Phoenix 2.4mm Atherectomy Plus System

K181877 · Volcano Atheromed, Inc. · MCW · Dec 17, 2018 · Cardiovascular

Device Facts

• Record ID: K181877
• Device Name: Phoenix 2.4mm Atherectomy Plus System
• Applicant: Volcano Atheromed, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Dec 17, 2018
• Decision: SESE
• Submission Type: Traditional
• 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. The system is not intended for use in the coronary, carotid, iliac, pulmonary, or renal vasculature. Phoenix Atherectomy Plus System: When used with the Phoenix Aspiration Pump as the vacuum source, the Phoenix 2.4 Deflecting Atherectomy System is indicated for the removal of thrombus from vessels of the peripheral arterial vasculature.

Device Story

System comprises Phoenix 2.4mm Deflecting Atherectomy Catheter, Handle, and new Phoenix Aspiration Pump; used for peripheral atherectomy and thrombus removal. Catheter features distal rotating cutter (helical flutes) to debulk lesions; mechanical conveyance moves excised material proximally through catheter/handle to external collection reservoir. Aspiration pump provides vacuum (≥ 25 inch Hg) to assist thrombus removal. Used in clinical setting by physicians; catheter/handle are sterile, single-use; pump is battery-operated. Output is physical removal of plaque/thrombus from vessel. Benefits include combined debulking and aspiration for improved vessel clearance.

Clinical Evidence

Bench testing included visual inspection, vacuum/leak tests, flow rate, simulated use, life cycle, tensile testing, comparative system/pump testing, sterilization validation, packaging/shelf-life, and electrical safety/EMC. Preclinical animal testing was also performed. No human clinical trial data provided.

Technological Characteristics

Catheter: DLC-coated stainless steel rotating cutter, 2.4mm diameter, 125-127cm length, 10,000-12,000 RPM. Handle: Battery-powered (6V DC). Aspiration Pump: Battery-powered (12V DC), diaphragm-type, ≥ 25 inch Hg vacuum. Connectivity: Standalone. Sterilization: Ethylene Oxide (EO). Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for atherectomy of peripheral vasculature and removal of thrombus from peripheral arterial vasculature. Contraindicated for use in coronary, carotid, iliac, pulmonary, 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

• Jetstream Atherectomy System (K130637)

Reference Devices

• Phoenix Atherectomy System (K172386)
• Penumbra INDIGO Aspiration System (K161523)

Submission Summary (Full Text)

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December 17, 2018

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

Re: K181877

Trade/Device Name: Phoenix 2.4mm Atherectomy Plus System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 15, 2018 Received: November 16, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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, Date: / 2018.12.17 Eleni Whatley 13:25:35 -05'00' 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) K181877

Device Name Phoenix 2.4 Atherectomy Plus System

#### Indications for Use (Describe)

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

Phoenix Atherectomy Plus System:

When used with the Phoenix Aspiration Pump as the vacuum source, the Phoenix 2.4 Deflecting Atherectomy System is indicated for the removal of thrombus from vessels of the peripheral arterial vasculature.

| Type of Use (Select one or both, as applicable) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <table border="0"><tr><td><span style="font-size: 100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td><span style="font-size: 100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size: 100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size: 100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | |
| <span style="font-size: 100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | |

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# Submitter Information:

| Date of 510(k) Summary Preparation: | November 29, 2018 |
|-------------------------------------|---------------------------------------------------------------------|
| Name and Address of Manufacturer: | Volcano AtheroMed, Inc.<br>1530 O'Brien Dr.<br>Menlo Park, CA 94025 |
| Contact Person: | Jean Chang<br>Senior Director, Operations<br>Phone: [phone] |

# Subject Device:

| Device Trade Name: | Phoenix® 2.4mm Atherectomy Plus System |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Atherectomy System |
| Regulation Description: | Intraluminal Artery Stripper |
| Regulation Number: | 21 CFR 870.4875 |
| Product Code: | MCW |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |
| Predicate Devices: | |
| Primary Predicate: | Jetstream Atherectomy System (K130637) |
| Reference Devices: | The Phoenix® Atherectomy System<br>(K172386) & the Penumbra INDIGOTM<br>Aspiration System (K161523) serve as<br>additional reference devices |

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510(k) Premarket Notification K181877

### Device Description:

The Phoenix 2.4mm Atherectomy Plus System comprises the currently cleared Phoenix 2.4mm Deflecting Atherectomy System (K172386) and a new Phoenix Aspiration Pump. which when used in conjunction with each other are designed for removal of thrombus from vessels of the peripheral arterial vasculature.

The Phoenix 2.4mm Deflecting Atherectomy System and the Phoenix Aspiration Pump are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The Phoenix 2.4mm Deflecting Atherectomy System comprises the Phoenix 2.4mm Deflecting Atherectomy Catheter and the Phoenix Atherectomy Handle with Wire Support Clip.

The Phoenix Catheter is an over-the-wire (OTW), multi-lumen Catheter with a cutter at the distal tip that continuously captures and clears debulked (excised) material 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 incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectorny Catheter at its specified rotational speed, and 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 Phoenix 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. The Phoenix Catheter is compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires.

For the purpose of this 510(k), the design of the Phoenix 2.4mm Deflecting Atherectomy System remains unchanged.

The Phoenix Aspiration Pump connects to the disposal outlet of the Phoenix Catheter via the pump's aspiration tubing. The exit end of the aspiration tubing is connected to a waste disposal bag to collect aspirated material. A 60 ml syringe is provided as part of the Aspiration Pump Assembly to assist in priming the pump aspiration tubing and purging the aspiration system of air. The Aspiration Pump is battery-operated and is operated by an ON/OFF switch. It serves as a vacuum source for the Aspiration System for aspirating the thrombus from the target vessel out of the Phoenix Catheter via the pump aspiration tubing and into the disposal bag. The Aspiration Pump is non-patient contacting.

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510(k) Premarket Notification K181877

#### Indications for Use:

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

#### Phoenix Atherectomy Plus System:

When used with the Phoenix Aspiration Pump as the vacuum source, the Phoenix 2,4mm Deflecting Atherectomy System is indicated for the removal of thrombus from vessels of the peripheral arterial vasculature.

### Comparison with Predicate:

The Phoenix 2.4mm Atherectomy Plus System is the subject of this submission for removal of thrombus from peripheral arterial vasculature. The Phoenix 2.4mm Atherectomy Plus System has been assessed for substantial equivalence relative to the currently marketed Boston Scientific Jetstream Atherectomy System as the predicate device, along with consideration of two additional reference devices, the Phoenix 2.4mm Deflecting Atherectomy System and the Penumbra INDIGO Aspiration System. The Phoenix 2.4mm Atherectomy Plus System has the same design, materials, technological characteristics and principle of operation of the reference Phoenix 2.4mm Deflecting Catheter and Handle, There is no change to the currently marketed 2.4mm Deflecting Atherectomy Catheter and Handle with Wire Support Clip. The Phoenix Aspiration Pump that is used as part of the Phoenix Atherectomy Plus System is comparable to the Penumbra INDIGO Aspiration System and shares a similar mechanism of action. The proposed indications for use to add aspiration for thrombus removal for the Phoenix Atherectomy Plus System are similar to those of the predicate Boston Scientific Jetstream Atherectomy System, with respect to a combined atherectomy and thrombectomy indication, as well as the reference Penumbra INDIGO System with thrombus removal using vacuum aspiration. Any differences between the subject and predicate device were evaluated through technological comparison (also taking into account the noted reference devices) and design verification and validation testing, which demonstrated no new questions of safety and effectiveness.

The similarities and differences between the subject device and the predicate and reference devices are outlined in the table below:

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| Table 1-1: Comparison Table | | | | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design/<br>Technological<br>Characteristic | Subject<br>Phoenix Atherectomy Plus<br>System | Predicate<br>Boston Scientific (Pathway<br>Medical)<br>Jetstream System<br>K130637 | Reference<br>Phoenix Atherectomy System<br>K172386 | Reference<br>Penumbra<br>Indigo Aspiration System<br>K161523 |
| Indications /<br>Intended Use | The Phoenix Atherectomy<br>System is intended for use<br>in atherectomy of the<br>peripheral vasculature. The<br>system is not intended for<br>use in the coronary, carotid,<br>iliac, pulmonary, or renal<br>vasculature.<br><br>Phoenix Atherectomy Plus<br>System:<br>When used with the<br>Phoenix Aspiration Pump<br>as the vacuum<br>source, the Phoenix 2.4mm<br>Deflecting Atherectomy<br>System is indicated for the<br>removal of thrombus from<br>vessels of the peripheral<br>arterial vasculature. | The Jetstream System is<br>intended for use in atherectomy<br>of the peripheral vasculature<br>and to break apart and remove<br>thrombus from upper and lower<br>extremity peripheral arteries. It<br>is not intended for use in<br>coronary, carotid, iliac or renal<br>vasculature. | Intended for use in atherectomy<br>of the peripheral vasculature. It<br>is not intended for use in<br>coronary, carotid, iliac or renal<br>vasculature. | INDIGO Aspiration Catheters and<br>Separators:<br>As part of the INDIGO Aspiration<br>System, the INDIGO Aspiration<br>Catheters and Separators are indicated<br>for the removal of fresh, soft emboli<br>and thrombi from vessels of the<br>peripheral arterial and venous<br>systems.<br><br>INDIGO Aspiration Tubing:<br>As part of the INDIGO Aspiration<br>System, the INDIGO Sterile<br>Aspiration Tubing is indicated to<br>connect the INDIGO Aspiration<br>Catheter to the Penumbra Aspiration<br>Pump.<br><br>Penumbra Aspiration Pump:<br>The Penumbra Aspiration Pump is<br>indicated as a vacuum source for the<br>Penumbra Aspiration Systems. |
| Table 1-1: Comparison Table | | | | |
| Design/<br>Technological<br>Characteristic | Subject<br>Phoenix Atherectomy Plus<br>System | Predicate<br>Boston Scientific (Pathway<br>Medical)<br>Jetstream System<br>K130637 | Reference<br>Phoenix Atherectomy System<br>K172386 | Reference<br>Penumbra<br>Indigo Aspiration System<br>K161523 |
| General<br>Technological<br>Design | Phoenix Catheter with distal<br>rotating cutter head cuts<br>through target lesion, where<br>the cutter geometry (helical<br>flutes) draws shaved<br>material proximally within<br>the catheter housing as it<br>cuts. The excised material is<br>removed continuously from<br>the patient by mechanical<br>conveyance along with<br>vacuum assist from the<br>Aspiration Pump and<br>deposited in a collection<br>bag outside the patient.<br>Catheter deflection allows<br>the catheter to cut<br>directionally to a diameter<br>larger than the catheter.<br>Aspiration Pump - handheld<br>battery powered pump<br>capable of providing a<br>vacuum source of ≥ 25inch<br>Mercury (Hg) to aspirate<br>blood and thrombus related<br>materials. | Atherectomy via rotating distal<br>tip advanced longitudinally<br>through target lesion. The distal<br>tip ("blades down") has cutting<br>flutes to remove lesion material<br>when rotating at the minimum<br>diameter. Simultaneous<br>irrigation/infusion and<br>continuous aspiration during<br>device activation remove<br>excised debris to a collection<br>bag outside the patient.<br>In certain Jetstream models,<br>rotational direction is reversed<br>to deploy expandable blades<br>("blades up") to achieve an<br>increased diameter for further<br>lesion treatment. | Phoenix Catheter with distal<br>rotating cutter cuts through<br>target lesion. The cutter<br>geometry (helical flutes) draws<br>shaved plaque proximally<br>within the catheter housing as it<br>cuts. Excised debris is removed<br>continuously from the patient<br>by mechanical conveyance and<br>deposited in a collection bag<br>outside the patient.<br>Catheter deflection allows the<br>catheter to cut directionally to a<br>diameter larger than the<br>catheter. | The Penumbra Aspiration System is<br>designed to remove thrombus from<br>vasculature by aspirating the proximal<br>side of the thrombus using continuous<br>aspiration through the Aspiration<br>Catheter from the pump directly to the<br>thrombus.<br>For the aspiration source, the<br>Aspiration Catheter is used in<br>conjunction with the Aspiration Pump,<br>which is connected using the<br>Aspiration Tubing and the Pump<br>Canister/Tubing.<br>The Aspiration Catheter is used with<br>the Aspiration Pump to aspirate<br>thrombus from an occluded vessel. As<br>needed, the Separator may be<br>deployed from the Aspiration Catheter<br>to assist with thrombus removal. The<br>Separator is advanced and retracted<br>through the Aspiration Catheter at the<br>proximal margin of the primary<br>occlusion to facilitate clearing of the<br>thrombus from the Aspiration<br>Catheter tip. |
| Table 1-1: Comparison Table | | | | |
| Design/<br>Technological<br>Characteristic | Subject<br>Phoenix Atherectomy Plus<br>System | Predicate<br>Boston Scientific (Pathway<br>Medical)<br>Jetstream System<br>K130637 | Reference<br>Phoenix Atherectomy System<br>K172386 | Reference<br>Penumbra<br>Indigo Aspiration System<br>K161523 |
| Debulking<br>Mechanism | Front Cutting Rotational<br>Device | Front Cutting Rotational<br>Device | Front Cutting Rotational<br>Device | Vacuum aspiration only |
| Debris<br>Collection &<br>Removal | Active aspiration<br>Continuous collection and<br>removal of thrombus by<br>mechanical conveyance of<br>Catheter and vacuum<br>provided by aspiration<br>pump | Active aspiration<br>Continuous collection and<br>removal of excised debris via<br>vacuum aspiration. | Continuous collection and<br>removal of excised debris by<br>mechanical conveyance of<br>Catheter. | Continuous aspiration and removal of<br>thrombus via vacuum aspiration with<br>the catheter targeting aspiration from<br>the pump to the thrombus. |
| Catheter<br>Rotational<br>Speed | 10,000-12,000 RPM | ~70,000 RPM (atherectomy)<br>~24,000 RPM (guidewire<br>removal) | 10,000-12,000 RPM | Not applicable |
| Vacuum<br>Aspiration | ≥ 25 inch Hg Vacuum<br>(battery powered.<br>diaphragm pump) | > 20 inch Hg Vacuum<br>(electrical, peristaltic pump) | Not applicable | Up to 29 inch Hg Vacuum<br>(electrical, piston vacuum pump) |
| Power Source | 6V DC Battery for Phoenix<br>Handle<br>12V DC Battery for<br>Aspiration Pump | 110/220 V AC, 50/60 Hz AC<br>power supply from wall socket | 6V DC Battery for Phoenix<br>Handle<br>Not applicable for aspiration | 100-115 V AC/ 230 V AC, 50/60 Hz<br>AC power supply from wall socket for<br>Penumbra Max Pump |
| Guidewire<br>Exchange | Over-the-wire | Over-the-wire | Over-the-wire | Over-the-wire |
| Guidewire<br>Compatibility | 0.014" | 0.014" | 0.014" | 0.014"-0.035" |
| Sheath<br>Compatibility | 7F | 7F | 7F | 6F-8F |
| Catheter<br>Working<br>Length (s) | 125 - 127 cm | 120cm - 145cm | 125 - 127 cm | 85cm - 120 cm |
| Table 1-1: Comparison Table | | | | |
| Design/<br>Technological<br>Characteristic | Subject<br>Phoenix Atherectomy Plus<br>System | Predicate<br>Boston Scientific (Pathway<br>Medical)<br>Jetstream System<br>K130637 | Reference<br>Phoenix Atherectomy System<br>K172386 | Reference<br>Penumbra<br>Indigo Aspiration System<br>K161523 |
| Tip Diameter or<br>Crossing Profile | 2.4mm (tip diameter and<br>crossing diameter) | 1.6mm – 2.4mm ("blades<br>down" range, tip diameter)<br>3.0mm - 3.4mm ("blades up"<br>range, tip diameter) | 2.4mm (tip diameter and<br>crossing diameter) | 2.2mm - 3.0mm |
| Minimum Vessel<br>Size for Device<br>Use | ≥ 3.0mm | ≥2.5mm (XC)<br>≥ 3.0mm (SC) | ≥ 3.0mm | ≥ 4.0mm |
| Deflection<br>mechanism | Deflecting Catheter:<br>Advancing slider forward<br>on catheter chassis causes<br>distal tip to deflect | No deflection mechanism.<br>However, certain Jetstream<br>models allow for a larger<br>diameter cutter ("blades up")<br>by reversing rotational direction<br>to deploy expandable blades. | Deflecting Catheter:<br>Advancing slider forward on<br>catheter chassis causes distal tip<br>to deflect | Not applicable<br>8F device with Angled tip |
| Steering<br>(Directional)<br>mechanism | Rotation of knob on handle<br>steers distal tip and cutter<br>by torqueing catheter shaft | Not applicable | Rotation of knob on handle<br>steers distal tip and cutter by<br>torqueing catheter shaft | Not applicable<br>8F Catheter with Angled Tip |
| Catheter<br>Coating | No…