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 AtheroMed 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 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. An optional Wire Support Clip can also be used to clip a guidewire torque device in a fixed position relative to the Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately as sterile, single-use components of the Phoenix Atherectomy System. There are three different models of the Phoenix Catheter. Two Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8mm and 2.2mm tip diameter sizes. A third, 2.4mm tip diameter model has a Catheter tip design that can be deflected and rotated by the user so that the cutter can eccentrically debulk to a larger diameter than the Catheter's 2.4mm distal cutter. The controls for deflection and rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All three Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260cm or greater) guidewires, and all use the same Phoenix Handle. This 510(k) includes modifications to the cutter and distal assembly of the 1.8mm and 2.2mm tip diameter Phoenix Catheter models, as well as modifications to the Catheter and proximal chassis design, to further optimize the device design and manufacturability of the device. Table 9-1 summarizes the subject modifications relative to the predicate device. Additionally, the Phoenix Guidewire has been added as a compatible guidewire in the product labeling.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the acceptance criteria implicitly through the various tests conducted and the conclusion that the device "meet defined design requirements" and "performs in a manner equivalent to the predicate Phoenix Atherectomy System." Since this is a 510(k) submission for modifications to an already cleared device, the primary acceptance criterion is substantial equivalence to the predicate device.

Acceptance Criterion	Reported Device Performance (Summary)
Overall Equivalence to Predicate Device	Modified Phoenix Atherectomy System performs in a manner equivalent to the predicate Phoenix Atherectomy System with identical intended use.
Dimensional and Visual Inspection	Met defined design requirements.
Simulated Use Performance	Met defined design requirements.
Comparative Predicate Testing in Simulated Lesion	Met defined design requirements.
Cutter Torque Chain Torque-to-Failure Test	Met defined design requirements.
Functional Outer Shaft Torque Test	Met defined design requirements.
Knob to Shaft Testing	Met defined design requirements.
Catheter Drive Train Stress Test	Met defined design requirements.
Cutter Stall Test	Met defined design requirements.
Temperature Rise of Catheter During Simulated Use	Met defined design requirements.
Corrosion Test	Met defined design requirements.
Kink Bend Radius Test	Met defined design requirements.
Guidewire Compatibility	Met defined design requirements.
Sheath Compatibility	Met defined design requirements.
Sheath Flow Rate	Met defined design requirements.
Catheter Trackability in Below-the-Knee Anatomy	Met defined design requirements.
Shelf Life	Met defined design requirements.
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolysis, Prothrombin Time Assay, Partial Thromboplastin Time Assay, In Vitro Platelet Aggregation Assay, Complement Activation, Pyrogenicity)	Met defined design requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual test. It mentions "Comparative Predicate Testing in Simulated Lesion," implying a test set was used, but the size or characteristics of the "simulated lesion" are not detailed.

The data provenance is from laboratory testing and simulations ("Simulated Use," "Comparative Predicate Testing in Simulated Lesion," "Temperature Rise of Catheter During Simulated Use," "Catheter Trackability in Below-the-Knee Anatomy"). No information is provided about patient data, animal studies, or specific geographic origins. Given the tests listed, the data is likely prospective in nature, as tests were performed specifically to evaluate the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are primarily engineering and bench-top performance evaluations, rather than clinical studies requiring expert interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The evaluations are based on objective engineering measurements and laboratory results, not on subjective interpretations from multiple readers requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. This document describes a 510(k) submission for an atherectomy system, which is a surgical tool, and the testing focuses on its physical and performance characteristics, not on diagnostic accuracy or interpretation by human readers. Therefore, the concept of "improving human readers with AI vs without AI assistance" is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to this device. The Phoenix Atherectomy System is a physical medical device (catheter-based system), not an AI algorithm. Its performance is intrinsically tied to human operation during a medical procedure.

7. The Type of Ground Truth Used

The "ground truth" for the various tests appears to be defined by engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, in "Cutter Torque Chain Torque-to-Failure Test" or "Kink Bend Radius Test," the ground truth would be the pre-defined acceptable limits of torque or bend radius. For "Biocompatibility," the ground truth is established by relevant ISO standards or guidelines for material safety.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device. Training sets are typically used for machine learning or AI models. This document describes the evaluation of a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set in the context of this device's evaluation, this question is not applicable.

Summary

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Public Health Service

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

August 22, 2014

AtheroMed, Inc. Ms. Jean Chang Vice President, Operations 1455 Adams Drive Suite 1120 Menlo Park, CA 94025

K140944 Re:

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: July 24, 2014 Received: July 25, 2014

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. Iisting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 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 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 yours,

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

Food and Drug Administration

Indications for Use

510(k) Number (if known) K140944

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)

ال Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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9 510(k) Summary

Submitter Information:

Date of 510(k) Summary Preparation:	July 24, 2014
Name and Address of Manufacturer:	AtheroMed, Inc.1455 Adams Dr.Menlo Park, CA 94025
Contact Person:	Jean ChangVice President, OperationsPhone: (650) 473-6846Fax: (650) 473-9927
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:	Phoenix Atherectomy System
510(k) Number:	K132682
Manufacturer:	AtheroMed, Inc.

Device Description:

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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 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. An optional Wire Support Clip can also be used to clip a guidewire torque device in a fixed position relative to the Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately as sterile, single-use components of the Phoenix Atherectomy System.

There are three different models of the Phoenix Catheter. Two Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8mm and 2.2mm tip diameter sizes. A third, 2.4mm tip diameter model has a Catheter tip design that can be deflected and rotated by the user so that the cutter can eccentrically debulk to a larger diameter than the Catheter's 2.4mm distal cutter. The controls for deflection and rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All three Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260cm or greater) guidewires, and all use the same Phoenix Handle.

This 510(k) includes modifications to the cutter and distal assembly of the 1.8mm and 2.2mm tip diameter Phoenix Catheter models, as well as modifications to the Catheter and proximal chassis design, to further optimize the device design and manufacturability of the device. Table 9-1 summarizes the subject modifications relative to the predicate device. Additionally, the Phoenix Guidewire has been added as a compatible guidewire in the product labeling.

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:

. Dimensional and Visual Inspection
. Simulated Use
. Comparative Predicate Testing in Simulated Lesion
. 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
. Corrosion Test
Kink Bend Radius Test
Guidewire Compatibility
. Sheath Compatibility

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ATHEROMED K140944 AI Response

Sheath Flow Rate
. Catheter Trackability in Below-the-Knee Anatomy
Shelf Life
. Biocompatibility
- o Cytotoxicity (L-929 MEM Test)
- Sensitization (Kligman Maximization Test, 2 extracts saline and SO) O
- Intracutaneous Reactivity (Injection Test, 2 extracts saline and SO) O
- Acute Systemic Toxicity (2 extracts saline and SO) o
- Hemolysis (Human Blood indirect contact) O
- Hemolysis (Human Blood direct contact) O
- Prothrombin Time Assay (ISO direct contact) O
- Partial Thromboplastin Time Assay (ISO direct contact) O
- In Vitro Platelet Aggregation Assay (ISO direct contact) O
- o Complement Activation (C3a and SC5a-9 direct contact)
- Pyrogenicity (Material Mediated) O
- Pyrogenicity Bacterial Endotoxin/LAL (Kinetic Turbidimetric Assay Pyrogen о Test)

The results from this testing demonstrate that the performance and technological characteristics of the modified Phoenix Atherectomy System meet 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: Summary of Technological Characteristics for the Modified PhoenixAtherectomy System
TechnologicalCharacteristic	Predicate Phoenix AtherectomySystem (K132682),5F (FG1105) and 6F (FG1493)Phoenix Catheters	Modified Phoenix AtherectomySystem (Subject Device),5F (FG1847) and 6F (FG1984)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	130 cm	Identical
Catheter Torque Shaft	Multi-Strand Stainless Steel (SS)	Multi-Strand Stainless Steel (SS)
Catheter Outer Shaft	Stainless Steel Outer Shaft andTeflon sheath	Stainless Steel Outer Shaft and thickerTeflon sheath
Catheter Shaft Diameter	1.7mm	Identical
Distal Cutter FluteMaximum Diameter	1.6mm (FG1105)2.0mm (FG1493)	1.8mm (FG1847)2.2mm (FG1984)(Modified Distal Cutter Flute is flushwith Cutter Housing)
Tip Diameter andCrossing Profile	1.8mm (FG1105)2.2mm (FG1493)	Identical (FG1847)Identical (FG1984)
Cutting Tip Port	None	Single exit port added to conveyexcised debris from the inner guidewirelumen into the Distal Cutting Flutechannel
Second StageMaceration withinHousing	Yes	Yes, with increased capacity/volume
Cutter Housing	Coated	No Coating
Distal Tip AssemblyCoating	Coated	Coated
Catheter ChassisMaterial Changes	Bearing Lubricant - Aerospace GradeSilicone O-Ring	Bearing Lubricant - Food GradeSilicone O-Ring - Medical Grade
Minimum Vessel Size forDevice Use	2.5mm (FG1105)3.0mm (FG1493)	Identical (FG1847)Identical (FG1984)
Debris Collection &Removal	Continuous collection and removal ofexcised 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).