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.

AI/ML Overview

The provided text describes a medical device, the Aspirex™ Thrombectomy System, and its performance data to demonstrate substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study related to an AI/algorithm-based device's performance, human reader assistance, or ground truth establishment for such a device.

The study described is a GLP animal study comparing the Aspirex™ catheter (test article) to the Indigo Aspiration Catheter (control article) in healthy veins. This study assesses the physical and biological performance of the catheters, not an AI algorithm.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria and performance based on the input text. The text does not discuss:

A table of acceptance criteria and the reported device performance for an AI/algorithm.
Sample size for a test set (related to AI data) or data provenance.
Number of experts or their qualifications for establishing ground truth for AI data.
Adjudication method for an AI test set.
Multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
Standalone performance of an AI algorithm.
Type of ground truth used for AI (e.g., expert consensus, pathology, outcomes data).
Sample size for a training set for an AI algorithm.
How ground truth for a training set for an AI algorithm was established.

The document focuses on the mechanical and biological performance of a physical medical device (thrombectomy system) through in vitro and animal studies, and its substantial equivalence to a predicate device, as required for FDA 510(k) clearance.

Summary

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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

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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

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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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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, Inc1625 West 3rd StreetTempe, 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:

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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.

CatheterSize	MinimumVesselDiameter	CatheterExternalDiameter	NominalRotation(RPM)	MaximumAspiration(ml/min)	GuidewireSize &Length
6F110 cm	3 mm	2.0 mm	60,000	45	0.018"270 cm
6F135 cm	3 mm	2.0 mm	60,000	45	0.018"320 cm
8F85 cm	5 mm	2.7 mm	40,000	75	0.018"220 cm
8F110 cm	5 mm	2.7 mm	40,000	75	0.018"270 cm
10F110 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 .

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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.

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Attribute	Subject Device - Aspirex™Thrombectomy Catheter	Predicate Device - IndigoAspiration 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 andreference devices.
Intended Use	Thrombectomy	Thrombectomy	Atherectomy and thrombusremoval	Identical to Indigo, andincluded in Rotarex® S use
Indications forUse	The Aspirex™Thrombectomy System isindicated for the removal ofacute emboli and thrombifrom vessels of theperipheral venous system.	As part of the IndigoAspiration System, the IndigoAspiration Catheters andSeparators are indicated forthe removal of fresh, softemboli and thrombi fromvessels of the peripheralarterial and venous systems,and for the treatment ofpulmonary embolism.	When operated with aRotarex™ S single usecatheter, the StraubEndovascular System isintended for use as anatherectomy device and tobreak up and removethrombus from upper andlower extremity peripheralarteries. It is not intended foruse in coronary, carotid,pulmonary, iliac or renalvasculature.	Similar to Indigo, but thelanguage has been clarifiedin the subject indications tobe more clinically relevant.Subject indications also donot include treatment ofpulmonary embolism orarterial vessels.
Contraindications	Not for use in vessels ofthe cardiac, pulmonary,coronary, orneurovasculature	Not for use in thecoronaries or theneurovasculature.	In the cardiopulmonary,coronary, cerebral, iliacand renal vasculature In the venousvasculature In instances of persistentvasospasm In patients not suitablefor atherectomy/thrombectomy In patients with known orsuspected allergies toany component of theStraub EndovascularSystem In patients withhaemodynamicinstability, shock orsevere coagulatorydisorders In patients where it isimpossible to achievesufficient anticoagulationand platelet aggregationinhibition In areas of known orsuspected infection,especially at the puncturesite or target vesselsegment In vessels which areoversized or undersizedfor the particularRotarex® S catheter used In stents, stent grafts orbypass grafts	Similar to Indigo, but use incardiac and pulmonaryvessels is alsocontraindicated, as thesubject device is notindicated for treatment ofpulmonary embolism.Subject has differentcontraindications fromRotarex® S, but please notethat the vast majority of thecontraindications listed forthe reference device wereremoved under K211738.

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K220270

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K220270

		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
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Attribute	Subject Device - Aspirex™Thrombectomy Catheter	Predicate Device - IndigoAspiration System(K192833)	Reference Device -Rotarex® S Catheter(K172315)	Rationale
			defibrillation. TheRotarex® S catheter andguidewire must beentirely removed beforethese therapies areadministered, even in anemergency situation• Where the recommendedseparation distancesfrom Radio Frequencyand Electro-MagneticInterference (EMI)sources cannot bemaintained (Referencethe manual for the DriveSystem)• Where any component ofthe Straub Rotarex® SEndovascular Systemhas sustained damage,including any breech ofthe sterile barrier
SystemComponents	Catheter, console/controlunit, guidewire, collectingbag, sterile drape for motor	Catheter, aspiration pumpand canister, aspirationtubing, separator	Catheter, console/controlunit, guidewire, collectingbag, sterile drape for motor	Identical to Rotarex® S
CatheterDiameter	6F, 8F, 10F	3F, 5F, 5.3F, 6F, 8F	6F, 8F	6F and 8F sizes identical toboth predicate and referencedevices. CAT12 model ofIndigo predicate (K192981) iscompatible with 12F sheath,so 10F subject device iswithin 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 - IndigoAspiration System(K192833)	Reference Device -Rotarex® S Catheter(K172315)	Rationale
GuidewireCompatibility	0.018", 0.025"	0.014"-0.038"	0.018"	Identical to Rotarex® S,addition of 10F size for0.025" wire, within samerange as Indigo.
Catheter Tip	Smooth, rounded stationaryhead	Torq, XTorq, Straight	Rotating atraumatic beveledhead	Similar to Rotarex® S, butless potential for vesseltrauma due to stationaryhead.
Aspiration	Active (Drive System)	Active (Aspiration Pump)	Active (Drive System)	Identical to Rotarex® S
Mechanism ofAction	Aspiration	Aspiration	Front cutting/rotational	Identical to Indigo
Materials	All materials that come incontact directly or indirectlywith body tissue or bloodmeet the guidelines in ISO10993-1.	Biocompatible, commonlyused for interventionaldevices	All materials that come incontact directly or indirectlywith body tissue or bloodmeet the guidelines in ISO10993-1.	Identical to Rotarex® S
Shelf Life	3 years	3 years	3 years	Identical to predicate andreference
SterilizationMethod	EO	EO	EO	Identical to predicate andreference
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 with130 ml/min rate for 10F size.which is within range ofIndigo rates.
CorrosionResistance	When tested in accordancewith the method in EN ISO10555-1 annex A, metalliccomponents of the cathetershall show no signs ofcorrosion.	Unknown	When tested in accordancewith the method in EN ISO10555-1 annex A, metalliccomponents of the cathetershall show no signs ofcorrosion.	Identical to Rotarex® S

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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

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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.

Regulation Number and Section

§ 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).