Aspirex™ Thrombectomy System

K230356 · C.R. Bard, Inc. · QEW · Mar 31, 2023 · Cardiovascular

Device Facts

• Record ID: K230356
• Device Name: Aspirex™ Thrombectomy System
• Applicant: C.R. Bard, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Mar 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Aspirex™ Thrombectomy System is a mechanical thrombectomy device for removing acute emboli and thrombi. System includes a motorized Drive System (control unit, motor, footswitch) and a catheter set (braided shaft, internal helix, metallic head with side windows). Operated by a physician in a clinical setting. The catheter tracks over a guidewire to the thrombus site; the motorized helix rotates (40,000–60,000 RPM) to create continuous, controlled aspiration, drawing thrombus into the catheter head and through the shaft. The atraumatic head design prevents vessel wall damage. Output is the physical removal of occlusions, restoring blood flow in peripheral veins and hemodialysis access sites. Benefits include improved vascular access patency and effective thrombus clearance.

Clinical Evidence

Systematic analysis of scientific literature and clinical study reports regarding Aspirex™ use in hemodialysis access grafts and native arteriovenous fistulas. Primary endpoint was patency rates. Results showed patency rates similar to other mechanical thrombectomy devices or surgery. Sub-group analyses confirmed pooled results, supporting safety and effectiveness for the expanded indication.

Technological Characteristics

System consists of a motorized drive unit and a catheter with a braided shaft and metallic head. Operates via mechanical aspiration using a rotating internal helix. Catheter sizes range from 6F to 10F; rotation speeds 40,000–60,000 RPM. Aspiration rates 45–130 ml/min. Compatible with 0.018" or 0.025" guidewires. Device is standalone, non-networked, and utilizes a magnetic clutch for motor-catheter connection.

Indications for Use

Indicated for removal of acute emboli and thrombi from peripheral venous system vessels, hemodialysis access grafts, and native arteriovenous fistulas. Contraindicated for use in cardiac, pulmonary, coronary, and neurovasculature.

Regulatory Classification

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.

Predicate Devices

• Aspirex™ Thrombectomy System (K220270)

Reference Devices

• AngioJet Ultra AVX Thrombectomy Set (K133629)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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):

| <div> <span> <svg height="12" width="12"> <polygon points="0,0 0,12 12,12 12,0" style="fill:none;stroke:black;stroke-width:1"></polygon> <polygon points="0,0 0,12 12,12 12,0" style="fill:none;stroke:black;stroke-width:1"></polygon> <polygon points="2,2 10,2 10,10 2,10" style="fill:black"></polygon> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
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| <div> <span> <svg height="12" width="12"> <polygon points="0,0 0,12 12,12 12,0" style="fill:none;stroke:black;stroke-width:1"></polygon> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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, Inc<br>1625 West 3rd Street<br>Tempe, 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:

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

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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.

| Catheter<br>Size | Minimum<br>Vessel<br>Diameter | Catheter<br>External<br>Diameter | Nominal<br>Rotation<br>(RPM) | Maximum<br>Aspiration<br>(ml/min) | Guidewire<br>Size &<br>Length |
|------------------|-------------------------------|----------------------------------|------------------------------|-----------------------------------|-------------------------------|
| 6F<br>110 cm | 3 mm | 2.0 mm | 60,000 | 45 | 0.018"<br>270 cm |
| 6F<br>135 cm | 3 mm | 2.0 mm | 60,000 | 45 | 0.018"<br>320 cm |
| 8F<br>85 cm | 5 mm | 2.7 mm | 40,000 | 75 | 0.018"<br>220 cm |
| 8F<br>110 cm | 5 mm | 2.7 mm | 40,000 | 75 | 0.018"<br>270 cm |
| 10F<br>110 cm | 8 mm | 3.3 mm | 40,000 | 130 | 0.025"<br>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.