(141 days)
No
The description focuses on mechanical components and aspiration technology, with no mention of AI, ML, or related concepts.
Yes
The device is indicated for "removal of acute emboli and thrombi" which directly eliminates or reduces problematic substances in the body, thus serving a therapeutic function.
No
The device is indicated for the removal of emboli and thrombi, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines multiple hardware components, including a catheter, guidewire, drive system (control unit, motor, footswitch), collecting bag, and sterile drape. It is a physical medical device system.
Based on the provided information, the Aspirex™ Thrombectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the "removal of acute emboli and thrombi from vessels of the peripheral venous system." This is a therapeutic procedure performed in vivo (within the living body) to treat a medical condition.
- Device Description: The description details a mechanical system designed to physically remove blockages from blood vessels. This involves a catheter, guidewire, and a drive system for aspiration. This is consistent with an interventional medical device used for treatment.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Aspirex™ system does not perform any such analysis of biological specimens.
Therefore, the Aspirex™ Thrombectomy System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.
Product codes
QEW, DQX
Device Description
The Aspirex™ Thrombectomy System-composed of the Aspirex™ Thrombectomy Catheter Set and the Drive System-is designed for efficient thrombus removal with strong, continuous, and controlled aspiration The Drive System is composed of the control unit, a motor, and a footswitch. The Drive System is small and portable, and designed for simple, quick set up and ease of use.
The Aspirex™ Thrombectomy Catheter Set is composed of multiple components, including the Aspirex™ Thrombectomy Catheter, the Aspirex™ Guidewire, collecting bag, and sterile drape. The Aspirex™ Thrombectomy Catheter consists of a braided shaft, to add strength and torque, through which runs a helix. The catheter shaft connects to a metallic head constructed with a side window(s) at the distal end. The head has a smooth, rounded, atraumatic shape so unintentional contact with the vessel wall will not cause to the vessel. Contact with the vessel wall is not necessary for the catheter to exert its effect. An ergonomic handle, connected to the catheter shaft at the proximal end, connects to the motorized Drive System via a magnetic clutch. The entire catheter tracks over the Aspirex™ Guidewire previously navigated across the thrombus/embolus.
The Aspirex™ Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated tungsten tip coated with DSM ComfortCoat® hydrophilic coating. The guidewire is used to initially cross through the area to be treated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the peripheral venous system
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
A GLP animal study was conducted to assess the safety and performance of the Aspirex™ catheter (test article) of the Aspirex Thrombectomy System in healthy veins, using the Indigo Aspiration Catheter (control article) of the Penumbra Indigo Aspiration System as a comparator. The secondary objective of this study was to assess the usability and performance of the other parts of the Aspirex™ Thrombectory System in association with the Aspirex™ catheter: Straub Medical Drive System, quidewire, collection baq and sterile drape.
No evidence of stenosis or occlusion was observed in the vessels of any of the study animals at any fluoroscopy (with contrast) assessment. No evidence of intimal irregularities, vessel dissection, perforation, rupture, or other evidence of vessel injury was observed in the vessels of any of the study animals at any fluoroscopy (with contrast) assessment or upon macroscopic assessment of the external aspect of the treated vessels. Microscopic findings in the treated vessels correlated with angiographic and macroscopic observations. Microscopic changes were of similar incidence and severity in both test and control groups and were limited to the intima (i.e. multifocal endothelial hypertrophy and intimal thickening due to fibrosis) in the treated vessels. with no vessel perforation, vessel dissection, rupture nor parietal hematoma, no medial injury (with the exception of degenerative changes in one acute control study animal) and no relevant inflammation of the vessel wall or surrounding tissues.
When comparing the results of clinical, biological and tissular response to the application of the Aspirex™ catheter and Indigo Aspiration Catheter, local and systemic tolerance appears equivalent in both groups. The usability and performance of the Aspirex™ catheter and Indigo Aspiration Catheter presented with similar results, with no adverse events.
Key Metrics
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 21, 2022
C.R. Bard, Inc. Aaron Conovaloff Regulatory Affairs Manager 1625 West 3rd St Tempe, Arizona 85281
Re: K220270
Trade/Device Name: Aspirex™ Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, DQX Dated: May 19, 2022 Received: May 20, 2022
Dear Aaron Conovaloff:
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
1
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 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,
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
2
Indications for Use
510(k) Number (if known) K220270
Device Name AspirexTM Thrombectomy System
Indications for Use (Describe)
The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.
| 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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3
Aspirex™ Thrombectomy System
510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 602-830-5453 |
| Fax: | 321-949-0436 |
| Contact: | Aaron Conovaloff, Regulatory Affairs Manager |
| Date: | January 28, 2022 |
Subiect Device Name:
| Device Trade Name: | Aspirex ™ Thrombectomy System |
|---|---|
| Common or Usual Name: | Embolectomy catheter |
| Product Code: | QEW, DQX |
| Classification: | Class II |
| Review Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.5150 |
Predicate Device:
- Indigo Aspiration System (K192833; cleared December 20, 2019) .
Reference Device:
- Straub Endovascular System (K172315; cleared April 12, 2018) .
Device Description:
The Aspirex™ Thrombectomy System-composed of the Aspirex™ Thrombectomy Catheter Set and the Drive System-is designed for efficient thrombus removal with strong, continuous, and controlled aspiration The Drive System is composed of the control unit, a motor, and a footswitch. The Drive System is small and portable, and designed for simple, quick set up and ease of use.
The Aspirex™ Thrombectomy Catheter Set is composed of multiple components, including the Aspirex™ Thrombectomy Catheter, the Aspirex™ Guidewire, collecting bag, and sterile drape. The Aspirex™ Thrombectomy Catheter consists of a braided shaft, to add strength and torque, through which runs a helix. The catheter shaft connects to a metallic head constructed with a
4
side window(s) at the distal end. The head has a smooth, rounded, atraumatic shape so unintentional contact with the vessel wall will not cause to the vessel. Contact with the vessel wall is not necessary for the catheter to exert its effect. An ergonomic handle, connected to the catheter shaft at the proximal end, connects to the motorized Drive System via a magnetic clutch. The entire catheter tracks over the Aspirex™ Guidewire previously navigated across the thrombus/embolus.
The Aspirex™ Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated tungsten tip coated with DSM ComfortCoat® hydrophilic coating. The guidewire is used to initially cross through the area to be treated.
| Catheter
Size | Minimum
Vessel
Diameter | Catheter
External
Diameter | Nominal
Rotation
(RPM) | Maximum
Aspiration
(ml/min) | Guidewire
Size &
Length |
|------------------|-------------------------------|----------------------------------|------------------------------|-----------------------------------|-------------------------------|
| 6F
110 cm | 3 mm | 2.0 mm | 60,000 | 45 | 0.018"
270 cm |
| 6F
135 cm | 3 mm | 2.0 mm | 60,000 | 45 | 0.018"
320 cm |
| 8F
85 cm | 5 mm | 2.7 mm | 40,000 | 75 | 0.018"
220 cm |
| 8F
110 cm | 5 mm | 2.7 mm | 40,000 | 75 | 0.018"
270 cm |
| 10F
110 cm | 8 mm | 3.3 mm | 40,000 | 130 | 0.025"
270 cm |
Indications for Use of Device:
The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.
Contraindications:
- . Not for use in vessels of the cardiac, pulmonary, coronary, or neurovasculature
Comparison to Predicate and Reference Devices:
The subject Aspirex ™ Thrombectory System has the following similarities to the predicate Indigo Aspiration System (K192833; cleared December 20, 2019):
- . Intended use
- Target population/conditions of use (anatomical location of use, how device interacts with . other devices, interaction with patient)
- Sterilization method .
5
K220270 Page 3
The subject Aspirex™ Thrombectomy System has the following similarities to the reference Rotarex® S catheter (a component of the Straub Endovascular System; K172315, cleared April 12, 2018):
- Intended use .
- . Indications for use
- Principles of operation/mechanism of action .
- . Fundamental scientific technology
- Target population/conditions of use (how device interacts with other devices, interaction with patient)
- . Sterilization method
- . Sterility assurance level
The subject Aspirex™ Thrombectomy System incorporates many of the design characteristics of the reference Rotarex® S catheter with the indication for use of the predicate Indigo Aspiration System.
6
| Attribute | Subject Device - Aspirex™
Thrombectomy Catheter | Predicate Device - Indigo
Aspiration System
(K192833) | Reference Device –
Rotarex® S Catheter
(K172315) | Rationale |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Straub Medical AG | Penumbra, Inc. | Straub Medical AG | Identical to Rotarex® S |
| Product Code | QEW/DQX | QEW/DXE | MCW/QEW/DQX | Combination of predicate and
reference devices. |
| Intended Use | Thrombectomy | Thrombectomy | Atherectomy and thrombus
removal | Identical to Indigo, and
included in Rotarex® S use |
| Indications for
Use | The Aspirex™
Thrombectomy System is
indicated for the removal of
acute emboli and thrombi
from vessels of the
peripheral venous system. | 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,
and for the treatment of
pulmonary embolism. | When operated with a
Rotarex™ S single use
catheter, the Straub
Endovascular System is
intended for use as an
atherectomy device and to
break up and remove
thrombus from upper and
lower extremity peripheral
arteries. It is not intended for
use in coronary, carotid,
pulmonary, iliac or renal
vasculature. | Similar to Indigo, but the
language has been clarified
in the subject indications to
be more clinically relevant.
Subject indications also do
not include treatment of
pulmonary embolism or
arterial vessels. |
| Contraindications | Not for use in vessels of
the cardiac, pulmonary,
coronary, or
neurovasculature | Not for use in the
coronaries or the
neurovasculature. | In the cardiopulmonary,
coronary, cerebral, iliac
and renal vasculature In the venous
vasculature In instances of persistent
vasospasm In patients not suitable
for atherectomy/
thrombectomy In patients with known or
suspected allergies to
any component of the
Straub Endovascular
System In patients with
haemodynamic
instability, shock or
severe coagulatory
disorders In patients where it is
impossible to achieve
sufficient anticoagulation
and platelet aggregation
inhibition In areas of known or
suspected infection,
especially at the puncture
site or target vessel
segment In vessels which are
oversized or undersized
for the particular
Rotarex® S catheter used In stents, stent grafts or
bypass grafts | Similar to Indigo, but use in
cardiac and pulmonary
vessels is also
contraindicated, as the
subject device is not
indicated for treatment of
pulmonary embolism.
Subject has different
contraindications from
Rotarex® S, but please note
that the vast majority of the
contraindications listed for
the reference device were
removed under K211738. |
7
8
| Without the use of a Straub provided guidewire When the Straub provided guidewire cannot completely cross the target lesion Where the Straub provided guidewire is in a subintimal position of any length Where the Straub provided guidewire has become threaded or entangled in the wire mesh of a stent, stent graft or the lining of a stent graft Where the target lesion is located in a region of marked vessel tortuosity (has a radius of curvature ≤2 cm) or is heavily calcified Where pre-existing damage is present in the vessel wall at or near the target lesion from prior surgery, aneurysms or other disease During MRI procedures or where electrical current may be passed to an undesired location via the catheter, e.g., during electrocautery, electrosurgery or | ||
|---|---|---|
| -- | -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
9
| Attribute | Subject Device - Aspirex™
Thrombectomy Catheter | Predicate Device - Indigo
Aspiration System
(K192833) | Reference Device -
Rotarex® S Catheter
(K172315) | Rationale |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | defibrillation. The
Rotarex® S catheter and
guidewire must be
entirely removed before
these therapies are
administered, even in an
emergency situation
• Where the recommended
separation distances
from Radio Frequency
and Electro-Magnetic
Interference (EMI)
sources cannot be
maintained (Reference
the manual for the Drive
System)
• Where any component of
the Straub Rotarex® S
Endovascular System
has sustained damage,
including any breech of
the sterile barrier | |
| System
Components | Catheter, console/control
unit, guidewire, collecting
bag, sterile drape for motor | Catheter, aspiration pump
and canister, aspiration
tubing, separator | Catheter, console/control
unit, guidewire, collecting
bag, sterile drape for motor | Identical to Rotarex® S |
| Catheter
Diameter | 6F, 8F, 10F | 3F, 5F, 5.3F, 6F, 8F | 6F, 8F | 6F and 8F sizes identical to
both predicate and reference
devices. CAT12 model of
Indigo predicate (K192981) is
compatible with 12F sheath,
so 10F subject device is
within that range. |
| Catheter Length | 85, 110, 135 cm | 50, 85, 115, 132, 135, 140,
150 cm | 85, 110, 135 cm | Identical to Rotarex® S,
within same range as Indigo. |
| Attribute | Subject Device - Aspirex™
Thrombectomy Catheter | Predicate Device - Indigo
Aspiration System
(K192833) | Reference Device -
Rotarex® S Catheter
(K172315) | Rationale |
| Guidewire
Compatibility | 0.018", 0.025" | 0.014"-0.038" | 0.018" | Identical to Rotarex® S,
addition of 10F size for
0.025" wire, within same
range as Indigo. |
| Catheter Tip | Smooth, rounded stationary
head | Torq, XTorq, Straight | Rotating atraumatic beveled
head | Similar to Rotarex® S, but
less potential for vessel
trauma due to stationary
head. |
| Aspiration | Active (Drive System) | Active (Aspiration Pump) | Active (Drive System) | Identical to Rotarex® S |
| Mechanism of
Action | Aspiration | Aspiration | Front cutting/rotational | Identical to Indigo |
| Materials | All materials that come in
contact directly or indirectly
with body tissue or blood
meet the guidelines in ISO
10993-1. | Biocompatible, commonly
used for interventional
devices | All materials that come in
contact directly or indirectly
with body tissue or blood
meet the guidelines in ISO
10993-1. | Identical to Rotarex® S |
| Shelf Life | 3 years | 3 years | 3 years | Identical to predicate and
reference |
| Sterilization
Method | EO | EO | EO | Identical to predicate and
reference |
| Rotation Speed | 40k, 60k RPM | N/A | 40k. 60k RPM | Identical to Rotarex® S |
| Aspiration Rate | 45, 75, 130 ml/min | 42, 168, 270, 480 ml/min | 45, 75 ml/min | Identical to Rotarex, but with
130 ml/min rate for 10F size.
which is within range of
Indigo rates. |
| Corrosion
Resistance | When tested in accordance
with the method in EN ISO
10555-1 annex A, metallic
components of the catheter
shall show no signs of
corrosion. | Unknown | When tested in accordance
with the method in EN ISO
10555-1 annex A, metallic
components of the catheter
shall show no signs of
corrosion. | Identical to Rotarex® S |
10
11
Performance Data:
To demonstrate substantial equivalence of the subject device to the predicate device, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures. the following in vitro tests were performed:
- Catheter .
- o Dimensional verification
- Simulated use o
- Kink resistance с
- Heat generation O
- Aspiration rate o
- Debris removal and O collection
- Embolization analysis O
- Fatigue O
- Particulate evaluation o
- O Trackability
- Torsional strength O
- Biocompatibility o
- Acute systemic toxicitv
- Cell cvtotoxicitv
- Complement activation
- I Direct hemolysis
- Extractables characterization
- I Guinea piq maximization
- Intracutaneous reactivity
- 트 Material mediated pyrogenicity
- Partial thromboplastin time
- . Platelet and leukocyte count
Animal Study
A GLP animal study was conducted to assess the safety and performance of the Aspirex™ catheter (test article) of the Aspirex Thrombectomy System in healthy veins, using the Indigo Aspiration Catheter (control article) of the Penumbra Indigo Aspiration System as a comparator. The secondary objective of this study was to assess the usability and performance of the other parts of the Aspirex™ Thrombectory System in association with the Aspirex™ catheter: Straub Medical Drive System, quidewire, collection baq and sterile drape.
No evidence of stenosis or occlusion was observed in the vessels of any of the study animals at any fluoroscopy (with contrast) assessment. No evidence of intimal irregularities, vessel dissection, perforation, rupture, or other evidence of vessel injury was observed in the vessels of
- . Guidewire
- o Surface
- Corrosion o
- Fracture о
- Bending O
- Tensile strength O
- Overall length O
- Coil length O
- Max tip diameter o
- Guidewire body diameter O
- Tip flexibility O
- O Coating integrity assessment
- Particulate evaluation O
- Kink resistance o
- Lubricity O
12
any of the study animals at any fluoroscopy (with contrast) assessment or upon macroscopic assessment of the external aspect of the treated vessels. Microscopic findings in the treated vessels correlated with angiographic and macroscopic observations. Microscopic changes were of similar incidence and severity in both test and control groups and were limited to the intima (i.e. multifocal endothelial hypertrophy and intimal thickening due to fibrosis) in the treated vessels. with no vessel perforation, vessel dissection, rupture nor parietal hematoma, no medial injury (with the exception of degenerative changes in one acute control study animal) and no relevant inflammation of the vessel wall or surrounding tissues.
When comparing the results of clinical, biological and tissular response to the application of the Aspirex™ catheter and Indigo Aspiration Catheter, local and systemic tolerance appears equivalent in both groups. The usability and performance of the Aspirex™ catheter and Indigo Aspiration Catheter presented with similar results, with no adverse events.
Conclusions:
The results from both in vitro studies and a GLP animal study demonstrate that the technological characteristics and performance criteria of the subject Aspirex™ Thrombectomy System are substantially equivalent to the predicate device, and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
The subject device. the Aspirex™ Thrombectomy System, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, quidance, test protocols and/or customer inputs. The Aspirex™ Thrombectomy System is substantially equivalent to the legally marketed predicate device, the Indigo Aspiration System.