(88 days)
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.
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.
The provided text describes a 510(k) summary for a medical device called "System 100 Modified/Alternate UF500 With In-line Needleless Access Port." However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in a quantitative sense as typically seen in AI/software medical device submissions.
This submission is for a modification of an existing device (UF500 circuit) by adding a commercially available, already cleared, in-line needleless access port. The "study" here is primarily a demonstration of substantial equivalence through bench testing, rather than a clinical trial or performance study with defined statistically-derived acceptance criteria.
Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of submission described.
Here's an analysis of what information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document implies that the acceptance criteria are met if the modified device remains compatible with the System 100, is sterile, nonpyrogenic, and satisfies the intended use without introducing new safety concerns compared to the predicate devices. The phrase "Bench tests demonstrate the modified/alternative UF500 is remains compatible with the System 100" serves as the primary "acceptance."
Reported Device Performance:
| Assessment Area | Reported Performance |
|---|---|
| Materials | Identical to predicate devices |
| Packaging | Identical to predicate devices |
| Sterilization | Identical to predicate devices |
| Sterility | Provided sterile |
| Pyrogenicity | Nonpyrogenic |
| Compatibility | Bench tests demonstrate the modified UF500 remains compatible with the System 100. |
| Intended Use | Safe and effective for its intended use (aspiration, injection, or gravity flow of fluids using a male luer fitting with System 100). |
| Substantial Equivalence | Substantially equivalent to predicate devices (CHF Solutions, System 100 (K013733) and B. Braun Medical Inc.'s ULTRASITE® valve (K955585)). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The study involved "bench tests," which are typically laboratory tests of the device itself rather than tests on human subjects or clinical data. The quantity of devices tested is not mentioned.
- Data Provenance: The "bench tests" are presumably conducted by the manufacturer, CHF Solutions, Inc., in the United States. They are retrospective in the sense that they were conducted on the modified device before submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is a hardware modification submission, not an AI/software device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This type of submission does not involve adjudication of clinical data or expert opinions. The evaluation is based on engineering and performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is not an AI or software device, and no MRMC study was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This is a physical medical device (circuit with a port), not an algorithm.
7. The Type of Ground Truth Used
- Not applicable in the typical sense for AI/software devices. The "ground truth" here is adherence to engineering specifications for compatibility, sterility, non-pyrogenicity, and mechanical integrity, as demonstrated through bench testing and comparison to predicate device characteristics.
8. The Sample Size for the Training Set
- Not applicable. No training set is mentioned or relevant for this type of device modification.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set is mentioned or relevant for this type of device modification.
Summary of the Study (as described in the document):
The study was a series of bench tests conducted by CHF Solutions, Inc. to demonstrate the safety and effectiveness of the modified UF500 circuit. The core of the study aimed to show that integrating an existing, cleared needleless access port into the UF500 circuit did not negatively impact the performance, safety, and compatibility with the System 100. Key aspects verified were:
- Materials, Packaging, and Sterilization: These were confirmed to be identical to the predicate System 100 circuit, leveraging the existing clearance for these aspects.
- Sterility and Nonpyrogenicity: The final modified product was confirmed to be sterile and nonpyrogenic.
- Compatibility: Bench tests specifically demonstrated that the modified/alternative UF500 circuit remains compatible with the System 100, which is crucial as the needleless port is an add-on.
The overall conclusion was that, based on these bench tests and the technological characteristics, the modified device is "safe and effective for its intended use" and "substantially equivalent" to the predicate devices.
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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 1MAR 1 4 2003 | |
|---|---|---|
| Trade Name: | UF500 Circuit with In-line Needleless Access Port | |
| Manufacturer: | Chf Solutions, Inc.Suite 170 – 7601 Northland DriveBrooklyn Park, MN 55428 | |
| OfficialContact: | Amy PetersonVice President, RA/QA/CRTelephone: 763-463-4620 Fax: 763-463-4606 | |
| DeviceGeneric Name: | Blood Filter Circuit | |
| Classification: | System 100 (Primary Classification)Class: II (21 CFR 876.5860) Panel: Gastroenterology-Urology Product code: KDI | Needleless Access Port featureClass: II (21 CFR 880.5440) Panel: General Hospital Product code: FPA |
| PredicateDevices: | CHF Solutions, System 100 (K013733) | B. Braun Medical Inc. (K955585) |
| DeviceDescription: | The modified/alternate UF500 circuit incorporates an in-line needleless valve onthe circuit withdrawal, infusion or both tubing lines. The in-line needless valve isindependently commercially available medical device cleared for commercialdistribution 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 System100 (K013733) with a tee connector. A sliding clamp is also included on theextension 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 thecircuit/vasculature without disconnecting the catheter connections or catheterextension (when used) for aspiration, injection, or gravity flow of fluids. | |
| Indicationfor 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 andpredicate devices are identical in materials of construction, packaging andsterilization. The modified/alternative UF500 circuit is provided sterile andnonpyrogenic. Bench tests demonstrate the modified/alternative UF500 isremains compatible with the System 100. | |
| Conclusion: | Based on the intended use, technology characteristics and bench testing, themodified/alternative UF500 circuit has been shown to be safe and effective forits intended use. This product is substantially equivalent and consideredacceptable 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.
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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.
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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
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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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§ 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.”