The AngioVac F18 85 is indicated as a venous drainage cannula for the non-surgical removal of thrombi or emboli during extracorporeal bypass for up to 6 hours.

Device Description

The AngioVacF1886 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 22 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 (tvpically 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 F188 out of the sheath deploying the self-expanding nitinol reinforced funnel shaped tip angle. Once optimal flow rate is achieved, the AngioVac F1885 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 venous return cannula. A benefit of the AngioVac F1805 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 Heart. The device is provided in an ~85° (AngioVac F1885) angled configuration.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study:

The provided FDA 510(k) summary (K212386 for AngioVac F18 85) does not describe a study involving an AI/Machine Learning device or a human-in-the-loop performance evaluation. Instead, it focuses on demonstrating substantial equivalence to a predicate device (AngioVac Cannula C20 and C180, K190594) through non-clinical bench testing and biocompatibility assessments.

Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment in that context is not applicable to this document.

However, I can extract information related to the device's performance based on the bench testing conducted.

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

The document describes various performance tests conducted to support the substantial equivalence of the AngioVac F18 85. For these types of medical devices, "acceptance criteria" are generally that the device performs as intended and meets established engineering specifications, often validated against the predicate device's performance or industry standards. The text states that the device "met all specified design and performance requirements."

Here's a table summarizing the areas of performance evaluated:

Acceptance Criteria Category (Evaluated)	Reported Device Performance
Mechanical/Physical Performance
Tensile Testing	Met requirement
Aspiration Strength	Met requirement
Cannula Actuation	Met requirement
Distal Cannula Shape Manipulation	Met requirement
Bend Angle	Met requirement
Hub Rotation	Met requirement
Distal Tip Functionality	Met requirement
Push and Pull Force	Met requirement
Kink Resistance	Met requirement
Leak Testing	Met requirement
Radiopacity	Met requirement
Flushability	Met requirement
Flow Rate	Met requirement
Product Interface (Compatibility) Testing	Met requirement
Dimensional Testing	Met requirement
Visual Inspection	Met requirement
Biocompatibility
Cytotoxicity	Acceptable results
Sensitization	Acceptable results
Irritation	Acceptable results
Systemic Toxicity	Acceptable results
Genotoxicity	Acceptable results
Hemocompatibility	Acceptable results
Sterilization/Shelf Life
Packaging Integrity	Robust, maintained integrity
Sterility	Ensured sterility
Distribution Cycle Suitability	Withstood extreme scenarios

Addressing Other Requested Information (and why some are not applicable):

Sample size used for the test set and the data provenance: Information is not provided in a way that relates to an "AI test set." The performance data refers to bench testing of the physical medical device. The exact number of samples for each specific bench test (e.g., how many cannulas were tested for tensile strength) is not stipulated, but the nature of bench testing implies multiple physical units were subjected to these tests. No separate "test set" in the context of data for an algorithm is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study where human experts established ground truth for an algorithm. Device performance was assessed against engineering specifications and industry standards during bench testing.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there is no "test set" in the context of an algorithm requiring expert adjudication.
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 document describes a physical medical device, not an AI-assisted diagnostic tool or system that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench testing, the "ground truth" would be engineering specifications, validated test methods, and industry standards (e.g., ISO 10993 for biocompatibility) that define acceptable performance. For the substantial equivalence, the predicate device served as the primary reference.
The sample size for the training set: Not applicable. There is no AI/ML training set described.
How the ground truth for the training set was established: Not applicable. There is no AI/ML training set described.

Summary

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September 30, 2021

AngioDynamics, Inc. Kasey Newcomb Specialist II. Global Regulatory Affairs 603 Oueensbury Ave Queensbury, New York 12804

Re: K212386

Trade/Device Name: AngioVac F18 85 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: July 30, 2021 Received: August 2, 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 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,

for Nicole Gillette Acting 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 Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K212386

Device Name AngioVac F18 85

Indications for Use (Describe)

The AngioVac F18 85 is indicated as a venous drainage cannula for the non-surgical removal of thrombi or emboli during extracorporeal bypass for up to 6 hours.

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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510(K) SUMMARY FOR THE ANGIOVAC F1885

A. SPONSOR

AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 USA

CONTACT B.

Kasey E Newcomb	Troy Roberts
Specialist II, Global Regulatory Affairs	Sr. Director, Global Regulatory Affairs
Tel: 508.658.7813	Tel: 508.658.7934
Email: knewcomb@angiodynamics.com	Email: troberts@angiodynamics.com

ﺯ DEVICE NAME

Trade Name:	AngioVac F1885
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):	K190594
Trade Name:	AngioVac Canula C20 and C180
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

F. INDICATION FOR USE

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The AngioVac F1885 is indicated as a venous drainage cannula for the non-surgical removal of thrombi or emboli during extracorporeal bypass for up to 6 hours.

G. STERILIZATION/SHELF LIFE

The AngioVac F1885 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 F1885 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 F1885 is a sterile single-use disposable instrument. AngioVac F1885 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 C20 and C180, cleared via K190594, 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 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
o 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 18F Cannula and 22F Sheath ●
. Addition of 85° angled configuration.
Addition of hemostatic valve on the proximal end of sheath o

The technological characteristics of the proposed Angio Vac Cannula is 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 F1885 met all specified design and performance requirements below:

Tensile Testing .
Aspiration Strength ●
Cannula Actuation ●
Distal Cannula Shape Manipulation
Bend Angle ●
Hub Rotation ●
. Distal Tip Functionality
Push and Pull Force .
Kink Resistance
Leak Testing
Radiopacity ●
Flushability ●
Flow Rate ●
Product Interface (Compatibility) Testing ●
Dimensional Testing ●
o Visual Inspection

Additionally, the AngioVac F1885 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).