(52 days)
No
The description focuses on the mechanical components and function of the device for aspiration, with no mention of AI or ML.
Yes
The device is specifically indicated for the non-surgical removal of thrombi or emboli and for the treatment of pulmonary embolism, which directly addresses a medical condition.
No.
The device is described as a system for the mechanical aspiration and removal of thrombus and emboli, not for diagnostic purposes.
No
The device description clearly outlines multiple hardware components (Cannula, Sheath, Obturator, Handle, Waste Bag and Tubing) that are integral to the device's function. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a catheter-based system designed for the physical removal of thrombi or emboli from the vasculature. It is a therapeutic device used within the body.
- Intended Use: The intended use clearly states the removal of material from the vasculature and aspiration of fluids from the vasculature. It does not involve the analysis of specimens outside the body for diagnostic purposes.
- Device Description: The description details a mechanical system for aspiration within blood vessels.
- Performance Studies: The performance study focuses on the clinical outcome of reducing the RV/LV ratio in patients with pulmonary embolism, which is a measure of the device's therapeutic effectiveness, not its diagnostic capability.
The device is a therapeutic medical device used for interventional procedures within the circulatory system.
N/A
Intended Use / Indications for Use
The Cannula is indicated for:
· the non-surgical removal of thrombi or emboli from the vasculature
· aspiration of contrast media and other fluids from the vasculature
The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.
The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration 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), Right Heart (Atrium (RA)), and Pulmonary Artery Vasculature. 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
iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), Right Heart (Atrium (RA)), and Pulmonary Artery Vasculature
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
AngioDynamics conducted the APEX-AV trial, a multicenter pivotal study to assess the use of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in subjects with acute intermediate-risk pulmonary embolism (PE). The trial enrolled 122 subjects at 25 clinical sites in the US with confirmed PE symptoms for ≤ 14 days and a right ventricle to left ventricle ratio (RV/LV ratio) of ≥ 0.9 on Computed Tomography (CTA). The primary safety endpoint was the rate of major adverse events (MAEs) within 48 hours after the index procedure. MAEs were defined to include device-related death, major bleeding, and device-related serious adverse events (SAEs) of clinical deterioration, pulmonary vascular injury, and cardiac injury. The primary effectiveness endpoint was the reduction in RV/LV ratio from baseline to 48 hours. Both the primary safety and effectiveness endpoints were met. Refer to the Instructions for Use for detailed clinical study information.
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 1, 2024
AngioDynamics, Inc. Kasey Newcomb Manager, Regulatory Affairs 603 Queensbury Ave Queensbury, New York 12804
Re: K240397
Trade/Device Name: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: February 8, 2024 Received: February 9, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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, Digitally signed by Ariel Ariel G. Ash-G. Ash-shakoor -S Date: 2024.04.01 shakoor -S 09:38:02 -04'00' For Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality
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Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
AlphaVac Multipurpose Mechanical Aspiration System (MMA) F1885 System
Indications for Use (Describe)
The Cannula is indicated for:
· the non-surgical removal of thrombi or emboli from the vasculature
· aspiration of contrast media and other fluids from the vasculature
The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.
The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) SUMMARY FOR THE
ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION (MMA) F1885 SYSTEM
A. SPONSOR AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 USA B. CONTACT Kasey E Newcomb Troy Roberts Manager, 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: Embolectomy Catheter (21 CFR § 878.5150, Class II, Pro-Code QEZ) Classification Panel: Cardiovascular D. PREDICATE DEVICE 510(k): K180466 Trade Name: FlowTriever Retrieval/Aspiration System Common/Usual Name: Embolectomy catheter Classification Name: Embolectomy catheter (21 CFR § 878.5150, Class II, Pro-Code QEW) Classification Panel: Cardiovascular E. REFERENCE DEVICE 510(k): K213388 Trade Name: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System Common/Usual Name: Aspiration Thrombectomy Catheter Classification Name: Embolectomy Catheter (21 CFR § 878.5150, Class II, Pro-Code QEZ) Classification Panel: Cardiovascular
5
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), Right Heart (Atrium (RA)), and Pulmonary Artery Vasculature. 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 the vasculature .
- . aspiration of contrast media and other fluids from the vasculature
The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.
The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration 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 F1885 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, the FlowTriever Retrieval/Aspiration System, cleared via K180466, was used to support 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 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.
The technological characteristics of the proposed AlphaVac MMA F1886 System are substantially equivalent with respect to the basic system design and function to that of the specified predicate device.
Additionally, a reference predicate (K213388 - AlphaVac F1885) has been identified to provide additional support as it is identical in materials, dimensions, manufacture, as the proposed 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 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. CLINICAL TESTING
AngioDynamics conducted the APEX-AV trial, a multicenter pivotal study to assess the use of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in subjects with acute intermediate-risk pulmonary embolism (PE). The trial enrolled 122 subjects at 25 clinical sites in the US with confirmed PE symptoms for ≤ 14 days and a right ventricle to left ventricle ratio (RV/LV ratio) of ≥ 0.9 on Computed Tomography (CTA). The primary safety endpoint was the rate of major adverse events (MAEs) within 48 hours after the index procedure. MAEs were defined to include device-related death, major bleeding, and device-related serious adverse events (SAEs) of clinical deterioration, pulmonary vascular injury, and cardiac injury. The primary effectiveness endpoint was the reduction in RV/LV ratio from baseline to 48 hours. Both the primary safety and effectiveness endpoints were met. Refer to the Instructions for Use for detailed clinical study information.
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.