(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 is a 510(k) summary for the Aquadex FlexFlow™ System, specifically addressing the addition of a new blood circuit (UF250). This document is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than outlining a clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML-based medical devices or devices undergoing extensive efficacy trials.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML device or a device requiring new clinical efficacy data. Instead, the acceptance is based on demonstrating safety and effectiveness through regression testing and bench tests for the software change and the new blood circuit.
| Acceptance Criteria Focus | Reported Device Performance |
|---|---|
| Software Validation | Regression testing verified and validated the software change. |
| New Component Validation (UF 250 Blood Circuit) | Bench tests were performed to validate the incorporation of the UF 250 Blood Circuit. |
| Overall Safety & Effectiveness | Data demonstrated the Aquadex FlexFlow System continues to be safe and effective. |
| Substantial Equivalence | The alternate UF 250 blood circuit (PN A1600) was shown to be safe and effective, substantially equivalent to the predicate, and acceptable for the intended use. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not mention "test sets" in the context of clinical data or AI/ML model evaluation. The "data" referred to is from regression testing and bench tests. Therefore, no information on sample size (e.g., number of patients or cases) or data provenance (country of origin, retrospective/prospective) is provided, as these types of studies were not conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to the provided document. The evaluation was based on engineering testing (regression and bench tests) of a medical device's components and software changes, not on expert-adjudicated ground truth from medical images or clinical outcomes.
4. Adjudication Method for the Test Set:
Not applicable, as there was no test set requiring expert adjudication.
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:
Not applicable. This device is an ultrafiltration system, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm. The "standalone" performance here refers to the device's functional operation in a controlled bench test environment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here is the expected functional performance and safety parameters of the device and its components, established through engineering specifications, regulatory standards, and comparison to the predicate device. This is determined through regression testing for software and bench testing for hardware (the UF 250 Blood Circuit). It is not based on expert consensus, pathology, or outcomes data in the traditional clinical trial sense for this submission.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established:
Not applicable.
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¥071854
SEP - 7 2007
- 2007
Page 11/1
Attachment C 510K Summary Safety and Effectiveness 510(k) Summary (Prepared on June 3rd, 2007)
This 510(k) Summary is submitted in accordance with 21 CFR 807.92.
| Trade Names: | Aquadex FlexFlow™ System |
|---|---|
| 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(K070512) |
| 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 adding the UF 250blood circuit. Bench testswere performed to validate the incorporation of the UF 250 Blood Circuit. Thedata demonstrated the Aquadex FlexFlow System continues to be safe andeffective |
| Conclusion: | Based on the similar intended use, patient population, technologycharacteristics, and performance as assessed with bench testing the alternateUF 250 blood circuit (PN A1600) has been shown to be safe and effective, issubstantially equivalent and considered acceptable for the intended use. |
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP - 7 2007
Mr. Chris Scavotto Director of Quality Assurance CHF Solutions, Inc. 7601 Northland Drive, Ste. 170 BROOKLYN PARK MN 55428
Re: K071854
Trade/Device Name: Aquadex FlexFlow™ System (Blood Circuit UF250) Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: August 8, 2007 Received: August 10, 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 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. The general controls provisions of the Act include requirements for annual registration, listing of devenes , 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition F F A may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "FDA" are in the center of the seal, and the word "Centennial" is below the letters. There are stars around the perimeter of the seal.
Protecting and Promoting Public Health
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Page 2 -
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
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 | 854 510(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 | K091854 |
CHF Solutions, Inc. Aquadex FlexFlow UF 250 Blood Circuit
§ 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.”