(29 days)
Not Found
No
The summary describes a physical medical device (a dialyzer) and its performance characteristics based on in vitro testing. There is no mention of AI, ML, image processing, or any software-based analytical capabilities that would typically involve these technologies.
Yes
The device is used for hemodialysis, which is a medical treatment that removes waste products and excess fluid from the blood. This function directly treats a medical condition, making it a therapeutic device.
No
The device, a dialyzer, is used for hemodialysis (a treatment) and not for diagnosing a condition. The performance studies also focus on clearances and physical properties, not diagnostic accuracy.
No
The device is a dialyzer, which is a physical medical device used in hemodialysis, not a software-only device. The performance studies described are in vitro tests of physical properties.
Based on the provided information, the Fresenius Ultraflux dialyzer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "single use acute and chronic hemodialysis." This describes a treatment for a medical condition (kidney failure), not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use is the primary indicator.
- Performance Studies: The performance studies listed are "in vitro testing" to determine physical and clearance characteristics of the dialyzer itself (priming volume, pressure drops, ultrafiltration coefficient, clearance of various substances). These are tests of the device's function, not tests on patient samples to diagnose or monitor a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures. The Fresenius Ultraflux dialyzer does not fit this definition. It is a therapeutic device used to filter blood.
N/A
Intended Use / Indications for Use
The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.
Product codes (comma separated list FDA assigned to the subject device)
78KDI
Device Description
Not Found
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
Not Found
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)
In vitro testing was performed to determine the following: priming volume, bloodside and dialysate-side pressure drops, ultrafiltration coefficient, urea clearance, creatinine clearance, Vitamin B12 clearance, phosphate and lysozyme clearance. No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Fresenius Medical Care
Fresenius Ultraflux Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | Fresenius Medical Care North America |
|---|---|
| Address: | 95 Hayden Ave |
| Lexington, MA 02420 | |
| Phone: | 1-781-402-9068 |
| Fax: | (781) 402-9635 |
| Contact Person: | Arthur Eilinsfeld, Director of Regulatory Affairs |
| Date of Preparation: | 29 April 2003 |
B. Device Name:
| Common Name: | Dialyzer, High Permeability with or without
Sealed Dialysate System |
|------------------------------------|------------------------------------------------------------------------|
| Product Code/Classification Panel: | 78KDI/Gastroenterology-Urology |
| Classification: | Class II per §876.5860 |
C. Predicate Device
The predicate devices for the Fresenius Ultraflux Hemodialyzers are:
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Fresenius Medical Care
Fresenius Ultraflux Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
D. Indications for Use:
The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.
E. Substantial Equivalence:
1. Is the product a device?
YES - The Ultraflux dialyzers are devices pursuant to 21 CFR §201 [321] (h).
2. Does the new device have the same intended use?
YES - The intended use for the Ultraflux is identical to that for the Optiflux 200NR and is as follows:
Intended Use for Ultraflux
The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.
Intended Use for Optiflux 200NR
Optiflux 200NR dialyzers are designed for single use acute and chronic hemodialysis.
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The Ultraflux are equivalent in materials, sterilization and indications for use to the currently manufactured Optiflux 200NR. The technological characteristics of the Ultraflux are equivalent to those of the Optiflux 200NR and Gambro Polyflux 17S and raise no new types of safety or effectiveness questions.
4. Does descriptive or performance information demonstrate equivalence?
YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the Ultraflux and demonstrates that it is substantially equivalent to the Optiflux 200NR.
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Ko 3 1378
Fresenius Ultraflux Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Summary of Safety and Effectiveness
F. Safety Summary
The Ultraflux hemodialyzers are substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Optiflux hemodialyzers. In addition, testing of Ultraflux hemodialyzers indicates that the dialyzers are safe and effective for their intended use.
In vitro testing was performed to determine the following: priming volume, bloodside and dialysate-side pressure drops, ultrafiltration coefficient, urea clearance, creatinine clearance, Vitamin B12 clearance, phosphate and lysozyme clearance. No clinical testing was performed.
G. General Safety and Effectiveness Concerns
The device labeling contains a Package Insert, which includes indications for use, cautions and warnings, as well as the general operating instructions required br proper use of the device. This information promotes safe and effective use of the dialyzer.
Arthur Eilinfeld
ur Eilinsfeld Director of Regulatory Affairs
4/29/03
Date
Date
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MAY 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nichole Riek Regulatory Affairs Supervisor Fresenius Medical Care North America Two Ledgemont Center 95 Hayden Avenue LEXINGTON MA 02173
Re: K031378
Trade/Device Name: Fresenius Ultraflux Single Use Hemodialyzer Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: April 29, 2003 Received: May 1, 2003
Dear Ms. Riek:
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 vour 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.
4
This letter will allow you to begin marketing your device as described in your 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:
| 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" (21 CFR Part 807.97). 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 Crogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Fresenius Ultraflux Single Use Hemodialyzer "Special" 510(k) Premarket Notification
Indications for Use Statement
Device Name:
Fresenius Ultraflux Hemodialyzers
Indications for Use:
The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.
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
David W. Sezmore
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
0000001