(211 days)
Not Found
No
The summary describes a physical medical device (dialyzer) and its performance characteristics based on standard testing methods. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate, and it works by transferring water and solutes between blood and dialysate to remove waste and fluid, which is a therapeutic intervention.
No
Explanation: The device is a dialyzer used for treating renal failure by transferring water and solutes from blood, not for diagnosing a condition.
No
The device description clearly states it is a physical dialyzer made of materials like polysulfone, polycarbonate, silicone, and polyurethane, and it undergoes physical performance and biological safety testing. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating patients with renal failure by removing waste products and excess fluid from their blood. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description clearly outlines a device that facilitates the physical process of hemodialysis, which involves filtering blood through a semi-permeable membrane. This is a treatment method.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, etc.) to diagnose a condition, monitor disease progression, or guide treatment decisions based on in vitro analysis. The performance metrics (urea clearance, sodium clearance) relate to the efficiency of the filtration process, not to the analysis of biological markers for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a therapeutic device used to treat a condition.
N/A
Intended Use / Indications for Use
Optiflux Dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers, which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. The Optiflux dialyzers are available in four (4) sizes. The sizes are differentiated by membrane surface area. The proposed Optiflux dialyzers are single use dialyzers manufactured from Advanced Fresenius Polysulfone, polycarbonate, silicone and polyurethane. The dialyzers are provided with the blood pathway sterile and non-pyrogenic. The dialyzers are sterilized using e-beam radiation. The Optiflux dialyzers are used in environments where acute and chronic hemodialysis are performed. The principle of hemodialysis involves the diffusion of solutes across a semi-permeable membrane. Dialyzers use a counter-current flow, where the dialysate is flowing in the opposite direction to the blood flow in the extracorporeal circuit. Counter-current flow maintains the concentration gradient across the membrane for waste removal (diffusion) and fluid removal (ultrafiltration). The Optiflux dialyzers are classified as an external communicating device with prolonged exposure (>24 hrs to ≤30 days) to circulating blood.
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)
Performance testing was conducted in accordance with ISO 8637:2010. Results of testing listed below support the determination of substantial equivalence.
- Performance testing clearance testing, sieving coefficient, ultrafiltration performance and membrane performance
- Structural integrity testing positive and negative pressure decay testing and blood compartment integrity (membrane integrity)
- Biological safety testing (biocompatibility)
- Sterility and pyrogenicity testing
Biocompatibility Testing:
The following testing was performed to support the biological safety of the polysulfone supplier change:
- Chemical analysis extractables and leachables
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Subacute/Subchronic Toxicity
- Genotoxicity
- Hemocompatibility
- Risk assessment of potential toxicity
Key result: Urea clearance is a key performance specification of the Optiflux dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance as sodium and urea exhibit similar movement across a membrane. Table 1 provides sodium clearance data from the instructions for use (IFU) for the Optiflux series of dialyzers.
In vitro Urea Clearance from the Optiflux Dialyzer Table 1: Instructions for Use (Qb= 300mL/min, Qd= 500mL/min, UFR=0mL/min)
| Trade Name | Urea Clearance (Sodium Used as Marker) |
|---|---|
| Optiflux F160NR Dialyzer | 271 |
| Optiflux F180NR Dialyzer | 277 |
| Optiflux F200NR Dialyzer | 280 |
| Optiflux F250NR Dialyzer | 287 |
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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a simple, modern design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2017
Fresenius Medical Care North America Denise Oppermann Senior Director Regulatory Affairs, Devices 920 Winter Street Waltham, MA 02451
Re: K162488
Trade/Device Name: Optiflux Dialyzers (F160NR, F200NR, and F250NR) Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: March 3, 2017 Received: March 6, 2017
Dear Denise Oppermann:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The text is black and appears to be printed on a white background. The letters are evenly spaced and the text is left-aligned.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162488
Device Name
Optiflux Dialyzers (F160NR, F180NR, F200NR and F250NR)
Indications for Use (Describe)
Optiflux Dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.
510(K) SUMMARY
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Regulatory Affairs – Devices | |
| Preparation Date: | August 30 2016 |
| Device Name | |
| Trade Name: | Optiflux® Series of Dialyzers F160NR, |
| F180NR, F200NR, F250NR | |
| Common Name: | Dialyzer, High Permeability with or |
| without Sealed Dialysate System | |
| Classification Name : | High permeability hemodialysis system |
| Regulatory Class: | Class II per 21 CFR §876.5860 |
| Product Code/ | KDI |
| Classification Panel: | Gastroenterology / Urology |
Legally Marketed Predicate Device
The predicate devices are the FMCRTG, LLC Optiflux dialyzers, model numbers F160NR, F180NR, F200NR and F250NR. The Optiflux dialyzers were cleared under K152367 (29 October 2015). The Optiflux dialyzers have not been the subject of a design-related recall.
Device Description
The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers, which allow for the transfer of water and solutes between blood and the dialysate through a semi-
4
Image /page/4/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing triangles stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
permeable membrane. The Optiflux dialyzers are available in four (4) sizes. The sizes are differentiated by membrane surface area.
Device Identification
The proposed Optiflux series of dialyzers includes the following sizes/models
- 0500316E Optiflux® F160NR Dialyzer ●
- 0500318E Optiflux® F180NR Dialyzer .
- 0500320E Optiflux® F200NR Dialyzer ●
- 0500325E Optiflux® F250NR Dialyzer ●
Device Characteristics
The proposed Optiflux dialyzers are single use dialyzers manufactured from Advanced Fresenius Polysulfone, polycarbonate, silicone and polyurethane. The dialyzers are provided with the blood pathway sterile and non-pyrogenic. The dialyzers are sterilized using e-beam radiation.
Environment of Use
The Optiflux dialyzers are used in environments where acute and chronic hemodialysis are performed.
Brief Written Description of the Devices
The principle of hemodialysis involves the diffusion of solutes across a semi-permeable membrane. Dialyzers use a counter-current flow, where the dialysate is flowing in the opposite direction to the blood flow in the extracorporeal circuit. Counter-current flow maintains the concentration gradient across the membrane for waste removal (diffusion) and fluid removal (ultrafiltration).
Materials of Use
The Optiflux dialyzers are manufactured from Advanced Fresenius Polysulfone, polycarbonate, silicone and polyurethane. The Optiflux dialyzers are classified as an external communicating device with prolonged exposure (>24 hrs to ≤30 days) to circulating blood.
Key Performance Specifications/Characteristics
Urea clearance is a key performance specification of the Optiflux dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance as sodium and urea exhibit similar movement across a membrane. Table 1 provides sodium clearance data from the instructions for use (IFU) for the Optiflux series of dialyzers.
5
Image /page/5/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue abstract symbol on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE", with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The text is also in blue and appears to be in a bold sans-serif font.
In vitro Urea Clearance from the Optiflux Dialyzer Table 1: Instructions for Use (Qb= 300mL/min, Qd= 500mL/min, UFR=0mL/min)
| Trade Name | Urea Clearance
(Sodium Used as Marker) |
|--------------------------|-------------------------------------------|
| Optiflux F160NR Dialyzer | 271 |
| Optiflux F180NR Dialyzer | 277 |
| Optiflux F200NR Dialyzer | 280 |
| Optiflux F250NR Dialyzer | 287 |
Intended Use
Optiflux dialyzers are designed for single use acute and chronic hemodialysis.
Indications for Use
Optiflux dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
Comparison of Technological Characteristics with the Predicate Device
The proposed Optiflux dialyzers and the predicate Optiflux dialyzers (K152367) have the following equivalent technological characteristics:
- Intended use including the same indications for use
- Design and configuration ●
- Basic scientific technology and principles of operation ●
- Sterilization method, packaging and sterility label claims ●
- Same materials Advanced Fresenius Polysulfone (PSF), polycarbonate (PC), . polyurethane (PU) and silicone (SI). This submission adds an additional supplier of polysulfone raw material for manufacture of the dialyzer fibers.
Performance Data
Performance testing was conducted in accordance with ISO 8637:2010. Results of testing listed below support the determination of substantial equivalence.
- Performance testing clearance testing, sieving coefficient, ultrafiltration ● performance and membrane performance
- Structural integrity testing positive and negative pressure decay testing and . blood compartment integrity (membrane integrity)
6
Image /page/6/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left is a blue symbol consisting of three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE", with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The text is also in blue.
- Biological safety testing (biocompatibility) ●
- . Sterility and pyrogenicity testing
Biocompatibility Testing
The following testing was performed to support the biological safety of the polysulfone supplier change:
- Chemical analysis extractables and leachables ●
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Systemic Toxicity ●
- Subacute/Subchronic Toxicity ●
- Genotoxicity ●
- Hemocompatibility ●
- Risk assessment of potential toxicity ●
Animal Studies
No animal studies were performed in support of the supplier change.
Clinical Studies
No clinical studies were performed in support of the supplier change.
Conclusions
Based on the information and data provided in this Traditional 510(k), the proposed Optiflux dialyzers are substantially equivalent in intended use, indications for use, design, principle of operation, technology, materials and performance to the predicate Optiflux dialyzers (K152367). The dialzyers remain safe and effective for their intended use.