The 6F and 8F Aspirex™ Thrombectomy Systems are indicated for the removal of acute emboli and thrombi from hemodialysis access grafts and native arteriovenous fistulas.

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 damage 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.

AI/ML Overview

The provided text is a 510(k) summary for the Aspirex™ Thrombectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving a device meets specific acceptance criteria through a study with predefined performance metrics like those typically found in an AI/ML context.

Therefore, many of the requested items (e.g., acceptance criteria table, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of FDA submission for a medical device that processes human biological material.

However, I can extract information related to the device, its intended use, and the performance data that was reviewed (rather than generated by a specific study to meet acceptance criteria).

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Not Applicable/Not Provided: This document does not present a table of specific acceptance criteria (e.g., target specificity, sensitivity, or image quality metrics) or reported device performance against those criteria in the way an AI/ML device would. Instead, it discusses the device's functional specifications and clinical outcomes in terms of existing literature and clinical study reports.

Here's information related to the device specifications that might be considered "performance" in a mechanical sense, but not quantitative "acceptance criteria" for an AI/ML model:

Metric	Catheter Size (6F)	Catheter Size (8F)	Catheter Size (10F)
Minimum Vessel Diameter	3 mm	5 mm	8 mm
Catheter External Diameter	2.0 mm	2.7 mm	3.3 mm
Nominal Rotation (RPM)	60,000	40,000	40,000
Maximum Aspiration (ml/min)	45	75	130

2. Sample sizes used for the test set and the data provenance:

Not Provided: The document states that a "review of clinical data from scientific literature and clinical study reports" was performed. It does not specify a "test set" sample size, as it's a review of existing data, not a new, controlled study to validate a new claim against a test set.
Data Provenance: The data provenance is "scientific literature and clinical study reports." The country of origin and whether it was retrospective or prospective is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable/Not Provided: This is not a study involving expert readers establishing ground truth for a diagnostic AI/ML device. The "performance data" is derived from a review of clinical outcomes reported in existing literature and studies, which reflects real-world clinical results, not expert "ground truth" for a device's diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable/Not Provided: No adjudication method is mentioned as this is not a study comparing human performance or diagnostic accuracy.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable/Not Provided: This is a physical medical device (thrombectomy system), not an AI/ML diagnostic aid. Therefore, an MRMC study and effects on human reader performance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable/None: This is a physical medical device (thrombectomy system) that is used by humans, not an algorithm.

7. The type of ground truth used:

Clinical Outcomes/Patency Rates: The "performance data" relied on reviewing "primary patency rates" in hemodialysis access grafts and native arteriovenous fistulas. This is long-term clinical outcome data, not a diagnostic "ground truth" established by experts or pathology for a specific event.

8. The sample size for the training set:

Not Applicable/Not Provided: This is not an AI/ML device, so there is no "training set." The device's design and manufacturing are identical to the predicate.

9. How the ground truth for the training set was established:

Not Applicable/Not Provided: No training set exists for this type of device.

Summary of Device Performance (from the document):

The performance data reviewed for the Aspirex™ Thrombectomy System focused on:

Type of data: Clinical data from scientific literature and clinical study reports.
Focus: Device performance and clinical outcomes of percutaneous mechanical thrombectomy with the Aspirex™ Thrombectomy System for the removal of occlusions from hemodialysis access grafts and native arteriovenous fistulas.
Key Metric Analyzed: Primary patency rates.
Conclusion: Vascular access patency rates after treatment with the Aspirex™ device are similar to those observed with treatment with other mechanical thrombectomy devices or surgery. Sub-group analyses confirmed these results. The review concluded that the use of the Aspirex™ Thrombectomy System in these expanded indications "does not raise new questions of safety and effectiveness" and "provides satisfactory clinical outcomes in terms of patency rates and the functioning of hemodialysis vascular access."

Summary

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March 31, 2023

C.R. Bard, Inc. Aaron Conovaloff Regulatory Affairs Manager 1625 West 3rd Street Tempe, Arizona 85281

Re: K230356

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: February 9, 2023 Received: February 9, 2023

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 W. Digitally signed by
Gregory W. O'connell -S
O'connell -S Date: 2023.03.31
14:49:03 -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

Enclosure

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Indications for Use

510(k) Number (if known) K230356

Device Name Aspirex™ 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.

The 6F and 8F Aspirex™ Thrombectomy Systems are indicated for the removal of acute emboli and thrombi from hemodialysis access grafts and native arteriovenous fistulas.

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)

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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:	February 9, 2023

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:

Aspirex™ Thrombectomy System (K220270; cleared June 21, 2022) .

Reference Device:

AngioJet Ultra AVX Thrombectomy Set (K133629; cleared February 14, 2014)

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 damage 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.

The 6F and 8F Aspirex™ Thrombectorny Systems are indicated for the removal of acute emboli and thrombi from hemodialysis access grafts and native arteriovenous fistulas.

Contraindications:

Not for use in vessels of the cardiac, pulmonary, coronary, and neurovasculature

Comparison to Predicate Devices:

The subject Aspirex™ Thrombectory System has the following similarities to the predicate Aspirex™ Thrombectomy System (K220270; cleared June 21, 2022):

Same intended use ●
Similar target population/conditions of use (how device interacts with other devices, . interaction with patient)
. Same method of sterilization
Same operating principle ●
. Same fundamental scientific technology

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. Same design and performance specifications, manufacturing methods, raw materials, formulation, processing, sterilization (including dose and duration), packaging, suppliers, proportional surface area of each patient contacting component, geometry, and chemical additives
The subject Aspirex™ Thrombectomy System has the following similarities to the reference AngioJet Ultra AVX Thrombectomy Set (K133629, cleared February 14, 2014):
Similar operating principle (mechanical aspiration) ●
. Similar fundamental scientific technology (mechanical aspiration)
Similar intended use
Similar target population/conditions of use (how device interacts with other ● devices, interaction with patient)

The subject Aspirex™ Thrombectomy System is identical in manufacturing and design to the predicate Aspirex™ Thrombectomy System, and adds an indication for arteriovenous use, which is similar to that of the reference AngioJet Ultra AVX Thrombectomy Set.

Performance Data:

A review of clinical data from scientific literature and clinical study reports, focusing on device performance and clinical outcomes of percutaneous mechanical thrombectomy with the Aspirex™ Thrombectomy System for the removal of occlusions from hemodialysis access grafts and native arteriovenous fistulas, was performed.

Primary patency rates were analyzed as clinical benefits, and it could be concluded that vascular access (in both hemodialysis access grafts and native arteriovenous fistulas) patency rates affer treatment with the Aspirex™ device are similar to that observed with treatment with other mechanical thrombectomy devices or surqery. Sub-group analyses of solely hemodialysis access grafts or native arteriovenous fistulas were also carried out and confirmed the results of the pooled analysis.

As demonstrated by the systematic analysis of the scientific literature and clinical study reports, it can be concluded that use of the Aspirex™ Thrombectomy System in thrombectomy in hemodialysis access grafts and native arteriovenous fistulas does not raise new questions of safety and effectiveness: the device provides satisfactory clinical outcomes in terms of patency rates and the functioning of hemodialysis vascular access.

Conclusions:

The subject and predicate devices are identical with respect to manufacturing and design. The only difference between the subject and predicate devices is an expanded indications for use statement to include use in hemodialysis access grafts and native arteriovenous fistulas. The clinical data obtained for the Aspirex™ Thrombectory System demonstrated that there are no new questions of safety and effectiveness raised by the expanded indications for use. Therefore, the Aspirex™ Thrombectomy System is substantially equivalent to the legally marketed predicate device, the Aspirex™ Thrombectomy 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).