(172 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the FDA for the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System. It describes the device, its indications for use, and the studies performed to demonstrate its substantial equivalence to a predicate device.
There is no information in this document related to any AI/ML model, ground truth, expert readers, or retrospective/prospective studies on patient data. This document focuses on the mechanical and functional performance of a medical device (aspiration catheter) and its substantial equivalence to a predicate device.
Therefore, I cannot provide a response that includes information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device. The request specifically asks for details pertinent to AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.), which are not present in this document.
The document outlines the following performance data to support substantial equivalence for the device itself (not an AI/ML component):
Acceptance Criteria and Device Performance (Mechanical/Functional Device)
The document states that "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."
The acceptance criteria are implied to be the successful demonstration that the device performs according to its design and functional requirements. The reported device performance is that it "met all specified design and performance requirements."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Testing | Met requirements |
| Visual Inspection | Met requirements |
| Tensile Testing | Met requirements |
| Column Strength | Met requirements |
| Cannula and Funnel Actuation | Met requirements |
| Distal Cannula Shape Manipulation | Met requirements |
| Hub Rotation | Met requirements |
| Distal Tip Functionality | Met requirements |
| Kink Resistance | Met requirements |
| Radiopacity | Met requirements |
| Flushability | Met requirements |
| Product Interface (Compatibility) Testing | Met requirements |
| Push/Pull/Retraction Force | Met requirements |
| Leak Testing | Met requirements |
| Siphoning Testing | Met requirements |
| Fluid Volume Removal | Met requirements |
| Handle Lock Testing | Met requirements |
| Pressure Testing | Met requirements |
| Handle Pull Force | Met requirements |
| Human Factors Evaluation/Usability Evaluation | Met requirements |
| Simulated Use | Met requirements |
| Torque | Met requirements |
| Sterilization/Shelf Life | Confirmed suitability, integrity, and sterility |
| Biocompatibility | Met requirements (ISO 10993; cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility with acceptable results) |
Non-Applicable AI-Specific Information from the Document:
The following points are not addressed or are not applicable based only on the provided text, as the document describes a mechanical medical device, not an AI/ML system:
- Sample size used for the test set and data provenance: No information on patient data test sets as it's a mechanical device.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a mechanical device.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes the regulatory clearance for a physical medical device (aspiration catheter) based on a demonstration of substantial equivalence through bench testing, biocompatibility, and sterilization validation, not an AI/ML product.
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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
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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 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) 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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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
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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.
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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.
§ 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).