(53 days)
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.
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
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.
The provided text is a 510(k) summary for the AlphaVac Multipurpose Mechanical Aspiration (MMA) System. It details information typically included in a regulatory submission for medical devices to prove substantial equivalence to a predicate device. However, it does not include specific information regarding acceptance criteria for device performance studies, nor does it describe a study that explicitly demonstrates the device "meets" those acceptance criteria in the way a clinical trial or a performance study with defined endpoints would.
Instead, the document focuses on demonstrating substantial equivalence through bench testing, biocompatibility, sterilization, and a comparison of technological characteristics with a predicate device. It briefly mentions "Previous animal studies also contributed to demonstrating substantial equivalence," but no details on the study design, acceptance criteria, or results are provided.
Therefore, many of the requested pieces of information cannot be extracted from the provided text. I will address the points that can be inferred or explicitly stated.
Acceptance Criteria and Device Performance for AlphaVac Multipurpose Mechanical Aspiration (MMA) System
The provided 510(k) summary does not explicitly list acceptance criteria in terms of specific performance thresholds for a study designed to prove the device meets those criteria. Instead, it outlines a series of tests performed to support substantial equivalence to a predicate device (FlowTriever Retrieval/Aspiration System). The "reported device performance" is described as successfully meeting "all specified design and performance requirements" for these non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria are not provided, this table will summarize the types of tests performed and the general outcome as stated in the document.
| Test Category | Acceptance Criteria (Not explicitly stated as numerical values) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | (Assumed to be internal design specifications) | Met all specified design and performance requirements for: |
| - 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 | ||
| - Torque | ||
| Functional/Operational | (Assumed to be internal design specifications) | Met all specified design and performance requirements for: |
| - 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 | ||
| Biocompatibility | (Per ISO 10993 requirements) | Met requirements for cytotoxicity, sensitization, systemic toxicity, |
| pyrogenicity, and hemocompatibility. | ||
| Sterilization/Shelf Life | (Per internal protocols and regulatory standards) | Confirmed packaging integrity, sterility, and distribution cycle; |
| withstood extreme distribution/environmental conditions maintaining integrity and sterility. |
2. Sample size used for the test set and the data provenance:
The document refers to "comprehensive bench testing" and "previous animal studies." However, no specific sample sizes for these tests are provided. Data provenance is not explicitly stated beyond "performed by AngioDynamics and independent test houses" for sterilization/shelf life and biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document describes non-clinical engineering and biological tests, not a clinical study with expert-established ground truth. Human Factors/Usability Evaluation was performed, which would typically involve users, but the details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a diagnostic device requiring adjudication of interpretations.
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. This is not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical aspiration device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the "ground truth" would be established engineering specifications, material standards, and regulatory requirements (e.g., ISO, FDA guidance). For biocompatibility, it's ISO 10993 standards. For animal studies, the ground truth would be based on physiological observations and post-mortem analysis.
8. The sample size for the training set:
Not applicable. This refers to a medical device's non-clinical performance and substantial equivalence, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (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) 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) | Prescription Use (Rx - S1 QEP 001 Subject P) Over The Counter Use (S1 QEP 001 Subject OTC) | Prescription Use (Rx - S1 QEP 001 Subject P) | Over The Counter Use (S1 QEP 001 Subject OTC) |
|---|---|---|---|
| Prescription Use (Rx - S1 QEP 001 Subject P) | Over The Counter Use (S1 QEP 001 Subject OTC) |
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: 508.658.7813 | Tel: 508.658.7934 |
| Email: knewcomb@angiodynamics.com | Email: troberts@angiodynamics.com |
| DEVICE NAME |
| Trade Name: | AlphaVac Multipurpose Mechanical Aspiration (MMA) System |
|---|---|
| Common/Usual Name: | Aspiration Thrombectomy Catheter |
| Classification Name: | Aspiration Thrombectomy Catheter(21 CFR § 878.5150, Class II, Pro-Code QEZ) |
| Classification Panel: | Cardiovascular |
| PREDICATE DEVICE | |
| 510(k): | K173672 |
| Trade Name: | FlowTriever Retrieval/Aspiration System |
| Common/Usual Name: | Peripheral Mechanical Thrombectomy With Aspiration |
| Classification Name: | Peripheral Mechanical Thrombectomy with Aspiration(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(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.
§ 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).