(157 days)
No
The device description and testing summary focus on mechanical and electrical components for atherectomy and aspiration, with no mention of AI/ML, image processing, or data-driven algorithms.
Yes
The device is used for atherectomy and removal of thrombus from vessels, which are medical procedures to treat conditions, thus classifying it as a therapeutic device.
No
The Phoenix Atherectomy System is designed for atherectomy, which is the removal of plaque or thrombus from blood vessels, making it a therapeutic device rather than a diagnostic one.
No
The device description clearly outlines physical hardware components including a catheter, handle with a motor and battery, and an aspiration pump with tubing and a syringe.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Phoenix Atherectomy System is a mechanical device used to physically remove material (atheroma and thrombus) from blood vessels within the body. It is an interventional device used in vivo, not in vitro.
- Intended Use: The intended use clearly states it's for "atherectomy of the peripheral vasculature" and "removal of thrombus from vessels of the peripheral arterial vasculature." This describes a procedure performed directly on the patient's blood vessels.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens outside of the body for diagnostic purposes. The collected material is described as being sent to a "collection reservoir" or "waste disposal bag."
Therefore, the Phoenix Atherectomy System is a therapeutic medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The system is not intended for use in the coronary, carotid, iliac, pulmonary, or renal vasculature.
Phoenix Atherectomy Plus System:
When used with the Phoenix Aspiration Pump as the vacuum source, the Phoenix 2.4mm Deflecting Atherectomy System is indicated for the removal of thrombus from vessels of the peripheral arterial vasculature.
Product codes (comma separated list FDA assigned to the subject device)
MCW
Device Description
The Phoenix 2.4mm Atherectomy Plus System comprises the currently cleared Phoenix 2.4mm Deflecting Atherectomy System (K172386) and a new Phoenix Aspiration Pump. which when used in conjunction with each other are designed for removal of thrombus from vessels of the peripheral arterial vasculature.
The Phoenix 2.4mm Deflecting Atherectomy System and the Phoenix Aspiration Pump are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The Phoenix 2.4mm Deflecting Atherectomy System comprises the Phoenix 2.4mm Deflecting Atherectomy Catheter and the Phoenix Atherectomy Handle with Wire Support Clip.
The Phoenix Catheter is an over-the-wire (OTW), multi-lumen Catheter with a cutter at the distal tip that continuously captures and clears debulked (excised) material 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 Atherectorny Catheter at its specified rotational speed, and is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold a guidewire in a fixed position relative to the Phoenix Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System. The Phoenix Catheter is compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires.
For the purpose of this 510(k), the design of the Phoenix 2.4mm Deflecting Atherectomy System remains unchanged.
The Phoenix Aspiration Pump connects to the disposal outlet of the Phoenix Catheter via the pump's aspiration tubing. The exit end of the aspiration tubing is connected to a waste disposal bag to collect aspirated material. A 60 ml syringe is provided as part of the Aspiration Pump Assembly to assist in priming the pump aspiration tubing and purging the aspiration system of air. The Aspiration Pump is battery-operated and is operated by an ON/OFF switch. It serves as a vacuum source for the Aspiration System for aspirating the thrombus from the target vessel out of the Phoenix Catheter via the pump aspiration tubing and into the disposal bag. The Aspiration Pump is non-patient contacting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, peripheral arterial 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)
Performance and technological characteristics were evaluated by completion of the following tests:
- Visual Inspection
- Vacuum and Leak Test
- Flow Rate Test
- System Simulated Use Test
- Life Cycle Test
- Tubing Tensile Test
- System Comparative Testing in Simulated Lesion
- Pump Comparative Test
- Sterilization Validation
- Packaging and Shelf Life
- Electrical Safety and EMC
- Preclinical Animal Testing
Key results: Any differences between the subject and predicate device were evaluated through design verification and validation testing which demonstrated no new questions of safety and effectiveness.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
December 17, 2018
Volcano AtheroMed Inc. Ms. Jean Chang Senior Director, Operations 1530 O'Brien Drive, Suite A Menlo Park, California 94025
Re: K181877
Trade/Device Name: Phoenix 2.4mm Atherectomy Plus System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 15, 2018 Received: November 16, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Date: / 2018.12.17 Eleni Whatley 13:25:35 -05'00' For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181877
Device Name Phoenix 2.4 Atherectomy Plus System
Indications for Use (Describe)
The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The system is not intended for use in the coronary, carotid, iliac, pulmonary, or renal vasculature.
Phoenix Atherectomy Plus System:
When used with the Phoenix Aspiration Pump as the vacuum source, the Phoenix 2.4 Deflecting Atherectomy System is indicated for the removal of thrombus from vessels of the peripheral arterial vasculature.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Submitter Information:
| Date of 510(k) Summary Preparation: | November 29, 2018 |
|---|---|
| Name and Address of Manufacturer: | Volcano AtheroMed, Inc. |
| 1530 O'Brien Dr. | |
| Menlo Park, CA 94025 | |
| Contact Person: | Jean Chang |
| Senior Director, Operations | |
| Phone: (650) 352 5255 |
Subject Device:
| Device Trade Name: | Phoenix® 2.4mm Atherectomy Plus System |
|---|---|
| Common Name: | Atherectomy System |
| Regulation Description: | Intraluminal Artery Stripper |
| Regulation Number: | 21 CFR 870.4875 |
| Product Code: | MCW |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |
| Predicate Devices: | |
| Primary Predicate: | Jetstream Atherectomy System (K130637) |
| Reference Devices: | The Phoenix® Atherectomy System |
| (K172386) & the Penumbra INDIGOTM | |
| Aspiration System (K161523) serve as | |
| additional reference devices |
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510(k) Premarket Notification K181877
Device Description:
The Phoenix 2.4mm Atherectomy Plus System comprises the currently cleared Phoenix 2.4mm Deflecting Atherectomy System (K172386) and a new Phoenix Aspiration Pump. which when used in conjunction with each other are designed for removal of thrombus from vessels of the peripheral arterial vasculature.
The Phoenix 2.4mm Deflecting Atherectomy System and the Phoenix Aspiration Pump are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The Phoenix 2.4mm Deflecting Atherectomy System comprises the Phoenix 2.4mm Deflecting Atherectomy Catheter and the Phoenix Atherectomy Handle with Wire Support Clip.
The Phoenix Catheter is an over-the-wire (OTW), multi-lumen Catheter with a cutter at the distal tip that continuously captures and clears debulked (excised) material 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 Atherectorny Catheter at its specified rotational speed, and is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold a guidewire in a fixed position relative to the Phoenix Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System. The Phoenix Catheter is compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires.
For the purpose of this 510(k), the design of the Phoenix 2.4mm Deflecting Atherectomy System remains unchanged.
The Phoenix Aspiration Pump connects to the disposal outlet of the Phoenix Catheter via the pump's aspiration tubing. The exit end of the aspiration tubing is connected to a waste disposal bag to collect aspirated material. A 60 ml syringe is provided as part of the Aspiration Pump Assembly to assist in priming the pump aspiration tubing and purging the aspiration system of air. The Aspiration Pump is battery-operated and is operated by an ON/OFF switch. It serves as a vacuum source for the Aspiration System for aspirating the thrombus from the target vessel out of the Phoenix Catheter via the pump aspiration tubing and into the disposal bag. The Aspiration Pump is non-patient contacting.
5
510(k) Premarket Notification K181877
Indications for Use:
The Phoenix Atherectomy System is intended for use in atherectomy of the perioheral vasculature. The system is not intended for use in the coronary, carotid, iliac, pulmonary, or renal vasculature.
Phoenix Atherectomy Plus System:
When used with the Phoenix Aspiration Pump as the vacuum source, the Phoenix 2,4mm Deflecting Atherectomy System is indicated for the removal of thrombus from vessels of the peripheral arterial vasculature.
Comparison with Predicate:
The Phoenix 2.4mm Atherectomy Plus System is the subject of this submission for removal of thrombus from peripheral arterial vasculature. The Phoenix 2.4mm Atherectomy Plus System has been assessed for substantial equivalence relative to the currently marketed Boston Scientific Jetstream Atherectomy System as the predicate device, along with consideration of two additional reference devices, the Phoenix 2.4mm Deflecting Atherectomy System and the Penumbra INDIGO Aspiration System. The Phoenix 2.4mm Atherectomy Plus System has the same design, materials, technological characteristics and principle of operation of the reference Phoenix 2.4mm Deflecting Catheter and Handle, There is no change to the currently marketed 2.4mm Deflecting Atherectomy Catheter and Handle with Wire Support Clip. The Phoenix Aspiration Pump that is used as part of the Phoenix Atherectomy Plus System is comparable to the Penumbra INDIGO Aspiration System and shares a similar mechanism of action. The proposed indications for use to add aspiration for thrombus removal for the Phoenix Atherectomy Plus System are similar to those of the predicate Boston Scientific Jetstream Atherectomy System, with respect to a combined atherectomy and thrombectomy indication, as well as the reference Penumbra INDIGO System with thrombus removal using vacuum aspiration. Any differences between the subject and predicate device were evaluated through technological comparison (also taking into account the noted reference devices) and design verification and validation testing, which demonstrated no new questions of safety and effectiveness.
The similarities and differences between the subject device and the predicate and reference devices are outlined in the table below:
6
| Table 1-1: Comparison Table | ||||
|---|---|---|---|---|
| Design/ | ||||
| Technological | ||||
| Characteristic | Subject | |||
| Phoenix Atherectomy Plus | ||||
| System | Predicate | |||
| Boston Scientific (Pathway | ||||
| Medical) | ||||
| Jetstream System | ||||
| K130637 | Reference | |||
| Phoenix Atherectomy System | ||||
| K172386 | Reference | |||
| Penumbra | ||||
| Indigo Aspiration System | ||||
| K161523 | ||||
| Indications / | ||||
| Intended Use | The Phoenix Atherectomy | |||
| System is intended for use | ||||
| in atherectomy of the | ||||
| peripheral vasculature. The | ||||
| system is not intended for | ||||
| use in the coronary, carotid, | ||||
| iliac, pulmonary, or renal | ||||
| vasculature. |
Phoenix Atherectomy Plus
System:
When used with the
Phoenix Aspiration Pump
as the vacuum
source, the Phoenix 2.4mm
Deflecting Atherectomy
System is indicated for the
removal of thrombus from
vessels of the peripheral
arterial vasculature. | The Jetstream System is
intended for use in atherectomy
of the peripheral vasculature
and to break apart and remove
thrombus from upper and lower
extremity peripheral arteries. It
is not intended for use in
coronary, carotid, iliac or renal
vasculature. | Intended for use in atherectomy
of the peripheral vasculature. It
is not intended for use in
coronary, carotid, iliac or renal
vasculature. | INDIGO Aspiration Catheters and
Separators:
As part of the INDIGO Aspiration
System, the INDIGO Aspiration
Catheters and Separators are indicated
for the removal of fresh, soft emboli
and thrombi from vessels of the
peripheral arterial and venous
systems.
INDIGO Aspiration Tubing:
As part of the INDIGO Aspiration
System, the INDIGO Sterile
Aspiration Tubing is indicated to
connect the INDIGO Aspiration
Catheter to the Penumbra Aspiration
Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is
indicated as a vacuum source for the
Penumbra Aspiration Systems. |
| Table 1-1: Comparison Table | | | | |
| Design/
Technological
Characteristic | Subject
Phoenix Atherectomy Plus
System | Predicate
Boston Scientific (Pathway
Medical)
Jetstream System
K130637 | Reference
Phoenix Atherectomy System
K172386 | Reference
Penumbra
Indigo Aspiration System
K161523 |
| General
Technological
Design | Phoenix Catheter with distal
rotating cutter head cuts
through target lesion, where
the cutter geometry (helical
flutes) draws shaved
material proximally within
the catheter housing as it
cuts. The excised material is
removed continuously from
the patient by mechanical
conveyance along with
vacuum assist from the
Aspiration Pump and
deposited in a collection
bag outside the patient.
Catheter deflection allows
the catheter to cut
directionally to a diameter
larger than the catheter.
Aspiration Pump - handheld
battery powered pump
capable of providing a
vacuum source of ≥ 25inch
Mercury (Hg) to aspirate
blood and thrombus related
materials. | Atherectomy via rotating distal
tip advanced longitudinally
through target lesion. The distal
tip ("blades down") has cutting
flutes to remove lesion material
when rotating at the minimum
diameter. Simultaneous
irrigation/infusion and
continuous aspiration during
device activation remove
excised debris to a collection
bag outside the patient.
In certain Jetstream models,
rotational direction is reversed
to deploy expandable blades
("blades up") to achieve an
increased diameter for further
lesion treatment. | Phoenix Catheter with distal
rotating cutter cuts through
target lesion. The cutter
geometry (helical flutes) draws
shaved plaque proximally
within the catheter housing as it
cuts. Excised debris is removed
continuously from the patient
by mechanical conveyance and
deposited in a collection bag
outside the patient.
Catheter deflection allows the
catheter to cut directionally to a
diameter larger than the
catheter. | The Penumbra Aspiration System is
designed to remove thrombus from
vasculature by aspirating the proximal
side of the thrombus using continuous
aspiration through the Aspiration
Catheter from the pump directly to the
thrombus.
For the aspiration source, the
Aspiration Catheter is used in
conjunction with the Aspiration Pump,
which is connected using the
Aspiration Tubing and the Pump
Canister/Tubing.
The Aspiration Catheter is used with
the Aspiration Pump to aspirate
thrombus from an occluded vessel. As
needed, the Separator may be
deployed from the Aspiration Catheter
to assist with thrombus removal. The
Separator is advanced and retracted
through the Aspiration Catheter at the
proximal margin of the primary
occlusion to facilitate clearing of the
thrombus from the Aspiration
Catheter tip. |
| Table 1-1: Comparison Table | | | | |
| Design/
Technological
Characteristic | Subject
Phoenix Atherectomy Plus
System | Predicate
Boston Scientific (Pathway
Medical)
Jetstream System
K130637 | Reference
Phoenix Atherectomy System
K172386 | Reference
Penumbra
Indigo Aspiration System
K161523 |
| Debulking
Mechanism | Front Cutting Rotational
Device | Front Cutting Rotational
Device | Front Cutting Rotational
Device | Vacuum aspiration only |
| Debris
Collection &
Removal | Active aspiration
Continuous collection and
removal of thrombus by
mechanical conveyance of
Catheter and vacuum
provided by aspiration
pump | Active aspiration
Continuous collection and
removal of excised debris via
vacuum aspiration. | Continuous collection and
removal of excised debris by
mechanical conveyance of
Catheter. | Continuous aspiration and removal of
thrombus via vacuum aspiration with
the catheter targeting aspiration from
the pump to the thrombus. |
| Catheter
Rotational
Speed | 10,000-12,000 RPM | ~70,000 RPM (atherectomy)
~24,000 RPM (guidewire
removal) | 10,000-12,000 RPM | Not applicable |
| Vacuum
Aspiration | ≥ 25 inch Hg Vacuum
(battery powered.
diaphragm pump) | > 20 inch Hg Vacuum
(electrical, peristaltic pump) | Not applicable | Up to 29 inch Hg Vacuum
(electrical, piston vacuum pump) |
| Power Source | 6V DC Battery for Phoenix
Handle
12V DC Battery for
Aspiration Pump | 110/220 V AC, 50/60 Hz AC
power supply from wall socket | 6V DC Battery for Phoenix
Handle
Not applicable for aspiration | 100-115 V AC/ 230 V AC, 50/60 Hz
AC power supply from wall socket for
Penumbra Max Pump |
| Guidewire
Exchange | Over-the-wire | Over-the-wire | Over-the-wire | Over-the-wire |
| Guidewire
Compatibility | 0.014" | 0.014" | 0.014" | 0.014"-0.035" |
| Sheath
Compatibility | 7F | 7F | 7F | 6F-8F |
| Catheter
Working
Length (s) | 125 - 127 cm | 120cm - 145cm | 125 - 127 cm | 85cm - 120 cm |
| Table 1-1: Comparison Table | | | | |
| Design/
Technological
Characteristic | Subject
Phoenix Atherectomy Plus
System | Predicate
Boston Scientific (Pathway
Medical)
Jetstream System
K130637 | Reference
Phoenix Atherectomy System
K172386 | Reference
Penumbra
Indigo Aspiration System
K161523 |
| Tip Diameter or
Crossing Profile | 2.4mm (tip diameter and
crossing diameter) | 1.6mm – 2.4mm ("blades
down" range, tip diameter)
3.0mm - 3.4mm ("blades up"
range, tip diameter) | 2.4mm (tip diameter and
crossing diameter) | 2.2mm - 3.0mm |
| Minimum Vessel
Size for Device
Use | ≥ 3.0mm | ≥2.5mm (XC)
≥ 3.0mm (SC) | ≥ 3.0mm | ≥ 4.0mm |
| Deflection
mechanism | Deflecting Catheter:
Advancing slider forward
on catheter chassis causes
distal tip to deflect | No deflection mechanism.
However, certain Jetstream
models allow for a larger
diameter cutter ("blades up")
by reversing rotational direction
to deploy expandable blades. | Deflecting Catheter:
Advancing slider forward on
catheter chassis causes distal tip
to deflect | Not applicable
8F device with Angled tip |
| Steering
(Directional)
mechanism | Rotation of knob on handle
steers distal tip and cutter
by torqueing catheter shaft | Not applicable | Rotation of knob on handle
steers distal tip and cutter by
torqueing catheter shaft | Not applicable
8F Catheter with Angled Tip |
| Catheter
Coating | No | No | No | Yes |
| Biocompatibility | per ISO 10993-1 | per ISO 10993-1 | per ISO 10993-1 | per ISO 10993-1 |
| Cutting Tip
Material | DLC coated Stainless Steel | Stainless Steel | DLC coated Stainless Steel | Not applicable |
| Sterilization | Ethylene Oxide | Ethylene Oxide -(Catheter/Pod
Component ) | Ethylene Oxide | Ethylene Oxide |
| Single-use only | Catheter and Handle: Yes
Aspiration Pump: Yes | Catheter and Pod- Yes
Console - Reusable/electrical | Catheter and Handle: Yes | Catheter: Yes
Aspiration Pump: Reusable/electrical |
7
8
9
10
Testing Summary:
Since there is no change to the currently marketed Phoenix 2.4 mm Deflecting Atherectomy Catheter and Handle with Wire Support Clip (K172386 and K151145) that is used as part of the subject Phoenix Atherectomy Plus System, previous testing for biocompatibility, bench performance, sterilization, packaging and shelf-life, electrical safety and EMC, remain applicable and was not repeated.
To demonstrate the substantial equivalence of the subject Phoenix Atherectomy Plus System to the selected predicate device, the performance and technological characteristics were evaluated by completion of the following tests:
- Visual Inspection
- . Vacuum and Leak Test
- Flow Rate Test .
- System Simulated Use Test ●
- Life Cycle Test ●
- Tubing Tensile Test ●
- System Comparative Testing in Simulated Lesion
- Pump Comparative Test
- Sterilization Validation ●
- Packaging and Shelf Life
- Electrical Safety and EMC ●
- . Preclinical Animal Testing
Conclusion
The subject Phoenix Atherectomy Plus System shares the same intended use, technological characteristics, and principles of operation with the currently marketed predicate and reference devices. Additionally, the design of the 2.4mm Phoenix Deflecting Catheter and Handle components are identical to that of the currently marketed reference Phoenix Atherectomy System. The Phoenix Aspiration Pump component of the subject Phoenix Atherectomy Plus System has similar indications for use and technological characteristics as those of the reference Penumbra INDIGO Aspiration System. Any differences between the subject and predicate device were evaluated through design verification and validation testing which demonstrated no new questions of safety and effectiveness.
Based on the information submitted in this 510(k) premarket notification, the subject Phoenix 2.4mm Atherectomy Plus System is substantially equivalent to the currently marketed predicate device.