(88 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical components and compatibility.
Yes
The device is described as a blood circuit for use with the System 100, which is indicated for temporary ultrafiltration treatment of patients with fluid overload. This constitutes a therapeutic use.
No
Explanation: The device is described as an "ultrafiltration treatment" system for "fluid overload" and allows for "aspiration, injection, or gravity flow of fluids." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical blood circuit with tubing, a needleless valve, a tee connector, and a sliding clamp. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload." This describes a therapeutic procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a "blood circuit" used with a system for ultrafiltration. It involves accessing the patient's blood circuit for aspiration, injection, or gravity flow of fluids. This is a direct interaction with the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, etc.) to provide diagnostic information about a patient's condition. The purpose is to remove excess fluid from the patient's body.
Therefore, the device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use with the System 100. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
The UF500 blood circuit with needleless access port allows for aspiration, injection, or gravity flow of fluids using a male luer fitting.
Product codes
KDI, FPA
Device Description
The modified/alternate UF500 circuit incorporates an in-line needleless valve on the circuit withdrawal, infusion or both tubing lines. The in-line needless valve is independently commercially available medical device cleared for commercial distribution since May 15, 1996 (K955585) known as the ULTRASITE valve. This is a luer activated valve manufactured and distributed by B. Braun Medical. CHF Solutions, Inc. is placing this valve at the end of a short piece of tubing (extension arm) that is permanently joined to the A1500 circuit of the System 100 (K013733) with a tee connector. A sliding clamp is also included on the extension arm and is blue on the withdrawal side and white on the infusion side. The in-line needleless access port allows the health care provided access to the circuit/vasculature without disconnecting the catheter connections or catheter extension (when used) for aspiration, injection, or gravity flow of fluids.
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
health care provided
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 tests demonstrate the modified/alternative UF500 is remains compatible with the System 100.
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.”
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System 100 Modified/Alternate UF500 With In-line Needleless Access Port
KO24124
510(k) Summary
Prepared on December 13, 2002
| This 510(k) Summary is submitted in accordance with 21 CFR 807.92. | | Page 1 of 1
MAR 1 4 2003 |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Trade Name: | UF500 Circuit with In-line Needleless Access Port | |
| Manufacturer: | Chf Solutions, Inc.
Suite 170 – 7601 Northland Drive
Brooklyn Park, MN 55428 | |
| Official
Contact: | Amy Peterson
Vice President, RA/QA/CR
Telephone: 763-463-4620 Fax: 763-463-4606 | |
| Device
Generic Name: | Blood Filter Circuit | |
| Classification: | System 100 (Primary Classification)
Class: II (21 CFR 876.5860) Panel: Gastroenterology-Urology Product code: KDI | Needleless Access Port feature
Class: II (21 CFR 880.5440) Panel: General Hospital Product code: FPA |
| Predicate
Devices: | CHF Solutions, System 100 (K013733) | B. Braun Medical Inc. (K955585) |
| Device
Description: | The modified/alternate UF500 circuit incorporates an in-line needleless valve on
the circuit withdrawal, infusion or both tubing lines. The in-line needless valve is
independently commercially available medical device cleared for commercial
distribution since May 15, 1996 (K955585) known as the ULTRASITE® valve.
This is a luer activated valve manufactured and distributed by B. Braun Medical.
CHF Solutions, Inc. is placing this valve at the end of a short piece of tubing
(extension arm) that is permanently joined to the A1500 circuit of the System
100 (K013733) with a tee connector. A sliding clamp is also included on the
extension arm and is blue on the withdrawal side and white on the infusion side.
The in-line needleless access port allows the health care provided access to the
circuit/vasculature without disconnecting the catheter connections or catheter
extension (when used) for aspiration, injection, or gravity flow of fluids. | |
| Indication
for Use: | For use with the System 100. For aspiration, injection, or gravity flow of fluids using a male luer fitting. | |
| Safety &
Performance: | The modified/alternate UF500 circuit with an in-line needleless access port and
predicate devices are identical in materials of construction, packaging and
sterilization. The modified/alternative UF500 circuit is provided sterile and
nonpyrogenic. Bench tests demonstrate the modified/alternative UF500 is
remains compatible with the System 100. | |
| Conclusion: | Based on the intended use, technology characteristics and bench testing, the
modified/alternative UF500 circuit has been shown to be safe and effective for
its intended use. This product is substantially equivalent and considered
acceptable for the intended use. | |
² 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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2003
Ms. Amy Peterson Vice President RA/QA/CR CHF Solutions, Inc. Suite 170-7601 Northland Drive BROOKLYN PARK MN 55428 Re: K024124
Trade/Device Name: UF500 with Needleless Access Port Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: December 13, 2002 Received: December 16, 2002
Dear Ms. Peterson:
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 (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 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
Page 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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.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
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if know): K024124_______________________________________________________________________________________________________________________________________
Device Name: UF500 with Needleless Access Port
FDA's Statement of the Indication For Use for device:
For use with the System 100. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
The UF500 blood circuit with needleless access port allows for aspiration, injection, or gravity flow of fluids using a male luer fitting.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
| Prescription Use | ✓ | OR | Over-The-Counter Use | _____ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | ||||
| (Division Sign-Off) | ||||
| Division of Reproductive, Abdominal, | ||||
| and Radiological Devices | ||||
| 510(k) Number | K024124 |
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