(244 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on mechanical ultrafiltration.
Yes
The device is described as a "Temporary ultrafiltration treatment of patients with fluid overload" which directly indicates a therapeutic purpose.
No
The Aquadex System is described as a treatment device that removes excess fluid from patients through ultrafiltration, rather than diagnosing a condition.
No
The device description explicitly states the system is comprised of a console mounted on a cart, proprietary software, and accessories (catheters, extensions, blood pump circuit). This indicates significant hardware components beyond just software.
Based on the provided information, the Aquadex System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to remove excess fluid from patients with fluid overload through ultrafiltration of blood. This is a therapeutic procedure performed directly on the patient's blood within an extracorporeal circuit.
- Device Description: The device description details a system that physically processes blood (ultrafiltration across a hemofilter) to remove fluid. It involves a console, cart, software, and accessories for accessing the patient's venous system.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. The Aquadex System operates on the patient's blood as it flows through the device, not on a separate specimen.
The Aquadex System is a therapeutic device used for extracorporeal blood processing.
N/A
Intended Use / Indications for Use
The Aquadex 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 healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.
Product codes
KDI
Device Description
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.
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
Not Found
Intended User / Care Setting
All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.
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 testing was performed to validate the disposable product and software changes in support of the Indication for Use change. A subset of 60 patients with 89 extended use (>8hrs) UF500 circuits use were summarized from a post market on-label prospective study in support of the Indication for Use change. The data generated demonstrated the Aquadex™ System continues to be safe and effective through 24 hours of continuous use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K0506 09
510(k) Summary Prepared on August 11, 2005
This 510(k) Summary is submitted in accordance with 21 CFR 807.92.
| Trade Names: | Aquadex™ System |
|---|---|
| Manufacturer: | CHF Solutions, Inc., Suite 170 - 7601 Northland Drive, Brooklyn Park, MN |
| 55428 | |
| Official | |
| Contact: | Chris Scavotto |
| Quality Assurance Manager | |
| Telephone: 763-463-4621 | |
| Fax: 763-463-4606 | |
| Device | |
| Generic Name: | Aquadex FlexFlow™ System |
| Classification: | High permeability dialysis systems - classified as Class II |
| Predicate | |
| Devices: | Aquadex FlexFlow™ System (K040489) |
| PRISMA™ CFM Systems (K981681) | |
| Device | |
| Description: | 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. | |
| Indication | |
| for Use: | The Aquadex 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 healthcare provider, under | |
| physician prescription, both of whom having received training in | |
| extracorporeal therapies. | |
| Safety & | |
| Performance: | Bench testing was performed to validate the disposable product and |
| software changes in support of the Indication for Use change. A subset of | |
| 60 patients with 89 extended use (>8hrs) UF500 circuits use were | |
| summarized from a post market on-label prospective study in support of the | |
| Indication for Use change. The data generated demonstrated the | |
| Aquadex™ System continues to be safe and effective through 24 hours of | |
| continuous use. | |
| Conclusion: | Based on the similar intended use, patient population, technology |
| characteristics, and performance characteristics as assessed with bench | |
| testing and clinical data the Indication for Use has been shown to be safe | |
| and effective for its intended use. This product is substantially equivalent' | |
| and considered acceptable for the intended use. |
CHF Solutions, Inc.
1 This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.
1
Image /page/1/Picture/2 description: The image shows a stylized graphic, possibly a logo or emblem. It features three vertical, wavy lines that appear to be grouped together, creating a sense of movement or flow. To the left of these lines, there is some text arranged vertically, but it is difficult to read due to the image quality and orientation. The overall impression is abstract and symbolic.
NOV - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris Scavotto Quality Assurance Manager CHF Solutions, Inc. Suite 170-7601 Northland Drive BROOKLYN PARK MN 55428
Re: K050609
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: August 17, 2005 Received: August 18, 2005
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 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 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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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 yours,
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
3
INDICATIONS FOR USE STATEMENT (Page 1 of 1)
510(k) Number:
050609
Device Name: Aquadex FlexFlow™ System
FDA's Statement of the Indication for Use for Device:
The Aquadex 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 healthcare 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_
Lancer
Name Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal.
and RadiologicalD
CHF Solutions, Inc.
f Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050609