(27 days)
None
No
The summary describes a dialyzer, a physical medical device for hemodialysis, and explicitly states its technological characteristics are equivalent to predicate devices, raising no new safety or effectiveness questions. There is no mention of AI, ML, software, or data processing capabilities.
Yes
This device is a dialyzer designed for hemodialysis, which is a medical treatment used to remove waste products from the blood of patients with kidney failure. As it actively treats a medical condition, it is considered a therapeutic device.
No
The device is described as a dialyzer used for hemodialysis, which is a treatment, not a diagnostic procedure. Its function is to filter blood, not to diagnose a condition.
No
The device description clearly states it is a physical dialyzer, which is a hardware component used in hemodialysis. It is not a software-only device.
Based on the provided information, the Optiflux F20NR, F18NR, and F16NR dialyzers are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is for "single use acute and chronic hemodialysis." Hemodialysis is a process that filters blood outside the body to remove waste products and excess fluid. This is a therapeutic procedure performed on the patient's blood, not a diagnostic test performed on a sample of the patient's body fluid or tissue to obtain information about their health status.
- Device Description: The description focuses on the physical characteristics and sterilization method of the dialyzers, which are components used in the hemodialysis process.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
IVD devices are used to perform tests on samples to diagnose, monitor, or screen for diseases or conditions. Dialyzers are used to treat a condition (kidney failure) by filtering the blood.
Therefore, the Optiflux F20NR, F18NR, and F16NR dialyzers are medical devices used for treatment, not IVD devices used for diagnosis.
N/A
Intended Use / Indications for Use
Optiflux F20NR , F18NR , and F16NR dialyzers are designed for single use acute and chronic hemodialysis.
Product codes
78KDI, 78FJI
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
Not Found
Key Metrics
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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KOL-3244-
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Fresenius Medical Care
Fresenius Optiflux F20NR , F18NR and F16NR Single Use Hemodialyzers "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 |
| Two Ledgemont Center | |
| Lexington, MA 02420 | |
| Phone: | 1-781-402-9068 |
| Fax: | (781) 402-9635 |
| Contact Person: | Arthur Eilinsfeld, Director of Regulatory Affairs |
| Date of Preparation: | 19 November, 2004 |
B. Device Name:
| Proprietary Name: | Fresenius Optiflux F20NR e, F18NRe and
F16NRe Hemodialyzers |
| ------------------- | ---------------------------------------------------------------- |
|---|
Common Name:
| • Optiflux F20NRe and Optiflux F18NRe: | Dialyzer, High Permeability with or without Sealed Dialysate System |
|---|---|
| • Optiflux F16NRe: | Dialyzer, Capillary, Hollow Fiber |
| Product Code/Classification Panel: | |
| • Optiflux F20NRe and Optiflux F18NRe: | 78KDI/Gastroenterology-Urology |
| • Optiflux F16NRe: | 78FJI/Gastroenterology-Urology |
| Classification: | |
| • Optiflux F20NRe and Optiflux F18NRe: | Class II per §876.5860 |
| • Optiflux F16NRe: | Class II per §876.5820 |
Image /page/0/Picture/12 description: The image shows the number 000042. The numbers are in a bold, sans-serif font. The numbers are all aligned horizontally and are evenly spaced apart. The image is black and white.
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Fresenius Medical Care
Fresenius Optiflux F20NR , F18NR and F16NR Single Use Hemodialyzers "Special" 510(k) Premarket Notification Summary of Safety and Effectiveness
C. Predicate Devices
The Fresenius Optiflux F20NR , F18NR , and F16NR8 are modified versions of the Fresenius Optiflux 200NR and Fresenius Hemoflow F7NR®, which were cleared under the following premarket notifications:
Optiflux 200NR:
- K002277 (8/25/00) .
Hemoflow F7NR®
- · #K002761 (12/04/00)
D. Indications for Use/Intended Use
Optiflux F20NR®, F18NR®, and F16NR® dialyzers are designed for single use acute and chronic hemodialysis.
E. Substantial Equivalence:
1. Is the product a device?
YES - The Fresenius Optiflux F20NR , F18NR , and F16NR® hemodialyzers 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 Optiflux F20NR , F18NR , and F16NR , hemodialyzers is equivalent to that for the Fresenius Optiflux 200NR and is as follows:
Optiflux F20NR®, F18NR®, and F16NR® - Intended Use
Optiflux F20NR , F18NR , and F16NR dialyzers are designed for single use acute and chronic hemodialysis.
Fresenius Optiflux 200NR - Intended Use
Optiflux 200NR dialyzers are designed for acute and chronic hemodialysis and are appropriate for single and multiple use.
Image /page/1/Figure/20 description: The image shows a sequence of numbers, specifically "000043". The numbers are printed in a bold, sans-serif font, and they appear to be stamped or printed with some slight imperfections, giving them a somewhat aged or vintage look. The digits are evenly spaced and aligned horizontally.
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Image /page/2/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a geometric shape resembling an inverted pyramid with horizontal lines inside, positioned above the text "Fresenius Medical Care". The text is in a simple, sans-serif font and is the primary identifier for the brand.
Fresenius Optiflux F20NR , F18NR and F16NR Single Use Hemodialyzers "Special" 510(k) Premarket Notification Summary of Safetv and Effectiveness
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The Optiflux F20NR , F18NR , and F16NR are e-beam sterilized, low-flux versions of the Optifiux 200NR. The technological characteristics of the Optiflux F20NR®, F18NR°, and F16NR° are equivalent to those of the Optiflux 200NR and Hemoflow F7NR8 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 Optiflux F20NR, and and demonstrates that they are substantially equivalent to the F16NR® Fresenius Optiflux 200NR and Hemoflow F7NR®.
F. Safety Summary
The Optiflux F20NR°, F18NR°, and F16NR° dialyzers are substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius F7NR® and Fresenius Optiflux 200NR dialyzers. In addition, testing of the Optiflux F20NR , F18NR , and F16NR indicates that they are safe and effective for their intended use.
0000-3
00004
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2004
Ms. Nichole Riek Regulatory Affairs Supervisor Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420
Re: K043244
Trade/Device Name: Fresenius Optiflux 20NR, 18NR and 16NRt Hemodialyzers Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Product Code: 78 KDI Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Product Code: 78 FJI Regulatory Class: II Dated: November 19, 2004 Received: November 23, 2004
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 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you'ts begin matter of substantial equivalence of your device to a legally prematication. "The PDF machassification 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 If you debite specific acries 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 00 : 77). " Cormal Manufacturers, International and Consumer Assistance at its toll-free number (800) D1 rison or climit in and on or at its Internet address http://www.fda.gov/cdrb/dsmaldsmamain.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
5
Indications for Use
510(k) Number (if known):
Device Name:
Fresenius Optiflux F20NR®, F18NR®, and F16NR® Hemodialyzers
Indications For Use:
Optiflux F20NR , F18NR , and F16NR dialyzers are designed for single use acute and chronic hemodialysis.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Legarra
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
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