(449 days)
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No
The summary describes a physical medical device (a dialyzer) and its performance characteristics, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is designed for hemodialysis, which is a medical treatment that removes waste products and excess fluid from the blood when the kidneys can no longer do so. This constitutes a therapeutic intervention.
No
This device is a dialyzer used for hemodialysis, which is a treatment process to filter blood, not to diagnose a condition.
No
The device description clearly outlines a physical medical device (dialyzer) with hardware components (polysulfone hollow fiber, plastic cylinder, ports). The performance studies focus on the physical and biological characteristics of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for single use in acute and chronic hemodialysis." Hemodialysis is a treatment that filters blood outside the body, not a diagnostic test performed on samples of bodily fluids or tissues.
- Device Description: The description details a physical device (dialyzer) with a membrane and ports for blood and dialysate, consistent with a therapeutic device for blood filtration.
- Performance Studies: The performance studies focus on the physical and functional aspects of the dialyzer (ultrafiltration rate, pressure drop, clearances, hemolysis), and clinical performance related to its function in hemodialysis. These are not studies related to the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
Therefore, the xevonta dialyzer is a therapeutic medical device used in the treatment of kidney failure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The xevonta dialyzer is designed for single use in acute and chronic hemodialysis.
Product codes
KDI
Device Description
The xevonta dialyzer is a polysulfone high flux dialyzer with the surface areas 1.2 m², 1.5 m², 1.8 m², 2.0 m², 2.3 m². It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.
The polysulfone hollow fiber (membrane) is housed within a plastic cylinder containing four ports: two ports for blood compartment access and two ports for dialysate access.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Safety and Effectiveness:
To assess the effects of the modified characteristics of the new device and to demonstrate equivalence with the predicate devices, the following data assessed by scientific methods, performance and clinical data are provided:
Biocompatibility testing:
Testing was performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for an externally communicating device contacting circulating blood for prolonged contact (category B).
In vitro performance testing:
- ultrafiltration rate
- pressure drop blood side and dialysate side
- clearances of urea, creatinine and vitamin B12
- mechanical hemolysis
Clinical testing: - comparison of in-vitro and in-vivo ultrafiltration coefficient
Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.”
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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, and it is used to represent the Department of Health and Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2016
B. Braun Avitum AG % Tracy Maddock, RAC Sr. Regulatory Affairs Specialist B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, PA 18109-9341
Re: K143482
Trade/Device Name: Xevonta Dialyzer Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: February 26, 2016 Received: February 29, 2016
Dear Tracy Maddock,
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 vours.
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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Indications for Use
510(k) Number (if known) K143482
Device Name xevonta dialyzer
Indications for Use (Describe)
The xevonta dialyzer is designed for single use in acute and chronic hemodialysis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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B. Braun Avitum AG 510(k) Premarket Notification xevonta dialyzers
| 5. 510(k) SUMMARY | K143482 |
|---|---|
| APPLICANT: | B. Braun Avitum AG |
| Schwarzenberger Weg 73-79 | |
| 34212 Melsungen | |
| Germany | |
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| 610-266-0500 | |
| Contact: Tracy Maddock,RAC | |
| Sr. Regulatory Affairs Specialist | |
| Phone: (610) 596-2545 | |
| Fax: (610) 266-4962 | |
| E-mail: tracy.maddock@bbraun.com | |
| DATE: | February 29, 2016 |
| DEVICE NAME: | xevonta dialyzer |
| Models: xevonta 1.2 m2, xevonta 1.5 m2, xevonta 1.8 m2, | |
| xevonta 2.0 m2, xevonta 2.3 m2 | |
| COMMON OR | |
| USUAL NAME: | High permeability polysulfone high flux dialyzer |
| DEVICE | |
| CLASSIFICATION: | Class II |
| 21 CFR §876.5860, High permeability hemodialysis system | |
| Product Code: KDI | |
| PREDICATE DEVICES: | Diacap HiFlo 23 Dialyzer, B. Braun Avitum AG, K100334, |
| Class II, KDI, 876.5860 | |
| Diacap HIPS Dialyzers, B. Braun Avitum AG, K071518, | |
| Class II, KDI, 876.5860 |
DESCRIPTION:
The xevonta dialyzer is a polysulfone high flux dialyzer with the surface areas 1.2 m², 1.5 m2, 1.8 m2, 2.0 m2, 2.3 m2. It is designed for single use in acute and chronic
4
B. Braun Avitum AG 510(k) Premarket Notification xevonta dialyzers
hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.
The polysulfone hollow fiber (membrane) is housed within a plastic cylinder containing four ports: two ports for blood compartment access and two ports for dialysate access.
INTENDED USE:
The xevonta dialyzer is designed for single use in acute and chronic hemodialysis.
COMPARISON FOR SUBSTANTIAL EQUIVALENCE:
Two predicate devices, i.e. B. Braun Avitum AG's Diacap HiFlo 23 Dialyzer (K100334) and Diacap HIPS dialyzer (K071518) were used for comparison with the new device.
The new device has the same indications for use as the marketed predicate devices, i.e. for single use in acute and chronic hemodialysis.
Membrane/ housing materials and surface areas of the new device correspond to those of the predicate devices.
Modified technological characteristics of the new device are changes to membrane design, change of cap colorant in addition to alternative suppliers (potting resin, PVP).
Briefly, modified design characteristics of the membrane include changes in the number of membrane fibers and length of the fiber bundle, the inner fiber diameter, the wall thickness of the membrane and the number of pores.
These modified characteristics of the membrane are achieved by a validated manufacturing process of the membrane.
SAFETY AND EFFECTIVENESS:
To assess the effects of the modified characteristics of the new device and to demonstrate equivalence with the predicate devices, the following data assessed by scientific methods, performance and clinical data are provided:
Biocompatibility testing:
Testing was performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for an externally communicating device contacting circulating blood for prolonged contact (category B).
In vitro performance testing:
- ultrafiltration rate l
- pressure drop blood side and dialysate side ।
5
B. Braun Avitum AG 510(k) Premarket Notification xevonta dialyzers
- clearances of urea, creatinine and vitamin B12
- = mechanical hemolysis
Clinical testing:
- comparison of in-vitro and in-vivo ultrafiltration coefficient
Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use.
CONCLUSION:
The data provided for the new device demonstrates that xevonta dialyzers are as safe and effective as the marketed predicate devices. The differences, between subject device and predicate devices, do not raise any new issues of safety and effectiveness. The xevonta dialyzers, therefore, are substantially equivalent to the predicate devices.