(147 days)
Not Found
No
The description focuses on the mechanical and microprocessor-controlled aspects of the device for ultrafiltration, with no mention of AI or ML capabilities for data analysis, decision support, or automated control beyond basic system parameters.
Yes: The device is a therapeutic device because its intended use is to provide continuous ultrafiltration therapy for fluid overload, which is a medical treatment administered by healthcare providers.
No
The Aquadex FlexFlow System is indicated for continuous ultrafiltration therapy to treat fluid overload unresponsive to medical management. This describes a therapeutic function, rather than a diagnostic one. While it monitors some parameters (like hematocrit with an optional component), its primary purpose is treatment by removing fluid.
No
The device description clearly outlines multiple hardware components including a console, blood circuit set, and venous access catheter, in addition to the software controlling the system.
Based on the provided information, the Aquadex FlexFlow® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes a therapy for fluid overload by removing excess fluid from the patient's blood. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device components and their functions (blood pump, hemofilter, ultrafiltrate pump) are all involved in processing blood outside the body for therapeutic purposes, not for analyzing samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The device's purpose is to treat a condition, not to diagnose or monitor it through laboratory analysis.
Therefore, the Aquadex FlexFlow® System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Aquadex FlexFlow® System is indicated for:
Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatic patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics.
All treatments must be administered by a healthcare provider, within an outpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The Aquadex FlexFlow system comprises the following components:
- . Aquadex FlexFlow console, microprocessor-controlled
- . Blood Circuit Set with integral hemofilter, disposable
- . Venous access catheter
The Aquadex FlexFlow console includes a blood pump, ultrafiltrate pump, control panel, weight scale, air detector, blood leak detector, electrical connectors for the circuit pressure sensors, and mechanical interfaces that hold the circuit in place. The console controls the rate at which the blood pump removes blood from the patient, and the clinician sets the maximum rate at which the ultrafiltrate pump extracts ultrafiltrate from the blood. Patient access is obtained either peripherally or through the central venous veins. Blood is withdrawn from a vein and passes through a withdrawal pressure sensor before entering the blood pump tubing loop. The rotating rollers propel the blood through the the air detector, then into the hemofilter before being returned to the patient. The console screen displays information to help the clinician prime, set up, and operate the system. All system alarm limits are set by the console.
The Aquadex FlexFlow blood circuit is a preassembled, sterile (EtO), single-patient use set. There are two models of the blood circuit: A06162 and A06163. The blood circuit set A06162 consists of a filter, tubing, pressure sensors, connectors, pinch clamps, a priming spike, an ultrafiltrate connecting bag and data key. The blood circuit set A06163 has the same components, except that it also has an inline blood chamber for use in monitoring the patient's hematocrit (Hct) during therapy.
CHF Solutions Inc. offers a dual lumen extended length catheter (dELC) for use with the Aquadex FlexFlow System. The catheter is a peripheral venous access device with stainless steel coil reinforcement. The venous access catheter was not reviewed in K192756 as it was already cleared for safe and effective use under K041791 with no changes since the original clearance affecting its safety and effectiveness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients weighing 20 kilograms or more
Intended User / Care Setting
All treatments must be administered by a healthcare provider, within an outpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies. (This is from the official Indications for Use statement on page 2. On page 4, the setting is broadened to "inpatient or outpatient clinical setting")
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)
Bench performance testing was performed on all three systems, Aquadex 1.0 (the primary predicate device), Aquadex 2.0 (the subject device), and Prismaflex® (the secondary predicate device) at the same therapy settings in order to derive a direct comparison of the fluid removal accuracies. Based on the accuracy calculations, the Aquadex FlexFlow System (1.0 and 2.0) met the design specifications and remained accurate within ±10% when comparing the displayed and actual ultrafiltration amount. The accuracy of the Aquadex FlexFlow System is comparable to the PrismaFlex System across all test scenarios.
In support of the clarified indication for use, CHF Solutions requested clinical data from a three-center retrospective study involving the use of Aquadex FlexFlow for pediatric patients and performed by investigators independent of the manufacturer. A total of 93 Aquadex blood circuits were used on 26 pediatric patients (21 years or younger) weighing 20 kilograms or more from 28 hospitalizations. More than half (57%) of the patients were female, and most patients were treated in the intensive care units, PICU (46%) and CICU (36%). The primary underlying disease for patients was cardiac disease at 39% or kidney disease at 29%.
None of the patients died during therapy with Aquadex (100% treatment course survival rate), and eight patients died after therapy but prior to hospital discharge (71% hospital survival rate). None of the deaths were related to the ultrafiltration device or procedure. No complications associated with treatment initiation were reported. Complications during therapy were infrequent, occurring in 11 cases (12% of circuits). Clot in the filter and hypotension during the treatment were the most common complications. In addition, no patient experienced a serious adverse event or device-related adverse event.
The Aquadex FlexFlow system was evaluated according to CHF procedures and performance testing protocols. The Aquadex FlexFlow system met all acceptance criteria. The performance testing demonstrates the Aquadex FlexFlow functions as intended. Below are high level summaries of testing used to demonstrate substantial equivalence along with FDA guidance documents and FDA recognized consensus standards.
- . Biocompatibility testing to the most recent ISO 10993 requirements
- . Electrical safety testing according to the most recent IEC 60601 standard
- Electromagnetic compatibility testing according to the most recent IEC 60601-1-2 standard
- . Performance testing to IEC 60601-2-16 that confirms the device meets requirements for Essential Performance
- Software verification and validation testing in accordance with FDA's guidance ● "Guidance for the Content of Premarket Submission for Software Contained in Medical Device's"
- Performance testing to ISO 8637-1 ●
- Human factors testing in accordance with IEC 62366-1, 62366-2 and FDA's ● Guidance "Applying Human Factors and Usability Engineering to Optimize Medical Device Design."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 24, 2020
CHF Solutions, Inc. Dawn Li Principal Regulatory Affairs Specialist 12988 Valley View Road Eden Prairie, MN 55344
K192756 Re:
Trade/Device Name: Aquadex FlexFlow System 2.0 Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: January 22, 2020 Received: January 23, 2020
Dear Dawn Li:
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,
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192756
Device Name Aquadex FlexFlow® System 2.0
Indications for Use (Describe) The Aquadex FlexFlow® System is indicated for:
Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatic patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics.
All treatments must be administered by a healthcare provider, within an outpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Revised December 22, 2019
1. Submitter information/ 510(k) Holder
| Submitter: | CHF Solutions, Inc. |
|---|---|
| Establishment Registration: | 3007137787 |
| Address: | 12988 Valley View Rd |
| Eden Prairie, MN 55344, U.S.A. | |
| Contact Information: | Dawn Li |
| Principal Regulatory Affairs Specialist | |
| (952) 715-6278 | |
| Dawn.li@chf-solutions.com |
2. Device Information
| Trade Name: | Aquadex FlexFlow® System 2.0 |
|---|---|
| Common Name: | Fluid Removal System |
| Classification Name: | High Permeability Hemodialysis System |
| Product Code: | KDI |
| Regulation Number: | Class II, 21 CFR 876.5860 |
3. Predicate Device Information
| Primary Predicate Device: | Aquadex FlexFlow System (K071854) |
|---|---|
| Secondary Predicate Device: | Prismaflex System (K171671) |
4. Device Description
The Aquadex FlexFlow system comprises the following components:
- . Aquadex FlexFlow console, microprocessor-controlled
- . Blood Circuit Set with integral hemofilter, disposable
- . Venous access catheter
The Aquadex FlexFlow console includes a blood pump, ultrafiltrate pump, control panel, weight scale, air detector, blood leak detector, electrical connectors for the circuit pressure sensors, and mechanical interfaces that hold the circuit in place. The console controls the rate at which the blood pump removes blood from the patient, and the clinician sets the
4
maximum rate at which the ultrafiltrate pump extracts ultrafiltrate from the blood. Patient access is obtained either peripherally or through the central venous veins. Blood is withdrawn from a vein and passes through a withdrawal pressure sensor before entering the blood pump tubing loop. The rotating rollers propel the blood through the the air detector, then into the hemofilter before being returned to the patient. The console screen displays information to help the clinician prime, set up, and operate the system. All system alarm limits are set by the console.
The Aquadex FlexFlow blood circuit is a preassembled, sterile (EtO), single-patient use set. There are two models of the blood circuit: A06162 and A06163. The blood circuit set A06162 consists of a filter, tubing, pressure sensors, connectors, pinch clamps, a priming spike, an ultrafiltrate connecting bag and data key. The blood circuit set A06163 has the same components, except that it also has an inline blood chamber for use in monitoring the patient's hematocrit (Hct) during therapy.
CHF Solutions Inc. offers a dual lumen extended length catheter (dELC) for use with the Aquadex FlexFlow System. The catheter is a peripheral venous access device with stainless steel coil reinforcement. The venous access catheter was not reviewed in K192756 as it was already cleared for safe and effective use under K041791 with no changes since the original clearance affecting its safety and effectiveness.
5. Indications for Use
The Aquadex FlexFlow® System is indicated for:
Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics.
All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.
6. Comparison of Technological Characteristics
There are no technological differences between the subject device and the primary predicate device (K071854). Both the subject and primary predicate devices remove excess fluid from the patient by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician-selected ultrafiltration rate. They have identical control mechanisms, operating principles, energy type, sterilization, packaging and all other design features.
5
The Prismaflex is a software-controlled device that performs Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload and Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. The technological characteristics of the Aquadex FlexFlow system are equivalent to the subset of the Prismaflex system (K171671) technology with the exception of the lower ultrafiltration rate, smaller extracorporeal volume, and lower extracorporeal blood flow rate. The technological differences between Aquadex and Prismaflex do not raise different questions of safety or effectiveness with regard to ultrafiltration in patients weighing 20 kilograms or more.
| Regulatory and Use Information | ||||
|---|---|---|---|---|
| Aquadex System with | ||||
| Modified Intended Use | ||||
| (subject device) | Aquadex System with | |||
| Original Intended Use | ||||
| (primary predicate) | Prismaflex System | |||
| (secondary predicate) | Comparison | |||
| Manufacturer | CHF Solutions, Inc. | CHF Solutions, Inc. | Baxter Healthcare Corp. | Same as primary predicate. |
| 510(k) Number | TBD | K071854 | K171671 | -- |
| Regulatory | ||||
| Classification | Dialyzer, High | |||
| Permeability With Or | ||||
| Without Sealed | ||||
| Dialysate System | Dialyzer, High | |||
| Permeability With Or | ||||
| Without Sealed | ||||
| Dialysate System | Dialyzer, High | |||
| Permeability With Or | ||||
| Without Sealed | ||||
| Dialysate System | Same for all three products. | |||
| Product Code | KDI | KDI | KDI | |
| Regulation | 876.5860, high | |||
| permeability | ||||
| hemodialysis system | 876.5860, high | |||
| permeability | ||||
| hemodialysis system | 876.5860, high | |||
| permeability | ||||
| hemodialysis system | ||||
| Device Class | 2 | 2 | 2 | |
| Available | ||||
| Therapies | Aquapheresis | |||
| (Ultrafiltration with | ||||
| Aquadex) | Aquapheresis | |||
| (Ultrafiltration with | ||||
| Aquadex) | SCUF | |||
| CVVH | ||||
| CVVHD | ||||
| CVVHDF | ||||
| TPE | Same as primary predicate. | |||
| Prismaflex has more therapy modes than Aquadex; aquapheresis is comparable to the Prismaflex SCUF mode. | ||||
| Anticoagulation | User-controllable as | |||
| continuous or bolus | User-controllable as | |||
| continuous or bolus | User-controllable as | |||
| continuous or bolus | Same for all three products |
Comparison of technological and performance characteristics are provided in the table below:
6
| Regulatory and Use Information | ||||
|---|---|---|---|---|
| Aquadex System with | ||||
| Modified Intended Use | Aquadex System with | |||
| Original Intended Use | Prismaflex System | |||
| (secondary predicate) | Comparison | |||
| (subject device) | (primary predicate) | |||
| Intended Use | The Aquadex FlexFlow | |||
| System is indicated for: | ||||
| Continuous | ||||
| ultrafiltration | ||||
| therapy for | ||||
| temporary (up to 8 | ||||
| hours) or extended | ||||
| (longer than 8 | ||||
| hours in patients | ||||
| who require | ||||
| hospitalization) use | ||||
| in adult and | ||||
| pediatric patients | ||||
| weighing 20 | ||||
| kilograms or more | ||||
| whose fluid | ||||
| overload is | ||||
| unresponsive to | ||||
| medical | ||||
| management. | ||||
| All treatments must be | ||||
| administered within an | ||||
| inpatient or outpatient | ||||
| clinical setting by a | ||||
| healthcare provider, | ||||
| under physician | ||||
| prescription, both of | ||||
| whom having received | ||||
| training in | ||||
| extracorporeal | ||||
| therapies. | The Aquadex FlexFlow | |||
| System is indicated for: | ||||
| Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, andExtended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies. | The Prismaflex control | |||
| unit is intended for: | ||||
| Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.All treatments administered via the Prismaflex control unit must be prescribed by a physician. | Compared to primary predicate: | |||
| the subject device clarifies the type of ultrafiltration, the weight minimum, and an unresponsive to medical management clause. | ||||
| Compared to secondary predicate: | ||||
| Aquadex is only indicated for ultrafiltration. | ||||
| All three products are prescription use only. |
| Device Components and Accessories | ||||
|---|---|---|---|---|
| Aquadex System with | ||||
| Modified Intended Use | ||||
| ( subject device ) | Aquadex System with | |||
| Original Intended Use | ||||
| ( primary predicate ) | Prismaflex System | |||
| (SCUF Mode) | ||||
| ( secondary predicate ) | Comparison | |||
| Dedicated | ||||
| Disposable Sets | ||||
| Available in U.S. | UF 500 Blood Circuit Set | UF 500 Blood Circuit Set | For CRRT (includes SCUF): | |
| M60/M100/M150, | ||||
| HF1000 & HF1400 | Same as primary | |||
| predicate. |
7
| Device Components and Accessories | ||||||
|---|---|---|---|---|---|---|
| Aquadex System with | ||||||
| Modified Intended Use | ||||||
| (subject device) | Aquadex System with | |||||
| Original Intended Use | ||||||
| (primary predicate) | Prismaflex System | |||||
| (SCUF Mode) | ||||||
| (secondary predicate) | Comparison | |||||
| Pumps | Effluent | |||||
| Blood | Effluent | |||||
| Blood | PBP solution | |||||
| Replacement solution | ||||||
| Dialysate solution | ||||||
| Effluent | ||||||
| Blood | Same as primary | |||||
| predicate. | ||||||
| Aquadex has fewer | ||||||
| pumps vs. Prismaflex | ||||||
| because replacement | ||||||
| solution and dialysate | ||||||
| are not administered | ||||||
| by Aquadex. | ||||||
| Scales | Effluent | Effluent | Dialysate | |||
| Replacement | ||||||
| Effluent | ||||||
| Pre blood (PBP) | Same as primary | |||||
| predicate. | ||||||
| Aquadex has fewer | ||||||
| scales vs. Prismaflex | ||||||
| because effluent is the | ||||||
| only solution to be | ||||||
| measured. | ||||||
| Device Specifications and Settings | ||||||
| Blood Flow Rate | ||||||
| Range | 10-40 ml/min | 10-40 ml/min | 10-450 ml/min | Same as primary | ||
| predicate. | ||||||
| Aquadex has a lower | ||||||
| maximum blood flow | ||||||
| rate than Prismaflex. | ||||||
| Blood Flow Rate | ||||||
| Accuracy | +15%/-20% of setting | |||||
| for withdrawal pressure | ||||||
| (Pw) ≥ -250 mmHg | +15%/-20% of setting | |||||
| for withdrawal | ||||||
| pressure (Pw) ≥ -250 | ||||||
| mmHg | ±10% of user set rate at | |||||
| nominal blood flow of | ||||||
| 450 ml/min | ||||||
| or the highest | ||||||
| achievable blood flow at | ||||||
| 37° C at an access | ||||||
| pressure of -200 mmHg l | ||||||
| pressure and without | ||||||
| any PBP flow | Same as primary | |||||
| predicate. | ||||||
| Aquadex Comparable | ||||||
| to Prismaflex. | ||||||
| Effluent Pump Flow | ||||||
| Rate | 0 to 500 ml/hr | 0 to 500 ml/hr | 0 to 10000 ml/hr | |||
| depending on the | ||||||
| therapy | Same as primary | |||||
| predicate. | ||||||
| Aquadex has a lower | ||||||
| maximum effluent | ||||||
| pump flow rate. | ||||||
| Patient Fluid | ||||||
| Removal | ||||||
| Performance Range | 0 to 500 ml/hr | 0 to 500 ml/hr | 0 to 2000 ml/hr | |||
| maximum for | ||||||
| CRRT | ||||||
| Increment: 10 ml/hr | Same as primary | |||||
| predicate. | ||||||
| Aquadex has a lower | ||||||
| maximum fluid removal | ||||||
| rate. | ||||||
| Patient Fluid | ||||||
| Removal | ||||||
| Performance Range | ||||||
| Accuracy | ±10% of user set rate | ±10% of user set rate | ±10% of user set rate | Aquadex accuracy is | ||
| statistically comparable | ||||||
| Prismaflex. |
7. Safety and Performance Data
8
Bench performance testing was performed on all three systems, Aquadex 1.0 (the primary predicate device), Aquadex 2.0 (the subject device), and Prismaflex® (the secondary predicate device) at the same therapy settings in order to derive a direct comparison of the fluid removal accuracies. Based on the accuracy calculations, the Aquadex FlexFlow System (1.0 and 2.0) met the design specifications and remained accurate within ±10% when comparing the displayed and actual ultrafiltration amount. The accuracy of the Aquadex FlexFlow System is comparable to the PrismaFlex System across all test scenarios.
In support of the clarified indication for use, CHF Solutions requested clinical data from a three-center retrospective study involving the use of Aquadex FlexFlow for pediatric patients and performed by investigators independent of the manufacturer. A total of 93 Aquadex blood circuits were used on 26 pediatric patients (21 years or younger) weighing 20 kilograms or more from 28 hospitalizations. More than half (57%) of the patients were female, and most patients were treated in the intensive care units, PICU (46%) and CICU (36%). The primary underlying disease for patients was cardiac disease at 39% or kidney disease at 29%.
None of the patients died during therapy with Aquadex (100% treatment course survival rate), and eight patients died after therapy but prior to hospital discharge (71% hospital survival rate). None of the deaths were related to the ultrafiltration device or procedure. No complications associated with treatment initiation were reported. Complications during therapy were infrequent, occurring in 11 cases (12% of circuits). Clot in the filter and hypotension during the treatment were the most common complications. In addition, no patient experienced a serious adverse event or device-related adverse event.
The Aquadex FlexFlow system was evaluated according to CHF procedures and performance testing protocols. The Aquadex FlexFlow system met all acceptance criteria. The performance testing demonstrates the Aquadex FlexFlow functions as intended. Below are high level summaries of testing used to demonstrate substantial equivalence along with FDA guidance documents and FDA recognized consensus standards.
- . Biocompatibility testing to the most recent ISO 10993 requirements
- . Electrical safety testing according to the most recent IEC 60601 standard
- Electromagnetic compatibility testing according to the most recent IEC 60601-1-2 standard
- . Performance testing to IEC 60601-2-16 that confirms the device meets requirements for Essential Performance
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- Software verification and validation testing in accordance with FDA's guidance ● "Guidance for the Content of Premarket Submission for Software Contained in Medical Device's"
- Performance testing to ISO 8637-1 ●
- Human factors testing in accordance with IEC 62366-1, 62366-2 and FDA's ● Guidance "Applying Human Factors and Usability Engineering to Optimize Medical Device Design."
8. Conclusion
The technological differences between Aquadex FlexFlow and Prismaflex were evaluated in a risk analysis process compliant with ISO 14971 (2012), in which hazards were identified, design and process failure modes were identified and mitigated, and residual risks were assessed and judged acceptably low. The fluid removal accuracy was evaluated through performance testing, which showed no statistical difference between Aquadex and Prismaflex. The lower maximum settings for blood flow rate and effluent pump flow rate on the Aquadex FlexFlow system do not raise safety concerns and likely mitigate safety in smaller patients. Aquadex clinical performance demonstrate that the system is viable, safe, and well-tolerated therapy for patients with volume overload in pediatric patients weighing ≥20 kg.
In conclusion, the Aquadex FlexFlow system is substantially equivalent to both the predicate Aqudex FlexFlow system (K071854) and the Prismaflex System (K171671).