The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

Device Description

The modified Ellipsys System remains a catheter-based system that is used to percutaneously create a vascular anastomosis of the proximal radial artery and adjacent vein using direct current (DC) thermal heating. The Ellipsys Power Controller (AMI-1001) is software driven and guides the user through the procedure using visual prompts via an LCD display. The Controller monitors the closure of the catheter tip, and supplies controlled DC energy to the catheter's heating element. The Ellipsys Catheter and Crossing Needle (AMI-6005) are a sterile single-use disposable devices that are responsible for approximating (bringing together) the arterial and venous vessel walls and applying thermal energy to create an anastomosis and join the two target vessels. The catheter is designed to be compatible with .014" guidewires and 6 French introducer sheaths commonly used with vascular interventional procedures. The system is designed to be used in a surgical or radiological suite or office based procedure room.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ellipsys Vascular Access System (K181725). This submission focuses on modifications to an already cleared predicate device (DEN170004). The document indicates that clinical performance testing was not performed in support of this specific submission. Instead, the substantial equivalence determination for this modified device largely relies on non-clinical performance data and the established performance of the predicate device.

Given that no clinical study was performed for this specific 510(k) submission (K181725), most of the requested information (acceptance criteria, device performance, sample size, ground truth, experts, adjudication method, MRMC study, standalone performance, training set) typically associated with a clinical trial to prove device effectiveness is not applicable or not provided in this document for the modified device.

However, the document does mention an animal study that was conducted. Therefore, I will extract information related to that, and acknowledge the absence of clinical data for this specific submission for the modified device.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since no clinical study was performed for this specific 510(k) submission, explicit quantitative acceptance criteria for clinical performance and reported device performance metrics in humans are not provided in this document. The document primarily focuses on demonstrating substantial equivalence to the predicate device based on non-clinical and animal testing.

Acceptance Criteria (Implied for Animal Study)	Reported Device Performance (Animal Study)
Device performs as intended under anticipated conditions of use	Successfully demonstrated delivery, deployment, and retrieval.
Compatibility with other labeled devices	Demonstrated compatibility.
Patency of the fistula (equivalent to predicate)	Patency demonstrated to be equivalent.
Characterization of blood flow at fistula creation (equivalent to predicate)	Blood flow demonstrated to be equivalent.
Gross pathology and histopathology assessing vascular injury and downstream embolization (equivalent to predicate)	Gross pathology and histopathology demonstrated to be equivalent.

2. Sample size used for the test set and the data provenance

Test set sample size: Not explicitly stated as a number in the animal study section. It mentions "An acute animal study was conducted in the sheep model."
Data provenance: Prospective animal study (sheep model). No country of origin is specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the document for the animal study.

4. Adjudication method for the test set

Not specified in the document for the animal study.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted based on this document. The device (Ellipsys Vascular Access System) is a medical device for creating arteriovenous fistulas, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a medical device for creating fistulas, not an algorithm/AI for diagnosis or interpretation. The "Power Controller" has software, but its performance is measured in terms of controlling the thermal energy for fistula creation, not in interpreting data for human users.

7. The type of ground truth used

For the animal study:

Pathology: Gross pathology and histopathology were used to assess vascular injury and downstream embolization.
Physiological measurements: Patency and characterization of blood flow were assessed.

8. The sample size for the training set

Not applicable/not provided for this submission, as no clinical or algorithmic training study for a diagnostic AI product is described. The device manufacturing and control software would have undergone internal development and testing, but this is distinct from training data for an AI model.

9. How the ground truth for the training set was established

Not applicable/not provided for this submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 5, 2018

Avenu Medical, Inc. Ms. Rebecca Pine Regulatory Consultant 27123 Calle Arrovo. Suite 2101 San Juan Capistrano, CA 92675

Re: K181725

Trade/Device Name: Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) Regulation Number: 21 CFR 870.1252 Regulation Name: Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access Regulatory Class: Class II Product Code: PQK Dated: September 4, 2018 Received: September 6, 2018

Dear Ms. Pine:

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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brian D. Pullin -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181725

Device Name

Ellipsys Vascular Access System (Ellipsys System) (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

Indications for Use (Describe)

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

SUBMITTER I.

Avenu Medical, Inc. 27123 Calle Arroyo, Suite 2101 San Juan Capistrano, CA 92675

Phone: 949-276-2483 FAX: 949-276-2493

Contact Person: Dave Campbell Date Prepared: August 28, 2018

II. DEVICE

Name of Device: Ellipsys Vascular Access System (Ellipsys® System), Model AMI-1001, Model AMI-6005 Common or Usual Name: Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access

Regulatory Class: II Product Code: POK Regulation Number: 21 CFR 870.1252

III. PREDICATE DEVICE

Name of Device: Ellipsys Vascular Access System (Ellipsys® System), Model AMI-1000. Model AMI-6050 De Novo Classification Number: DEN170004 Regulation Number: 21 CFR 870.1252

This predicate has not been subject to a recall.

IV. DEVICE DESCRIPTION

The device that is the subject of this 510(k) is a modified Ellipsys Vascular Access System. The Ellipsys System recently gained market clearance through the de novo classification pathway (DEN170004). The specific modifications subject to this submission consist of a redesigned Ellipsys Power Controller (AMI-1001) and several minor modifications to the Ellipsys catheter and crossing needle (AMI-6005). The catheter and crossing needle are supplied sterile (EtO).

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Controller monitors the closure of the catheter tip, and supplies controlled DC energy to the catheter's heating element. The Ellipsys Catheter and Crossing Needle (AMI-6005) are a sterile single-use disposable devices that are responsible for approximating (bringing together) the arterial and venous vessel walls and applying thermal energy to create an anastomosis and join the two target vessels. The catheter is designed to be compatible with .014" guidewires and 6 French introducer sheaths commonly used with vascular interventional procedures. The system is designed to be used in a surgical or radiological suite or office based procedure room.

V. INDICATIONS FOR USE

The Ellipsys® System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Ellipsys Vascular Access System described and cleared by FDA in de novo DEN170004. serves as the predicate for the modified device that is the subject of this 510(k). Endovascular creation of an AV fistula is the technological principle for both the modified Ellipsys System and the predicate device. Both systems utilize ultrasonically guided endovascular techniques and instrumentation for approximating (bringing together) the arterial and venous vessel walls and applying DC thermal energy to join the target vessels creating a side by side anastomosis and thereby creating an AV fistula for dialysis access.

The modified and predicate devices are based on the same technological elements as described below:

Power Controller, Model #AMI-1001

Software controlled device that guides the user through the procedure using visual ● prompts via a graphical user interface. monitors the closure of the catheter tip, and supplies controlled DC energy to the catheter's heating element.
Software provides closed loop control of the sealing algorithm and thermal profile. ●
Both devices utilize the same sealing algorithm and thermal profile. ●

Vascular Access Kit, Model # AMI-6005 (Catheter & Crossing Needle)

. The Crossing Needle is inserted into the vasculature over a guidewire through an introducer sheath to cross from the vein into the adjacent artery.
The Catheter is inserted over the guidewire through the introducer sheath so the distal . tip is inside the artery and the proximal portion of the tip remains in the vein. The catheter mechanically captures and approximates the vessel walls.
The Catheter seals the walls of the proximal radial arterv and the adjacent vein creating ● an arteriovenous fistula utilizing DC thermal energy delivered by the Power

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Controller.

The following provides a technological comparison between the modified and predicate devices:

The modified Power Controller (AMI-1001) is a redesign of the predicate using updated hardware and software to improve manufacturability and availability. Although the hardware and software design has changed, the same control algorithm and thermal profile were retained in the new design.

The modified Vascular Access Kit contains the Crossing Needle and Catheter. There are no changes to the crossing needle as it is identical to the predicate. There are no changes to the basic design, patient contact materials, or function of the modified Catheter aside from minor enhancements.

A comparison of the characteristics of the modified Ellipsys System versus the predicate is provided in TABLE 6.1 below. (Note: The differences between the Modified Ellipsys System and the predicate are highlighted in blue font)

Characteristic	Modified Device(AMI-1001/AMI-6005)	Predicate Device(AMI-1000/AMI-6050)	Comparison
Indication for Use	The Ellipsys System is indicatedfor the creation of a proximalradial artery to perforating veinanastomosis via a retrogradevenous access approach inpatients with a minimum vesseldiameter of 2.0mm and less than1.5mm of separation between theartery and vein at the fistulacreation site who have chronickidney disease requiring dialysis	The Ellipsys System is indicatedfor the creation of a proximalradial artery to perforating veinanastomosis via a retrogradevenous access approach inpatients with a minimum vesseldiameter of 2.0mm and less than1.5mm of separation between theartery and vein at the fistulacreation site who have chronickidney disease requiring dialysis	Identical
Power Controller
Enclosure	Molded Plastic	Sheet Metal	Similar
Energy Source & Type	DC thermal energy(Same)	DC thermal energy	Identical
User Interface	LCD Display / MultifunctionMembrane Switch	Tablet PC w/Touch Screen	Similar
Main Board and Processor	MCU Board (PCBA) w/ST Micro 32 bit processor	MCU Board (PCBA) w/ Freescale32 bit processor	Similar
System Software	System software (C++ code)(Same)	System software (C++ code)	Similar
GUI software	Linux OS	Windows OS	Similar
Temperature ControlAlgorithm	PID control(Same)	PID control	Identical

TABLE 6.1 - Device Comparison

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Temperature Profile	Maximum of 7 cycles (2 sec @700°F followed by 8 sec coolingphase)(Same)	Maximum of 7 cycles (2 sec @700°F followed by 8 sec coolingphase)	Identical
Catheter Compatibility	AMI-6005	AMI-6050	Similar
Crossing Needle
Material/Design	ABS/Stainless Steel(Same)	ABS/Stainless Steel	Identical
Design	No change	Existing	Identical
Function & Operation	Function: Approximates (bringstogether) the target arterial andvenous vessel walls and appliesthermal energy to create ananastomosis.(Same)Operation: Catheter Handle &Thumb Tab control insertion andActuation of the tip(Same)	Function: Approximates (bringstogether) the target arterial andvenous vessel walls and appliesthermal energy to create ananastomosis.Operation: Catheter Handle &Thumb Tab control insertion andActuation of the tip.(Same)	Identical
Materials - Patient Contact	ABS/Polyimide/Parylene/SS(Same)	ABS/Polyimide/Parylene/SS	Identical
Catheter Design	Minor enhancements	Existing	Similar

The minor technological differences between the modified Ellipsys System and the predicate device do not raise different questions of safety and effectiveness and the performance data described in Section VII establishes that the modified device is substantially equivalent to the predicate device.

VII. PERFORMANCE DATA

The following performance data were provided in support of the special controls requirements of 21 CFR 870.1252 and the substantial equivalence determination. All devices used for evaluation performance were representative of finished devices.

1) Clinical Performance Testing

Clinical data was not performed in support of the special controls requirement and substantial equivalence for the following reasons:

1. The modified Power Controller utilizes the same control algorithm, energy type and source, and heat profile as the predicate.
1. The design and function of the modified catheter remain essentially unchanged from the predicate.

2) Animal Testing

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An acute animal study was conducted in the sheep model to demonstrate that the modified device performs as intended under anticipated conditions of use. The following characteristics were addressed by the study:

i. Delivery, deployment, and retrieval of the device;
ii. Compatibility with other devices labeled for use with the device;
iii. Patency of the fistula;
iv. Characterization of blood flow at the time of the fistula creation procedure; and
Gross pathology and histopathology assessing vascular injury and downstream v. embolization.

Chronic follow-up was not performed as the study demonstrated the equivalence of fistulae created by the modified device in a side by side comparison with the predicate. Patency, blood flow, gross pathology and histopathology were demonstrated to be equivalent. Therefore, chronic performance is expected to be the same as the predicate.

This study demonstrated that the Ellipsvs Vascular Access System. Model AMI-1001. Model AMI-6005 can safely create a percutaneous AV fistula equivalent in performance to that which is created by the predicate device.

3) Non-Clinical Performance Testing

All necessary non-clinical performance testing was performed for the modified Ellipsys Vascular Access System to demonstrate that the modified device performs as intended under anticipated conditions of use. The following characteristics were addressed by the testing:

i. Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, activation, and retrieval of the device;
ii. Tensile strengths of joints and components;
iii. Accurate positioning and alignment of the device to achieve fistula creation; and
Characterization and verification of all dimensions. iv.

The non-clinical performance testing demonstrated that the physical characteristics of the modified device performed as expected meeting all required specificaitons.

4) Electromagnetic Compatibility (EMC) and Electrical Safety Testing

Electromagnetic Compatibility (EMC) and Electrical Safety testing were conducted on the modified Ellipsys Vascular Access System, AMI-1001 and AMI-6005. The system complies with the IEC 60601-1/A1:2012 standard for electrical safety and IEC 60601-1- 2:2007 standard for EMC.

5) Software Verification and Validation Testing

Software verification, validation and hazard analysis was completed to demonstrate the minor design enhancements and has no adverse effect on the established performance of the device.

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6) Biocompatibility of Patient-Contacting Components

No new patient-contacting components are incorporated into the device, therefore, the biocompatibility testing for the predicate has been adopted in support of the required biocompatibility special control.

7) Sterilization Performance

The construction, packaging and density of the modified product is identical to the predicate therefore the existing EO sterilization process was adopted in support of the special control for sterility.

8) Shelf Life Performance

The construction, packaging and density of the modified product is identical to the predicate therefore the existing package shelf life validation demonstrates continued sterility, package integrity, and device functionality over the identified shelf life.

9) Device Labeling

Labeling for the device includes the following characteristics as is supplied as part of this application.

i. Instructions for use;;
ii. Identification of system components and compatible devices :
iii. Expertise needed for the safe use of the device;
iv. A detailed summary of the clinical testing conducted and the patient population studied; and
A shelf life and storage conditions. V.

As a prescription device the modified Ellipsys System complies with 21 CFR 801.109

VIII. CONCLUSIONS

Based on a comparison of the intended use and an assessment of the different technological characteristics related to the modifications, it has been established that the modified Ellipsys System is substantially equivalent to the legally marketed predicate device. Minor differences in technological characteristics did not raise new or different questions of safety and effectiveness. Additionally, the data and information in the 510(k) demonstrate that the modified device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1252 Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.

(a)
Identification. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate:
(i) The ability to safely deliver, deploy, and remove the device;
(ii) The ability of the device to create an arteriovenous fistula;
(iii) The ability of the arteriovenous fistula to attain a blood flow rate and diameter suitable for hemodialysis;
(iv) The ability of the fistula to be used for vascular access for hemodialysis;
(v) The patency of the fistula; and
(vi) The rates and types of all adverse events.
(2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:
(i) Delivery, deployment, and retrieval of the device;
(ii) Compatibility with other devices labeled for use with the device;
(iii) Patency of the fistula;
(iv) Characterization of blood flow at the time of the fistula creation procedure and at chronic followup; and
(v) Gross pathology and histopathology assessing vascular injury and downstream embolization.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, activation, and retrieval of the device;
(ii) Tensile strengths of joints and components;
(iii) Accurate positioning and alignment of the device to achieve fistula creation; and
(iv) Characterization and verification of all dimensions.
(4) Electrical performance, electrical safety, and electromagnetic compatibility (EMC) testing must be performed for devices with electrical components.
(5) Software verification, validation, and hazard analysis must be performed for devices that use software.
(6) All patient-contacting components of the device must be demonstrated to be biocompatible.
(7) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(8) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(9) Labeling for the device must include:
(i) Instructions for use;
(ii) Identification of system components and compatible devices;
(iii) Expertise needed for the safe use of the device;
(iv) A detailed summary of the clinical testing conducted and the patient population studied; and
(v) A shelf life and storage conditions.