(445 days)
Not Found
No
The summary describes a physical medical device (dialyzer) and its performance characteristics, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as "intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate," indicating its use in treating a medical condition.
No
Explanation: The device is a dialyzer used for patients with renal failure to transfer water and solutes from blood, which is a treatment process rather than a diagnostic one.
No
The device description clearly states it is a physical dialyzer, a hardware component used in dialysis, and the performance studies focus on physical characteristics and performance of the membrane and assembly.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "patients with acute or chronic renal failure." This indicates a direct interaction with the patient's blood for treatment (dialysis), not for analyzing a sample of blood or other bodily fluid in vitro (outside the body) to diagnose a condition.
- Device Description: The description explains how the device transfers water and solutes between blood and dialysate through a membrane. This is the mechanism of dialysis, a treatment, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, etc.)
- Detecting specific analytes (proteins, enzymes, etc.)
- Providing diagnostic information
- Using reagents or assays
The Optiflux Ultra dialyzer is a therapeutic device used for hemodialysis, a treatment for kidney failure.
N/A
Intended Use / Indications for Use
The Optiflux Ultra dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
Product codes
KDI
Device Description
The Optiflux Ultra dialyzers are the next generation of the Fresenius Optiflux family of single use dialyzers, which allow for the transfer of water and solutes between the blood and the dialysate through a semipermeable membrane. Available in five sizes, the dialyzers are differentiated by membrane surface area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
Testing was selected through the application of a risk management process, appropriate guidance documents and relevant standards. Results of validation and verification testing support the determination of substantial equivalence:
- . Sterility and non-pyrogenicity testing
- Structural integrity filter assembly positive and negative pressure testing and . blood compartment integrity (transmembrane pressure testing)
- Performance clearance testing, ultrafiltration performance testing, membrane ◆ performance
- Biological Safety Biocompatibility testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.”
0
Optiflux Ultra Traditional 510(k) Notification
Section 5 510(k) Summary
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92. A copy of this summary is also provided in Appendix 2.
5.1 Submitter's Information
| Name: | Fresenius Medical Care North America |
|---|---|
| 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 | |
| Renal Therapies | |
| Date of Preparation: | 03 June 2013 |
5.2 Device Name
| Trade Name: | Optiflux* Ultra F160, F180, F190, F210, F230 |
|---|---|
| Common Name: | Dialyzer, High Permeability with or without |
| Sealed Dialysate System | |
| Product Code/Classification Panel: | KDI Gastroenterology-Urology |
| Classification Name: | 21 CFR§876.5860 |
| High Permeability Hemodialysis System |
5.3 Legally Marketed Predicate Devices (unmodified devices)
Fresenius Optiflux F250NR, K082414 (10-28-2008) · Baxter Xenium XPH dialyzers, K083778 (02-20-2009)
5.4 Device Description
The Optiflux Ultra dialyzers are the next generation of the Fresenius Optiflux family of single use dialyzers, which allow for the transfer of water and solutes between the blood and the dialysate through a semipermeable membrane. Available in five sizes, the dialyzers are differentiated by membrane surface area.
1
5.5 Indications for Use
The Optiflux Ultra dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
Technological Characteristics 5.6
The Optiflux Ultra dialyzers and Fresenius Optiflux F250NR dialyzer (K082414) have equivalent technological characteristics:
- . Design/Configuration
- Basic Scientific Technology membrane of microcrimped, hollow fiber, Advanced . Fresenius Polysulfone
- Sterility E-Beam, single use, non- pyrogenic .
- Materials polyurethane (PU), polysulfone (PS), polycarbonate (PC), and silicone . (ટા)
The Optiflux Ultra dialyzers, Fresenius Optiflux F250NR dialyzer (K082414), and Baxter Xenium XPH dialyzers (K083778), have equivalent technological characteristics:
- . Intended Use
- Design Characteristics effective surface area, priming volume .
Performance Data 5.7
Testing was selected through the application of a risk management process, appropriate guidance documents and relevant standards. Results of validation and verification testing support the determination of substantial equivalence:
- . Sterility and non-pyrogenicity testing
- Structural integrity filter assembly positive and negative pressure testing and . blood compartment integrity (transmembrane pressure testing)
- Performance clearance testing, ultrafiltration performance testing, membrane ◆ performance
- Biological Safety Biocompatibility testing .
Conclusion 5.8
Based on the information and data provided in this Traditional 510(k), the Optiflux Ultra dialyzers are substantially equivalent in design, principle of operation, technology, materials to the predicate Fresenius Optiflux F250NR dialyzer (K082414). The Optiflux Ultra dialyzers are substantially equivalent in intended use, indications for use, and performance to the predicate devices, Fresenius Optiflux F250NR dialyzer (K082414) and Baxter Xenium dialyzers (K083778), and are safe and effective for their intended use.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is black and appears to be centered on a white background. The words are stacked on a single line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2014
Fresenius Medical Care North America Denise Oppermann Senior Director, Regulatory Affairs - Devices 920 Winter Street Waltham, MA 02451
Re: K123262
Trade/Device Name: Fresenius Optiflux® Ultra F160, F190, F210, F230 dialyzers Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: December 18, 2013 Received: December 20, 2013
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.
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Page 2 - Denise Oppermann
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Herbert P. Lerner -S
for
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
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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Indications for Use Statement Section 4
510(k) Number: K123262
Device Name:
Fresenius Optiflux Ultra F160, F180, F180, F210, F230 dialyzers
Indications for Use: Optiflux Ultra F160, F190, F210, F230 dialyzers
The Optiflux Ultra dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
XPrescription Use (Per 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)