PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA
Device Facts
| Record ID | K132682 |
|---|---|
| Device Name | PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA |
| Applicant | Atheromed, Inc. |
| Product Code | MCW · Cardiovascular |
| Decision Date | Jan 17, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
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 device is operated by a physician in a clinical setting. The catheter features a front-cutting tip that debulks plaque; excised debris is continuously captured and transported proximally through the catheter and handle into an external collection reservoir. Three catheter models are available: two fixed-tip models (1.8mm and 2.2mm) and one deflectable model (2.4mm) allowing eccentric debulking. The handle controls cutter rotation (10,000-12,000 RPM) and tip deflection. By removing obstructive plaque, the device restores blood flow in peripheral arteries, potentially improving patient symptoms related to peripheral artery disease.
Clinical Evidence
The EASE study was a prospective, multi-center, non-randomized, single-arm clinical trial (n=128 enrolled, 105 per-protocol). Primary safety endpoint: 30-day freedom from major adverse events (MAE) was 94.3%. Primary effectiveness endpoint: acute technical success (residual stenosis <50%) was 95.1%. Initial study phase showed higher-than-expected complications (dissections/perforations), leading to protocol updates regarding vessel sizing and anatomical recommendations. Bench testing included mechanical, electrical (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility assessments.
Technological Characteristics
Peripheral atherectomy catheter; over-the-wire; 1.8mm-2.4mm tip diameters. Mechanical cutting via battery-powered motor (10,000-12,000 RPM). Continuous mechanical debris conveyance to external reservoir. Deflectable tip model available. Compatible with 0.014" guidewires and 5F-7F sheaths. Sterilized via Ethylene Oxide. No software/AI components.
Indications for Use
Indicated for percutaneous atherectomy of de novo and restenotic atherosclerotic lesions in infrainguinal peripheral vasculature. Contraindicated 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
- ev3 SilverHawk™ Peripheral Plaque Excision System (K024243, K043553, K053460, K061063, K061188)
- Pathway Medical Jetstream System (K081328, K093918, K101334, K111229, K120242)
Submission Summary (Full Text)
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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
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## 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,<br>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,<br>including K081328, K093918, K101334, K111229 and K120242 | | |
## 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.
## 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.
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## 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
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- 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
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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.
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## K132682
## p. 6 of 6
| Technological<br>Characteristic | AtheroMed<br>Phoenix Atherectomy<br>System | Predicate FoxHollow/ev3<br>SilverHawk | Predicate Pathway<br>Medical<br>Jetstream 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 Crossing<br>Profile | 1.8mm - 2.4mm (tip<br>diameter and crossing<br>diameter) | 1.9mm - 2.7mm (crossing<br>profile) | 1.6mm - 2.4mm ("blades<br>down" range, tip<br>diameter)<br>3.0mm - 3.4mm ("blades<br>up" range, tip diameter) |
| Minimum Vessel Size for<br>Device Use | 2.5mm - 4.5mm | 1.5mm - 7.0mm | 2.5mm - 4.5mm |
| Debris Collection & Removal | Continuous collection<br>and removal of excised<br>debris by mechanical<br>conveyance. | Debris collection in distal<br>nosecone during use, with<br>emptying of nosecone via<br>catheter removal. | Continuous collection<br>and removal of excised<br>debris via vacuum<br>aspiration. |
| Deflection mechanism | Deflecting Catheter:<br>Advancing knob on<br>handle causes distal tip to<br>deflect, creating off-axis<br>apposition of cutter to<br>plaque.<br>Tracking Catheters: Not<br>applicable - no<br>deflection capability. | All Catheters: Advancing<br>knob on handle causes<br>nosecone to deflect,<br>creating off axis<br>apposition of cutter to<br>plaque. | No deflection<br>mechanism. However,<br>certain Jetstream models<br>allow for a larger<br>diameter cutter ("blades<br>up") by reversing<br>rotational direction to<br>deploy expandable<br>blades. |
| Steering (Directional)<br>mechanism | Rotation of knob on<br>handle steers distal tip<br>and cutter by torqueing<br>catheter shaft. | Rotation knob steers distal<br>tip and cutter by torqueing<br>catheter shaft. | Not applicable. |
| Catheter Coating | No | Yes (hydrophilic coating) | No |
| Sterilization | Ethylene Oxide | Ethylene Oxide (catheter)<br>Gamma (cutter driver) | Ethylene Oxide |
| Single-use only | Yes | Yes | Yes |
# END OF DOCUMENT
:
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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
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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
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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
