← Product Code [KDI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI) · K024124 # SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT (K024124) _Chf Solutions, Inc. · KDI · Mar 14, 2003 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI/K024124 ## Device Facts - **Applicant:** Chf Solutions, Inc. - **Product Code:** [KDI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI.md) - **Decision Date:** Mar 14, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5860 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended 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. ## Device Story The UF500 circuit is a blood filter circuit component for the System 100; it incorporates an in-line needleless valve (ULTRASITE valve) on the withdrawal and/or infusion tubing lines. The valve is attached via a short extension arm permanently joined to the A1500 circuit with a tee connector. A sliding clamp is included on the extension arm. The device allows healthcare providers to access the circuit or vasculature for aspiration, injection, or gravity flow of fluids without disconnecting catheter connections. This facilitates fluid management in clinical settings while maintaining a closed system. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Blood filter circuit with integrated luer-activated needleless valve. Materials, packaging, and sterilization are identical to the predicate System 100 circuit. Provided sterile and nonpyrogenic. Mechanical design includes a tee connector and sliding clamps on extension tubing. ## Regulatory 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). ## Special Controls *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.” ## Predicate Devices - CHF Solutions, System 100 ([K013733](/device/K013733.md)) - B. Braun Medical Inc. ([K955585](/device/K955585.md)) ## Related Devices - [K980127](/device/K980127.md) — 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT · Catheter Innovations, Inc. · Mar 11, 1998 - [K093271](/device/K093271.md) — EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD · Victus, Inc. · Jan 27, 2010 - [K242339](/device/K242339.md) — Intravascular Extension Sets and Accessories · Baxter Healthcare Corporation · Feb 28, 2025 - [K222766](/device/K222766.md) — Disposable Extension Set · Shandong Ande Healthcare Apparatus Co., Ltd. · Apr 12, 2024 - [K023874](/device/K023874.md) — SYSTEM 100 ULTRAFILTRATION CATHETER · Chf Solutions, Inc. · Nov 20, 2003 ## Submission Summary (Full Text) {0}------------------------------------------------ Page 1/1 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<br>MAR 1 4 2003 | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | Trade Name: | UF500 Circuit with In-line Needleless Access Port | | | Manufacturer: | Chf Solutions, Inc.<br>Suite 170 – 7601 Northland Drive<br>Brooklyn Park, MN 55428 | | | Official<br>Contact: | Amy Peterson<br>Vice President, RA/QA/CR<br>Telephone: 763-463-4620     Fax: 763-463-4606 | | | Device<br>Generic Name: | Blood Filter Circuit | | | Classification: | System 100 (Primary Classification)<br>Class: II (21 CFR 876.5860) Panel: Gastroenterology-Urology Product code: KDI | Needleless Access Port feature<br>Class: II (21 CFR 880.5440) Panel: General Hospital Product code: FPA | | Predicate<br>Devices: | CHF Solutions, System 100 (K013733) | B. Braun Medical Inc. (K955585) | | Device<br>Description: | The modified/alternate UF500 circuit incorporates an in-line needleless valve on<br>the circuit withdrawal, infusion or both tubing lines. The in-line needless valve is<br>independently commercially available medical device cleared for commercial<br>distribution since May 15, 1996 (K955585) known as the ULTRASITE® valve.<br>This is a luer activated valve manufactured and distributed by B. Braun Medical.<br>CHF Solutions, Inc. is placing this valve at the end of a short piece of tubing<br>(extension arm) that is permanently joined to the A1500 circuit of the System<br>100 (K013733) with a tee connector. A sliding clamp is also included on the<br>extension arm and is blue on the withdrawal side and white on the infusion side.<br>The in-line needleless access port allows the health care provided access to the<br>circuit/vasculature without disconnecting the catheter connections or catheter<br>extension (when used) for aspiration, injection, or gravity flow of fluids. | | | Indication<br>for Use: | For use with the System 100. For aspiration, injection, or gravity flow of fluids using a male luer fitting. | | | Safety &<br>Performance: | The modified/alternate UF500 circuit with an in-line needleless access port and<br>predicate devices are identical in materials of construction, packaging and<br>sterilization. The modified/alternative UF500 circuit is provided sterile and<br>nonpyrogenic. Bench tests demonstrate the modified/alternative UF500 is<br>remains compatible with the System 100. | | | Conclusion: | Based on the intended use, technology characteristics and bench testing, the<br>modified/alternative UF500 circuit has been shown to be safe and effective for<br>its intended use. This product is substantially equivalent and considered<br>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) | | | | | | <hr/> | | | | | | (Division Sign-Off) | | | | | | Division of Reproductive, Abdominal, | | | | | | and Radiological Devices | | | | | | 510(k) Number | K024124 | | | | Page 7 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI/K024124](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDI/K024124) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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