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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Phoenix Atherectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria from an AI/reader study perspective.

Therefore, many of the requested categories for AI/reader study evaluation cannot be fulfilled from this document.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not detail specific acceptance criteria with numerical targets. Instead, it states that the modified Phoenix Atherectomy System's performance and technological characteristics were evaluated by a series of tests to demonstrate equivalence to the predicate device. The general acceptance is that the device "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."

The tests performed include:

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 document asserts that "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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described appears to be bench testing and simulated use, not clinical or human-data-driven studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document does not describe an AI/reader study or the establishment of ground truth by experts in that context. The "ground truth" here would relate to the engineering specifications and performance capabilities verified through the various tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as this is not an AI/reader study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a manual atherectomy system, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be derived from engineering specifications, material properties, and the results of the described bench and simulated use tests. It is based on the device's physical and functional capabilities as measured against design requirements for safety and effectiveness, and comparison to the predicate device.

8. The sample size for the training set

Not applicable. There is no AI model or training set described.

9. How the ground truth for the training set was established

Not applicable. There is no AI model or training set described.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.1530 O'Brien Drive, Suite A.Menlo Park, CA 94025
Contact Person:	Jean ChangSr Director, OperationsPhone: (916) 281-2937

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:

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
TechnologicalCharacteristic	Predicate Phoenix Atherectomy System(K140944),5F (FG1847) and 6F (FG1984) PhoenixCatheters	Modified PhoenixAtherectomy System,(Subject Device),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 Teflonsheath	Identical
Catheter Shaft Diameter	1.7mm	Identical
Distal Cutter Flute MaximumDiameter	1.8 mm (FG1847)2.2 mm (FG1984)	2.4 mm
Tip Diameter and CrossingProfile	1.8 mm (FG1847)2.2 mm (FG1984)	2.4 mm
Cutting Tip Port	Single exit port conveys excised debris fromthe inner guidewire lumen into the DistalCutting Flute channel	Identical
Second Stage Macerationwithin Housing	Yes	Yes
Cutter Housing	No Coating	Identical
Distal Tip Assembly Coating	DLC Coating	Identical
Minimum Vessel Size forDevice Use	2.5 mm (FG1847)3.0 mm (FG1984)	Identical to FG1984 (3.0 mm)
Debris Collection & Removal	Continuous collection and removal ofexcised debris by mechanical conveyance	Identical
Steering (Directional)mechanism	Rotation of knob on handle steers distal tipand 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 Modified149 cm Phoenix Atherectomy System
TechnologicalCharacteristic	Predicate Phoenix AtherectomySystem (K143328),5F (FG2160) and 6F (FG2162)Phoenix Catheters	Modified Phoenix AtherectomySystem, (Subject Device),5F (FG2160) and 6F (FG2162)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 andTeflon sheath	Identical with Modified Flexibilityalong shaft
Catheter Shaft Diameter	1.7 mm	Identical
Distal Cutter Flute MaximumDiameter	1.8 mm (FG2160)2.2 mm (FG2162)	Identical (FG2160)Identical (FG2162)
Tip Diameter and CrossingProfile	1.8 mm (FG2160)2.2 mm (FG2162)	Identical (FG2160)Identical (FG2162)
Cutting Tip Port	Single exit port conveys exciseddebris from the inner guidewirelumen into the Distal Cutting Flutechannel	Identical
Second Stage Maceration withinHousing	Yes	Yes(modified to further optimize internalmaceration)
Cutter Housing	No Coating	Identical
Distal Tip Assembly Coating	DLC Coating	Identical
Minimum Vessel Size for DeviceUse	2.5 mm (FG2160)3.0 mm (FG2162)	Identical (FG2160)Identical (FG2162)
Debris Collection & Removal	Continuous collection and removalof excised debris by mechanicalconveyance	Identical
Steering (Directional)mechanism	Rotation of knob on handle steersdistal tip and cutter by torqueingcatheter shaft	Identical
Catheter Coating	No	Identical
Sterilization	Ethylene Oxide	Identical
Single-use only	Yes	Identical

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).