Identical |
| Guidewire Compatibility | 0.014" | Identical |
| Sheath Compatibility | 5F - 6F | Identical |
| Catheter Working Length | 149 cm | Identical |
| Catheter Torque Shaft | Multi-Strand Stainless Steel (SS) | Identical |
| Catheter Outer Shaft | Stainless Steel Outer Shaft and<br>Teflon sheath | Identical with Modified Flexibility<br>along shaft |
| Catheter Shaft Diameter | 1.7 mm | Identical |
| Distal Cutter Flute Maximum<br>Diameter | 1.8 mm (FG2160)<br>2.2 mm (FG2162) | Identical (FG2160)<br>Identical (FG2162) |
| Tip Diameter and Crossing<br>Profile | 1.8 mm (FG2160)<br>2.2 mm (FG2162) | Identical (FG2160)<br>Identical (FG2162) |
| Cutting Tip Port | Single exit port conveys excised<br>debris from the inner guidewire<br>lumen into the Distal Cutting Flute<br>channel | Identical |
| Second Stage Maceration within<br>Housing | Yes | Yes<br>(modified to further optimize internal<br>maceration) |
| Cutter Housing | No Coating | Identical |
| Distal Tip Assembly Coating | DLC Coating | Identical |
| Minimum Vessel Size for Device<br>Use | 2.5 mm (FG2160)<br>3.0 mm (FG2162) | Identical (FG2160)<br>Identical (FG2162) |
| Debris Collection & Removal | Continuous collection and removal<br>of excised debris by mechanical<br>conveyance | Identical |
| Steering (Directional)<br>mechanism | Rotation of knob on handle steers<br>distal tip and cutter by torqueing<br>catheter shaft | Identical |
| Catheter Coating | No | Identical |
| Sterilization | Ethylene Oxide | Identical |
| Single-use only | Yes | Identical |