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.

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.

AI/ML Overview

This document is a 510(k) summary for the AngioVac Cannula, a medical device. It does not describe a study that uses AI or machine learning models. Therefore, it is impossible to extract information about AI/ML specific acceptance criteria, test set, training set, or expert adjudication as requested in the prompt.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments.

However, I can provide the acceptance criteria and performance data that are present in the document for the AngioVac Cannula, even though they are not related to AI/ML performance.

Acceptance Criteria and Reported Device Performance (Non-AI/ML)

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Functional Performance	Tensile Testing	Met all specified design and performance requirements.
	Stiffness Testing	Met all specified design and performance requirements.
	Aspiration Strength	Met all specified design and performance requirements.
	Cannula Actuation	Met all specified design and performance requirements.
	Distal Cannula Shape Manipulation	Met all specified design and performance requirements.
	Bend Angle	Met all specified design and performance requirements.
	Hub Rotation	Met all specified design and performance requirements.
	Distal Tip Functionality	Met all specified design and performance requirements.
	Kink Resistance	Met all specified design and performance requirements.
	Sheath Flushability	Met all specified design and performance requirements.
	Flow Rate	Met all specified design and performance requirements.
	Product Interface (Compatibility) Testing	Met all specified design and performance requirements.
Physical/Dimensional	Radiopacity (presence of markers on distal tip)	Radiopaque markers on distal tip to assist tip visualization.
	Dimensional Testing	Met all specified design and performance requirements.
	Visual Inspection	Met all specified design and performance requirements.
Biocompatibility	Cytotoxicity (ISO 10993 Part 1)	Performed with acceptable results.
	Sensitization (ISO 10993 Part 1)	Performed with acceptable results.
	Systemic Toxicity (ISO 10993 Part 1)	Performed with acceptable results.
	Genotoxicity (ISO 10993 Part 1)	Performed with acceptable results.
	Hemocompatibility (ISO 10993 Part 1)	Performed with acceptable results.
	Irritation (ISO 10993 Part 1)	Performed with acceptable results.
Sterilization/Shelf Life	Packaging Integrity, Sterility, Distribution Cycle Tests	Confirmed suitability of sterile packaging to protect and maintain sterility within stated shelf life.

Information Not Applicable or Not Found (Due to Non-AI/ML Nature of the Device/Study):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this device does not involve an AI/ML model with a test set of data. The performance data refers to bench test results.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
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): The "ground truth" for the non-clinical tests would be the established engineering and ISO standards for device performance and biocompatibility.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of the Document's Conclusion:

The study submitted (non-clinical testing) demonstrates that the proposed AngioVac Cannula is substantially equivalent to the predicate device (AngioVac Cannula, cleared via K142593) based on functional performance, physical characteristics, biocompatibility, and sterilization/shelf life data. The differences in technological characteristics (addition of 180° angled configuration, different distal funnel tip design with embedded nitinol basket actuated by sheath) were addressed through comprehensive bench testing, which AngioDynamics states met all specified design and performance requirements.

Summary

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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

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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,

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

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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.

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FORM FDA 3881 (7/17)

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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

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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.

Regulation Number and Section

§ 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).