(120 days)
Not Found
No
The description focuses on the mechanical design and function of the cannula for thrombus removal and does not mention any AI/ML components or capabilities.
Yes
The device is used for the removal of thrombi or emboli, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is indicated for the removal of thrombi or emboli, which is a therapeutic function, not a diagnostic one. While it uses "image guidance," this is for operational positioning during a therapeutic procedure, not for diagnosing a condition.
No
The device description clearly details a physical, invasive medical device (a cannula with a nitinol basket) used in conjunction with an extracorporeal circuit and pump. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of thrombi or emboli during extracorporeal bypass. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a cannula designed to be inserted into the venous system to physically remove material. This is an invasive medical device used for treatment.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for these purposes.
The device is clearly intended for a therapeutic intervention within the patient's body, not for in vitro analysis of samples.
N/A
Intended Use / Indications for Use
The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
Product codes
DWF
Device Description
The AngioVac Cannula is a venovenous cannula with a nitinol basket reinforced, self-expandable funnel shaped distal tip collapsed using an over-sheath that can be advanced through a 26 Fr sheath and over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit, an AngioVac Circuit, a commercially available centrifugal pump and bubble trap. A commercially available reinfusion cannula is placed for venous return (typically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. The funnel tip is actuated by advancing the AngioVac Cannula out of the sheath deploying the self-expanding nitinol reinforced funnel shaped tip angle. Once optimal flow rate is achieved, the AngioVac Cannula is advanced under image guidance towards the undesirable intravascular (i.e. thrombus or emboli) until it is engaged, suctioned into the cannula and removed from the vasculature. The blood is then circulated though the filter and returned to the patient via the venous return cannula. A benefit of the AngioVac Cannula is that it allows for removal of thrombus and embolic material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. Target vessels for the thrombus/embolus extraction include but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA). The device is provided in ~20° (AngioVac C20) and ~180° (AngioVac C180) angled configurations.
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) and Right 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comprehensive bench testing (integrity and functional performance) was performed to support substantial equivalence of the specified predicate device. The AngioVac Cannula met all specified design and performance requirements below:
- Tensile Testing .
- Stiffness Testing ●
- Aspiration Strength ●
- Cannula Actuation
- Distal Cannula Shape Manipulation ●
- Bend Angle ●
- Hub Rotation ●
- Distal Tip Functionality
- Kink Resistance
- . Radiopacity
- Sheath Flushability
- Flow Rate ●
- Product Interface (Compatibility) Testing ●
- Dimensional Testing ●
- Visual Inspection ●
Additionally, the AngioVac Cannula has fulfilled the biocompatibility testing requirements identified in ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing in the risk management process for an externally communicating device with circulation blood of a limited duration. Specifically, the following test were performed with acceptable results, cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and hemocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(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: a symbol on the left and the text on the right. The symbol on the left is a stylized image of a bird or eagle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 5, 2019
AngioDynamics, Inc. Kasey Newcomb Regulatory Affairs Specialist II 26 Forest St. Marlborough, Massachusetts 01752
Re: K190594
Trade/Device Name: AngioVac Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: March 6, 2019 Received: March 7, 2019
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,
Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| Number (if known) |
510(k) Numb K190594
Device Name AngioVac Cannula
Indications for Use (Describe)
The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracopereal bypass for up to 6 hours.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (101)-445-6740 EF
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510(K) SUMMARY FOR THE ANGIOVAC CANNULA
A. SPONSOR
AngioDynamics, Inc. 26 Forest St. Marlborough, MA 01752 USA
B. CONTACT
Kasev E Newcomb Specialist II, Global Regulatory Affairs Tel: 508.658.7813 Email: knewcomb@angiodynamics.com
C. DEVICE NAME
| Trade Name: | AngioVac Cannula |
|---|---|
| Common/Usual Name: | Cardiopulmonary Bypass Venous Cannula Extraction Catheter |
| Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass |
| (21 CFR § 878.4210, Class II, Pro-Code DWF) | |
| Classification Panel: | Cardiovascular |
PREDICATE DEVICE D.
| 510(k): | K142593 |
|---|---|
| Trade Name: | AngioVac Canula |
| Common/Usual Name: | Cardiopulmonary Bypass Venous Cannula Extraction Catheter |
| Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass |
| (21 CFR § 878.4210, Class II, Pro-Code DWF) | |
| Classification Panel: | Cardiovascular |
E. DEVICE DESCRIPTION
The AngioVac Cannula is a venovenous cannula with a nitinol basket reinforced, self-expandable funnel shaped distal tip collapsed using an over-sheath that can be advanced through a 26 Fr sheath and over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit, an AngioVac Circuit, a commercially available centrifugal pump and bubble trap. A commercially available reinfusion cannula is placed for venous return (typically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. The funnel tip is actuated by advancing the AngioVac Cannula out of the sheath deploying the self-expanding nitinol reinforced funnel shaped tip angle. Once optimal flow rate is achieved, the AngioVac Cannula is advanced under image guidance towards the undesirable intravascular (i.e. thrombus or emboli) until it is engaged, suctioned into the cannula and removed from the vasculature. The blood is then circulated though the filter and returned to the patient via the venous return cannula. A benefit of the AngioVac Cannula is that it allows for removal of thrombus and embolic material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. Target vessels for the thrombus/embolus extraction include but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA). The device is provided in ~20° (AngioVac C20) and ~180° (AngioVac C180) angled configurations.
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F. INDICATION FOR USE
The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
STERILIZATION/SHELF LIFE G.
The AngioVac Cannula 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 AngioVac Cannula 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.
H. BIOCOMPATIBILITY
The AngioVac Cannula is a sterile single-use disposable instrument. AngioVac Cannula has fulfilled the biocompatibility testing requirements identified in ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing in the risk management process for an externally communicating device with circulation blood of a limited duration. Specifically, the following test were performed with acceptable results; cytotoxicity, sensitization, systemic toxicity, genotoxicity, and hemocompatibility.
G. TECHNOLOGY CHARACTERISTICS
Predicate device, AnigoVac Cannula, cleared via K142593, was used to support safety and effectiveness of the subject device. Both the subject device and specified reference device include the following technological characteristics:
- Designed for use as a venous drainage cannula and for removal of fresh, soft thrombi or ● emboli during extracorporeal bypass for 6 hours.
- . Wire reinforced to enhance trackability and vessel navigation and are designed with atraumatic tips to prevent vessel damage
- Funnel shaped distal tip that allows for engagement and entrapment of undesirable intravesical ● material such as soft emboli and thrombi.
- Radiopaque markers on distal tip to assist tip visualization.
- Used in connection with the AngioVac Circuit (an extracorporeal bypass circuit) with . centrifugal pump, bubble trap and reinfusion cannula.
Technological characteristics that are different between the subject and specified reference device are as follows:
- . Addition of 180° angled configuration.
- Distal funnel tip design comprised of an embedded, self-expanding, memory shaped nitinol . basket funnel shaped distal tip.
- . Distal funnel tip is actuated by the sheath so that when retracted the funnel tip naturally deploys due to the nitinol shape memory rather balloon actuated expandable funnel.
The technological characteristics of the proposed AngioVac Cannula are substantially equivalent with respect to the basic system design and function to that of the specified predicate device
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H. PERFORMANCE DATA
Comprehensive bench testing (integrity and functional performance) was performed to support substantial equivalence of the specified predicate device. The AngioVac Cannula met all specified design and performance requirements below:
- Tensile Testing .
- Stiffness Testing ●
- Aspiration Strength ●
- Cannula Actuation
- Distal Cannula Shape Manipulation ●
- Bend Angle ●
- Hub Rotation ●
- Distal Tip Functionality
- Kink Resistance
- . Radiopacity
- Sheath Flushability
- Flow Rate ●
- Product Interface (Compatibility) Testing ●
- Dimensional Testing ●
- Visual Inspection ●
Additionally, the AngioVac Cannula has fulfilled the biocompatibility testing requirements identified in ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing in the risk management process for an externally communicating device with circulation blood of a limited duration. Specifically, the following test were performed with acceptable results, cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and hemocompatibility.
I. 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.