(64 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on mechanical ultrafiltration and software for control, not AI/ML capabilities.
Yes
The device is indicated for "ultrafiltration treatment of patients with fluid overload," which describes a therapeutic action to treat a medical condition.
No
The device is a treatment system that removes excess fluid from patients; it does not diagnose conditions.
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), indicating it includes significant hardware components beyond just software.
Based on the provided information, the Aquadex FlexFlow™ System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a treatment 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 description details a system that performs ultrafiltration of blood using a hemofilter. This is an extracorporeal therapy, meaning it involves processing blood outside the body and returning it to the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Aquadex FlexFlow System does not perform these functions. It is a treatment device.
Therefore, the Aquadex FlexFlow System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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 health care 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)
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.
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
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 | |
| Official | |
| Contact: | Chris Scavotto |
| QA Director | |
| Telephone: 763-463-4621 | |
| Fax: 763-463-4606 | |
| Device | |
| Generic Name: | Ultrafiltration (Aquapheresis) System |
| Classification: | High permeability dialysis systems - classified as Class II |
| Predicate | |
| Devices: | Aquadex FlexFlow System |
| (K062922) | |
| 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 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. | |
| Safety & | |
| Performance: | 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. | |
| Conclusion: | Based on the similar intended use, patient population, technology |
| characteristics, and performance as assessed |
1
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
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.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
3
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