(172 days)
No
The device description focuses on mechanical components and aspiration, with no mention of AI or ML capabilities. The performance studies are also focused on mechanical and functional testing.
Yes
The device is intended for the non-surgical removal of thrombi or emboli from venous vasculature, which is a therapeutic intervention.
No
Explanation: The device is described as a "single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot" and its intended uses are "the non-surgical removal of thrombi or emboli" and "aspiration of contrast media and other fluids." These are therapeutic or interventional actions, not diagnostic ones. There is no mention of the device being used to identify or characterize medical conditions.
No
The device description clearly outlines multiple physical components including a cannula, sheath, obturator, handle, waste bag, and tubing. The performance studies also focus on physical characteristics and functionality of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The AlphaVac MMA System is a mechanical device used within the body (in the venous vasculature) to physically remove thrombi or emboli. It does not analyze biological specimens outside the body.
- Intended Use: The intended use clearly states "non-surgical removal of thrombi or emboli from venous vasculature" and "aspiration of contrast media and other fluids from venous vasculature." These are interventional procedures performed directly on the patient's circulatory system.
Therefore, the AlphaVac MMA System is a medical device used for therapeutic and interventional purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cannula is indicated for the non-surgical removal of thrombi or emboli from venous vasculature. aspiration of contrast media and other fluids from venous vasculature. The Cannula is intended for use in the venous system. The Handle is indicated as a vacuum source for the AlphaVac MMA System.
Product codes
QEZ
Device Description
The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA F186 System is comprised of six main components packaged together:
- . a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip (18F)
- AlphaVac Sheath (22F)
- AlphaVac Obturator (17F) ●
- AlphaVac Handle .
- . Waste Bag and Tubing
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 and contained within the waste bag for disposal. Target vessels 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 ~85° (AlphaVac F1885) angled configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous vasculature, iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), and Right Heart (Atrium (RA))
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
Comprehensive bench testing (integrity and functional performance) was performed to support substantial equivalence of the specified predicate device. The AlphaVac MMA F1885 System met all specified design and performance requirements below:
- Dimensional Testing .
- Visual Inspection
- Tensile Testing ●
- Column Strength
- Cannula and Funnel Actuation ●
- Distal Cannula Shape ● Manipulation
- Hub Rotation
- Distal Tip Functionality .
- Kink Resistance ●
- Radiopacity ●
- Flushability
- Product Interface (Compatibility) Testing
- Push/Pull/Retraction Force ●
- Leak Testing ●
- Siphoning Testing ●
- Fluid Volume Removal
- Handle Lock Testing ●
- Pressure Testing
- Handle Pull Force ●
- Human Factors Evaluation/Usability Evaluation
- Simulated Use ●
- Torque
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 4, 2022
AngioDynamics, Inc. Kasey Newcomb Manager, Global Regulatory Affairs 26 Forest Street Marlborough, MA 01742
Re: K213388
Trade/Device Name: AlphaVac Multipurpose Mechanical Aspiration (MMA) F188 System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ Dated: February 23, 2022 Received: February 23, 2022
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
1
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 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) K213388
Device Name
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
Indications for Use (Describe)
- The Cannula is indicated for
- · the non-surgical removal of thrombi or emboli from venous vasculature.
- · aspiration of contrast media and other fluids from venous 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY FOR THE ALHAVAC MULTIPURPOSE MECHANICAL ASPIRATION (MMA) F1885 SYSTEM
A. SPONSOR AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 USA B. CONTACT Kasey E Newcomb Troy Roberts Specialist II, Global Regulatory Affairs VP, Regulatory Affairs Tel: 508.658.7813 Tel: 508.658.7934 Email: knewcomb@angiodynamics.com Email: troberts@angiodynamics.com C. DEVICE NAME Trade Name: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System Common/Usual Name: Aspiration Thrombectomy Catheter Classification Name: Aspiration Thrombectomy Catheter (21 CFR § 878.5150, Class II, Pro-Code QEZ) Classification Panel: Cardiovascular D. PREDICATE DEVICE 510(k): K211081 Trade Name: AlphaVac Multipurpose Mechanical Aspiration (MMA) System Aspiration Thrombectomy Catheter Common/Usual Name: Classification Name: Aspiration Thrombectomy Catheter (21 CFR § 878.5150, Class II, Pro-Code QEZ) Classification Panel: Cardiovascular E. REFERENCE DEVICE 510(k): K212386 AngioVac F1885 Trade Name: Common/Usual Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Cardiopulmonary bypass vascular catheter, cannula, or tubing Classification Name: (21 CFR § 878.4210, Class II, Pro-Code DWF) Classification Panel: Cardiovascular
4
F. DEVICE DESCRIPTION
The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA F186 System is comprised of six main components packaged together:
- . a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip (18F)
- AlphaVac Sheath (22F)
- AlphaVac Obturator (17F) ●
- AlphaVac Handle .
- . Waste Bag and Tubing
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 and contained within the waste bag for disposal. Target vessels 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 ~85° (AlphaVac F1885) angled configuration.
G. INDICATION FOR USE
The Cannula is indicated for
- . the non-surgical removal of thrombi or emboli from venous vasculature.
- . aspiration of contrast media and other fluids from venous 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 F1885 System is sterilized via ethylene oxide (EO). 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 F1865 System and ensure 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 conditions at the most extreme environmental conditions while maintaining packaging integrity and sterility.
I. BIOCOMPATIBILITY
The AlphaVac MMA F1865 System is a sterile single-use disposable instrument. The AlphaVac MMA F1885 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, irritation, systemic toxicity, pyrogenicity, and hemocompatibility.
5
J. TECHNOLOGY CHARACTERISTICS
Predicate device, AlphaVac Multipurpose Mechanical Aspiration (MMA) System cleared via K211081, was used to support and evaluate substantial equivalence 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 removal of thromboemboli 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 in the subject device are as follows:
- The cannula is available with an 85°angle distal tip
- The cannula outside diameter is 22F and working length of 44.4 inches ●
- . Hemostatic Valve on sheath proximal end allows sheath and cannula to be separated
The technological characteristics of the proposed AlphaVac MMA F1885 System are substantially equivalent with respect to the basic system design and function to that of the specified predicate device.
Additionally, a reference predicate (K212386 - AngioVac F1885) has been identified to provide additional support as it is identical in materials, dimensions, manufacture, and used within the same vasculature to the proposed AlphaVac F1885 System
K. PERFORMANCE DATA
Comprehensive bench testing (integrity and functional performance) was performed to support substantial equivalence of the specified predicate device. The AlphaVac MMA F1885 System met all specified design and performance requirements below:
- Dimensional Testing .
- Visual Inspection
- Tensile Testing ●
- Column Strength
- Cannula and Funnel Actuation ●
- Distal Cannula Shape ● Manipulation
- Hub Rotation
- Distal Tip Functionality .
- Kink Resistance ●
- Radiopacity ●
- Flushability
- Product Interface (Compatibility) Testing
- Push/Pull/Retraction Force ●
- Leak Testing ●
- Siphoning Testing ●
- Fluid Volume Removal
- Handle Lock Testing ●
- Pressure Testing
- Handle Pull Force ●
- Human Factors Evaluation/Usability Evaluation
- Simulated Use ●
- Torque
L. 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.