(142 days)
Not Found
No
The description focuses on mechanical components and operation, with no mention of AI/ML, image processing, or data analysis for decision-making.
Yes.
The device is used for "atherectomy of the peripheral vasculature," which is a medical procedure to remove plaque from arteries, indicating a therapeutic purpose.
No
The device is an atherectomy system designed for the percutaneous removal of atherosclerotic plaque from peripheral arteries, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components including a catheter, handle, battery-powered motor, and an optional wire support clip. These are hardware components, not software.
Based on the provided information, the Phoenix® Atherectomy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "atherectomy of the peripheral vasculature," which is a surgical procedure performed in vivo (within the living body) to remove plaque from blood vessels.
- Device Description: The description details a system designed to be inserted into the body to physically remove material. It involves a catheter, handle, motor, and cutter.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The Phoenix Atherectomy System does not perform any such analysis of specimens.
The device is clearly designed for a therapeutic intervention within the patient's body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MCW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vasculature (excluding coronary, carotid, iliac or renal vasculature)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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).
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:
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.
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