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. The 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. 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Primary Safety Endpoint: Freedom from Major Adverse Events (MAE) at 30 days	94.3% (99/105 subjects)
Primary Effectiveness Endpoint: Acute technical success, defined as ability to achieve a residual diameter stenosis <50% (prior to any adjunctive therapy) using quantitative angiography or visual estimate	95.1% (117/123 lesions)

Note: The document states that "Both primary endpoints met the predefined IDE study success criteria." However, the specific numerical thresholds for these success criteria are not explicitly stated in the provided text.

Study Information

1. Study Type and Design:

Study Name: EASE clinical study
Study Design: Prospective, multi-center, non-randomized, single-arm study.

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

Total Patients Enrolled: 128
Per-Protocol Group: 105 subjects (with 123 treated lesions)
Data Provenance: Multi-center, prospective study. The country of origin is not explicitly stated, but the submission is to the FDA, implying a US-based or internationally recognized standard, likely including US centers given the FDA submission.

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

Number of Experts: An "independent physician adjudicator" was used to assess the primary safety endpoint. The exact number is not explicitly stated beyond "an" adjudicator, implying one or a group acting as a single entity for this purpose.
Qualifications: "independent physician adjudicator." Specific medical specialty or years of experience are not provided.
The primary effectiveness endpoint (acute technical success) was "assessed by the study investigator at the time of treatment." This implies the treating physician or a designated study investigator at each center made this assessment. Their qualifications are not further detailed.

4. Adjudication Method for the Test Set:

Safety Endpoint: "assessed by an independent physician adjudicator." This implies a form of independent review, though the specific method (e.g., 2+1, 3+1) is not detailed.
Effectiveness Endpoint: "assessed by the study investigator." This suggests local assessment rather than a centralized adjudication committee for this particular endpoint.

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

No. The study described (EASE clinical study) is a single-arm study evaluating the device's performance, not a comparative effectiveness study involving human readers with and without AI assistance. The device in question is an atherectomy system, a physical medical device, not an AI software.

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

This question is not applicable as the Phoenix Atherectomy System is a physical medical device, not an algorithm or AI software intended for standalone performance without human interaction. Its design inherently involves human-in-the-loop (the clinician using the device).

7. Type of Ground Truth Used:

Safety Endpoint: Clinical outcomes for Major Adverse Events (MAE) at 30 days, independently adjudicated.
Effectiveness Endpoint: Angiographic assessment (quantitative angiography or visual estimate) of residual diameter stenosis <50% at the time of treatment. This is a direct measure based on medical imaging and clinical assessment.

8. Sample Size for the Training Set:

The provided document describes a clinical study (EASE) for performance evaluation. It does not mention a "training set" in the context of machine learning or AI development. The device itself is a mechanical system, not an AI model.

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

Not applicable, as there is no mention of a training set for an AI model. The device is a mechanical atherectomy system.

Summary

{0}------------------------------------------------

K132682 p. 1 of 6

JAN 17 2014

5 510(k) Summary

Submitter Information:

Date of 510(k) Summary Preparation:

January 15, 2014

Name and Address of Manufacturer: AtheroMed, Inc. 1455 Adams Dr.

Contact Person:

Jean Chang Vice President, Operations Phone: (650) 473-6846 Fax: (650) 473-9927

Menlo Park, CA 94025

Subject Device:

Device Trade Name: · Common Name: Regulation Description: Regulation Number: Product Code: Device Class:

Classification Panel:

Phoenix® Atherectomy System Peripheral Atherectomy Catheter Intraluminal Artery Stripper 21 CFR 870.4875 MCW Class II Cardiovascular

{1}------------------------------------------------

Predicate Devices:

	(1) Device Trade Name: ev3 SilverHawk™ Peripheral Plaque Excision System
510(k) Numbers:	Multiple 510(k)s for the SilverHawk System family of devices,including K024243, K043553, K053460, K061063 and K061188
	(2) Device Trade Name: Pathway Medical Jetstream System
510(k) Numbers:	Multiple 510(k)s for the Jetstream System family of devices,including K081328, K093918, K101334, K111229 and K120242

Device Description:

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.

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.

{2}------------------------------------------------

Testing Summary:

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

. Dimensional and Visual Inspection
. Catheter Sweep & Deflection Span Verification
. Simulated Use
Comparative Predicate Testing in Simulated Lesion .
Cutter Torque Chain Torque-to-Failure Test .
. Functional Outer Shaft Torque Test
. Proximal Catheter Shaft Assembly Tensile Test - Deflection Catheter
. 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
. Sheath Flow Rate
. Radiopacity
. Catheter Trackability in Below-the-Knee Anatomy
Handle and Wire Support Clip Visual and Functional Testing
Handle Life Testing .
. Minimum Debulking Diameter for Deflection Catheter
. Sterilization Validation
. Packaging and Shelf Life
. Electrical Safety Testing in accordance with IEC 60601-1, Edition 3.0: Medical Electrical Equipment - Part 1: General Requirements for Safety
Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2, Edition 3.0: . Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
. Usability in accordance with IEC 60601-1-6. Edition 3.0: Medical Electrical Equipment -Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability and IEC 62366:2007, Application of Usability Engineering to Medical Devices
. Biocompatibility
- Cytotoxicity (L929 MEM Test) o
- o Sensitization (Kligman Maximization Test, 2 extracts - saline and SO)
- Intracutaneous Reactivity (Injection Test, 2 extracts saline and SO) o
- Acute Systemic Toxicity (2 extracts saline and SO) o
- Hemolysis (Human Blood indirect contact) ರ

{3}------------------------------------------------

Hemolysis (Human Blood direct contact) 0
Prothrombin Time Assay (ISO direct contact) o
Partial Thromboplastin Time Assay (ISO direct contact) o
In Vitro Platelet Aggregation Assay (ISO direct contact) o
Complement Activation (C3a and SC5a-9 direct contact) o
Pyrogenicity (Material Mediated) o
Pyrogenicity LAL (Kinetic Turbidimetric Assay Pyrogen Test) o
. Preclinical Animal Testing
- o Porcine study with acute, 3-day, and 28-day assessments and in vivo performance comparison to a predicate device
- Acute porcine study of largest (2.4mm) Phoenix Catheter size O
- Acute porcine study of smallest (1.8mm) Phoenix Catheter size o

The results from this testing demonstrate that the performance and technological characteristics of the Phoenix Atherectomy System meet defined design requirements and that the Phoenix Atherectomy System performs in a manner equivalent to the predicate devices currently on the market with the same intended atherectomy use.

Table 1 on the following page presents a summary of technological characteristics of the Phoenix Atherectomy System, as compared to the predicate devices.

Clinical Summary:

The EASE clinical study was a prospective, multi-center, non-randomized, single-arm study to evaluate the safety, effectiveness, and performance of the Phoenix Atherectomy System in the percutaneous atherectomy treatment of de novo and restenotic atherosclerotic lesions of infrainguinal lower extremity arteries. 128 total patients were enrolled across 16 centers for treatment. 105 subjects (with 123 treated lesions) comprising the Per-Protocol group were enrolled in accordance with the vessel sizing and anatomic location requirements corresponding to each Phoenix Catheter device size. The primary safety endpoint was freedom from major adverse events (MAE) at 30 days, as assessed by an independent physician adjudicator. The primary effectiveness endpoint was acute technical success, defined as the ability to achieve a residual diameter stenosis <50% as assessed by the study investigator at the time of treatment with the Phoenix Atherectomy System (prior to any adjunctive therapy) using quantitative angiography or visual estimate. Patients were monitored for 6 months following baseline atherectomy treatment.

The 30-day freedom from MAE rate was 94.3% (99/105) and technical success was achieved in 95.1% (117/123) of the lesions treated in the per protocol group. Both primary endpoints met the predefined IDE study success criteria.

Following treatment of the first 36 subjects enrolled in the EASE Study, a higher than anticipated complication was observed. Of the first 36 subjects treated, there were 19 serious procedure or

{4}------------------------------------------------

device related adverse events and 6 adverse events met the definition of major adverse events (MAE). Specific to the MAE, there have been 5 dissections/perforations and one vessel occlusion requiring treatment. AtheroMed initiated a review of available data to assess the underlying causes. The analysis of these early results led to additional sizes of the Phoenix Atherectomy Catheter being added to the EASE Study protocol, as well as updated recommendations regarding minimum vessel diameters and anatomical locations for device use.

{5}------------------------------------------------

K132682

p. 6 of 6

TechnologicalCharacteristic	AtheroMedPhoenix AtherectomySystem	Predicate FoxHollow/ev3SilverHawk	Predicate PathwayMedicalJetstream System
Rotational Speed	10,000-12,000 RPM	~8,000 RPM	~70,000 RPM
Guidewire Exchange	Over-the-wire	Monorail	Over-the-wire
Guidewire Compatibility	0.014"	0.014"	0.014"
Sheath Compatibility	5F - 7F	6F - 8F	7F
Catheter Working Length(s)	130cm	107cm - 136cm	120cm - 145cm
Tip Diameter or CrossingProfile	1.8mm - 2.4mm (tipdiameter and crossingdiameter)	1.9mm - 2.7mm (crossingprofile)	1.6mm - 2.4mm ("bladesdown" range, tipdiameter)3.0mm - 3.4mm ("bladesup" range, tip diameter)
Minimum Vessel Size forDevice Use	2.5mm - 4.5mm	1.5mm - 7.0mm	2.5mm - 4.5mm
Debris Collection & Removal	Continuous collectionand removal of exciseddebris by mechanicalconveyance.	Debris collection in distalnosecone during use, withemptying of nosecone viacatheter removal.	Continuous collectionand removal of exciseddebris via vacuumaspiration.
Deflection mechanism	Deflecting Catheter:Advancing knob onhandle causes distal tip todeflect, creating off-axisapposition of cutter toplaque.Tracking Catheters: Notapplicable - nodeflection capability.	All Catheters: Advancingknob on handle causesnosecone to deflect,creating off axisapposition of cutter toplaque.	No deflectionmechanism. However,certain Jetstream modelsallow for a largerdiameter cutter ("bladesup") by reversingrotational direction todeploy expandableblades.
Steering (Directional)mechanism	Rotation of knob onhandle steers distal tipand cutter by torqueingcatheter shaft.	Rotation knob steers distaltip and cutter by torqueingcatheter shaft.	Not applicable.
Catheter Coating	No	Yes (hydrophilic coating)	No
Sterilization	Ethylene Oxide	Ethylene Oxide (catheter)Gamma (cutter driver)	Ethylene Oxide
Single-use only	Yes	Yes	Yes

END OF DOCUMENT

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 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 symbol that resembles a human figure embracing or supporting another form, possibly representing health and well-being.

Public Health Service

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

January 17, 2014

Atheromed, Inc.

Ms. Jean Chang Vice President, Operations 1455 Adams Drive Suite | 120 Menlo Park, CA 94025

Re: K132682

Trade/Device Name: Phoenix® Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: II Product Code: MCW Dated: November 21, 2013 Received: November 29, 2013

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{7}------------------------------------------------

Page 2 - Ms. Jean Chang

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

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

{8}------------------------------------------------

AtheroMed, Inc.

Phoenix® Atherectomy System 510(k) Premarket Notification

Indications for Use 4

510(k) Number: K132682

Device Name: Phoenix® Atherectomy System

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Please do not write below this line - continue on another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kenneth J. Cavanaugh -S

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).