(105 days)
No
The summary describes a modification to an existing device (Ellipsys System) that involves an additional procedural step (balloon dilation) and updates to the Instructions for Use. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is indicated for creating a vascular anastomosis in patients with chronic kidney disease requiring dialysis, which is a therapeutic intervention.
No
Explanation: The device description and intended use clearly state that the Ellipsys® System is used to create a vascular anastomosis (a surgical connection between blood vessels) for patients with chronic kidney disease requiring dialysis. This is a therapeutic procedure, not a diagnostic one.
No
The device description explicitly states it is a "catheter-based system" and mentions specific hardware components like the "Ellipsys Power Controller," "Ellipsys Needle," and "Ellipsys Catheter." The modification is to the Instructions for Use, not a change to the fundamental hardware nature of the device.
Based on the provided information, the Ellipsys® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Ellipsys System Function: The Ellipsys System is a catheter-based system used to create a vascular anastomosis (a connection between blood vessels) directly within the patient's body. It uses thermal heating to achieve this.
- Intended Use: The intended use clearly states it's for creating a fistula in patients for dialysis, not for analyzing samples from patients.
- Device Description: The description focuses on the physical components and how they are used to perform a surgical procedure, not on analyzing biological samples.
Therefore, the Ellipsys System is a surgical/interventional device, not an IVD.
N/A
Intended Use / 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.
Product codes
POK
Device Description
The device that is the subject of this 510(k) is a modified Ellipsys Vascular Access System. The Ellipsys System gained market clearance through the 510(k) Premarket Notification pathway (K183615). The specific modification subject to this submission consists of an update to the Instructions for Use to allow an additional procedural step for balloon dilation of the anastomosis junction at the radial artery and adjacent outflow vein of the AVF immediately after creation with the Ellipsys Catheter.
The Ellipsys System remains a catheter-based system that is used to percutaneously create a vascular anastomosis of the proximal radial artery and adjacent perforating vein using direct current (DC) thermal heating. No changes have been made to the intended use, technological characteristics, design, function, or manufacturing processes of the Ellipsys Power Controller (AMI-1001), Ellipsys Needle (AMI-3000) or the Ellipsys Catheter (AMI-6005).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonically guided endovascular techniques
Anatomical Site
proximal radial artery to perforating vein anastomosis
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)
Clinical Performance Testing:
The studies were prospective, IRB approved registry studies.
Sample Size: US study: 55 subjects, OUS study: 200 subjects.
Data Source: Two different physician sources in the United States (US) and outside the United States (OUS).
Key Results:
- In the US study, a total of 11 adverse events (AEs) were reported among the 55 subjects (11/55 = 20%) throughout 90 days. The complications included 9 access thrombosis-stenosis events and 2 mild hematomas at the access site.
- In the OUS study, a total of 16 AEs were reported among the 200 subjects (16/200 = 8%). The AEs included 9 deaths (9/200 = 4.5%), 6 access thromboses, and 1 pseudoaneurysm.
- The rates of AEs appeared to be numerically similar to the rates of AEs observed in the IDE study that supported the De Novo application for this device (DEN170004).
- The death rate of 4.5% appeared to be substantially equivalent to the 12-month death rate from the De Novo study (7.8%).
- The reported rate of acute occlusions of the AVF was 1/255 (0.4%), which appeared to be numerically lower than the rate of acute occlusions of the AVF in the De Novo IDE study, where 15/103 subjects (14.6%) experienced an occlusion of the AVF within 24 hours of the study procedure.
- There were no new adverse event types experienced as a result of implementation of the balloon dilation procedure in either study.
- The number of secondary procedures required to achieve maturation and/or maintenance of the Ellipsys AVF appeared to be numerically lower than in the De Novo IDE study.
- The reported follow-up data appeared to show that AVF patency and the rates of anastomotic complications were substantially equivalent to the predicate, although the data were not adjudicated or reviewed by independent third parties.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
August 9, 2019
Avenu Medical, Inc. Dave Campbell VP of Quality Assurance and Regulatory Affairs 27123 Calle Arroyo. Suite 2101 San Juan Capistrano, CA 92675
Re: K191114
Trade/Device Name: Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001, Catheter Model No. AMI-6005, and Crossing Needle Model No. AMI-3000) 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: POK Dated: July 10, 2019 Received: July 12, 2019
Dear Mr. Campbell:
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
1
542 of the Act); 21 CFR 1000-1050.
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 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-
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,
Brian Pullin Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Prostheses OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191114
Device Name
Ellipsys® Vascular Access System (Ellipsys® System) (Power Controller, Model No. AMI-1001; Catheter, Model No. AMI-6005 & Needle, Model No. AMI-3000)
Indications for Use (Describe)
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.
| 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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3
510(k) Summarv
I. SUBMITTER
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: April 25, 2019
II. DEVICE
Name of Device: Ellipsys Vascular Access System (Ellipsys® System), Model AMI-1001, Model AMI-6005 and AMI-3000
Common or Usual Name: Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access
Regulatory Class: II
Product Code: PQK
Regulation Number: 21 CFR 870.1252
III. PREDICATE DEVICE
Ellipsys Vascular Access System (Ellipsys® System), Model AMI-1001, Model AMI-6005 and AMI-3000
510(k) Premarket Notification: K183615 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 gained market clearance through the 510(k) Premarket Notification pathway (K183615). The specific modification subject to this submission consists of an update to the Instructions for Use to allow an additional procedural step for balloon dilation of the anastomosis junction at the radial artery and adjacent outflow vein of the AVF immediately after creation with the Ellipsys Catheter.
The Ellipsys System remains a catheter-based system that is used to percutaneously create a vascular anastomosis of the proximal radial artery and adjacent perforating vein using direct current (DC) thermal heating. No changes have been made to the intended use, technological
4
characteristics, design, function, or manufacturing processes of the Ellipsys Power Controller (AMI-1001), Ellipsys Needle (AMI-3000) or the Ellipsys Catheter (AMI-6005).
INDICATIONS FOR USE V.
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. No changes have been made to the indications for use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Ellipsys Vascular Access System described and cleared by FDA in 510(k) K183615, serves as the predicate for the modified device that is the subject of this 510(k). Both the modified device and the predicate device are identical in design and intended use. The technological principle for both the modified Ellipsys System and the predicate device is endovascular creation of an AV fistula. 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 only change in the modified device is an added procedural step of balloon dilation immediately post-AVF creation, though all other characteristics remain unchanged. The purpose of the balloon dilation step is to mitigate the acute vessel spasm and partial occlusion commonly seen at the anastomosis and outflow vein associated with any AVF creation (e.g. surgical or Ellipsys). As the dilation is performed immediately post-AVF creation, the same initial access puncture, guidewire and sheath can be utilized, saving additional potential risks related to placement of these devices during the index procedure.
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.
Ellipsys Needle, Model #AMI-3000
- The Needle is inserted into the vasculature over a guidewire through an introducer sheath to cross from the vein into the adjacent artery.
Ellipsys Catheter, Model #AMI-6005
- 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
5
catheter mechanically captures and approximates the vessel walls.
- The Catheter seals the walls of the proximal radial artery and the adjacent vein creating . an arteriovenous fistula utilizing DC thermal energy delivered by the Power Controller.
The following provides a technological comparison between the modified and predicate devices:
The Ellipsys Power Controller (AMI-1001) remains unchanged from the predicate. No changes have been made to the hardware design, software design, power source, control algorithm, thermal profile or manufacturing processes.
The Ellipsys the Needle (AMI-3000) is identical to the predicate. There are no changes to the design, patient contact materials, manufacturing processes, packaging materials or function of the modified device.
The Ellipsys Catheter (AMI-6005) is identical to the predicate. There are no changes to the design, patient contact materials, manufacturing processes, packaging materials or function of the modified device.
The Instructions for Use (IFUs) for the catheter will change to reflect the added procedural step.
A comparison of the technological characteristics of the modified Ellipsys System versus the predicate is provided in TABLE 6.1 below.
| Characteristic | Modified Device
(AMI-1001/AMI-6005/AMI-3000) | Modified Device
(AMI-1001/AMI-6005/AMI-3000) | Comparison |
|----------------------------------|-------------------------------------------------|---------------------------------------------------------------------------|------------|
| Indication for Use | No change | No change | Identical |
| Instructions for Use (IFU) | No change | Clarify use of post-AVF balloon
dilation | Similar |
| Power Controller (AMI-1001) | | | |
| Design:
Hardware/Electronics | No change | Existing | Identical |
| Energy Source & Type | No change | Mechanical
DC thermal energy | Identical |
| System Software | No change | System software (C++ code) | Identical |
| Temperature Control
Algorithm | No change | PID control | Identical |
| Temperature Profile | No change | Maximum of 7 cycles (2 sec @
700°F followed by 8 sec cooling
phase) | Identical |
| Catheter Compatibility | No change | AMI-6005 | Identical |
| Needle (AMI-3000) | | | |
TABLE 6.1 - Device Comparison
6
| Design | |||
|---|---|---|---|
| Materials - Patient | No change | ABS/Stainless Steel (SS) | Identical |
| Packaging Configuration | No change | Needle individually packaged in a separate Tyvek pouch w/ backer card | Identical |
| Catheter (AMI-6005) | |||
| Function & Operation | No change | Function: Approximates (brings together) the target arterial and venous vessel walls and applies thermal energy to create an anastomosis. | |
| Operation: Catheter Handle & Thumb Tab control insertion and Actuation of the tip. | Identical | ||
| Materials - Patient Contact | No change | ABS/Polyimide/Parylene/Stainless Steel (SS) | Identical |
| Catheter Design | No change | Existing | Identical |
| Packaging Configuration | No change | Catheter individually packaged in a separate Tyvek Pouch w/ backer card | Identical |
There are no technological differences between the modified Ellipsys System and the predicate device and as a result no new or different questions of safety and effectiveness are raised. Performance data described in Section VII in support of the modification to the instructions for use establishes that the device is substantially equivalent to the predicate device.
VII. PERFORMANCE DATA
The following performance data are provided in support of the special controls requirements of 21 CFR 870.1252 and the substantial equivalence determination. All devices used for evaluation of performance were representative of finished devices.
1) Clinical Performance Testing
Clinical data is provided in support of the special controls requirement and substantial equivalence for the modification of the Instructions for Use of the Ellipsys System. The data provided is a post-market summary of data from two different physician sources in the United States (US) and outside the United States (OUS) to support continued safety, efficacy and substantial equivalence. This data and has been summarized, and is being submitted in support of this added procedural step of balloon dilatation after AVF creation. The additional procedural step as described in the modified Instructions for Use results in the creation of the AVF in the same anatomic location in the proximal radial artery.
2) Summary of Clinical Performance Testing
Clinical Data Design
Both the US and OUS studies were prospective, IRB approved registry studies. End stage renal disease (ESRD) patients were screened for eligibility for a proximal radial artery to
7
perforating vein arteriovenous fistula (AVF) per Ellipsys commercial Instructions For Use (IFUs). All patients who were determined to be eligible and provided informed consent (IC) had their procedures scheduled. All patients had their AVF created per Ellipsys commercial IFUs. All patients had immediate post-AVF creation balloon dilation per proposed IFUs. All patients were brought back for follow-up monitoring visits per clinical standard of care. In the US study, patients were followed at 1 week, 4 weeks, and 3 months. In the OUS study, patients completed follow-up visits between days 30-60 and after at least 90 days. Data were summarized and reported for various parameters including: technical success, clinical success, maturation procedures, maintenance procedures, procedural success for secondary procedures, suitability for dialysis, procedural clinical complications, and AVF patency as determined by ultrasound and/or physical examination. Data were collected on case report forms and were reported by the study investigators.
Clinical Results
In the US study, a total of 11 adverse events (AEs) were reported among the 55 subjects (11/55 = 20%) throughout 90 days. The complications included 9 access thrombosisstenosis events and 2 mild hematomas at the access site.
In the OUS study, a total of 16 AEs were reported among the 200 subjects (16/200 = 8%). The AEs included 9 deaths (9/200 = 4.5%), 6 access thromboses, and 1 pseudoaneurysm.
The rates of AEs appeared to be numerically similar to the rates of AEs observed in the IDE study that supported the De Novo application for this device (DEN170004). Given that the mean duration of patient follow-up in the OUS study was 352 days (almost 12 months), the death rate of 4.5% appears to be substantially equivalent to the 12-month death rate from the De Novo study (7.8%). The reported rate of acute occlusions of the AVF was 1/255 (0.4%), which appeared to be numerically lower than the rate of acute occlusions of the AVF in the De Novo IDE study, where 15/103 subjects (14.6%) experienced an occlusion of the AVF within 24 hours of the study procedure. There were no new adverse event types experienced as a result of implementation of the balloon dilation procedure in either study.
The number of secondary procedures required to achieve maturation and/or maintenance of the Ellipsys AVF appeared to be numerically lower than in the De Novo IDE study. The reported follow-up data appeared to show that AVF patency and the rates of anastomotic complications were substantially equivalent to the predicate, although the data were not adjudicated or reviewed by independent third parties. Long-term data regarding AVF complications, adverse events, AVF patency, and AVF functionality will be collected in a post market evaluation.
VIII. CONCLUSIONS
Based on a comparison of the additional data related to the modification to the Instructions for Use, it has been established that the modified Ellipsys System is substantially equivalent to the legally marketed predicate device. The modification of the Instructions for Use that provides for an additional procedural step of balloon dilatation immediately following AVF
8
creation with the Ellipsys Catheter 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.