AlphaVac Multipurpose Mechanical Aspiration (MMA) System

K211081 · AngioDynamics, Inc. · QEZ · Jun 4, 2021 · Cardiovascular

Device Facts

• Record ID: K211081
• Device Name: AlphaVac Multipurpose Mechanical Aspiration (MMA) System
• Applicant: AngioDynamics, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Jun 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cannula is indicated for · the non-surgical removal of thrombi or emboli from vasculature. · aspiration of contrast media and other fluids from vasculature. The Cannula is intended for use in the venous system. The Handle is indicated as a vacuum source for the AlphaVac MMA System.

Device Story

AlphaVac MMA System is a single-use, over-the-wire, catheter-based system for percutaneous mechanical thrombectomy. Components include a flexible cannula with a nitinol-reinforced, angled, self-expanding funnel tip, sheath, obturator, vacuum handle, and waste bag. Used in clinical settings (e.g., IR, OR) by physicians. The device is advanced over a guidewire to the target venous site; the funnel expands to engage thrombus. The handle is manually operated to create suction, aspirating thrombus and fluids into the waste bag. The system features a vacuum lock/unlock mechanism and volume-limited switch for aspiration control. The waste bag allows visual monitoring of aspirated material and blood loss. The device facilitates minimally invasive clot removal, potentially reducing the need for surgical intervention.

Clinical Evidence

No clinical trial data provided. Evidence consists of comprehensive bench testing (integrity, functional performance, tensile, kink resistance, leak, pressure, and simulated use) and animal studies demonstrating safety and performance in anatomical locations consistent with predicate and reference devices.

Technological Characteristics

Single-use, over-the-wire catheter system. Materials include nitinol (reinforced funnel tip). Energy source: manual vacuum (syringe-like handle). Dimensions: 25F cannula in ~20° and ~180° configurations. Sterilization: Ethylene Oxide (EtO). Biocompatibility: ISO 10993 compliant (cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemocompatibility).

Indications for Use

Indicated for non-surgical removal of thrombi or emboli from the venous system and aspiration of contrast media/fluids. Intended for use in vasculature including iliofemoral vein, IVC, SVC, and right heart.

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

• FlowTriever Retrieval/Aspiration System (K173672)

Reference Devices

• AngioVac C20, AngioVac C180 (K190594)

Submission Summary (Full Text)

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June 4, 2021

AngioDynamics, Inc. Kasey Newcomb Specialist II, Global Regulatory Affairs 603 Queensbury Ave Queensbury, New York 12804

## Re: K211081

Trade/Device Name: AlphaVac Multipurpose Mechanical Aspiration (MMA) System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: April 9, 2021 Received: April 12, 2021

## Dear Kasey Newcomb:

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 ([e-mail]) or phone [phone] 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) K211081

Device Name

AlphaVac Multipurpose Mechanical Aspiration (MMA) System

Indications for Use (Describe)

The Cannula is indicated for

· the non-surgical removal of thrombi or emboli from vasculature.

· aspiration of contrast media and other fluids from vasculature.

The Cannula is intended for use in the venous system.

The Handle is indicated as a vacuum source for the AlphaVac MMA System.

| Type of Use (Select one or both, as applicable) | <table><tr><td><span style="text-decoration: underline;">Prescription Use</span> (Rx - S1 QEP 001 Subject P) <input checked="" type="checkbox"/></td><td>Over The Counter Use (S1 QEP 001 Subject OTC) <input type="checkbox"/></td></tr></table> | <span style="text-decoration: underline;">Prescription Use</span> (Rx - S1 QEP 001 Subject P) <input checked="" type="checkbox"/> | Over The Counter Use (S1 QEP 001 Subject OTC) <input type="checkbox"/> |
|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use</span> (Rx - S1 QEP 001 Subject P) <input checked="" type="checkbox"/> | Over The Counter Use (S1 QEP 001 Subject OTC) <input type="checkbox"/> | | |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(K) SUMMARY FOR THE ALHAVAC MULTIPURPOSE MECHANICAL ASPIRAITON (MMA) SYSTEM

#### A. SPONSOR

AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 USA

#### B. CONTACT

C.

D.

| Kasey E Newcomb | Troy Roberts |
|------------------------------------------|-----------------------------------|
| Specialist II, Global Regulatory Affairs | Sr Director, Regulatory Affairs |
| Tel: [phone] | Tel: [phone] |
| Email: [e-mail] | Email: [e-mail] |
| DEVICE NAME | |

| Trade Name: | AlphaVac Multipurpose Mechanical Aspiration (MMA) System |
|-------------------------|---------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Aspiration Thrombectomy Catheter |
| Classification Name: | Aspiration Thrombectomy Catheter<br>(21 CFR § 878.5150, Class II, Pro-Code QEZ) |
| Classification Panel: | Cardiovascular |
| <b>PREDICATE DEVICE</b> | |
| 510(k): | K173672 |
| Trade Name: | FlowTriever Retrieval/Aspiration System |
| Common/Usual Name: | Peripheral Mechanical Thrombectomy With Aspiration |
| Classification Name: | Peripheral Mechanical Thrombectomy with Aspiration<br>(21 CFR § 878.5150, Class II, Pro-Code QEW) |

Cardiovascular

Classification Panel:

#### E. REFERENCE DEVICE

| 510(k): | K190594 |
|-----------------------|---------------------------------------------------------------------------------------------------------------|
| Trade Name: | AngioVac C20, AngioVac C180 |
| Common/Usual Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass |
| Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass<br>(21 CFR § 878.4210, Class II, Pro-Code DWF) |
| Classification Panel: | Cardiovascular |

#### F. DEVICE DESCRIPTION

The AlphaVac Multipurpose Mechanical Aspiration (MMA) System is a single use-over-wire catheter- based system that facilitates the removal of thrombus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA System is comprised of six main components packaged together:

- a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped ● distal tip
- . AlphaVac Sheath
- . AlphaVac Obturator
- AlphaVac Handle
- Waste Bag and Tubing

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The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e. Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured within the waste bag for disposal. Target vessels for include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), and Right Heart (Atrium (RA)). The device is provided in ~20° (AlphaVac 25F/C20) and ~180° (AlphaVac 25F/C180) angled configurations.

#### G. INDICATION FOR USE

The Cannula is indicated for

- the non-surgical removal of thrombi or emboli from vasculature. ●
- aspiration of contrast media and other fluids from vasculature. .

The Cannula is intended for use in the venous system.

The Handle is indicated as a vacuum source for the AlphaVac MMA System.

#### H. STERILIZATION/SHELF LIFE

The AlphaVac MMA System is sterilized via ethylene oxide (EtO). A series of tests, performed by AngioDynamics and independent test houses, have been conducted to assess the suitability of the sterile packaging to protect the proposed AlphaVac MMA System and ensure its sterility within its stated shelf life at point of use. These tests confirm the packaging integrity, sterility and distribution cycle. Testing demonstrated that the packaging is robust enough to withstand extreme distribution scenario at the most extreme environmental conditions while maintaining packaging integrity and sterility.

#### I. BIOCOMPATIBILITY

The AlphaVac MMA System is a sterile single-use disposable instrument. AlphaVac MMA System has met the biocompatibility testing requirements identified in ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process. Specifically, the following tests were performed with acceptable results; cytotoxicity, sensitization, systemic toxicity, pyrogenicity, and hemocompatibility.

#### J. TECHNOLOGY CHARACTERISTICS

Predicate device, the FlowTriever Retrieval/Aspiration System, cleared via K173672, was used to support safety and effectiveness of the subject device. Both the subject device and specified predicate device include the following technological characteristics:

- Both the proposed and predicate devices are designed for the non-surgical removal of ● thrombi or emboli from vasculature.
- Both devices are intended to be used with commonly available vascular access tools (e.g., guidewire, vascular introducer, etc.) to facilitate the removal of thrombus, embolus, and clot during minimally invasive percutaneous procedures.
- . Both devices are large bore catheters with a syringe-like aspiration source.
- . Both devices have similar operating principles by being advanced through a sheath over a guidewire to target location with a mechanical aspiration source that is used to aspirate thrombus/emboli from vasculature.

Technological characteristics that are different between the subject and specified predicate device are as follows:

- Handle Vacuum Lock/Unlock: provides the user with the ability to maintain suction when material is engaged.

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- Handle Volume Limited Switch: Allows user to control aspiration volume.
- Waste bag allows visibility of aspirated material and continuous monitoring of procedural ● blood loss.
- . FlowTriever offers an optional catheter with expanding wire form disks that are deployed to engage thrombus, which is not included with the AlphaVac MMA System.

The technological characteristics of the proposed AlphaVac MMA System are substantially equivalent with respect to the basic system design and function to that of the specified predicate device.

#### K. PERFORMANCE DATA

Comprehensive bench testing (integrity and functional performance) was performed to support substantial equivalence of the specified predicate device. The AlphaVac MMA System met all specified design and performance requirements below:

- Dimensional Testing ●
- Visual Inspection ●
- Tensile Testing ●
- Stiffness Testing
- Cannula and Funnel Actuation
- Distal Cannula Shape Manipulation
- Bend Angle
- Hub Rotation ●
- . Distal Tip Functionality
- . Kink Resistance
- Radiopacity ●
- Flushability
- Product Interface (Compatibility) Testing ●
- Leak Testing ●
- Siphoning Testing
- Fluid Volume Removal ●
- Handle Lock Testing
- Pressure Testing ●
- Handle Pull Force
- Human Factors Evaluation/Usability Evaluation .
- Simulated Use ●
- Torque

#### L. ANIMAL STUDY

Previous animal studies also contributed to demonstrating substantial equivalence in the safety and performance profile of the AlphaVac Cannula in anatomical locations consistent with the predicate and reference device uses.

#### M. CONCLUSIONS

The results of the non-clinical testing and a comparison of similarities and differences demonstrates that the proposed and predicate devices are substantially equivalent.