(64 days)
The Aquadex FlexFlow™ System is indicated for:
• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and
• Extended (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 health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.
The Aquadex FlexFlow System removes excess fluid from the patient in fluid overload by ultrafiltration of blood across a hollow-fiber hemofilter at the clinician selected rate. The system is comprised on a console mounted on a cart, proprietary software and accessories (venous access catheters, extensions and a blood pump circuit). Patient access is obtained via either peripheral or central venous veins.
The provided document does not contain detailed acceptance criteria for the Aquadex FlexFlow™ System's performance, nor does it describe a specific study that proves the device meets such criteria in terms of quantitative performance metrics.
Instead, the document primarily focuses on the 510(k) submission for a software change to the Aquadex FlexFlow™ System and a labeling change incorporating a catheter compatibility chart. The "Safety & Performance" section states:
"Regression testing was performed to verify and validate the software change and to generate data in support of the labeling change which incorporates a catheter compatibility chart using the principles of ISO 14971:2000 "Medical devices - Application of risk management to medical devices. Data generated demonstrated the Aquadex FlexFlow System continues to be safe and effective."
This statement indicates that a study (regression testing) was performed, but it doesn't provide specific acceptance criteria or quantitative performance results relevant to the device's functional operation (e.g., fluid removal rate accuracy, filter efficiency).
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Based on the available text:
-
Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms. The general criterion appears to be "continues to be safe and effective" after software and labeling changes.
- Reported Device Performance: "Data generated demonstrated the Aquadex FlexFlow System continues to be safe and effective." No specific performance metrics or values are provided.
-
Sample size used for the test set and the data provenance: Not specified.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external ground truth establishment is described for performance evaluation. The "data generated" would likely pertain to internal testing.
-
Adjudication method for the test set: Not applicable.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrafiltration system, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "software change" was validated, but the overall system's operation always involves human interaction and monitoring.
-
The type of ground truth used: For the regression testing, the "ground truth" would likely be the expected function and output of the device following the software and labeling changes, verified against design specifications and established safety/effectiveness parameters of the predicate device. This is internal testing, not external ground truth from patient data or experts.
-
The sample size for the training set: Not applicable. This is not a machine learning model requiring a training set in the typical sense. The "training" here refers to the device's internal software development and testing, not a dataset for model training.
-
How the ground truth for the training set was established: Not applicable.
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Page _________________________________________________________________________________________________________________________________________________________________________
Ko70512
Attachment C 510K Summary Safety and Effectiveness 510(k) Summary (Prepared on February xx®, 2007)
APR 2 7 2007
This 510(k) Summary is submitted in accordance with 21 CFR 807.92.
| Trade Names: | Aquadex FlexFlow™ System (trademark pending) |
|---|---|
| Manufacturer: | CHF Solutions, Inc., Suite 170 - 7601 Northland Drive,Brooklyn Park, MN 55428 |
| OfficialContact: | Chris ScavottoQA DirectorTelephone: 763-463-4621Fax: 763-463-4606 |
| DeviceGeneric Name: | Ultrafiltration (Aquapheresis) System |
| Classification: | High permeability dialysis systems - classified as Class II |
| PredicateDevices: | Aquadex FlexFlow System(K062922) |
| DeviceDescription: | The Aquadex FlexFlow System removes excess fluid from the patient in fluidoverload by ultrafiltration of blood across a hollow-fiber hemofilter at theclinician selected rate. The system is comprised on a console mounted on acart, proprietary software and accessories (venous access catheters,extensions and a blood pump circuit). Patient access is obtained via eitherperipheral or central venous veins. |
| Indicationfor Use: | The Aquadex FlexFlow™ System is indicated for:• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluidoverload who have failed diuretic therapy, and• Extended (longer than 8 hours) ultrafiltration treatment of patients withfluid overload who have failed diuretic therapy and require hospitalization.All treatments must be administered by a health care provider, underphysician prescription, both of whom having received training inextracorporeal therapies. |
| Safety &Performance: | Regression testing was performed to verify and validate the software changeand to generate data in support of the labeling change which incorporates acatheter compatibility chart using the principles of ISO 14971:2000 "Medicaldevices - Application of risk management to medical devices.Datagenerated demonstrated the Aquadex FlexFlow System continues to be safeand effective. |
| Conclusion: | Based on the similar intended use, patient population, technologycharacteristics, and performance as assessed |
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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUM." is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 7
Mr. Chris Scavotto Director of Quality Assurance CHF Solutions®, Inc. 7601 Northland Drive, Suite 170 BROOKLYN PARK MN 55428
Re: K070512
Trade/Device Name: Aquadex FlexFlow™ System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 27, 2007 Received: March 28, 2007
Dear Mr. Scavotto:
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 indivations for use stated in the enclosure) to legally marketed predicate devices marketed in intearchis in 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, That, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major resulations affection 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.
Image /page/1/Picture/9 description: The image is a black and white circular logo or seal. The text "1906-2006" is at the top of the circle. Below that is the acronym "FDA" in bold, stylized letters. The word "Centennial" is written in a cursive font below the acronym. Three stars are at the bottom of the circle.
Protecting and Promoting Public Health
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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 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) . premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT (Page 1 of 1)
K07 9512 510(k) Number (if known):
Device Name: Aquadex FlexFlow™ System
FDA's Statement of the Indication For Use for Device:
The Aquadex FlexFlow™ System is indicated for:
- Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload . who have failed diuretic therapy, and
- Extended (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 health care provider, under physician prescription, both of whom having received training in extracorporeal therapies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K070512 |
|---|---|
| --------------- | --------- |
CHF Solutions, Inc. Aquadex FlexFlow Rev. L Software Update
§ 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.”