(152 days)
No
The device description and performance studies focus on mechanical aspiration and physical properties, with no mention of AI or ML.
Yes.
The device is intended for the removal of emboli and thrombi from vessels, which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The device is described as a "Mechanical Thrombectomy System" intended for "removal of fresh, soft emboli and thrombi." Its function is to remove blockages from vessels, which is a therapeutic intervention, not a diagnostic one. It does not provide information about a patient's medical condition or disease.
No
The device description explicitly lists multiple hardware components including a pump, syringe, catheters, obturator, and waste collection bag. The performance studies also detail testing on these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems." This describes a therapeutic procedure performed in vivo (within the body) to remove blockages.
- Device Description: The device components (catheters, pump, syringe, waste bag) are designed for mechanical aspiration and removal of material from blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, the QuickClear Mechanical Thrombectomy System is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
Product codes
QEZ, DXE
Device Description
The QuickClear Mechanical Thrombectomy System is an aspiration thrombectomy system designed for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The QuickClear Mechanical Thrombectomy System removes thrombus from the peripheral vasculature using continuous vacuum aspiration, through a single lumen aspiration catheter. The system components are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The QuickClear Mechanical Thrombectomy System comprises the following devices and accessories:
- . QuickClear Aspiration Pump: The QuickClear Aspiration Pump is identical to the previously cleared Phoenix Aspiration Pump that is part of the Phoenix 2.4 Atherectomy Plus System (K181877) and remains unchanged as part of the QuickClear Mechanical Thrombectomy System. The pump is sterile, single-use, battery-operated, has an ON/OFF button, and serves as a vacuum source for aspirating thrombus from target vessel/s out of the QuickClear Aspiration Catheter via the pump aspiration tubing into a waste collection bag (connected to the pump outlet). Aspiration is controlled via an inline flow control switch. The aspiration pump is non-patient contacting.
- . A 60cc Syringe assists in priming the pump tubing and purging the aspiration system of air. The syringe can also be used to provide additional vacuum by pulling the plunger during active aspiration. The 60cc Syringe is provided with the Aspiration Pump Kit
- QuickClear Aspiration Catheters: Catheters are available in the following sizes: 6F straight tip, 8F straight tip, 8F shaped tip and 10F shaped tip. The QuickClear Aspiration Catheters continuously aspirate and remove thrombus and emboli from the vasculature when connected to the QuickClear Aspiration Pump. The catheters have a marker band tip for enhanced fluoroscopic visualization and are hydrophilic-coated to enhance lubricity. A Hemostasis Valve Y-connector is supplied with the catheter and connects to the proximal catheter hub. The QuickClear Aspiration Pump tubing is attached to the Hemostasis Valve Y-connector port to provide vacuum to the catheter for removal of thrombus.
- . An Obturator is supplied with the 8F and 10F catheters. The Obturator is intended to be used as an over-the-wire (OTW) accessory, positioned within the lumen of the catheter, for tracking over commercially available 0.035" guidewires. The Obturator provides catheter support and atraumatic advancement through the vasculature during catheter placement.
- A Waste Collection Bag is connected to the proximal end of the aspiration pump tubing ● to collect aspirated material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the peripheral arterial and venous systems.
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)
Study Type: Bench Performance, Biocompatibility, Preclinical Animal Testing
Sample Size: Not explicitly stated for bench performance or biocompatibility.
Key Results:
- Bench Performance:
- Catheter Visual Inspection
- Catheter Dimensional Inspection
- Catheter Dry Leak Test
- Catheter Vacuum Test
- Catheter Flow Rate Test
- Catheter Tensile Test
- Catheter Torque Strength Test
- Catheter Lubricity Test
- QuickClear Mechanical Thrombectomy System Simulated Use Test
- Guidewire Compatibility Test for Aspiration Catheter and Obturator
- Kink Resistance Test for Aspiration Catheter and Obturator
- Obturator Visual Inspection
- Obturator Dimensional Inspection
- QuickClear vs. Predicate System Comparative Test
- Sterilization Validation
- Packaging and Shelf Life Tests
- Biocompatibility: Conducted per ISO 10993-1. Tests included:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Partial Thromboplastin Time (PTT)
- Material-Mediated Pyrogenicity
- Hemocompatibility
- Particulate Analysis
- In vivo Thrombogenicity
- Preclinical Animal Testing: GLP animal study.
- No vessel trauma
- No evidence of side effects
- Minimal to no vascular injury
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
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November 1, 2021
Volcano AtheroMed Inc. Anna Stephen Regulatory Operations Specialist 1530 O'Brien Drive, Suite A Menlo Park, California 94025
Re: K193197
Trade/Device Name: QuickClear Mechanical Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Anna Stephen:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 20, 2020. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.11.01 15:10:59 -04'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". To the left of the FDA logo is the Department of Health & Human Services logo, which features a stylized human figure.
April 20, 2020
Volcano AtheroMed Inc. Ms. Anna Gloria Stephen Regulatory Operations Specialist 1530 O'Brien Drive, Suite A Menlo Park, California 94025
Re: K193197
Trade/Device Name: QuickClear Mechanical Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: March 20, 2020 Received: March 23, 2020
Dear Ms. Stephen:
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
2
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2020.04.20
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193197
Device Name
QuickClear Mechanical Thrombectomy System
Indications for Use (Describe)
The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary 5
Submitter Information: Date of 510(k) Summary Preparation: April 20, 2020 Name and Address of Manufacturer: Volcano AtheroMed, Inc. 1530 O'Brien Drive, Suite A Menlo Park, CA 94025 Establishment Registration Number: 3008847191 Anna Gloria Stephen Contact Person: Phone: (612) 666-3260 Fax: (916) 638-8812 Email: annagloria.stephen@philips.com Subject Device Information: Device Trade Name: QuickClear Mechanical Thrombectomy System Common Name: Aspiration System Regulation Description: Embolectomy Catheter Regulation Number: 21 CFR 870.5150 Product Code: DXE Device Class: Class II Classification Panel: Cardiovascular
This 510(k) Summary was prepared in accordance with 21 CFR 807.92 (c)
Predicate Device: Primary: Penumbra INDIGO Aspiration System 510(k) Number: K180939, DXE, 870.5150
Reference: Teleflex Pronto .035" Extraction Catheter 510(k) Number: K070403, DXE, 870.5150 serves as a reference predicate with similar indications for use and the same catheter size (10F).
Reference: Phoenix 2.4 mm Atherectomy Plus System
510(k) Number: K181877, MCW, 870.4875 serves as a reference predicate for the QuickClear Aspiration Pump that was cleared as the Phoenix Aspiration Pump in K181877.
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Intended Use/ Indication for Use:
The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral anterial and venous systems.
Device Description:
The QuickClear Mechanical Thrombectomy System is an aspiration thrombectomy system designed for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The QuickClear Mechanical Thrombectomy System removes thrombus from the peripheral vasculature using continuous vacuum aspiration, through a single lumen aspiration catheter. The system components are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The QuickClear Mechanical Thrombectomy System comprises the following devices and accessories:
- . QuickClear Aspiration Pump: The QuickClear Aspiration Pump is identical to the previously cleared Phoenix Aspiration Pump that is part of the Phoenix 2.4 Atherectomy Plus System (K181877) and remains unchanged as part of the QuickClear Mechanical Thrombectomy System. The pump is sterile, single-use, battery-operated, has an ON/OFF button, and serves as a vacuum source for aspirating thrombus from target vessel/s out of the QuickClear Aspiration Catheter via the pump aspiration tubing into a waste collection bag (connected to the pump outlet). Aspiration is controlled via an inline flow control switch. The aspiration pump is non-patient contacting.
- . A 60cc Syringe assists in priming the pump tubing and purging the aspiration system of air. The syringe can also be used to provide additional vacuum by pulling the plunger during active aspiration. The 60cc Syringe is provided with the Aspiration Pump Kit
- QuickClear Aspiration Catheters: Catheters are available in the following sizes: 6F straight tip, 8F straight tip, 8F shaped tip and 10F shaped tip. The QuickClear Aspiration Catheters continuously aspirate and remove thrombus and emboli from the vasculature when connected to the QuickClear Aspiration Pump. The catheters have a marker band tip for enhanced fluoroscopic visualization and are hydrophilic-coated to enhance lubricity. A Hemostasis Valve Y-connector is supplied with the catheter and connects to the proximal catheter hub. The QuickClear Aspiration Pump tubing is attached to the Hemostasis Valve Y-connector port to provide vacuum to the catheter for removal of thrombus.
- . An Obturator is supplied with the 8F and 10F catheters. The Obturator is intended to be used as an over-the-wire (OTW) accessory, positioned within the lumen of the catheter, for tracking over commercially available 0.035" guidewires. The Obturator provides catheter support and atraumatic advancement through the vasculature during catheter placement.
- A Waste Collection Bag is connected to the proximal end of the aspiration pump tubing ● to collect aspirated material.
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Comparison with Predicate:
The QuickClear Mechanical Thrombectomy System has been assessed for substantial equivalence relative to the currently marketed Penumbra INDIGO Aspiration System (K180939) as the predicate device, along with consideration of two additional reference devices, the Phoenix 2.4mm Atherectomy Plus System (K181877) and the Teleflex Pronto .035" Extraction Catheter (K070403). The indications for QuickClear Mechanical Thrombectomy System are similar to the indications for use of the predicate device Penumbra INDIGO Aspiration System. The QuickClear System and the INDIGO System have similar technological characteristics and operating principles. Both devices consist of two main components Aspiration Catheter and Aspiration Pump. The pump provides continuous vacuum through the single-lumen catheter for the removal of fresh, soft emboli and thrombi from the peripheral vasculature.
The basic operating principle of the Pronto Extraction Catheteris similar to the QuickClear 10F Aspiration Catheter. The Pronto .035" Extraction Catheter serves as a reference predicate with similar indications for use and technological characteristics based on the 10F catheter size to compare with the 10F subject catheter size targeting safe thrombus removal from the larger diameter venous and arterial vessels. Both catheters are designed to be delivered through a 10F or larger introducer sheath over a 0.035" guidewire.
Additionally, the Phoenix 2.4 mm Atherectomy Plus System serves as a direct reference predicate since the QuickClear Aspiration Pump is identical to the Phoenix Aspiration Pump cleared in K181877.
Any differences between the subject and predicate device were evaluated through technological comparison (also taking into account the noted reference devices), design verification and validation testing to demonstrate that the subject QuickClear Mechanical Thrombectomy System is substantially equivalent to the currently marketed predicate device..
Some of the similarities and differences between the subject device and the predicate devices are outlined in Table 5-1 below
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| Table 5-1:Comparative Summary of QuickClear Mechanical Thrombectomy System and Predicate Devices | ||||
|---|---|---|---|---|
| Attribute | Subject Device | Predicate Device | Reference Device | Direct Reference Device |
| Trade Name | QuickClear Mechanical | Penumbra INDIGO Aspiration | Teleflex Pronto .035" | Philips Volcano AtheroMed |
| (510(k) #) | Thrombectomy System | System | Extraction Catheter | Phoenix 2.4mm Atherectomy |
| (K193197) | (K180939) | (M20650400) | Plus System | |
| (K070403) | (K181877) | |||
| Classification | Class II, DXE | Class II, DXE | Class II, DXE | Class II, MCW |
| Regulation Description | Embolectomy Catheter | Embolectomy Catheter | Embolectomy Catheter | Catheter, Peripheral, Atherectomy |
| Regulation Number | 870.5150 - Embolectomy | 870.5150 - Embolectomy | 870.5150 - Embolectomy | 870.4875, Intraluminal Artery |
| Catheter | Catheter | Catheter | Stripper | |
| Classification Panel | Cardiovascular | Cardiovascular | Cardiovascular | Cardiovascular |
| Indications For Use | The QuickClear Mechanical | |||
| Thrombectomy System is | ||||
| intended for removal of | ||||
| fresh, soft emboli and | ||||
| thrombi from vessels of the | ||||
| peripheral arterial and | ||||
| venous systems. | 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
Catheters to the Penumbra
Aspiration Pump. | The Pronto .035"extraction
catheter is indicated for:
● The removal/aspiration
of embolic material
(Thrombus/Debris)
from vessels of the
arterial system.
● The removal/aspiration
of embolic material
(Thrombus/Debris)
from vessels of the
deep venous system.
● To infuse/deliver
diagnostic or
therapeutic agents. | 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. |
| | | Penumbra Aspiration Pump: The
Penumbra Aspiration Pump is
indicated as a vacuum source for
Penumbra Aspiration Systems. | | |
| Thrombus
Collection and Removal | Continuous aspiration and
removal of emboli and
thrombus via a vacuum
aspiration source with the | Continuous aspiration and
removal of emboli and thrombus
via a vacuum aspiration source
with the catheter targeted at | Removal of emboli and
thrombus mechanically via a 60
cc syringe based aspiration
through the extension line and | Continuous collection and removal of
emboli and thrombus via mechanical
conveyance of |
| Table 5-1:Comparative Summary of QuickClear Mechanical Thrombectomy System and Predicate Devices | | | | |
| Attribute | Subject Device | Predicate Device | Reference Device | Direct Reference Device |
| Trade Name
(510(k) #) | QuickClear Mechanical
Thrombectomy System
(K193197) | Penumbra INDIGO Aspiration
System
(K180939) | Teleflex Pronto .035"
Extraction Catheter
(M20650400)
(K070403) | Philips Volcano AtheroMed
Phoenix 2.4mm Atherectomy
Plus System
(K181877) |
| | catheter targeted at
thrombus in the peripheral
vasculature. | thrombus in the peripheral
vasculature. | stopcock source with the
catheter targeted at thrombus in
the peripheral vasculature. | Catheter assisted by a vacuum
aspiration source. |
| Basic Operating Principle/
General Technological
Design | Continuous aspiration and
removal of emboli and
thrombus via a vacuum
aspiration source with the
catheter targeted at thrombus
in the peripheral vasculature. | Continuous aspiration and removal
of emboli and thrombus via a
vacuum aspiration source with the
catheter targeted at thrombus in the
peripheral vasculature. | The Pronto .035" extraction
catheter is a dual lumen, over-
the-wire (OTW) catheter with
related accessories. The catheter
is designed to be delivered
through a 10F or larger
introducer sheath over a 0.035"
guidewire. The larger lumen
allows for the removal of
thrombus by use of the included
syringe through the extension
line and stopcock. The catheter
has a rounded distal tip with a
protected, extraction lumen to
facilitate advancement of the
catheter into the blood vessel
and maximize extraction of
thrombus through the extraction
lumen. | Phoenix Aspiration System Pump -
handheld
battery powered pump
capable of providing a
vacuum source of ≥ 25inches
Mercury (Hg) to aspirate
blood and thrombus related
materials. |
| | The aspiration catheter
accesses the thrombotic
occlusions within the
vasculature and is used to
aspirate material directly
through the catheter lumen.
The catheter is introduced
over a guidewire (0.035") to
the site of the target
occlusion to perform
aspiration when connected
to the aspiration pump that
serves as a vacuum source.
An obturator, supplied with
the catheter (8F & 10F
only), may be used to
facilitate access through the
vessel while providing an
atraumatic transition to the
front edge of the catheter.
The catheter connects to the | The aspiration catheter accesses the
thrombotic occlusions within the
vasculature and is used to aspirate
material directly through the
catheter lumen.
The catheter is introduced over a
guidewire (0.035") to the site of the
target occlusion to perform
aspiration when connected to the
aspiration pump that serves as a
vacuum source.
A separator may be deployed
within the Aspiration Catheter to
assist with thrombus removal by
clearing the lumen of the
Aspiration Catheter should it
become blocked with thrombus.
The separator is manually
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. | The catheter has a radiopaque
marker band located
approximately 4mm from the
distal tip. The proximal end of
the catheter incorporates a
hemostatic Y-junction that
allows for the attachment of the
catheter to the included
extension line, stopcock and
syringe; and can be tightened
down on the guidewire to
prevent blood leakage. | |
| | distal end of a vacuum pump
through hemostasis and
inline ON/OFF valve. The
male luer on the exit port of
the vacuum pump tubing
connects to the female luer | A separator may not be necessary
when using an Aspiration Catheter
with an ID of 0.054" (4Fr) or
larger. | | |
| Volcano Aheromed, Inc. Traditional 510(k) Premarket Notification for QuickClear Mechanical Thrombectomy System K19319 pg. 6 of 9 | | | | |
| | on the waste collection bag
tubing.
Aspirated material is
collected in a waste
collection bag.
Aspiration Pump - handheld
battery powered pump
capable of providing a
vacuum source of ≥ 25inch
Mercury (Hg) to aspirate
blood and thrombus related
materials. | Aspirated material is collected in a
suction canister. | | |
| Power Source | 12V DC Battery for
Aspiration Pump | 100-115V AC/230V AC, 50/60
HZ AC Power supply for
Penumbra Max Pump | N/A (manual aspiration) | 12V DC Battery for Phoenix
Aspiration System Pump |
| Vacuum Source | ≥ 25 inch Hg Vacuum | Up to 29 inch Hg Vacuum
(electrical, piston vacuum pump) | 60 ml Syringe with locking
plunger located on the
extension line. | ≥ 25 inch Hg Vacuum |
| Syringe Accessory | 60cc Syringe | N/A | 60cc syringe | 60cc Syringe |
| Waste Collection Source | 1400ml Waste Collection
Bag | 1200ml Waste Collection Canister | 60cc Syringe | 1400ml Waste Collection Bag |
| Aspiration Catheter | | | | |
| Aspiration Catheter Outer
Diameters | 6F=0.081"
8F= 0.107"
10F=0.130" | 6F= 0.079"
8F=0.105" | 10F=0.128" | N/A |
| Tip Shape Configurations | 6F - Straight
8F - Straight
8F - Shaped
10F - Shaped | 6F - Straight
8F - Straight
8F - Shaped | 10F - rounded tip | N/A |
| Catheter Working Lengths | 6F= 130 cm
8F= 85 cm
10F= 85 cm | 6F= 135 cm
8F= 85 cm | 10F = 115 cm | N/A |
| Target Vessel Diameters | 6F: > 3.0 mm
8F: > 4.0 mm
10F: > 5.0 mm | 6F: > 4.0 mm
8F: > 4.0 mm | 10F: > 4.0 mm | N/A |
| Guidewire
Compatibility | .035" | .035" | .035" | N/A |
| Obturator Outer Diameter | 8F = 0.084 – 0.088"
10F=0.104 – 0.108" | N/A | N/A | N/A |
| Tubing Inner Diameter
(ID) | 0.100 – 0.125" | 0.071" – 0.110" | N/A | N/A |
| General | | | | |
| Materials | Polymeric blends commonly
utilized for interventional
devices | Polymeric blends commonly
utilized for interventional devices | Polymeric blends commonly
utilized for interventional
devices | N/A |
| Catheter Coating | Yes | Yes | No | N/A |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | N/A pump is non patient contacting |
| Packaging Configuration | Catheters and pump are
Individually packaged in
Tyvek Pouch and chipboard
boxes | Catheters are Individually
packaged in Tyvek Pouch and
chipboard boxes | Catheters are Individually
packaged in Tyvek Pouch and
chipboard boxes | Pump is individually packaged in
Tyvek Pouch and chipboard boxes |
| Sterilization | Ethylene Oxide (EO)
All components | Ethylene Oxide (EO)
(Catheter/separator) | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| Single Use Only | Catheter: Yes
Aspiration Pump: Yes | Catheter/separator : Yes
Vacuum Pump :
(reusable/electrical) | Catheter : Yes | Catheter: Yes
Aspiration Pump: Yes |
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Testing Summary:
Since there is no change to the currently marketed Phoenix Aspiration Pump that is used as part of the subject QuickClear Mechanical Thrombectomy System (K181877), 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 OuickClear Mechanical Thrombectomy System to the selected predicate device, the performance and technological characteristics were evaluated by completion of the following tests:
Aspiration Catheter Tests: ●
- Catheter Visual Inspection O
- Catheter Dimensional Inspection O
- Catheter Dry Leak Test O
- o Catheter Vacuum Test
- Catheter Flow Rate Test O
- Catheter Tensile Test o
- Catheter Torque Strength Test O
- Catheter Lubricity Test O
Quick QuickClear Mechanical Thrombectomy System Test: ●
- QuickClear Mechanical Thrombectomy System Simulated Use Test O
● Aspiration Catheter and Obturator Test:
- Guidewire Compatibility Test for Aspiration Catheter and Obturator o
- Kink Resistance Test for Aspiration Catheter and Obturator O
Obturator Test (8F and 10F Aspiration Catheter Only): ●
- o Obturator Visual Inspection
- O Obturator Dimensional Inspection
- QuickClear vs. Predicate System Comparative Test ●
- Sterilization Validation ●
- Packaging and Shelf Life Tests
. Biocompatibility Tests:
The following biocompatibility tests were conducted on the QuickClear Aspiration Catheters and Obturators per ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process:
- Cytotoxicity o
- Sensitization O
- Irritation or Intracutaneous Reactivity O
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- Acute Systemic Toxicity o
- Partial Thromboplastin Time (PTT) O
- Material-Mediated Pyrogenicity o
- Hemocompatibility O
- Particulate Analysis O
- In vivo Thrombogenicity O
The QuickClear Aspiration Pump is a non-patient contacting device, and therefore, biocompatibility testing was not required or conducted on the Aspiration Pump.
Preclinical Animal Testing: .
A GLP animal study was conducted to evaluate the safety and performance of the QuickClear Mechanical Thrombectomy System in an animal model. The study concluded:
- o No vessel trauma
- o No evidence of side effects
- Minimal to no vascular injury o
Conclusion
The subject QuickClear Mechanical Thrombectomy System shares the same intended use, technological characteristics, and principles of operation with the currently marketed predicate and reference devices. The QuickClear Pump is identical to the currently cleared reference Phoenix Aspiration Pump that is part of the Phoenix 2.4 Atherectomy Plus System (K181877). The QuickClear Aspiration catheters are similar in design and construction as the predicate Penumbra Indigo Catheters. Any differences between the subject and predicate devices were evaluated through design verification and validation testing to demonstrate that the subject QuickClear Mechanical Thrombectomy System is substantially equivalent to the currently marketed predicate device.
Based on the information submitted in this 510(k) premarket notification, the subject QuickClear Mechanical Thrombectomy System is substantially equivalent to the currently marketed predicate Penumbra INDIGO Aspiration System.