(29 days)
Not Found
No
The 510(k) summary describes a mechanical atherectomy system with a motor and cutter. There is no mention of AI or ML in the device description, intended use, or performance studies. The modifications are related to physical dimensions (working length).
Yes
The device is designed for atherectomy of the peripheral vasculature, which is a medical procedure to remove plaque and restore blood flow, thus providing a therapeutic benefit to the patient.
No
The device is an atherectomy system designed for removing plaque from peripheral vasculature. Its described function is therapeutic, not diagnostic.
No
The device description clearly outlines physical components like a catheter, handle, battery-powered motor, and a collection reservoir, indicating it is a hardware-based medical device.
Based on the provided text, 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 in vivo (within the body) to remove plaque from blood vessels.
- Device Description: The description details a mechanical device (catheter, handle, motor, cutter) designed for physical intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is clearly designed for a therapeutic procedure performed in vivo.
N/A
Intended Use / Indications for Use
The Phoenix® Atherectomy System is 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 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 multiple models of the Phoenix Catheter. The smaller Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8 mm and 2.2 mm tip diameter sizes. The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle.
This 510(k) includes modifications to the 1.8 mm and 2.2 mm tip diameter Phoenix Catheter models to increase the overall working length from 130 cm to 149 cm and thereby create two new longer-length models within the Phoenix Catheter product family.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature. It is not intended for use in 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)
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
- . 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
- Kink Bend Radius Test
- o Guidewire Compatibility
- Catheter Trackability in Below-the-Knee Anatomy
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Volcano Atheromed, Inc. Ms. Jean Chang Vice President, Operations 1455 Adams Drive. Suite 1120 Menlo Park, California 94025
Re: K143328
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: November 19, 2014 Received: November 20, 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, 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 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,
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
Enclosure
2
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143328
Device Name
Phoenix® Atherectomy System
Indications for Use (Describe)
The Phoenix® Atherectomy System is 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)
3
Page 1 of 4
9 510(k) Summary
Submitter Information:
| Date of 510(k) Summary Preparation: | November 19, 2014 |
|---|---|
| Name and Address of Manufacturer: | Volcano 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: 510(k) Number: Manufacturer:
Phoenix Atherectomy System K140944 Volcano AtheroMed, Inc.
4
Device Description:
The 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 multiple models of the Phoenix Catheter. The smaller Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8 mm and 2.2 mm tip diameter sizes. The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle.
This 510(k) includes modifications to the 1.8 mm and 2.2 mm tip diameter Phoenix Catheter models to increase the overall working length from 130 cm to 149 cm and thereby create two new longer-length models within the Phoenix Catheter product family. Table 9-1 summarizes the subject modifications relative to the predicate device.
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
- . Cutter Torque Chain Torque-to-Failure Test
- Functional Outer Shaft Torque Test
- Knob to Shaft Testing
5
- Catheter Drive Train Stress Test ●
- Cutter Stall Test
- Temperature Rise of Catheter During Simulated Use
- Kink Bend Radius Test
- o Guidewire Compatibility
- Catheter Trackability in Below-the-Knee Anatomy
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 (K140944), | ||
| 5F (FG1847) and 6F (FG1984) | ||
| Phoenix Catheters | Modified Phoenix Atherectomy | |
| System, (Subject Device), | ||
| 5F (FG2160) and 6F (FG2162) | ||
| Phoenix Catheters) - 149 cm length | ||
| 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 | 149 cm |
| Catheter Torque Shaft | Multi-Strand Stainless Steel (SS) | Identical |
| Catheter Outer Shaft | Stainless Steel Outer Shaft and | |
| Teflon sheath | Identical | |
| Catheter Shaft Diameter | 1.7mm | Identical |
| Distal Cutter Flute | 1.8mm (FG1847) | Identical (FG2160) |
| Maximum Diameter | 2.2mm (FG1984) | Identical (FG2162) |
| Tip Diameter and | 1.8mm (FG1847) | Identical (FG2160) |
| Crossing Profile | 2.2mm (FG1984) | Identical (FG2162) |
| Cutting Tip Port | Single exit port conveys excised | |
| debris from the inner guidewire | ||
| lumen into the Distal Cutting Flute | ||
| channel | Identical | |
| Second Stage | ||
| Maceration within | ||
| Housing | Yes | Identical |
| Cutter Housing | No Coating | Identical |
| Distal Tip Assembly | ||
| Coating | Coated | Identical |
| Minimum Vessel Size for | 2.5mm (FG1847) | Identical (FG2160) |
| Device Use | 3.0mm (FG1984) | Identical (FG2162) |
| 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 |