(130 days)
Not Found
No
The description focuses on mechanical components, a battery-powered motor, and user-controlled features. There is no mention of AI, ML, image processing, or data analysis for decision-making or control.
Yes.
The device is used for atherectomy, which is a medical procedure to remove plaque from arteries, fitting the definition of a therapeutic intervention.
No
The device description clearly states its purpose is for "atherectomy of the peripheral vasculature," which is a treatment procedure for removing plaque, not for diagnosing a condition.
No
The device description clearly outlines physical components like a catheter, handle with a battery-powered motor, and a collection reservoir, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "atherectomy of the peripheral vasculature." This is a surgical procedure performed directly on the patient's blood vessels to remove plaque.
- Device Description: The device is a mechanical system (catheter and handle) designed to physically remove plaque from within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly an interventional medical device used for a therapeutic procedure within the patient's 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
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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)
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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of three stylized human profiles facing right, with flowing lines extending from the bottom of the profiles.
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
1
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
2
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Chang |
| Vice President, Operations | |
| Phone: (650) 473-6846 | |
| Fax: (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:
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.
4
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
5
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.
6
| Table 9-1: Summary of Technological Characteristics for the Modified Phoenix
| Atherectomy System | ||
|---|---|---|
| Technological | ||
| Characteristic | Predicate Phoenix Atherectomy | |
| System (K132682), | ||
| 5F (FG1105) and 6F (FG1493) | ||
| Phoenix Catheters | Modified Phoenix Atherectomy | |
| System (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 and | |
| Teflon sheath | Stainless Steel Outer Shaft and thicker | |
| Teflon sheath | ||
| Catheter Shaft Diameter | 1.7mm | Identical |
| Distal Cutter Flute | ||
| Maximum Diameter | 1.6mm (FG1105) | |
| 2.0mm (FG1493) | 1.8mm (FG1847) | |
| 2.2mm (FG1984) | ||
| (Modified Distal Cutter Flute is flush | ||
| with Cutter Housing) | ||
| Tip Diameter and | ||
| Crossing Profile | 1.8mm (FG1105) | |
| 2.2mm (FG1493) | Identical (FG1847) | |
| Identical (FG1984) | ||
| Cutting Tip Port | None | Single exit port added to convey |
| excised debris from the inner guidewire | ||
| lumen into the Distal Cutting Flute | ||
| channel | ||
| Second Stage | ||
| Maceration within | ||
| Housing | Yes | Yes, with increased capacity/volume |
| Cutter Housing | Coated | No Coating |
| Distal Tip Assembly | ||
| Coating | Coated | Coated |
| Catheter Chassis | ||
| Material Changes | Bearing Lubricant - Aerospace Grade | |
| Silicone O-Ring | Bearing Lubricant - Food Grade | |
| Silicone O-Ring - Medical Grade | ||
| Minimum Vessel Size for | ||
| Device Use | 2.5mm (FG1105) | |
| 3.0mm (FG1493) | Identical (FG1847) | |
| Identical (FG1984) | ||
| Debris Collection & | ||
| Removal | Continuous collection and removal of | |
| excised debris by mechanical | ||
| conveyance | Identical | |
| Steering (Directional) | ||
| mechanism | Rotation of knob on handle steers | |
| distal tip and cutter by torqueing | ||
| catheter shaft | Identical | |
| Catheter Coating | No | Identical |
| Sterilization | Ethylene Oxide | Identical |
| Single-use only | Yes | Identical |